Medical Device Recall Listings - Sorted by Trade Name

January 2010 - March 2010

Trade Name

3M Micropore Surgical Tape

Recall Posting Date

2010-03-01

Manufacturer

3M Health Care

Recall Start Date

2010-02-03

Recall Number

53073

Hazard Classification

Type II

Model or Catalog #

1530S-1

Lot or Serial #

>100 Numbers, Contact Manufacturer

Reason for Recall

3M has received complaints from hemodialysis centres that the single use rolls, with specific lot numbers containing '2014' and others beginning with '2015-01', are not adequately adhering resulting in possible needle loosening and dislodgement.

Trade Name

3M Micropore Surgical Tape

Recall Posting Date

2010-03-29

Manufacturer

3M Health Care

Recall Start Date

2010-03-05

Recall Number

53558

Hazard Classification

Type II

Model or Catalog #

1530-154

Lot or Serial #

200903XH, 200904BK, 200911OJ

Reason for Recall

Bulk-packaged rolls of Micropore Surgical Tape may exhibit the same inconsistent performance that was observed with single use rolls recalled (recall number 53073) if used as the primary securement device for dialysis needles or pressure dressings used after dialysis treatments. Only the identified lots were imported by 3M Canada.

Trade Name

903 Newborn Screening Card

Recall Posting Date

2010-03-01

Manufacturer

Whatman, Part Of GE Healthcare

Recall Start Date

2010-01-27

Recall Number

53017

Hazard Classification

Type II

Model or Catalog #

10534785

Lot or Serial #

W083 6840309

Reason for Recall

It has been observed that there may be a detachment of the demographic portion from the blood sample paper. This may impact patient safety.

Trade Name

A High RES SSP Unitray

Recall Posting Date

2010-03-29

Manufacturer

Invitrogen Corporation

Recall Start Date

2010-02-22

Recall Number

53314

Hazard Classification

Type III

Model or Catalog #

47290-10

Lot or Serial #

012 666804

Reason for Recall

Affected kits may contain a disc labelled with the incorrect batch number 625731 instead of batch number 666804.

Trade Name

A High RES SSP Unitray

Recall Posting Date

2010-03-29

Manufacturer

Invitrogen Corporation

Recall Start Date

2010-03-08

Recall Number

53483

Hazard Classification

Type III

Model or Catalog #

47290-10

Lot or Serial #

011 484916, 011 536590, 012 625731

Reason for Recall

This field safety notice serves to notify customers that lane 42 (A24-34D) in the affected A High Resolution SSP Unitrays does not amplify a*2432 allele. This issue would produce a mistyping for a*2432 positive sample.

Trade Name

A) #8 Scorpio 4:1 Ceramic Blocks
B) #9 Scorpio 4:1 Ceramic Blocks
C) #3 Scorpio 4:1 Ceramic Blocks
D) #4 Scorpio 4:1 Ceramic Blocks
E) #5 Scorpio 4:1 Ceramic Blocks
F) #6 Scorpio 4:1 Ceramic Blocks
G) #7 Scorpio 4:1 Ceramic Blocks
H) #11 Scorpio 4:1 Ceramic Blocks
I) #13 Scorpio 4:1 Ceramic Blocks

Recall Posting Date

2010-02-01

Manufacturer

Howmedica Osteonics Corporation

Recall Start Date

2009-12-13

Recall Number

52242

Hazard Classification

Type II

Model or Catalog #

A) 8000-0008
B) 8000-0009
C) 8000-0003
D) 8000-0004
E) 8000-0005
F) 8000-0006
G) 8000-0007
H) 8000-0011
I) 8000-0013

Lot or Serial #

A) All Lots
B) All Lots
C) All Lots
D) All Lots
E) All Lots
F) All Lots
G) All Lots
H) All Lots
I) All Lots

Reason for Recall

Stryker Orthopaedics has become aware that the ceramic guide rails, within the Scorpio (xcelerate) 4.1 ceramic cutting blocks, may fracture and displace from the block. The size of the pieces that can be displaced range from small fragments to complete rails.

Trade Name

A) ABC SSP Unitray and B Locus SSP Unitray
B) AB/DR SSP Unitray

Recall Posting Date

2010-03-29

Manufacturer

Invitrogen Corporation

Recall Start Date

2010-03-01

Recall Number

53486

Hazard Classification

Type III

Model or Catalog #

A) 78000-10, 78001-10, 78700-10
B) 78100-10

Lot or Serial #

A) 036 616504, 036 656155, 025 663049
B) 034 625679

Reason for Recall

Primer mix PML69A contained in the named kits may produce a weak true positive band at the correct base pair size of 135BP. The primer mix is designed to detect B*15 alleles. The problem of a weak true positive signal could mean that a test would have to be repeated.

Trade Name

A) AC Power Cord Used With 9200 Advisor
B) AC Power Cord Used With 8400 Capnocheck
C) AC Power Cord Used With BCI 3180 Pulse

Recall Posting Date

2010-02-15

Manufacturer

Smiths Medical PM, Inc.

Recall Start Date

2010-01-21

Recall Number

52815

Hazard Classification

Type II

Model or Catalog #

A) WW3005
B) 8404
C) WW3005

Lot or Serial #

A) W43998
B) W44880, W43487
C) W46452

Reason for Recall

A small number of Electri-Cord AC power cords (part number ww3005) used with 9200 BCI Advisor Vital Signs Monitor may pose a risk of sparking, charring and fires.

Trade Name

A) Access Immunoassay System-Tropnin Assay
B) Unicel DXI600 Access Immuno. Sys.-ACCUTNI
C) Unicel DXI800 Access Immuno. Sys.-ACCUTNI

Recall Posting Date

2010-01-04

Manufacturer

Beckman Coulter Inc.

Recall Start Date

2009-12-10

Recall Number

52233

Hazard Classification

Type II

Model or Catalog #

A) A78803
B) A78803
C) A78803

Lot or Serial #

A) 911748, 913265, 913500, 915417, 915850
B) 911748, 913265, 913500, 915417, 915850
C) 911748, 913265, 913500, 915417, 915850

Reason for Recall

Beckman Coulter has confirmed reports that, under certain circumstances, certain assays may produce elevated values at the low end when run in conjunction with the access immunoassay systems enhanced ACCUTNI Reagent Kit.

Trade Name

A) Access System - Cortisol Assay
B) Access System - Progesterone Assay
C) Unicel DXI600 Acc.Immuno.Sys.-Cortisol
D) Unicel DXI600 Acc.Imm.Sys.-Progesterone
E) Unicel DXI800 Acc.Imm.Sys.-Cortisol
F) Unicel DXI800 Acc.Imm.Sys.-Progesterone

Recall Posting Date

2010-03-29

Manufacturer

Beckman Coulter, Inc.

Recall Start Date

2010-02-04

Recall Number

53210

Hazard Classification

Type II

Model or Catalog #

A) 33600
B) 33550
C) 33600
D) 33550
E) 33600
F) 33550

Lot or Serial #

A) N/A
B) N/A
C) N/A
D) N/A
E) N/A
F) N/A

Reason for Recall

Beckman Coulter has reported intermittent suppressed patient results and an increased incidence of IND flags associated with the Progesterone Reagent Pack lots identified. Suppressed patient results have also been noted with the Access Cortisol Reagent Pack lot identified.

Trade Name

A) Access System - Folate Assay
B) Unicel DXI600 Access Immuno.Sys.-Folate
C) Unicel DXI800 Access Immuno.Sys.-Folate

Recall Posting Date

2010-02-15

Manufacturer

Beckman Coulter, Inc.

Recall Start Date

2010-01-14

Recall Number

52916

Hazard Classification

Type III

Model or Catalog #

A) A14207
B) A14207
C) A14207

Lot or Serial #

A) 828289, 830252, 909009
B) 828289, 830252, 909009
C) 828289, 830252, 909009

Reason for Recall

Beckman Coulter has confirmed that the 12 month stability for the Access Folate Calibrators (lot numbers: 828289, 830252 and 909009) may not be achieved. Customers may see erroneous but believable patient values.

Trade Name

A) Access System-Free T3 Assay
B) Unicel DXI600 Access Immuno. System
C) Unicel DXI800 Access Immuno. System

Recall Posting Date

2010-01-18

Manufacturer

Beckman Coulter, Inc.

Recall Start Date

2009-12-17

Recall Number

52425

Hazard Classification

Type II

Model or Catalog #

A) A13430
B) A13430
C) A13430

Lot or Serial #

A) 989902, 989903, 989904, 989905, 989906, 989907
B) 989902, 989903, 989904, 989905, 989906, 989907
C) 989902, 989903, 989904, 989905, 989906, 989907

Reason for Recall

Beckman Coulter has confirmed that the Access Free T3 calibrator failed the internal 9-month real-time stability testing and will show a decline in performance before reaching their stated expiration date of 12 months.

Trade Name

A) Access -Unconjugated Estriol Assay
B) Unicel DXI600 Access-Unconjugated Estriol Assay
C) Unicel DEI800 Access-Unconjugated Estriol Assay

Recall Posting Date

2010-01-04

Manufacturer

Beckman Coulter Inc.

Recall Start Date

2009-12-08

Recall Number

52102

Hazard Classification

Type III

Model or Catalog #

A) 33570
B) 33570
C) 33570

Lot or Serial #

A) 913348
B) 913348
C) 913348

Reason for Recall

A single lot of Access Unconjugated Estriol reagent might produce suppressed patient results and an increased incident of indeterminate flags.

Trade Name

A) Acuson Antares System-Main Unit
B) Acuson Antares System-Refurbished Unit
C) Acuson Antares System-With 5.0 Upgrades

Recall Posting Date

2010-03-29

Manufacturer

Siemens Medical Solutions USA, Inc.

Recall Start Date

2010-03-02

Recall Number

53440

Hazard Classification

Type III

Model or Catalog #

A) 5936518
B) 8653771
C) 10032746, 10032747

Lot or Serial #

A) 111843, 111922, 111923, 112267, 10134, 111786, 112070
B) 111994
C) 114573, 116119, 116146, 115416, 115996, 113510, 116172, 116181, 116198, 116199, 113469, 115300, 114916, 116012, 116015, 115723

Reason for Recall

Advisory notice to notify affected customers of a software error encountered after running through the following workflow steps 1)zoom in live image, 2)store a retrospective clip, 3)go to exam review or an offline workstation, and measure the zoomed clip. Measured results may be incorrect with no indication to the user they are wrong.

Trade Name

A) Allura XPER FD10/10 - Main Unit
B) Allura XPER FD20/10 System - Main Unit
C) Integris H5000C Catdiology Imaging System
D) Integris Allura
E) Allura XPER FD10
F) Allura XPER FD20

Recall Posting Date

2010-03-29

Manufacturer

Philips Medical Systems Nederland B.V.

Recall Start Date

2010-02-01

Recall Number

52986

Hazard Classification

Type II

Model or Catalog #

A) Allura XPER FD10/10
B) Allura XPER FD10/10
C) 722016
D) 722043*
E) Allura XPER FD10
F) Allura XPER FD20

Lot or Serial #

A) SN085257, SN085194, SN09004890
B) SN074546, SN064966
C) 34660
D) 44701
E) >10 Numbers, Contact Manufacturer
F) >10 Numbers, Contact Manufacturer

Reason for Recall

Due to intermittent shortcuts inside the Velara Generator, a system lock-up might occur that can only be resolved by a warm or cold system restart. In exceptional cases the generator is damaged and the system cannot be restarted. As this is an intermittent failure no work around is available and no actions can be done by the user to prevent the failure from happening.

Trade Name

A) APO CAL (Apolipoprotein Calibrator)
B) Synchron Systems APO-B Reagent

Recall Posting Date

2010-03-29

Manufacturer

Beckman Coulter, Inc.

Recall Start Date

2010-02-04

Recall Number

53213

Hazard Classification

Type III

Model or Catalog #

A) 469170
B) 467905

Lot or Serial #

A) M901536, M904505
B) M908383, M908768

Reason for Recall

Beckman Coulter has determined upward shift in patient and control recovery with Synchron Systems Apolipoprotein B (APOB) reagent lots M908383 and higher when used with Apolipoprotein Calibrator (APO CAL) lots M901536 and M904505.

Trade Name

A) Arctic Front Catheters
B) CryoConsole

Recall Posting Date

2010-01-04

Manufacturer

Medtronic Cryocath LP

Recall Start Date

2009-11-23

Recall Number

51952

Hazard Classification

Type III

Model or Catalog #

A) 2AF231/2AF281
B) 105A2 VS.4.01

Lot or Serial #

A) All Lots
B) All Lots

Reason for Recall

The deficiency of the system is that the pressure sensor system failed to detect the inner balloon failure and thus the console did not terminate injection and did not trigger an error message.

Trade Name

A) Arjo Flites
B) Arjo Slings

Recall Posting Date

2010-01-04

Manufacturer

Medibo N.V.

Recall Start Date

2009-05-05

Recall Number

48918

Hazard Classification

Type III

Model or Catalog #

A) MFA1000
B) MAA2000-X, MAA2040-X, MAA2050-X, MAA2070-X, MAA2080-X, MAA2090-X, MAA2091-X, MAA2100-X, MAA4000-X, MAA4020-X, MAA4031-X, MAA4040-X, MAA4060-X, MAA4061-X, MAA4070-X, MAA4080-X, MAA4100-X, MAA4160-X

Lot or Serial #

A) All Serial Numbers
B) All Serial Numbers

Reason for Recall

Complaint trending has shown a number of events relating to what has been generally described as clip detachments.

Trade Name

A) Arnold-Bruening Intracordal Injection
B) Trach Tube Jackson
C) Trocar Needle & Stylet
D) Speaking Tube
E) Visco-Expression Cannula
F) Terry IRR Scapper
G) Can FNT SNUS Van Alyea
H) Can Antrum Van Alyea
I) Arnold-Bruen Laryngeal Injection Set
J) Laryngeal Injection Set Needle Rubin
K) Lyrngeal Injector Set Arnold Adaptor
L) ENT Trocar Antrum Coakley
M) Trachea-Speaking Tube Sterling
N) Jackson Lacrimal Intubation Set
O) X-BLD F/N/N-250 DISP STORZ
P) Surgilens Corneal Shield
Q) Cannula Angled Graether

Recall Posting Date

2010-01-04

Manufacturer

Bausch & Lomb Canada Inc.

Recall Start Date

2009-03-01

Recall Number

51949

Hazard Classification

Type II

Model or Catalog #

A) N7754
B) N8034 R6
C) N2530
D) N8176, N8178
E) SP7-55978
F) E3123
G) N2462
H) N2472
I) N7754
J) N7762, N7764
K) N7759
L) N2505
M) N8177
N) E5651
O) N0522
P) G11X-S
Q) E0566, E0566 S, E0566 SA

Lot or Serial #

A) All Lots
B) All Lots
C) All Lots
D) All Lots
E) All Lots
F) All Lots
G) All Lots
H) All Lots
I) All Lots
J) All Lots
K) All Lots
L) All Lots
M) All Lots
N) All Lots
O) All Lots
P) All Lots
Q) All Lots

Reason for Recall

Notification to customers that unlicenced medical devices were sold.

Trade Name

A) Artis Zee
B) Axiom Artis

Recall Posting Date

2010-01-04

Manufacturer

Siemens AG

Recall Start Date

2009-11-04

Recall Number

51604

Hazard Classification

Type III

Model or Catalog #

A) 07555365, 10094139
B) 5904466

Lot or Serial #

A) 57017, 57026, 57030, 57047, 57052, 57064, 57068, 57119, 57123, 57160, 157105, 157158, 157222
B) 20002, 20018, 20039, 20069, 20070, 20151, 20163, 20215

Reason for Recall

It was discovered that under certain circumstances the gearbox at the C-arm of the Axiom Artis MC, Artis DMP or Artis Zee multipurpose can be damaged. The precondition for this damage and the resulting consequences is a user-initiated movement of the C-arm against an obstacle inserted temporarily or permanently in its range of motion.

Trade Name

A) Artis Zee
B) Axiom Artis
Updated recall # 51604 previously posted on 2010-01-04.

Recall Posting Date

2010-03-15

Manufacturer

Siemens AG

Recall Start Date

2009-11-04

Recall Number

51604

Hazard Classification

Type III

Model or Catalog #

A) 07555365, 10094139
B) 5904466

Lot or Serial #

A) 57017, 57026, 57030, 57047, 57052, 57064, 57068, 57119, 57123, 57160, 157105, 157158, 157222, 157225
B) 20002, 20018, 20039, 20069, 20070, 20151, 20163, 20215

Reason for Recall

It was discovered that under certain circumstances the gearbox at the C-arm of the Axiom Artis MC, Artis DMP or Artis Zee multipurpose can be damaged. The precondition for this damage and the resulting consequences is a user-initiated movement of the C-arm against an obstacle inserted temporarily or permanently in its range of motion.

Trade Name

A) Artiste MV-Syngo RT Therapist Assist
B) Artiste MV-Syngo RT Therapist
Updated recall # 51246 previously posted on 2009-11-09.

Recall Posting Date

2010-03-15

Manufacturer

Siemens Medical Solutions USA, Inc. Oncology Care Systems

Recall Start Date

2009-09-23

Recall Number

51246

Hazard Classification

Type III

Model or Catalog #

A) 08162807
B) 08162815

Lot or Serial #

A) 10024, 10048
B) 10040, 10003

Reason for Recall

Fractions delivered on the Artiste might not be recorded in Lantis and subsequently patients might be mistreated.

Trade Name

A) Artiste MV-Syngo RT Therapist Assist
B) Artiste MV-Syngo RT Therapist
Updated recall # 51605 previously posted on 2009-12-07.

Recall Posting Date

2010-03-15

Manufacturer

Siemens Medical Solutions USA, Inc. Oncology Care Systems

Recall Start Date

2009-11-05

Recall Number

51605

Hazard Classification

Type III

Model or Catalog #

A) 08162807
B) 08162815

Lot or Serial #

A) 10024, 10048
B) 10040, 10003

Reason for Recall

Two or more treatment plans with different ISOcenter positions are stored together in one course in Lantis, e.g. main treatment plan and boost plan. If the cone beam is acquired using calculation of table shift coordinates will be based on ISOcenter position. This will lead to an incorrect table shift.

Trade Name

A) Avalon Fetal Monitor FM30 - Main Unit
B) Avalon Fetal Monitor FM20 - Main Unit
C) Avalon Fetal Monitor FM40
D) Avalon Fetal Monitor FM50

Recall Posting Date

2010-01-18

Manufacturer

Philips Medizin Systeme Boeblingen GMBH

Recall Start Date

2009-12-18

Recall Number

52234

Hazard Classification

Type II

Model or Catalog #

A) M2703A
B) M2702A
C) M2704A
D) M2705A

Lot or Serial #

A) >100 Numbers, Contact Manufacturer
B) >10 Numbers, Contact Manufacturer
C) DE81001152
D) >10 Numbers, Contact Manufacturer

Reason for Recall

Philips has received a number of complaints of inaccurate ultrasound-derived fetal heart rate readings from users of the Philips Avalon Fetal Monitors (models FM20, FM30, FM40 and FM50). Although the types of inaccuracies described in these complaints reflect known limitations inherent to ultrasound fetal heart rate monitoring, the frequency of such complaints is greater for these devices than for the previous-generation Philips series 50 fetal monitors. Clinical decisions based on unrecognized inaccuracies in fetal heart traces may lead health care professionals to perform unnecessary interventions such as caesarean delivery, fail to identify the need for interventions, or fail to identify fetal distress.

Trade Name

A) Axiom Iconos R200 C20-C
B) Axiom Iconos R200 C90-C
C) Axiom Iconos R200 T90_A
D) Axiom Iconos R200 T90_B

Recall Posting Date

2010-03-29

Manufacturer

Siemens AG

Recall Start Date

2010-02-17

Recall Number

53209

Hazard Classification

Type III

Model or Catalog #

A) 10093962
B) 10093961
C) 5904086
D) 5902783, 5902791

Lot or Serial #

A) 2039, 2139, 2214, 2239, 2247, 2255, 2537
B) >10 Numbers, Contact Manufacturer
C) 1022, 1028, 1032, 1033, 1037, 1046
D) 1406, 1007, 1011, 1012, 1019, 1202, 1206, 1207, 1209, 1212, 1405

Reason for Recall

This update instruction improves the quality and reliability of the Axiom Iconos ND/Axiom Iconos R200 system with the following fixes. Load units/heat units counter in the direct and series technique. Tilt the table up to the end switch. Unexpected movement can cause injury.

Trade Name

A) Bair Hugger Warming Unit
B) Bair Paws Patient Adj. Warming System
C) Ranger Irrigation Fluid Warming System
D) Bair Paws Model 875 Warming Unit
E) Ranger Blood/Fluid Warming System

Recall Posting Date

2010-01-04

Manufacturer

Arizant Healthcare Inc.

Recall Start Date

2009-12-18

Recall Number

52223

Hazard Classification

Type II

Model or Catalog #

A) 500/OR 505, 750, 775
B) 850
C) 24700
D) 875
E) 24500

Lot or Serial #

A) N/A
B) N/A
C) N/A
D) N/A
E) N/A

Reason for Recall

Power cords provided with the affected devices may crack and fail at/inside the plug and may lead to electric shock, delay & interruption in setup & therapy, device failure, and fire.

Trade Name

A) Bar Code Scanner
B) Bar Code Scanner

Recall Posting Date

2010-01-04

Manufacturer

Abbott Molecular Inc.

Recall Start Date

2009-11-26

Recall Number

51920

Hazard Classification

Type III

Model or Catalog #

A) 06L89-01(BAR CODE SCANNER), 9K15-01
B) 06L89-01(BAR CODE SCANNER), 9K14-01, 9K14-02

Lot or Serial #

A) All Lots
B) All Lots

Reason for Recall

When hand-held bar code scanner is used for entering (scanning) data under condition that the computer keyboard caps lock key is enabled, upper case letters encoded in the bar codes will be reported by the computer as lower case ones, and lower case letters will be reported as upper case ones. Additionally, when hand-held bar code scanner is used for entering data under condition that some other keyboard keys are enabled, data scanned can be altered such that those recognized by the M2000 may not match the codes contained on the bar code for all cases.

Trade Name

A) Bath Safe Adjustable Shower Seat w/o Back and Arms
B) Bath Safe Adjustable Shower Seat with Back
C) Bath Safe Shower Seat w/Back and Arms, Blue
D) Bath Safe Adjustable Transfer Bench, Brown Box

Recall Posting Date

2010-03-29

Manufacturer

Maddak Inc.

Recall Start Date

2009-07-09

Recall Number

53348

Hazard Classification

Type II

Model or Catalog #

A) 72714-2001
B) 72714-2101
C) 72714-2124
D) 72714-2501

Lot or Serial #

A) N/A
B) N/A
C) N/A
D) N/A

Reason for Recall

Bath and shower seats manufactured by Maddak between May 1 and July 7, 2009 can tip over or collapse under the weight of the user, which poses a risk of injury from falling from the seat.

Trade Name

A) Campylobacter CVA Agar
B) Campylobacter CCDA-Preston Agar
C) Campylobacter Agar, Blood-Free
D) PEA Agar + 5% Sheep Blood (SB)
E) Columbia CNA/Macconkey
F) Sabouraud Liquid (Broth)

Recall Posting Date

2010-03-01

Manufacturer

PML Micrologicals, Inc.

Recall Start Date

2009-07-16

Recall Number

49997

Hazard Classification

Type II

Model or Catalog #

A) P1232
B) P1233
C) P1236
D) P2200
E) P4200
F) T7325

Lot or Serial #

A) 291531-1, 292079-1, 292599-1
B) 289878-1, 289879-1, 290576-1, 290577-1, 291140-1, 291141-1, 288066-1, 292096-1, 292097-1
C) 291532-1
D) 290755-1
E) 291003-1, 291180-3, 291694-1, 292455-1
F) 285622-1, 287306-1, 288421-1

Reason for Recall

A conflict has been identified with the product labelling as described in CLSI standard M22-A3 “quality assurance for commercially prepared microbiological media”.

Trade Name

A) CH-HI Ultrafyn Reusable Thermal Cautery
B) CT-2121 Disposable Thermal Cautery Tips

Recall Posting Date

2010-03-15

Manufacturer

Advanced Meditech International, Inc.

Recall Start Date

2009-12-02

Recall Number

52942

Hazard Classification

Type II

Model or Catalog #

A) N/A
B) N/A

Lot or Serial #

A) N/A
B) N/A

Reason for Recall

Sale of unlicenced medical device.

Trade Name

A) Chromophare Surgical Lighting System
B) Chromoview Flat Panel Arm

Recall Posting Date

2010-01-18

Manufacturer

Berchtold Corporation

Recall Start Date

2010-01-01

Recall Number

52179

Hazard Classification

Type II

Model or Catalog #

A) C200, C300, C450, C450/452, C570, C571, C571/572, C950, D500, D530, D530LED, D540, D650, D660, E520, E550, E650, E655, E800, E805, LED 558, LED 668, LED 778, X65, X66
B) 224, 224 FP, FP, TRAGARM

Lot or Serial #

A) >100 Numbers, Contact Manufacturer
B) >100 Numbers, Contact Manufacturer

Reason for Recall

The problem involves a mechanical failure of the welted joint within the spring arm, resulting in the rapid drop of a light spot to the mechanical stop.

Trade Name

A) Clinac Linear Accelerator
B) Trilogy
C) Clinac IX Radiotherapy Delivery System

Recall Posting Date

2010-02-15

Manufacturer

Varian Medical Systems, Inc.

Recall Start Date

2009-12-01

Recall Number

52708

Hazard Classification

Type II

Model or Catalog #

A) 2100C/D, 21EX, 2300C/D, 23EX
B) Trilogy
C) Clinac IX

Lot or Serial #

A) >10 Numbers, Contact Manufacturer
B) H140836, H294403, H293883, H291172, H294134, H293787, H291166
C) >10 Numbers, Contact Manufacturer

Reason for Recall

An anomaly was discovered in which, under certain circumstances of control circuit adjustments and component failure, a C-series Clinac can beam on with an asymmetric electron beam, which is undetected by the interlocks intended to prevent it. The anomaly can occur in the rare event a balance potentiometer in the electron programming PCB fails and the other circuit settings are such that the effect is not detected.

Trade Name

A) Cognis Cardiac Resynchronization
B) Cognis CRT-d
C) Teligen ICD (VR_HE DF1)
D) Teligen ICD (DR_HE IS-1)

Recall Posting Date

2010-01-04

Manufacturer

Cardiac Pacemakers Incorporated

Recall Start Date

2009-12-01

Recall Number

52105

Hazard Classification

Type II

Model or Catalog #

A) N106
B) N107
C) E102
D) E110

Lot or Serial #

A) N/A
B) N/A
C) N/A
D) N/A

Reason for Recall

The bond between the header and case could be weakened by mechanical stress associated with a subpectoral implant procedure or when a device in a subpectoral position is pushed against a rib during contraction of pectoralis muscle. It may alter lead impedance and introduce noise that may inhibit pacing therapy or initiate inappropriate tachytherapy.

Trade Name

A) Colleague Volumetric Infusion Pump
B) Colleague 3 Volumetric Infusion Pump
C) Colleague Guardian CXE Color Pump
D) Colleague Guardian 3 CXE Color Pump
E) French Colleague CXE Volumetric Pump
F) French Colleague 3 CXE Volumetric Pump

Recall Posting Date

2010-03-15

Manufacturer

Baxter Healthcare Corporation

Recall Start Date

2010-02-10

Recall Number

53158

Hazard Classification

Type II

Model or Catalog #

A) 2M8151, 2M8161, 2M8161LU, DMN 8151
B) 2M8153, 2M8163, 2M8163LU, DNM 8153
C) 2M9161, 2M9161L
D) 2M9163
E) DNM9161, DNM9161L
F) DNM9163

Lot or Serial #

A) >10 Numbers, Contact Manufacturer
B) 11100952CT, 11120044TC, 12070339TC, 12080182TC, 15010004TC, 15010161TC
C) >10 Numbers, Contact Manufacturer
D) 15081038TC, 16020133TP, 16050153TP, 16080046TP, 17020012TP, 17062329TP, 17062364TP
E) 17080209JF, 17080322JF, 18010089JF, 18020088JF, 17060477JF
F) 18110034KF

Reason for Recall

During a review of records for the service activities performed by Baxter Corporation's local test service, it was identified that required functional tests were potentially not performed on the identified Colleague Volumetric Infusion Pumps.

Trade Name

A) Coulter Prepplus
B) Coulter Prepplus 2

Recall Posting Date

2010-03-29

Manufacturer

Beckman Coulter, Inc.

Recall Start Date

2010-01-21

Recall Number

53044

Hazard Classification

Type II

Model or Catalog #

A) 286600
B) 378600

Lot or Serial #

A) All lots
B) All lots

Reason for Recall

Beckman Coulter has confirmed reports of potential dilution of reagent vials on the Prepplus or Prepplus 2 systems. The problem is due to the probe prematurely dispensing isoflow prior to arriving at the wash station which may diminish cellular fluorescence staining and presenting a risk of erroneously low results.

Trade Name

A) C-Reamer Cannulated, 9 and 10 mm
B) Digit Trap Finger Grasping Device
C) Arthro-Knife Banana Serrated, Straight
D) Arthro-Knife Banana Serrated, Left
E) Arthro-Knife Hook, Straight
F) Arthro-Knife Retro, Straight
G) Arthro-Knife Serrated, Straight Rosette
H) Arthro-Knife Mini Meniscus, Straight
I) Arthro-Knife Serrated, Straight 2-Sided
J) Arthro-Knife Serrated, Straight, Round

Recall Posting Date

2010-03-01

Manufacturer

Linvatec Corporation D.B.A. Conmed Linvatec

Recall Start Date

2010-02-12

Recall Number

53019

Hazard Classification

Type II

Model or Catalog #

A) 8772A, 8773A
B) 9906
C) 70-0071-103
D) 70-0071-113
E) 70-0072-003
F) 70-0073-003
G) 70-0074-103
H) 70-0075-003
I) 70-0077-103
J) 70-0078-103

Lot or Serial #

A) Exp. Date 2014/07 to 2014/12
B) Exp. Date 2014/07 to 2014/12
C) Exp. Date 2014/07 to 2014/12
D) Exp. Date 2014/07 to 2014/12
E) Exp. Date 2014/07 to 2014/12
F) Exp. Date 2014/07 to 2014/12
G) Exp. Date 2014/07 to 2014/12
H) Exp. Date 2014/07 to 2014/12
I) Exp. Date 2014/07 to 2014/12
J) Exp. Date 2014/07 to 2014/12

Reason for Recall

There is a possibility that the products may have a sterility breach in the tyvek pouch, thereby potentially compromising the sterility of the device.

Trade Name

A) Defia Neonatal Thyroid Stimulating Hormone Assay
B) Defia Neonatal IRT Assay
C) 1235 Auto Delfia System Plate Processor Class 2

Recall Posting Date

2010-01-04

Manufacturer

Wallac OY

Recall Start Date

2009-12-08

Recall Number

52122

Hazard Classification

Type II

Model or Catalog #

A) A032-310
B) 1244-105
C) B118-100

Lot or Serial #

A) 548303
B) 554345
C) 543325, 545065, 548295, 552105

Reason for Recall

Enhancement solutions used in all Delfia/AutoDelfia Assays and Delfia Neonatal HTHS might be contaminated. The contamination could cause a significant decrease of the fluorescence signal in Delfia and AutoDelfia Assays. When the signal decreased significantly there might be an effect on the analyte concentrations measured. This outcome would cause a delay in reporting the results.

Trade Name

A) Depuy ASR Acetabular Cup System - Heads
B) ASR XL Acetabular Cup System - Heads
C) ASR XL Acetabular Cup - Sleeve Adaptors
D) Depuy ASR Acetabular Cup System-Shells

Recall Posting Date

2010-03-29

Manufacturer

Depuy International Ltd.

Recall Start Date

2010-03-09

Recall Number

53553

Hazard Classification

Type II

Model or Catalog #

A) 9998-03-239, 9998-03-441, 9998-03-643, 9998-03-845, 9998-03-946, 9998-04-047, 9998-04-249, 9998-04-451, 9998-04-653, 9998-04-855, 9998-05-057, 9998-05-359, 9998-05-561, 9998-05-763
B) 9998-90-139, 9998-90-141, 9998-90-143, 9998-90-145, 9998-90-146, 9998-90-147, 9998-90-149, 9998-90-151, 9998-90-153, 9998-90-155, 9998-90-157, 9998-90-159, 9998-90-161, 9998-90-163
C) 9998-00-102, 9998-00-105, 9998-00-108, 9998-00-200, 9998-00-203, 9998-00-206, 9998-00-209, 9998-00-300, 9998-00-303, 9998-00-313
D) 9998-03-944, 9998-04-146, 9998-04-348, 9998-04-550, 9998-04-652, 9998-04-754, 9998-04-956, 9998-05-158, 9998-05-360, 9998-05-562, 9998-05-764, 9998-05-966, 9998-06-168, 9998-06-370

Lot or Serial #

A) >100 Numbers, Contact Manufacturer
B) >100 Numbers, Contact Manufacturer
C) >100 Numbers, Contact Manufacturer
D) >100 Numbers, Contact Manufacturer

Reason for Recall

The manufacturer has issued a field safety notice to inform customers of an increase in revision rates for the Depuy ASR Acetabular Cup System and ASR XL Acetabular Cup System linked to usage of Monoblock Mom Cups with corresponding head sizes less than 50mm in diameter. The notice reminds customers to strictly follow the implantation techniques per instruction for use.

Trade Name

A) Dimension Vista System-Immunoglobulin G
B) Dimension Vista System-Microalbumin

Recall Posting Date

2010-01-04

Manufacturer

Siemens Healthcare Diagnostics Products
GMBH

Recall Start Date

2009-11-05

Recall Number

51586

Hazard Classification

Type III

Model or Catalog #

A) K7056
B) K7062

Lot or Serial #

A) 0733MA
B) 09105MA, 08162MA, 08247MA, 08233MA

Reason for Recall

Received customer complaints that patient results for Microalbumin dropped off after a certain amount of tests. Intensive internal investigations of all products in shelf life revealed further under filled Dimension Vista Flex Reagents.

Trade Name

A) Dixtal Pulse Oximetry Products
B) Dixtal Pulse Oximetry Products

Recall Posting Date

2010-01-04

Manufacturer

Dixtal Medical, Inc.

Recall Start Date

2009-12-09

Recall Number

52058

Hazard Classification

Type II

Model or Catalog #

A) 2001
B) 515B, 520A

Lot or Serial #

A) N/A
B) N/A

Reason for Recall

AC power cord could be defective and could cause sparking, charring and/or fire. The potential risks from this power cord failure include electric shock, delay in setup and therapy, interruption of therapy, device failure and fires which may occur in an oxygen-rich environment.

Trade Name

A) Economy Dual Channel Tens
B) Self-Adhesive Electrodes
C) Neb to Go
D) Deluxe Dual Channel Tens
E) APP Pad
F) Fingertip Pulse Oximeter

Recall Posting Date

2010-03-01

Manufacturer

Drive Medical Design

Recall Start Date

2009-12-02

Recall Number

52943

Hazard Classification

Type II

Model or Catalog #

A) AGF-5X
B) AGF-602
C) AGF-601RB
D) AGF-601
E) 14003EF
F) 18705

Lot or Serial #

A) All lots
B) All lots
C) All lots
D) All lots
E) All lots
F) All lots

Reason for Recall

Sale of unlicensed medical devices in Canada.

Trade Name

A) Elecsys CK-MB Reagent Cap
B) Elecsys Vitamin D3 reagent Cap
C) Elecsys pro BNP reagent Cap
D) Elecsys TG Gen.2 Reagent Cap
E) Elecsys PTH Reagent Cap
F) Elecsys B-Crosslaps Reagent Cap
G) Elecsys DHEA-S Reagent Cap
H) Elecsys Insulin Reagent Cap
I) Elecsys CA 19-9 Reagent Cap
J) Elecsys SHBG Reagent Cap
K) Elecsys Testosterone II Reagent Cap

Recall Posting Date

2010-03-29

Manufacturer

Roche Diagnostics GMBH

Recall Start Date

2010-02-15

Recall Number

53200

Hazard Classification

Type III

Model or Catalog #

A) 11821598-322
B) 03314847-190
C) 04842464-190
D) 05118921-190
E) 04892470-190, 11972103-122
F) 11972308-122
G) 03000087-122
H) 12017547-122
I) 11776193-122
J) 03052001-190
K) 05200067-190

Lot or Serial #

A) >10 Numbers, Contact Manufacturer
B) >10 Numbers, Contact Manufacturer
C) >10 Numbers, Contact Manufacturer
D) >10 Numbers, Contact Manufacturer
E) >10 Numbers, Contact Manufacturer
F) >10 Numbers, Contact Manufacturer
G) >10 Numbers, Contact Manufacturer
H) >10 Numbers, Contact Manufacturer
I) >10 Numbers, Contact Manufacturer
J) >10 Numbers, Contact Manufacturer
K) >10 Numbers, Contact Manufacturer

Reason for Recall

Potential for sporadic damage reagent cap hinges on different Elecsys products lots. In consequence, the affected cap may not remain in the correct open position on the instrument during pipetting causing the system probe or bead mixer to hit the cap.

Trade Name

A) Elecsys Free PSA Reagent Caps
B) Elecsys CEA Reagent Cap
C) Elecsys CA 15-3 Reagent Cap
D) Elecsys CA 125 II Reagent Cap
E) Elecsys Troponin T Reagent Cap
F) Elecsys CK-MB (Stat) Reagent Cap
G) Elecsys TSH Reagent Cap
H) Elecsys Free T4 Reagent Cap
I) Elecsys T3 Reagent Cap
J) Elecsys Free T3 Reagent Cap
K) Elecsys LH Reagent Cap
L) Elecsys FSH Reagent Cap
M) Elecsys Progesterone II Reagent Cap
N) Elecsys Prolactin Reagent Cap
O) Elecsys Testosterone Reagent Cap
P) Elecsys Vitamin B12 Reagent Cap
Q) Elecsys Ferritin Reagent Cap
R) Elecsys Digoxin Reagent Cap
S) Elecsys IGE Reagent Cap
T) Elecsys C-Peptide Reagent Cap
U) HCG & Beta II Reagent Cap
V) HCG Stat II Reagent Cap
W) Elecsys AFP Reagent Cap
X) Elecsys S100 Reagent Cap
Y) Elecsys Total PSA reagent Cap
Z) Elecsys ACTH Regant Cap

Recall Posting Date

2010-03-29

Manufacturer

Roche Diagnostics GMBH

Recall Start Date

2010-02-15

Recall Number

53200

Hazard Classification

Type III

Model or Catalog #

A) 03289788-190
B) 11731629-322
C) 03045838-122
D) 11776223-322
E) 04491815-190, 04660307-190
F) 11731432-122
G) 11731459-122
H) 11731297-122
I) 11731360-122
J) 03051986-190
K) 11732234-122
L) 11775863-122
M) 12145383-122
N) 03203093-190
O) 11776061-122
P) 04745736-190
Q) 03737551-190, 04491785-190
R) 11820796-322
S) 04827031-190
T) 03184897-190
U) 03271749-190
V) 03300811-190
W) 04481798-190, 04491742-190
X) 03175243-190
Y) 04491734-190, 04641655-190
Z) 03255751-190

Lot or Serial #

A) >10 Numbers, Contact Manufacturer
B) >10 Numbers, Contact Manufacturer
C) >10 Numbers, Contact Manufacturer
D) >10 Numbers, Contact Manufacturer
E) >10 Numbers, Contact Manufacturer
F) >10 Numbers, Contact Manufacturer
G) >10 Numbers, Contact Manufacturer
H) >10 Numbers, Contact Manufacturer
I) >10 Numbers, Contact Manufacturer
J) >10 Numbers, Contact Manufacturer
K) >10 Numbers, Contact Manufacturer
L) >10 Numbers, Contact Manufacturer
M) >10 Numbers, Contact Manufacturer
N) >10 Numbers, Contact Manufacturer
O) >10 Numbers, Contact Manufacturer
P) >10 Numbers, Contact Manufacturer
Q) >10 Numbers, Contact Manufacturer
R) >10 Numbers, Contact Manufacturer
S) >10 Numbers, Contact Manufacturer
T) >10 Numbers, Contact Manufacturer
U) >10 Numbers, Contact Manufacturer
V) >10 Numbers, Contact Manufacturer
W) >10 Numbers, Contact Manufacturer
X) >10 Numbers, Contact Manufacturer
Y) >10 Numbers, Contact Manufacturer
Z) >10 Numbers, Contact Manufacturer

Reason for Recall

Potential for sporadic damage reagent cap hinges on different Elecsys products lots. In consequence, the affected cap may not remain in the correct open position on the instrument during pipetting causing the system probe or bead mixer to hit the cap.

Trade Name

A) Exel Huber Needles
B) Huber Infusion Set

Recall Posting Date

2010-03-01

Manufacturer

Exelint International Co.

Recall Start Date

2010-01-26

Recall Number

52890

Hazard Classification

Type I

Model or Catalog #

A) 27941R, 27944R, 27945R, 27946R, 27948R, 27949R, 27950R, 27954R, 27958R, 27959R
B) 27941R, 27944R, 27945R, 27946R, 27948R, 27949R, 27950R, 27954R, 27958R, 27959R

Lot or Serial #

A) >10 Numbers, Contact Manufacturer
B) >10 Numbers, Contact Manufacturer

Reason for Recall

When inserted into a port, the needles have been shown during testing to core (ie punch-out) the silicone port septum which may then result in damage to the port septum.

Trade Name

A) GEN*S Analyzer
B) Coulter LH 780 Hematology Analyzer
C) Unicel DXH800 Coulter Cellular Analyzer System
D) Coulter GEN*S Slidestainer
E) Coulter LH 750 Hematology Analyzer
F) Coulter LH 500 Hematology Analyzer

Recall Posting Date

2010-03-15

Manufacturer

Beckman Coulter, Inc.

Recall Start Date

2010-02-04

Recall Number

53214

Hazard Classification

Type II

Model or Catalog #

A) 6605360, 6605681
B) 723585
C) 629029
D) 6605470
E) 6605632
F) 178833

Lot or Serial #

A) All lots
B) All lots
C) All lots
D) All lots
E) All lots
F) All lots

Reason for Recall

Beckman Coulter has identified the following four (4) issues with the products: issue 1:there is a potential for misidentification to occur when the system is configured in languages other than English or Chinese. The characters #@[\]`{|}~ are substituted or omitted in other languages. The issue affects the GENS, lH750, lH780, lH500 and DXH 800. Issue 2:independent of language, the DXH 800 omits the characters *?" when used as part of the selected demographics including specimen ID and patient ID. Issue 3:in the DXH 800, space(s) used as leading character(s) in a patient or specimen ID, can cause random insertion of extra character(s) within that identifier. Issue 4:the LH500 instrument omits the tilde character (~) from the barcode when read by the primary mode (automatic aspiration) scanner.

Trade Name

A) Heartstart FRx AED
B) Heartstart HS1 Onsite Defrillator

Recall Posting Date

2010-01-18

Manufacturer

Philips Medical Systems

Recall Start Date

2009-11-04

Recall Number

51902

Hazard Classification

Type II

Model or Catalog #

A) 861304
B) M5066A

Lot or Serial #

A) B09J-02902
B) A09J-02142, A09J-02210, A09J-02207, A09J-02209, A09J-02223, A09J-02236, A09J-01298, A09J-02145, A09J-02204

Reason for Recall

Some Heartstart FRX automated external defibrillators (AEDS), model 861304 contain a high voltage (HV) capacitor from a lot that does not meet Philips' quality standards. If the AED has an HV capacitor exhibiting low capacitance or a high dissipation factor, the device may be unable to deliver the appropriate therapy.

Trade Name

A) HeartStart MRx Monitor/Defibrillator
B) HeartStart MRx AC Power Module Kit

Recall Posting Date

2010-03-01

Manufacturer

Philips Medical Systems

Recall Start Date

2009-11-19

Recall Number

52858

Hazard Classification

Type II

Model or Catalog #

A) M3535A, M3536A
B) M3538A

Lot or Serial #

A) >1000 Numbers, Contact Manufacturer
B) N/A

Reason for Recall

Certain types of Electri-Cord Manufacturing Company power cords used with medical devices sold by Philips Healthcare Resuscitation, Patient Monitoring, Respironics, and Dixtal may be defective in that the power cord's prongs may crack and fail at/or inside the plug. The issue affects medical device AC power cords equipped with a plug that has a prong and ground-pin insert design and a black plastic bridge connecting the terminal prongs on the plug ("taller bridge" design). Medical device power cords that do not have a black bridge connecting the terminal prongs on the plug are not affected.

Trade Name

A) Horizon Pump Blood Set NF/US3120,V7490
B) Horizon Pump Set V7453 AND V7402
C) Horizon Pump Nitroglycerin Sets V7450
D) Horizon Pump IV Sets Numerous Cat.#
E) Outlook Pump Set NF3115M
F) Outlook Pump IV SET W/Univer.Spike V7416F

Recall Posting Date

2010-01-04

Manufacturer

B. Braun Medical Inc.

Recall Start Date

2009-11-30

Recall Number

52133

Hazard Classification

Type II

Model or Catalog #

A) NF3120, US3120, V7490
B) V7402, V7453
C) V7450
D) 352430, 375040, 375196, NF3106, NF3140, US3130, V7405, V7410
E) 375122
F) 352461

Lot or Serial #

A) >10 Numbers, Contact Manufacturer
B) 61034231, 61034264, 61055331
C) 61051425, 61057269, 61057270
D) >10 Numbers, Contact Manufacturer
E) 61062522
F) 61040782, 61048455

Reason for Recall

Horizon/Outlook IV Pump Sets are recalled due to reports of system error 9 alarms. Further distribution or use of the product should be discontinued immediately.

Trade Name

A) i-Stat EG7+ Cartridges
B) i-Stat EG6+ Cartridges
C) i-Stat CG8+ Cartridges
D) i-Stat CHEM8+ Cartridges

Recall Posting Date

2010-01-18

Manufacturer

Abbott Point Of Care Inc.

Recall Start Date

2009-10-14

Recall Number

52262

Hazard Classification

Type II

Model or Catalog #

A) 06F01-01, 06F01-02
B) 06F02-01, 06F02-02
C) 03M86-01, 03M86-02
D) 03M88-01, 03M88-02

Lot or Serial #

A) N/A
B) N/A
C) N/A
D) N/A

Reason for Recall

Abbott Point Of Care has determined that while using specific non-blood sample types (hematocrit calibration verification, control and hematocrit proficiency), certain lot and box numbers of i-Stat cartridges may exhibit an increased rate of hematocrit (HCT) suppressed results (star outs). In-house testing has confirmed that the hematocrit suppressed results are not observed in patient samples and results generated are within the expected performance range.

Trade Name

A) Jazzy Select
B) Jazzy Select 6

Recall Posting Date

2010-03-15

Manufacturer

Pride Mobility Products Corp

Recall Start Date

2010-02-22

Recall Number

53190

Hazard Classification

Type III

Model or Catalog #

A) N/A
B) N/A

Lot or Serial #

A) >10 Numbers, Contact Manufacturer
B) >10 Numbers, Contact Manufacturer

Reason for Recall

An incorrect positioning of the wire harness can allow wire(s) to be pulled from their intended position and become "caught" under the motor mounting bracket located under the power chair.

Trade Name

A) Journey Uni Tibial Baseplate
B) Journey Uni Tibial Insert

Recall Posting Date

2010-02-15

Manufacturer

Smith & Nephew, Inc.

Recall Start Date

2010-01-07

Recall Number

52679

Hazard Classification

Type III

Model or Catalog #

A) 71422221, 71422222, 71422223, 71422224, 71422225, 71422226, 71422231, 71422232, 71422233, 71422234, 71422235, 71422236
B) 71422241, 71422242, 71422243, 71422244, 71422245, 71422246, 71422247, 71422248, 71422251, 71422252, 71422253, 71422254, 71422255, 71422256, 71422257, 71422258, 71422261, 71422262, 71422263, 71422264, 71422265, 71422266, 71422267, 71422268

Lot or Serial #

A) All lots
B) All lots

Reason for Recall

Reports of fractured Journey Partial Tibial Knee Baseplate components have been received. If a breakage/fracture occurs, the broken baseplate must be revised and/or changed. If left unrevised, a broken base could lead to instability and premature wear of the construct.

Trade Name

A) Legendair Ventilator
B) Moltech / Accutronics Battery

Recall Posting Date

2010-02-15

Manufacturer

Airox

Recall Start Date

2010-01-12

Recall Number

52620

Hazard Classification

Type I

Model or Catalog #

A) 4095705
B) 2963500, 2963599

Lot or Serial #

A) >100 Numbers, Contact Manufacturer
B) >100 Numbers, Contact Manufacturer

Reason for Recall

The internal batteries (Moltech / Accutronic) in conjunction with electrostatic discharge in specific environments are causing the internal battery controller to switch the battery to standby security mode while initiating a high security alarm.

Trade Name

A) Lifeshield Nonvented Primary IV Set
B) Lifeshield Microdrip Primary Piggyback

Recall Posting Date

2010-02-01

Manufacturer

Hospira Inc.

Recall Start Date

2009-12-07

Recall Number

52078

Hazard Classification

Type II

Model or Catalog #

A) N/A
B) N/A

Lot or Serial #

A) 580654W, 591284W, 601474W
B) 540494W, 540604W

Reason for Recall

Difficulty to set flow rate due to a difference in the zone of control compared to the original cair clamp design.

Trade Name

A) Lightspeed CT750 CT Scanner System
B) Lightspeed VCT CT System - Console

Recall Posting Date

2010-01-18

Manufacturer

GE Medical Systems, LLC

Recall Start Date

2009-12-21

Recall Number

52236

Hazard Classification

Type III

Model or Catalog #

A) 5232083-X
B) 5212920-3XX

Lot or Serial #

A) 409191CN4, 409447CN0, 409449CN6, 409530CN3
B) 412477CN2, 413732CN9

Reason for Recall

When using HD or Lightspeed 7.2 systems, the 80 KVP CTDI (CT dose index) adjustment factors & CTDI adjustment factors associated with 2x0.625 (1.25mm) & 4x0.625 (2.5mm) aperture settings were incorrect.

Trade Name

A) LMA Pain Care 3000
B) LMA Pain Care 4200

Recall Posting Date

2010-03-01

Manufacturer

The Laryngeal Mask Company Limited

Recall Start Date

2010-01-18

Recall Number

53106

Hazard Classification

Type II

Model or Catalog #

A) 10314
B) 11090

Lot or Serial #

A) All lots
B) All lots

Reason for Recall

Device not licenced for sale in Canada. Device supplied into Canada in error.

Trade Name

A) Mevaton Primus Accessories
B) Mevatron Linear Accelerators

Recall Posting Date

2010-03-29

Manufacturer

Siemens Medical Solutions USA, Inc. Oncology Care Systems

Recall Start Date

2010-03-02

Recall Number

53388

Hazard Classification

Type III

Model or Catalog #

A) 8485971
B) 4504200

Lot or Serial #

A) 3284
B) 3284

Reason for Recall

As result of an internal audit, Siemens determined that the digital electron variable applicator is compliant with IEC 60601-2-1 with the exception of the radiation leakage at a distance of 2cm from the side of the applicator body in combination with field sizes of 5cm x 5cm or smaller and energies of below 6mev.

Trade Name

A) Moeller Arginine + Agar
B) Moeller lysine + Agar
C) Moeller Arginine + Broth
D) Moeller Decarb. Control
E) Moeller Lysine Decarb
F) Moller Ornith Decarb

Recall Posting Date

2010-03-29

Manufacturer

PML Microbiologicals, Inc.

Recall Start Date

2010-02-16

Recall Number

53374

Hazard Classification

Type III

Model or Catalog #

A) T3311
B) T3312
C) T6940
D) T6945
E) T6950
F) T6955

Lot or Serial #

A) 298413-1, 299272-1
B) 296157-1, 296761-1, 297437-1, 298414-1, 299432-1, 299869-1, 303150-1, 304938-1
C) 296784-1, 298439-1, 303182-1
D) 296164-1, 298440-1, 299295-1, 303183-1
E) 296165-1, 304227-1
F) 297915-1, 303184-1

Reason for Recall

A raw material used in the production of some Biomerieux products may not produce the correct biochemical reactions with quality control organisms over the shelf life of the product.

Trade Name

A) Nexus 1
B) Nexus 2

Recall Posting Date

2010-02-01

Manufacturer

Dana Douglas Inc.

Recall Start Date

2009-12-21

Recall Number

52535

Hazard Classification

Type I

Model or Catalog #

A) 4520185F, 4520225F, 4520245F
B) 4515185F, 4515225F, 4515245F

Lot or Serial #

A) >10 Numbers, Contact Manufacturer
B) >10 Numbers, Contact Manufacturer

Reason for Recall

Manufacturer has received a large number of reports in which the Nexus products experienced weakening just below the weld on the rear frame that resulted in breakage, some of these users fell and suffered injury and bruising. There is a potential for serious injury, broken bones and bruising.

Trade Name

A) Nexus 1
B) Nexus 2
Updated recall # 52535 previously posted on 2010-02-01

Recall Posting Date

2010-03-29

Manufacturer

Dana Douglas Inc.

Recall Start Date

2009-12-21

Recall Number

52535

Hazard Classification

Type I

Model or Catalog #

A) 4520185F, 4520225F, 4520245F
B) 4515185F, 4515225F, 4515245F

Lot or Serial #

A) >10 Numbers, Contact Manufacturer
B) >10 Numbers, Contact Manufacturer

Reason for Recall

Rollators manufactured prior to October 30, 2008 may experience a weakening just below the weld on the rear frame which could result in breakage when used by consumers above 187 pounds to a maximum of 250 pounds. If breakage occurs the user could fall and suffer injury including broken bones and bruising. 75 incidents with 6 resulting in injury have been reported.

Trade Name

A) Nexus 3
B) Nexus 1
C) Nexus 2

Recall Posting Date

2010-02-01

Manufacturer

Dana Douglas Inc.

Recall Start Date

2009-12-14

Recall Number

52172

Hazard Classification

Type III

Model or Catalog #

A) 4500185F, 4500225F, 4500245F
B) 4520185F, 4520225F, 4520245F
C) 4515185F, 4515225F, 4515245F

Lot or Serial #

A) >10 Numbers, Contact Manufacturer
B) >10 Numbers, Contact Manufacturer
C) >10 Numbers, Contact Manufacturer

Reason for Recall

Because of a dealer complaint, the manufacturer is notifying all dealers of a remote possibility of the bearing failing to cause the front fork to fall off when the rollator is lifted out of the box.

Trade Name

A) Nexus 3
B) Nexus 1
C) Nexus 2

Recall Posting Date

2010-02-01

Manufacturer

Dana Douglas Inc.

Recall Start Date

2009-12-11

Recall Number

52173

Hazard Classification

Type III

Model or Catalog #

A) 4500185F, 4500225F, 4500245F
B) 4520185F, 4520225F, 4520245F
C) 4515185F, 4515225F, 4515245F

Lot or Serial #

A) >10 Numbers, Contact Manufacturer
B) >10 Numbers, Contact Manufacturer
C) >10 Numbers, Contact Manufacturer

Reason for Recall

Dealer called to report a broken front fork after use. Broken fork sent to manufacturer for testing as well as a third party testing facility. After testing it was determined that some nylon 66 material was found in the part.

Trade Name

A) Olympus Trocar Spikes (Conical Tip)
B) Olympus Trocar Spikes (Triangular Tip)

Recall Posting Date

2010-03-01

Manufacturer

Olympus Winter & IBE GMBH

Recall Start Date

2010-02-08

Recall Number

53040

Hazard Classification

Type II

Model or Catalog #

A) A5949
B) A5821, A5948, WA58341L

Lot or Serial #

A) 075W, 076W, 077W, 078W, 07XW, 07YW, 081W, 083W, 084W
B) 075W, 076W, 077W, 078W, 07XW, 07YW, 081W

Reason for Recall

The manufacturer has received one complaint that the Trocar tip had fallen off during a surgical procedure. As a consequence the tip needed to be removed in an additional surgical procedure. The Trocar tip was detached from the Trocar shaft due to a fracture in the weld seam between the tip and shaft.

Trade Name

A) Omega 1V Table
B) Omega V Table

Recall Posting Date

2010-01-04

Manufacturer

GE Medical Systems SCS

Recall Start Date

2009-12-01

Recall Number

51642

Hazard Classification

Type II

Model or Catalog #

A) 2120637, 2181400, 2219154, 2243720, 2252036, 2252037, 2320221, 2320221-2, 2320221-3
B) 2261470, 2320044, 2320045-2, 2320045-4, 2320045-5

Lot or Serial #

A) >10 Numbers, Contact Manufacturer
B) >10 Numbers, Contact Manufacturer

Reason for Recall

Potential weakness of table rotational brakes may result in unintended table rotation while the table is locked, which could lead to a patient fall during patient transfer.

Trade Name

A) OneTouch SureStep Test Strips (100s)
B) SureStepPro Test Strips (50s)

Recall Posting Date

2010-03-29

Manufacturer

Lifescan Inc.

Recall Start Date

2010-03-01

Recall Number

53306

Hazard Classification

Type II

Model or Catalog #

A) 010-665
B) 010-894

Lot or Serial #

A) 2988755, 2966726, 2983464
B) 2963593009, 2990938010, 2990939009, 2994365010, 2991903010, 2992693010, 2992694010, 2997401011, 3002715009

Reason for Recall

Test strips may provide falsely low glucose results when the glucose level is higher than 22.2 mmol/l.

Trade Name

A) Opthalmic Cannula
B) I/A Handpiece
C) Opthalmic Surgical Cannulas-Reusable
D) Excellus Hanstome Microkeratome
E) Sharpoint Ultra Plug
F) Millenium Microsurgical System
G) Millenium Microsurgical System-Connecto
H) Ryan 90 Degree Pick
I) Antrum Killian Sterling
J) Can Antrum Killian Chrome Cannula
K) Needle Fascia Wright
L) Sceral Plugs
M) Suct TB Guilford-Wright
N) TB Silastic
O) Silicone Tubing
P) Suction Tube Tonsil Yankauer
Q) Suct TB Tonsil Goodhil-Pynchon
R) Suct TB Baron W/Cut-Off
S) TB Suct Ferg-Frazier
T) Suction Tube Rosen
U) Needle House
V) Needle Utility Rosen Type House
W) Needle Perforating McGee
X) Needle Schuknech Straight Rigid
Y) Algerbrush Rust Ring Cornea Burrs
Z) Tonsil Needle Luer-LK

Recall Posting Date

2010-01-04

Manufacturer

Bausch & Lomb Canada Inc.

Recall Start Date

2009-03-01

Recall Number

51949

Hazard Classification

Type II

Model or Catalog #

A) CX9679
B) E7187, ET4750 A23, MVS1061L
C) 109-2725, E0566, E0566S, E0566SA
D) 507-0063
E) PPLUG4, PPLUG8
F) CX9679
G) D1800
H) DP9605
I) N2485
J) N2487
K) E2488
L) MVS 1041, MVS 1042
M) N1701 9A, N1701 9B, N1701 9C, N1701 9D
N) N5941 4, N5941 5, N5941 5A
O) N5941 10, N5941 8
P) N7550
Q) N7557
R) N0610
S) N1362, N1363, N1364, N1365, N1366, N1367, N1370, N1371, N1372, N1373, N1377, N1378, N1379, N1380, N1382
T) N1690 11A, N1690 11B, N1690 11C, N1690 11D, N1690 11E, N1690 11G, N1690 11H, N1690 11I, N1690 11J
U) N1705 01
V) N1705 02D
W) N1685 D10
X) N1698 57
Y) E0815 A, E0815 B
Z) N7570, N7574

Lot or Serial #

A) All Lots
B) All Lots
C) All Lots
D) All Lots
E) All Lots
F) All Lots
G) All Lots
H) All Lots
I) All Lots
J) All Lots
K) All Lots
L) All Lots
M) All Lots
N) All Lots
O) All Lots
P) All Lots
Q) All Lots
R) All Lots
S) All Lots
T) All Lots
U) All Lots
V) All Lots
W) All Lots
X) All Lots
Y) All Lots
Z) All Lots

Reason for Recall

Notification to customers that unlicenced medical devices were sold.

Trade Name

A) Powerheart AED G3
B) Powerheart AED G3Pro
C) Powerheart AED G3Plus
D) Powerheart G3Plus
E) Powerheart AED G3 (Biphasic)
F) FirstSave AED G3
G) CardioVive 92530
H) CardioVive 92532

Recall Posting Date

2010-02-01

Manufacturer

Cardiac Science Corporation

Recall Start Date

2009-12-16

Recall Number

52269

Hazard Classification

Type II

Model or Catalog #

A) Powerheart 9300A
B) Powerheart 9300P
C) Powerheart 9390E
D) Powerheart 9390A
E) Powerheart 9300E
F) Firstsave 9300C
G) Cardiovive 92530
H) Cardiovive 92532

Lot or Serial #

A) >100 Numbers, Contact Manufacturer
B) >10 Numbers, Contact Manufacturer
C) >100 Numbers, Contact Manufacturer
D) >100 Numbers, Contact Manufacturer
E) >1000 Numbers, Contact Manufacturer
F) Serial # 335430
G) Serial # 92530-0000413
H) Serial # 4018084, 4022088, 4035451, 4037302, 92532-0000794

Reason for Recall

Certain AEDS have resistors which may fail and the failure will not be detected by the AEDS' periodic self-tests. If the issue were to occur, the AED may not be able to deliver therapy during a rescue attempt and may affect resuscitation of the patient. This could lead to serious adverse health events or death.

Trade Name

A) Quantanase Neonatal Phenylalanine Screening Kit
B) Quantanase Neonatal Elution Buffer

Recall Posting Date

2010-03-29

Manufacturer

Bio-Rad Laboratories Europe Ltd.

Recall Start Date

2010-02-10

Recall Number

53297

Hazard Classification

Type III

Model or Catalog #

A) 532-5040
B) 532-5035

Lot or Serial #

A) N/A
B) N/A

Reason for Recall

The manufacturer reported that the pressure contained within the Elution Buffer vial may expel the ruber stopper upon removing the metal seal.

Trade Name

A) Radiant Warmer
B) Birthing Room Warmer

Recall Posting Date

2010-01-18

Manufacturer

Draeger Medical Systems, Inc.

Recall Start Date

2009-08-01

Recall Number

50181

Hazard Classification

Type II

Model or Catalog #

A) RW82, RW82-1
B) WBR82, WBR82-1

Lot or Serial #

A) Manufactured between Jan. 07 and June 08/09
B) Manufactured between Jan. 07 and June 08/09

Reason for Recall

The design and construction of the warmer head enclosure, along with the flame ratings/characteristics of the involved materials (i.e. enclosure wire installation, quick connect insulation).

Trade Name

A) RealSeal Cartridges
B) Elements Gutta Percha

Recall Posting Date

2010-01-04

Manufacturer

Sybron Endo

Recall Start Date

2009-10-27

Recall Number

51912

Hazard Classification

Type II

Model or Catalog #

A) 972-2001, 972-2002
B) 972-1002 , 972-1003

Lot or Serial #

A) 07 0987641, 08 0992277, 05 0941553, 07 0977947, 05 0948690, 07 0987642, 08 0992278, 08 0998612, 06 0955241
B) 06 0959663, 06 0957595

Reason for Recall

Breakages of the lock nuts used in the Elements Gutta Percha and RealSeal cartridges. Investigation determined that during the manufacturing process, the moulding process resulted in weak lock nuts. More specifically, the affected products may not be able to withstand the pressures exhibited by the Elements Obturation unit with which the cartridges are used.

Trade Name

A) Servo 900D
B) Servo 300/300A/300 With NO/Servo 300ANO
C) Servo 900C

Recall Posting Date

2010-01-18

Manufacturer

Maquet Critical Care AB

Recall Start Date

2009-11-18

Recall Number

51871

Hazard Classification

Type III

Model or Catalog #

A) 9098492
B) 6150614, 6424712, 6437631, 6437805
C) 6932552

Lot or Serial #

A) S/N 01001-188499
B) S/N 00410-24999
C) S/N 01001-188499

Reason for Recall

A letter to inform users not to use a system that may generate negative pressure below -100 cm H2O due to the risk of damaging the ventilator's pressure transducers if applied improperly.

Trade Name

A) Spot LX1 With BP & Temperature
B) Spot LXI With NIBP, Temperature & SPO2

Recall Posting Date

2010-03-29

Manufacturer

Welch Allyn, Inc.

Recall Start Date

2010-01-19

Recall Number

53049

Hazard Classification

Type III

Model or Catalog #

A) 450E0-E1, 450E0-F1, 450T0-E1, 450T0-F1
B) 45ME0-E1, 45ME0-F1, 45MT0-E1, 45MT0-F1, 45NE0-E1, 45NE0-F1, 45NT0-E1, 45NT0-F1

Lot or Serial #

A) 2009XXXXXXX
B) 2009XXXXXXX

Reason for Recall

The printed circuit board assembly responsible for blood pressure measurement and analysis (material number 400387, referred to as the "Mod F" board) includes a capacitor (C600) that was installed backwards. Affected devices may intermittently report C02 and C12 error codes, which result in the device being unavailable for use.

Trade Name

A) Staclot LA 20
B) Start 4 NG DSI 115V

Recall Posting Date

2010-03-15

Manufacturer

Diagnostica Stago SAS

Recall Start Date

2010-02-12

Recall Number

53133

Hazard Classification

Type II

Model or Catalog #

A) 0594
B) 58230

Lot or Serial #

A) 102788, 104449, 104679
B) >10 Numbers, Contact Manufacturer /

Reason for Recall

Internal investigations have determined that certain lots of the product were marketed in Canada utilizing the incorrect reference number and consequently without proper registration with Health Canada (unlicenced device). However, there is an equivalent product utilizing a different reference that is properly registered with Health Canada. There is no functional difference between the two product reference numbers with the exception of the number of tests that can be conducted.

Trade Name

A) Stellaris Vision Enhancement W/AVS
B) Stellaris Vision Enhancement W/AFS
C) Stellaris Vision Enhancement W/AFS, HSV
D) Millenium Microsurgical System-Unit

Recall Posting Date

2010-03-29

Manufacturer

Bausch & Lomb Inc.

Recall Start Date

2010-02-15

Recall Number

53207

Hazard Classification

Type III

Model or Catalog #

A) N/A
B) N/A
C) N/A
D) N/A

Lot or Serial #

A) SYS01048, SYS01044, SYS01046, SYS00921, SYS01065, SYS01037, SYS01097, SYS01128, SYS00931, SYS00896, SYS00983
B) SYS01217, SYS01230, SYS01059, SYS01040
C) SYS00446, SYS00139, SYS00514, SYS00136, SYS00170, SYS00447, SYS00171, SYS00564, SYS00570
D) >10 Numbers, Contact Manufacturer

Reason for Recall

Alert issued on reports of sparking, charring, and fires on power cords reported by Hospira & Abbott Nutrition which are similar to the ones used in Bausch & Lomb products.

Trade Name

A) Suresigns VM4 Patient Monitor
B) Suresigns VM6 Patient Monitor
C) Suresigns VM8 Patient Monitor
D) Suresigns VS3 Patient Monitor
E) Suresigns Vital Signs Viewer

Recall Posting Date

2010-01-18

Manufacturer

Philips Medical Systems

Recall Start Date

2009-11-04

Recall Number

51582

Hazard Classification

Type II

Model or Catalog #

A) N/A
B) N/A
C) N/A
D) N/A
E) N/A

Lot or Serial #

A) >10 Numbers, Contact Manufacturer
B) >10 Numbers, Contact Manufacturer
C) US90328668, US63506498, US91929777, US72010335, US63507187, US74917316
D) >10 Numbers, Contact Manufacturer
E) US80501208, US80501179, US80501178, US74101045

Reason for Recall

Philips' Suresigns Patient Monitors, Vital Signs Monitors and Vital Signs Viewers allow the device speaker volume to be adjusted by the user. Philips Healthcare has determined that, in rare instances, the continued use of these speakers at their maximum volume setting may result in the premature failure of the internal speaker. If the device speaker fails during use, this may contribute to a delay in treatment of a patient.

Trade Name

A) Symbia T/T2/T6/T16
B) Symbia S

Recall Posting Date

2010-01-18

Manufacturer

Siemens Medical Solutions USA, Inc. Molecular Imaging Group

Recall Start Date

2009-12-14

Recall Number

52258

Hazard Classification

Type III

Model or Catalog #

A) 08717733, 10275008, 10275009
B) 08717741

Lot or Serial #

A) 1068, 1076, 1128, 1143, 1153, 1082, 1026, 1056
B) 1021, 2100, 1103, 1159, 1405

Reason for Recall

Distribute customer safety advisory notice for Symbia Systems regarding the hand controller pull-up resistor switch was not installed and lack of this could cause an un-intended motion.

Trade Name

A) Symbiq Set Backcheck Valve Clave Port
B) Lifeshield Latexfree Primary Symbiq

Recall Posting Date

2010-01-18

Manufacturer

Hospira Inc.

Recall Start Date

2009-11-26

Recall Number

51955

Hazard Classification

Type II

Model or Catalog #

A) 16000, 16008, 16013, 16019, 16021, 16022
B) 16089, 16090, 16093

Lot or Serial #

A) N/A
B) N/A

Reason for Recall

Retrograde flow of fluid (backflow) past the backcheck valve on Symbiq Administration Sets.

Trade Name

A) T2 Ankle System-Arthrodesis Nails,Left
B) T2 Ankle System-Arthrodesis Nails,Right

Recall Posting Date

2010-01-04

Manufacturer

Stryker Trauma GMBH

Recall Start Date

2009-12-11

Recall Number

52186

Hazard Classification

Type II

Model or Catalog #

A) 1818-1030S, 1818-1130S, 1818-1230S
B) 1819-1030S, 1819-1130S, 1819-1230S

Lot or Serial #

A) All Lots
B) All Lots

Reason for Recall

Stryker Trauma has become aware of the potential for the blister packaging to become damaged. During transportation the nail fixed in the blister with on foam inlay at both ends has the potential to leave its intended position and can damage the unprotected blister. The sterility of the device could be compromised.

Trade Name

A) Tidal Wave Model 610
B) Tidal Wave SP Model 710
C) Tidal Wave SP Model 715
D) NICO Model 7300
E) Tidal Wave Model 615

Recall Posting Date

2010-01-04

Manufacturer

Respironics Novametrix, LLC

Recall Start Date

2009-12-08

Recall Number

52112

Hazard Classification

Type II

Model or Catalog #

A) 6700-00
B) 9110-00
C) 9146-00
D) 9226-00
E) 9425-00

Lot or Serial #

A) N/A
B) N/A
C) N/A
D) N/A
E) N/A

Reason for Recall

The products have an AC power cord manufactured by Electri-Cord Manufacturing Corporation (ECM) that could be defective. Potential risks associated with a defective power cord include burns, electrical shock, and/or delay in therapy.

Trade Name

A) Trusat Oximeter
B) Trusat Oximeter - With Expension Option

Recall Posting Date

2010-03-29

Manufacturer

GE Healthcare Finland OY

Recall Start Date

2010-02-26

Recall Number

53326

Hazard Classification

Type I

Model or Catalog #

A) 6051-0000-190, 6051-0000-192
B) 6051-0000-191, 6051-0000-193

Lot or Serial #

A) >10 Numbers, Contact Manufacturer
B) >100 Numbers, Contact Manufacturer

Reason for Recall

Under certain conditions enclosure leakage current exceeds allowed limits. The measured enclosure currents can be 8 - 10ma. Maximum allowed value for enclosure leakage current for single fault condition is 0.5ma according to IEC60601-1:2005.

Trade Name

A) Unicel DXC 600
B) Unicel DXC 800
C) Unicel DXC 600I
D) Unicel DXC 880I
E) Unicel DXC 660I
F) Unicel DXC 680I
G) Unicel DXC 860I

Recall Posting Date

2010-02-15

Manufacturer

Beckman Coulter, Inc.

Recall Start Date

2010-01-08

Recall Number

52600

Hazard Classification

Type II

Model or Catalog #

A) 4764
B) 4764
C) 4767
D) 4768
E) 4771
F) 4772
G) 4773

Lot or Serial #

A) All lots
B) All lots
C) All lots
D) All lots
E) All lots
F) All lots
G) All lots

Reason for Recall

Excessive build up of protein, bacteria and sample tube additives in the ISE flow cell may cause erroneous results in the Unicel DXC systems.

Trade Name

A) Unicel DXC600I Synchron Access Clinical Analyzer
B) Synchron LXI 725

Recall Posting Date

2010-02-15

Manufacturer

Beckman Coulter, Inc.

Recall Start Date

2010-01-18

Recall Number

52857

Hazard Classification

Type II

Model or Catalog #

A) 4767
B) 476501

Lot or Serial #

A) Part#: A25633, Serial#: All
B) Part#: 389695, Serial#: All

Reason for Recall

Hardware failures in the closed tube aliquotter (CTA), including loose sample probe tubing, sample probe failures, and clogged sample probes may result in erroneous access immunoassay results or Synchron chemistry results.

Trade Name

A) Unicel DXI600 Access.Imm.Sys.-ACCU TNI
B) Access Immunoassay System-ACCU TNI
C) Unicel DXI800 Acc.Immuno.Sys.-ACCUT TNI

Recall Posting Date

2010-03-29

Manufacturer

Beckman Coulter Inc.

Recall Start Date

2010-02-06

Recall Number

53131

Hazard Classification

Type II

Model or Catalog #

A) 33340, 33345, A78803
B) 33340, 33345, A78803
C) 33340, 33345, A78803

Lot or Serial #

A) >10 Numbers, Contact Manufacturer
B) >10 Numbers, Contact Manufacturer
C) >10 Numbers, Contact Manufacturer

Reason for Recall

Beckman Coulter has confirmed that different results have been obtained from the same patient samples assayed on Access/Access 2 and Unicel DXI platforms when using all lots of Troponin reagent.

Trade Name

A) Vital Signs 300 Monitor w/Pulse Rate
B) Vital Signs 300 Monitor w/Pulse Rate/Printer
C) Vital Signs 300 w/Pulse Rate/Map/Printer
D) Vital Signs 300 w/Temperature and Printer
E) Vital Signs 300 Monitor/Nellcor SPO2
F) Vital Signs 300 Monitor/Nellcor SPO2 Printer
G) Vital Signs 300 Monitor/Nellcor SPO2/Temp
H) Vital Signs 300 Monitor/SPO2/Temp/Printer

Recall Posting Date

2010-01-18

Manufacturer

Welch Allyn Protocol, Inc.

Recall Start Date

2009-12-04

Recall Number

52292

Hazard Classification

Type II

Model or Catalog #

A) 53000-E1, 53000-F1
B) 5300P-E1, 5300P-F1
C) 530T0-E1, 530T0-F1
D) 530TP-E1, 530TP-F1
E) 53N00-E1, 53N00-F1, 53S00-E1, 53S00-F1
F) 53N0P-E1, 53N0P-F1, 53S0P-E1, 53S0P-F1
G) 53NT0-E1, 53NT0-F1, 53ST0-E1, 53ST0-F1
H) 53NTP-E1, 53NTP-E1R, 53NTP-F1, 53STP-E1, 53STP-F1

Lot or Serial #

A) All Serial Numbers
B) All Serial Numbers
C) All Serial Numbers
D) All Serial Numbers
E) All Serial Numbers
F) All Serial Numbers
G) All Serial Numbers
H) All Serial Numbers

Reason for Recall

The firm distributed a field correction letter notifying users to check that the audio function is working each time they use the device with a label for each unit and new updated DFUS.

Trade Name

Acuson Antares

Recall Posting Date

2010-01-18

Manufacturer

Siemens Medical Solutions USA, Inc.

Recall Start Date

2009-12-02

Recall Number

52189

Hazard Classification

Type III

Model or Catalog #

10032746

Lot or Serial #

114348, 114388

Reason for Recall

This update corrects the following software errors on Acuson & Sonoline Antares 4.0 systems at software version 100.0.009, 100.0.17a, 100.0.018a, 100.0.021a & 100.0.23a.

Trade Name

Acuson Antares

Recall Posting Date

2010-03-29

Manufacturer

Siemens Medical Solutions USA, Inc.

Recall Start Date

2010-03-02

Recall Number

53439

Hazard Classification

Type III

Model or Catalog #

10032746

Lot or Serial #

114348, 114388

Reason for Recall

Software error after running the following workflow steps 1)zoom in live image, 2)store a respective clip, 3)go to exam review or an offline workstation, or 4) measure the zoomed clip, potential risk is that the measured results can be incorrect with no indication to the user they are wrong.

Trade Name

Acuson X300

Recall Posting Date

2010-01-04

Manufacturer

Siemens Medical Solutions USA, Inc.

Recall Start Date

2009-09-02

Recall Number

50794

Hazard Classification

Type II

Model or Catalog #

10037409

Lot or Serial #

310351

Reason for Recall

1) Doppler signals may be truncated and peak gradients be potentially obscured, may result in the underestimation of peak velocity and a disease process, 2) User records of heart be recorded using calipers on the ecg, the heart rate value does not get reset during a new patient registration and calculations are based on the previous patient's results. 3) When a user searches for data, the search result is for the patient in the study browser, new study results are saved under patient the study brower is focused on.4)When new patient is registered with no new parameters, image from the last patient is appearing in the text for the new patient, could result in misdiagnosis.

Trade Name

Acuson X300

Recall Posting Date

2010-01-04

Manufacturer

Siemens Medical Solutions USA, Inc.

Recall Start Date

2009-09-17

Recall Number

51247

Hazard Classification

Type III

Model or Catalog #

10037409

Lot or Serial #

311610, 311642

Reason for Recall

When using the ultrasound cardiac workflow algorithm under specific depths and scales, the affected systems create a band of lost signals in a horizontal orientation which could result in the underestimation of the peak velocity and therefore a disease process.

Trade Name

Acuson X300

Recall Posting Date

2010-02-15

Manufacturer

Siemens Medical Solutions USA, Inc.

Recall Start Date

2009-09-17

Recall Number

51248

Hazard Classification

Type III

Model or Catalog #

10348531

Lot or Serial #

313171, 313273

Reason for Recall

When using the ultrasound cardiac workflow under specific depths and scales, the affected systems create a band of lost signals in a horizontal orientation which could result in the underestimation of the peak velocity and a disease process.

Trade Name

Advance Tibial Wedge Augment

Recall Posting Date

2010-03-01

Manufacturer

Wright Medical Technology Inc.

Recall Start Date

2010-02-13

Recall Number

53128

Hazard Classification

Type II

Model or Catalog #

KTAGW115 TO KTAGW625

Lot or Serial #

087441267, 097441268

Reason for Recall

Packages from two lots of Advance Tibial augments, catalog # KTAGW315, incorrectly contain 15mm length screws instead of the correct 5mm length screws. These products are assembled on the back table during the surgical procedure when the augment is attached to the tibial base by use of the screws provided. The incorrect length screws can be easily noted during the assembly process.

Trade Name

Ammonia/Ethanol/CO2 Control A

Recall Posting Date

2010-01-18

Manufacturer

Roche Diagnostics GMBH

Recall Start Date

2009-12-10

Recall Number

52169

Hazard Classification

Type III

Model or Catalog #

20753009190

Lot or Serial #

154345

Reason for Recall

The current lot #154345 of the control material Ammonia/Ethanol/CO2 Control A may generate values of >10% above the specified limit.

Trade Name

Amsco 3085SP Surgical Table

Recall Posting Date

2010-03-29

Manufacturer

Steris Corporation

Recall Start Date

2010-02-19

Recall Number

53236

Hazard Classification

Type III

Model or Catalog #

STO1-010-1 to 010-2, STO1-020-1 to 020-2, STO1-030-1, STO1-050-1 to 010-2, STO1-060-1 to 010-2

Lot or Serial #

B420702032 to 0402110097

Reason for Recall

Steris has learned that some customers may be storing objects, including surgical items and table accessories, on the base and/or around the column of the Amsco Surgical Table. This practice can damage the centre column of the table by accessories impinging the column and causing separation along the mating seam of the sheet metal shroud. This misuse can lead to damage of the override switch assembly located at the top of the column cover. It is possible that the table could articulate/move without prompting by an operator.

Trade Name

Amsco Harmony Surgical Lighting and Media System

Recall Posting Date

2010-03-29

Manufacturer

Steris Corporation

Recall Start Date

2010-02-23

Recall Number

53489

Hazard Classification

Type III

Model or Catalog #

Harmony 500 and 700

Lot or Serial #

S/N: B0428102135 - B0430207104

Reason for Recall

Steris has learned that some customers may experience premature bulb failures due to loosening of wires and overheating of the lamp housing assemblies within the Harmony LA, LC 500 and LA 700 surgical lighting and media systems.

Trade Name

Aplio Artida Ultrsound System

Recall Posting Date

2010-01-04

Manufacturer

Toshiba Medical Systems Corporation

Recall Start Date

2009-11-10

Recall Number

51965

Hazard Classification

Type II

Model or Catalog #

SSH-880CV

Lot or Serial #

W1F0982239, W1F0862082, W1F0982235, W1F0982240, W1F0982231, W1F0982232, W1F0982233, W1F0982234

Reason for Recall

In Artida Ultrasound Systems model SSH-880CV, there are two issues noted regarding (1) measurement value display, and (2) text display, when flex-M mode and annotation function are used respectively.

Trade Name

Aquarius System

Recall Posting Date

2010-03-15

Manufacturer

Edwards Lifesciences LLC

Recall Start Date

2010-02-09

Recall Number

53150

Hazard Classification

Type II

Model or Catalog #

GEF09700

Lot or Serial #

N/A

Reason for Recall

Edwards LifeSciences has received reports of clinically significant fluid imbalance in patients relating to the repeated overriding of the fluid balance alarms of the Aquarius system, contrary to the operating manual of the device.

Trade Name

Aquilion One

Recall Posting Date

2010-02-01

Manufacturer

Toshiba Medical Systems Corporation

Recall Start Date

2009-12-23

Recall Number

52445

Hazard Classification

Type II

Model or Catalog #

TSX-301A/2

Lot or Serial #

2CA0822017, 2CA07X2007, 2CA0842022, 2CA0852028, 2CA0862035, 2CA0872046, 2CA0972125

Reason for Recall

When wide-volume scanning is performed in prospective CTA or target CTA studies with ECG gating, unnecessary intervals may be set before starting the volume scan.

Trade Name

Architect HAVAB-IGM Reagent

Recall Posting Date

2010-03-29

Manufacturer

Abbott GMBH & Co. K.G.

Recall Start Date

2010-03-03

Recall Number

53442

Hazard Classification

Type III

Model or Catalog #

6C30-20, 6C30-25

Lot or Serial #

>10 Numbers, Contact Manufacturer

Reason for Recall

Customers are observing an increase in the negative control values and/or grayzone/reactive (GZ/R) results when using the Architect HAVAB-IGM (LN 6C30) assay. An increase in sample to cut off (S/CO) values has been observed when Architect HAVAB-IGM and Architect Anti-HBS (LN 7C18) assays are run together on the same architect module. The increase in S/CO observed could shift a nonreactive sample to grayzone or reactive and/or shift the negative control values out of range high when the architect HAVAB-IGM assay is preceded by the Architect Anti-HBS assay.

Trade Name

Architect HIV AG/AB Combo Calibrator

Recall Posting Date

2010-01-18

Manufacturer

Abbott GMBH & Co. K.G.

Recall Start Date

2009-12-18

Recall Number

52235

Hazard Classification

Type III

Model or Catalog #

4J27-01

Lot or Serial #

73507HN00

Reason for Recall

The calibrator values for Architect HIV AG/AB Combo Calibrator are decreasing over time which leads to out of range high control values and/or invalid calibration due to control(s) out of range. Testing of all non-expired calibrator and control lots indicates no other lot is affected by the quality issue.

Trade Name

Architect i2000 And i2000SR Systems

Recall Posting Date

2010-01-04

Manufacturer

Abbott Laboratories Diagnostic Division

Recall Start Date

2009-07-23

Recall Number

50097

Hazard Classification

Type III

Model or Catalog #

08C89-01, 3M74-01, 3M74-02

Lot or Serial #

N/A

Reason for Recall

Under specific conditions (such as spills, leaks, or improper maintenance) on the Architect i2000 or i2000SR Systems, the concentrated wash buffer (containing sodium azide) can come in contact with the wash zone mechanism ground straps (cables) on either of the two wash zones. The copper in the ground strap may corrode and form an unstable chemical substance (metal azide) that may be sensitive to direct pressure and impact.

Trade Name

Architect Reaction Vessels

Recall Posting Date

2010-01-18

Manufacturer

Abbott Laboratories Diagnostic Division

Recall Start Date

2009-12-22

Recall Number

52290

Hazard Classification

Type III

Model or Catalog #

7C15-01

Lot or Serial #

>10 Numbers, Contact Manufacturer

Reason for Recall

Abbott has observed an increase in complaints with Architect RV lots 78387P100 and 80275P100. These complaints are due to discharge of static electricity from the Architect RV when it is at the optics reader of an Architect iSystem instrument. The static discharge can potentially result in an error code.

Trade Name

Artesense (PMMA Collagen Dermal Implant)

Recall Posting Date

2010-02-15

Manufacturer

European Medical Contract Manufacturing B.V. (EMCM)

Recall Start Date

2010-01-08

Recall Number

52836

Hazard Classification

Type II

Model or Catalog #

227014

Lot or Serial #

N/A

Reason for Recall

Modification to the instruction for use: removal of lips indication.

Trade Name

Artiste MV System

Recall Posting Date

2010-03-15

Manufacturer

Siemens Medical Solutions USA, Inc. Oncology Care Systems

Recall Start Date

2010-02-04

Recall Number

53047

Hazard Classification

Type II

Model or Catalog #

8139789

Lot or Serial #

5414, 5485

Reason for Recall

A failure of one of the gear-boxes controlling the joints that move the flat panel imager has resulted in a rapid, unintended movement of the flat panel.

Trade Name

Axiom Artis

Recall Posting Date

2010-01-04

Manufacturer

Siemens AG

Recall Start Date

2009-09-02

Recall Number

50792

Hazard Classification

Type III

Model or Catalog #

7008605

Lot or Serial #

1005, 1008, 1010, 1012, 1014, 1018, 1073

Reason for Recall

If a study is not closed at completion before new patient information is entered, a potential exists for images from the completed study to be relabeled to this new patient.

Trade Name

BD BBL Trypticase Soy Agar

Recall Posting Date

2010-01-04

Manufacturer

Becton Dickinson And Company

Recall Start Date

2009-12-08

Recall Number

52103

Hazard Classification

Type III

Model or Catalog #

299896

Lot or Serial #

9264228

Reason for Recall

TSA Agar may exhibit reduced growth of candida albicans ATCC 10231 at 30-35 degrees c. or no growth of candida albicansatcc 10231 at 20-25 degress c. over the shelf life of the product. At the time of release, all products met established requirements during quality control testing.

Trade Name

BD Difco Decarboxylase Base Moeller

Recall Posting Date

2010-02-15

Manufacturer

Becton Dickinson And Company

Recall Start Date

2009-12-15

Recall Number

52188

Hazard Classification

Type III

Model or Catalog #

289020

Lot or Serial #

9055843, 9131598

Reason for Recall

Product may not produce the correct biochemical reactions with quality control organisms over the shelf life of the product. At the time of release, all products met requirements during quality control testing.

Trade Name

Bioprep Bone Preparation System

Recall Posting Date

2010-02-15

Manufacturer

Stryker Instruments

Recall Start Date

2010-01-21

Recall Number

52914

Hazard Classification

Type II

Model or Catalog #

206-715-000

Lot or Serial #

>10 Numbers, Contact Manufacturer

Reason for Recall

Stryker Instruments has become aware that the supplier of the femoral sponge, part of the Bioprep Bone Preparation System, had no process or equipment validation and no documentation to support a 2, 3, or 5 year shelf life.

Trade Name

Blood Tubing Set for Hemodialysis

Recall Posting Date

2010-01-18

Manufacturer

Nipro Corporation

Recall Start Date

2009-11-24

Recall Number

52178

Hazard Classification

Type II

Model or Catalog #

A231TR/V811TR

Lot or Serial #

09/11

Reason for Recall

There is a possibility of the wrong pump tube connector being used in the production of this lot of bloodlines. The incorrect pump tube connector is component number TR-69, which is a closed connector. As the heparin line is assembled to this connector, if the closed type is used the heparin line will be occluded.

Trade Name

Brain Heart Infusion Broth

Recall Posting Date

2010-03-29

Manufacturer

Oxoid Limited

Recall Start Date

2009-12-10

Recall Number

52123

Hazard Classification

Type I

Model or Catalog #

CM0225B

Lot or Serial #

762134, 793640, 762133, 819692, 819693

Reason for Recall

Products have deteriorated since manufacture and may fail to support the growth of streptococcus pneumoniae.

Trade Name

Cadd-Solis Infusion Pump-AC Power Cord

Recall Posting Date

2010-03-01

Manufacturer

Smiths Medical ASD, Inc.

Recall Start Date

2010-01-29

Recall Number

52967

Hazard Classification

Type II

Model or Catalog #

21-2145-01

Lot or Serial #

0068858-1-1

Reason for Recall

Smiths Medical is conducting a recall of a limited number of AC power cords manufactured by Electri-Cord Manufacturing Co., used as an accessory with Cadd-Solis ambulatory infusion pumps. Affected cords may pose a risk of sparking, charring and fires.

Trade Name

Cell-Dyn 1700 System

Recall Posting Date

2010-02-15

Manufacturer

Abbott Laboratories Diagnostic Division

Recall Start Date

2010-01-11

Recall Number

52677

Hazard Classification

Type III

Model or Catalog #

03H57-01

Lot or Serial #

N/A

Reason for Recall

A complaint indicated a waste sensor failure on the Cell-Dyn system with a subsequent overflow splash. The investigation focussed on the waste outlet tube assembly and waste outlet tubing. It was determined that the potential for failure exists when the waste sensor is at the end of its useful life.

Trade Name

Cell-Dyn Vent Head Spring Assembly

Recall Posting Date

2010-03-01

Manufacturer

Abbott Laboratories Diagnostic Division

Recall Start Date

2010-01-26

Recall Number

52983

Hazard Classification

Type II

Model or Catalog #

01H01-01, 01H01-03, 01H02-01, 01H02-03, 01H03-01, 07H95-01(VENT HEAD SPRING)

Lot or Serial #

N/A

Reason for Recall

The vent head assembly (list number 07H95-01) is an assembly that is used on the Cell-Dyn 4000 analyzer. During manufacturing, it was determined that a component of the vent head spring assembly may be out of specification.

Trade Name

Clearcanvas RIS PACS

Recall Posting Date

2010-03-15

Manufacturer

Clearcanvas Inc.

Recall Start Date

2010-02-05

Recall Number

53081

Hazard Classification

Type III

Model or Catalog #

Workstation VX.Y

Lot or Serial #

V1.5, V1.5 sp1

Reason for Recall

In the rare case that an image composed of non-square pixels is viewed, a malfunction occurs when applying the calibration tool to the angle tool. When the calibration tool or the angle tool is applied to such an image, measured distances and angles will be incorrect.

Trade Name

Clear-Guard II Breathing Filter

Recall Posting Date

2010-03-29

Manufacturer

Intersurgical Incorporated

Recall Start Date

2010-02-11

Recall Number

53292

Hazard Classification

Type II

Model or Catalog #

1844

Lot or Serial #

2092840, 2093243

Reason for Recall

Devices labelled with the incorrect instructions for use. The product is a breathing filter and it is labelled as a heat and moisture exchanger.

Trade Name

Clearguide Precision Bipolar Devices

Recall Posting Date

2010-01-04

Manufacturer

Sorin Group USA, Inc.

Recall Start Date

2009-11-26

Recall Number

51914

Hazard Classification

Type II

Model or Catalog #

KTV15, PBD01

Lot or Serial #

0914600040, 0918700209, 0913100047, 0918700001, 0928600055,
0927200175

Reason for Recall

Sorin Group has noted an increase in the number of reports of jaw breakage on Clearguide Precision Bipolar Devices. The breakage can potentially result in a piece of the jaw remaining in the patient, if it occurs during use and goes unnoticed.

Trade Name

Cobas AmpliPrep Reagent Tip

Recall Posting Date

2010-03-29

Manufacturer

Roche Diagnostics Ltd.

Recall Start Date

2010-02-22

Recall Number

53307

Hazard Classification

Type III

Model or Catalog #

28173362001

Lot or Serial #

470266 to 483672

Reason for Recall

The manufacturer has confirmed that some reagent-tips may develop cracks in the grey plastic handle (upper region of the R-tip).

Trade Name

Concept Grafix Tendon Stripper

Recall Posting Date

2010-03-01

Manufacturer

Linvatec Corporation D.B.A. Conmed Linvatec

Recall Start Date

2010-02-05

Recall Number

53020

Hazard Classification

Type II

Model or Catalog #

TS8850

Lot or Serial #

11708A, 11708B, 11708C, 11708D

Reason for Recall

There is the possibility the tip of the Grafix Tendon Stripper may break and potentially cause injury to the user or patient.

Trade Name

ConchaTherm Neptune Heated Humidifiers

Recall Posting Date

2010-02-15

Manufacturer

Teleflex Medical

Recall Start Date

2010-01-12

Recall Number

52699

Hazard Classification

Type II

Model or Catalog #

425-00

Lot or Serial #

All lots

Reason for Recall

Teleflex Medical have received reports of artifacts being generated in patient monitors. It occurs when the heated wire breathing circuits are used in close proximity to the leads and electrodes of patient monitors, and where electrical conductivity has degraded.

Trade Name

Conmed Linvatec 24K Irrigation Console

Recall Posting Date

2010-02-15

Manufacturer

Linvatec Corporation D.B.A. Conmed Linvatec

Recall Start Date

2010-01-15

Recall Number

52745

Hazard Classification

Type III

Model or Catalog #

24K

Lot or Serial #

BBC84446, BBC84448, BBC94618, BBC94619, BBC94634, BBD71500

Reason for Recall

The manufacturer has determined the 24k irrigation console has created customer satisfaction issues - reports of frequent error codes and cassette disengagement.

Trade Name

Coseal Surgical Sealant

Recall Posting Date

2010-02-01

Manufacturer

Baxter Healthcare Corporation

Recall Start Date

2010-01-14

Recall Number

52696

Hazard Classification

Type III

Model or Catalog #

934070, 934071

Lot or Serial #

HA081216, HA090225, HA090342

Reason for Recall

The recall is being conducted as a precautionary measure due to out of specification (OOS) results observed at the 18-month and 21-month time points (out of 24-month licensed shelf life) during a Coseal stability study. The OOS parameter is an indicator of possible failure for the product to gel appropriately.

Trade Name

Crotor

Recall Posting Date

2010-01-04

Manufacturer

Siemens Healthcare Diagnostics Inc.

Recall Start Date

2009-12-08

Recall Number

52101

Hazard Classification

Type II

Model or Catalog #

Crotor

Lot or Serial #

NH42-251-09

Reason for Recall

Siemens Healthcare Diagnostics has received customer complaints regarding Crotor, an accessory part, lot NH42-251-09 for the Stratus CS Stat Fluorometric Analyzer. There is a low frequency defect in the gel filling of this lot that may result in inadequate separation of cells during centrifugation.

Trade Name

CW High Resolution SSP Unitray Kit

Recall Posting Date

2010-02-01

Manufacturer

Invitrogen Corporation

Recall Start Date

2010-01-08

Recall Number

52540

Hazard Classification

Type III

Model or Catalog #

47190-10

Lot or Serial #

005/678905

Reason for Recall

Product base pair size for a PCR Amplicon was incorrectly labelled on product documentation. For the affected CW Locus Kits, the product size for a primer mix was labelled as 110 base pairs where it should have been 200 base pairs. This problem does not cause a mistyping or a no typing, but it may cause confusion within interpretation.

Trade Name

Cyberknife Robotic Radiosurgery System

Recall Posting Date

2010-03-01

Manufacturer

Accuray, Inc.

Recall Start Date

2010-01-18

Recall Number

52935

Hazard Classification

Type II

Model or Catalog #

Software Versions 3.0, 3.1, 3.5.0, 3.5.1

Lot or Serial #

N/A

Reason for Recall

When a user modified the align center of an existing plan during the treatment planning process the effective depths of each beam on the plan were not updated by the system. These depths were incorrect and led to an incorrect dose calculation. The erroneous dose was not delivered to the patient therefore serious injury did not occur.

Trade Name

CyberKnife Robotic Radiosurgery System

Recall Posting Date

2010-02-01

Manufacturer

Accuray, Inc.

Recall Start Date

2009-12-29

Recall Number

52664

Hazard Classification

Type II

Model or Catalog #

30000

Lot or Serial #

C202

Reason for Recall

As part of commissioning the treatment planning system, the user is required to obtain and enter the CT number to relative electron density and CT number to mass density calibration curves for a given CT scanner. If the electron density values are empty, the calculation of radiation dose in the patient will be modelled as air - like density material rather than the correct density. By using this incorrect model, plans saved and created as deliverable will display a radiation dose that is incorrect.

Trade Name

Dexcam 2 Intraoral Camera

Recall Posting Date

2010-01-04

Manufacturer

Gendex Corporation

Recall Start Date

2009-07-17

Recall Number

50039

Hazard Classification

Type III

Model or Catalog #

PLU752

Lot or Serial #

N/A

Reason for Recall

The Dexcam 2 Intraoral Cameras will fail upon install. The driver software was inadvertently updated causing an interface issue between the camera driver software and application software.

Trade Name

Dimension Vista System

Recall Posting Date

2010-03-29

Manufacturer

Siemens Healthcare Diagnostics Inc.

Recall Start Date

2010-02-25

Recall Number

53327

Hazard Classification

Type III

Model or Catalog #

KC120

Lot or Serial #

9GM001

Reason for Recall

Siemens Healthcare Diagnostics received customer complaints regarding Dimension Vista System, Chemistry 2 Calibrator KC120. An alert message "calibrator insert missing" comes up when scanning the vial barcode for chem 2 cal level B lot 9GM001. An investigation of the barcode indicates that there are two additional digits in the barcode sequence.

Trade Name

Dimension Vista System Ecrea Flex Cart.

Recall Posting Date

2010-03-01

Manufacturer

Siemens Healthcare Diagnostics Inc.

Recall Start Date

2010-02-02

Recall Number

52989

Hazard Classification

Type III

Model or Catalog #

K1270

Lot or Serial #

09224aa

Reason for Recall

Siemens Healthcare Diagnostics received customer complaints regarding Dimension Vista Ecrea Flex results when using lot 09224aa. Siemens has confirmed complaints of inaccurate results. The test results may be falsely depressed or elevated and only a portion of the lot is affected.

Trade Name

Dimension Vista System-Chem Calibrators

Recall Posting Date

2010-01-04

Manufacturer

Siemens Healthcare Diagnostics Inc.

Recall Start Date

2009-09-10

Recall Number

50778

Hazard Classification

Type III

Model or Catalog #

KC110

Lot or Serial #

9DM001

Reason for Recall

Siemens has confirmed that this lot number may result in high recovery of quality control, results show a positive bias of quality control results of up to 23% at uric acid concentrations of 3.5 mg/dl and 9.6 mg/dl.

Trade Name

DRB1*04 SSP Unitray

Recall Posting Date

2010-03-29

Manufacturer

Invitrogen Corporation

Recall Start Date

2009-12-15

Recall Number

53386

Hazard Classification

Type III

Model or Catalog #

45040-4, 45041-4

Lot or Serial #

010/529773, 010/576600, 010/617620, 010/650982, 010/660310, 010/670484, 010/706704, 010/712450

Reason for Recall

Lane 27 (R04-28A) in the DRB1*04 SSP Unitray Kit lots and batches mentioned, was found to produce a false positive band in the correct base pair size. This will affect typing results on samples that are DRB1*0401 homozygotes, since they could be erroneously reported as DRB1*0426.

Trade Name

DRB1*08 SSP Unitray

Recall Posting Date

2010-02-01

Manufacturer

Invitrogen Corporation

Recall Start Date

2010-01-06

Recall Number

52297

Hazard Classification

Type III

Model or Catalog #

450504D

Lot or Serial #

010/652266

Reason for Recall

Field safety notice issued to inform customers that 200904v1 allele update .uch files on certain High Resolution kits, do not separate cross locus alleles string results when creating reports in UniMatch v4.01. With UniMatch software interpretation, this causes a no typing. With manual worksheet interpretation, customers are not affected and receive a correct typing.

Trade Name

DRB1*11 SSP Unitry

Recall Posting Date

2010-02-15

Manufacturer

Invitrogen Corporation

Recall Start Date

2009-12-22

Recall Number

52859

Hazard Classification

Type III

Model or Catalog #

450604D

Lot or Serial #

011 536591

Reason for Recall

Affected kits of DRB1*11 SSP Unitray produce a false negative in lane 11 in the presence of DRB1*1165. A laboratory would be unable to identify the sample as a DRB1*1165.

Trade Name

DSL-8600 Active Aldosterone RIA

Recall Posting Date

2010-01-18

Manufacturer

Diagnostic Systems Laboratories Inc., DSL

Recall Start Date

2009-12-23

Recall Number

52318

Hazard Classification

Type III

Model or Catalog #

DSL-8600

Lot or Serial #

991343, 991582, 991947, 991948, 991855, 992113, 992290

Reason for Recall

Beckman Coulter has determined that random failures of standards and/or controls have been noted for several lot numbers of Aldosterone.

Trade Name

Dycal Radiopaque Calcium Hydroxide Composition Cavity Base/Liner

Recall Posting Date

2010-03-29

Manufacturer

Dentsply Caulk

Recall Start Date

2010-02-08

Recall Number

53377

Hazard Classification

Type II

Model or Catalog #

623400, 623401Y, 623450, 623451Y, 623701, 623702

Lot or Serial #

091002, 091106, 091013, 091017, 090919, 091120, 091218, 091022, 090925

Reason for Recall

Several recent lots of Dycal may exhibit faster setting characteristics than is normal for these products. The catalyst may also seem thicker than usual when extruded from the tube.

Trade Name

Dyonics 25 Fluid Management System-Patient Tube Set

Recall Posting Date

2010-03-29

Manufacturer

Smith & Nephew, Inc., Endoscopy Division

Recall Start Date

2010-02-19

Recall Number

53313

Hazard Classification

Type II

Model or Catalog #

7211008

Lot or Serial #

32109Y

Reason for Recall

During the assembly of the product(Dyonics 25 Fluid Management System-Patient Tube Set), the check valve was assembled backwards which prevents fluid from passing beyond the check valve. There is no opportunity to correct or modify the check valve assembly.

Trade Name

Ear Thermometer model 49531

Recall Posting Date

2010-02-01

Manufacturer

Dorel Juvenile Group, A Division Of Dorel Industries Inc.

Recall Start Date

2009-09-17

Recall Number

52685

Hazard Classification

Type II

Model or Catalog #

49531

Lot or Serial #

0805, 0806

Reason for Recall

Some complaints of battery leakage on the infrared ear thermometer, model 49531. DDC requested stop sale and remove from shelves.

Trade Name

Eclipse

Recall Posting Date

2010-02-15

Manufacturer

Varian Medical Systems, Inc.

Recall Start Date

2009-12-09

Recall Number

52741

Hazard Classification

Type II

Model or Catalog #

V.6.5

Lot or Serial #

>10 Numbers, Contact Manufacturer

Reason for Recall

An error in Eclipse appears when multiple carriage group dynamic MLC fields are generated from a plan that has had its primary reference point deleted.

Trade Name

Eclipse Oxygen System, Model 1000

Recall Posting Date

2010-02-01

Manufacturer

Sequal Technologies Inc.

Recall Start Date

2009-11-12

Recall Number

52267

Hazard Classification

Type II

Model or Catalog #

Model 1000

Lot or Serial #

>10 Numbers, Contact Manufacturer

Reason for Recall

Sequal Technologies Inc. has identified that some Eclipse Oxygen System (model 1000) units may experience premature wear on an electrical connector between the battery bridge printed circuit board and the power manager printed circuit board that could lead to a temporary power interruption when operating from the power cartridge.

Trade Name

Electrical Adapter

Recall Posting Date

2010-02-15

Manufacturer

Fisher And Paykel Healthcare Ltd.

Recall Start Date

2009-07-15

Recall Number

52720

Hazard Classification

Type III

Model or Catalog #

900MR801

Lot or Serial #

All lots

Reason for Recall

Replace older model with new model that provides surge protection hardware that will reduce the risk of breathing circuit heater wire malfunction.

Trade Name

Entake Tri-Funnel G-Tube

Recall Posting Date

2010-03-29

Manufacturer

Conmed Endoscopic Technologies, Inc.

Recall Start Date

2010-03-01

Recall Number

53424

Hazard Classification

Type II

Model or Catalog #

RMGB1400, RMGB1800, RMGB2000, RMGB2400

Lot or Serial #

>10 Numbers, Contact Manufacturer

Reason for Recall

The lubricating jelly packet contained within the kit may have an expiration date that expires prior to the expiration date stated on the product label.

Trade Name

Eosin Stain SS035C

Recall Posting Date

2010-03-29

Manufacturer

Wescor Inc.

Recall Start Date

2010-01-12

Recall Number

53028

Hazard Classification

Type II

Model or Catalog #

N/A

Lot or Serial #

102366, 102783, 130108, 103492, 103839, 104398, 104844, 105163

Reason for Recall

Products contain bacterial contamination and precipitate.

Trade Name

Estrone Radioimmunoassay (RIA) Kit

Recall Posting Date

2010-01-04

Manufacturer

Diagnostic Systems Laboratories Inc., DSL

Recall Start Date

2009-12-03

Recall Number

52196

Hazard Classification

Type III

Model or Catalog #

N/A

Lot or Serial #

991913, 992114, 992165, 991735, 991736

Reason for Recall

Beckman Coulter customers reported that results for the Estrone Radioimmunoassay (RIA) Kit Control I were reading higher than the confidence limits provided on the vial.

Trade Name

EV3 Silverhawk Cutter Driver

Recall Posting Date

2010-03-01

Manufacturer

EV3 Inc.

Recall Start Date

2010-01-29

Recall Number

53104

Hazard Classification

Type II

Model or Catalog #

N/A

Lot or Serial #

7497872, 7408387, 7505507, 7516513, 7381976

Reason for Recall

Some lots of the EV3 Silverhawk Cutter Driver, model FG 02550, may have been damaged during the manufacturing process thereby compromising the sterile barrier of the cutter driver.

Trade Name

Evacuated Containers

Recall Posting Date

2010-03-29

Manufacturer

Baxter Healthcare Corporation

Recall Start Date

2010-02-19

Recall Number

53325

Hazard Classification

Type III

Model or Catalog #

1A8502, 1A8503, 1A8504

Lot or Serial #

>10 Numbers, Contact Manufacturer

Reason for Recall

During stability testing an out of specification PH was found prior to the 12 month expiry date in the various product code glass bottles.

Trade Name

Exactamix Empty Eva Container

Recall Posting Date

2010-01-04

Manufacturer

Baxa Corporation

Recall Start Date

2009-11-12

Recall Number

52180

Hazard Classification

Type II

Model or Catalog #

738, 739, 740

Lot or Serial #

>10 Numbers, Contact Manufacturer

Reason for Recall

Complaints were received for gross leaks or disengaging of the administration port of multiple lots of Exactamix bags. Product testing revealed that an intermittent automatic manufacturing problem resulted in mis-assembly of the center port. The solvent (cyclohexanone) used to fuse the port assembly to the bag was missed or inadequately applied.

Trade Name

Express 4 Statspin Centrifuge

Recall Posting Date

2010-03-29

Manufacturer

Statspin Incorporated
DBA Iris Sample Processing

Recall Start Date

2010-02-08

Recall Number

53141

Hazard Classification

Type II

Model or Catalog #

SSH4

Lot or Serial #

Start # 00100. Ending # 001679

Reason for Recall

Possibility of rotor disrupting and pieces of a rotor and sample ejecting from the housing. This may result in serious personal injury and damage to the surrounding area.

Trade Name

EZCARE Negative Pressure Wound Therapy System

Recall Posting Date

2010-03-01

Manufacturer

Smith & Nephew Inc. Wound Management Division

Recall Start Date

2010-01-27

Recall Number

53008

Hazard Classification

Type II

Model or Catalog #

P/N 66800187

Lot or Serial #

Serial Numbers Starting With E07

Reason for Recall

The EZCARE have exhibited inconsistent battery performance and may after repeated battery charging cycles, experience battery failure due to overheating when charging for a prolonged period.

Trade Name

Flow-Count Fluorospheres

Recall Posting Date

2010-01-18

Manufacturer

Beckman Coulter, Inc.

Recall Start Date

2009-12-22

Recall Number

52319

Hazard Classification

Type III

Model or Catalog #

7547053

Lot or Serial #

754805F

Reason for Recall

Beckman Coulter has identified problem with the Flow-Count Fluorospheres reagent, lot number 7548054F. The reagent is showing intermittent absolute count recovery failures for mid-point closed vial testing with Immunotrol control cell on the two color panel.

Trade Name

Fresenius 2008H Hemodialysis Machine

Recall Posting Date

2010-01-18

Manufacturer

Fresenius USA, Inc.

Recall Start Date

2009-06-18

Recall Number

49355

Hazard Classification

Type II

Model or Catalog #

150254, 501228, 507115

Lot or Serial #

>100 Numbers, Contact Manufacturer

Reason for Recall

User errors during conversion of concentrate types on the model 2008H Hemodialysis machine has led to exposure of some patients to incorrect dialysate concentrations.

Trade Name

Galileo Echo Blood Bank Analyzer

Recall Posting Date

2010-03-29

Manufacturer

Immucor Inc.

Recall Start Date

2010-02-22

Recall Number

53353

Hazard Classification

Type II

Model or Catalog #

0087000

Lot or Serial #

N/A

Reason for Recall

Immucor is investigating complaints of sporadic no type determined interpretations (NTD) due to unexpected equivocal or unexpected weak positive reactions for various test wells of hemagglutinaton based assays on the echo.

Trade Name

GlucoPro Insulin Syringes

Recall Posting Date

2010-02-15

Manufacturer

Nipro Corporation

Recall Start Date

2010-01-19

Recall Number

52753

Hazard Classification

Type II

Model or Catalog #

JD+01U3108-5C

Lot or Serial #

A08013-000500, B08013-000500, C08013-000500

Reason for Recall

These syringes may have needles that separate from the syringe.

Trade Name

Guider Softip Guiding Catheter

Recall Posting Date

2010-01-18

Manufacturer

Boston Scientific Corporation

Recall Start Date

2009-12-21

Recall Number

52296

Hazard Classification

Type II

Model or Catalog #

N/A

Lot or Serial #

>100 Numbers, Contact Manufacturer

Reason for Recall

Potential for a distal section of the catheter to degrade following exposure to UV (i.e. sunlight) or fluorescent (i.e. office) light and reminded users to store the device in a cool, dry, dark area.

Trade Name

Handi-Fil Disposable Syringe Fill Tube

Recall Posting Date

2010-03-01

Manufacturer

Tyco Healthcare Liebel-Flarsheim Company

Recall Start Date

2010-02-03

Recall Number

53027

Hazard Classification

Type II

Model or Catalog #

302050

Lot or Serial #

7159027

Reason for Recall

The manufacturer received reports of sterilized packages, of Handi-Fil Disposable Syringe Fill Tube, that are unsealed.

Trade Name

HeartStart FR2+ AED

Recall Posting Date

2010-01-18

Manufacturer

Philips Medical Systems

Recall Start Date

2009-10-22

Recall Number

51392

Hazard Classification

Type II

Model or Catalog #

M3860A, M3861A

Lot or Serial #

>10 Numbers, Contact Manufacturer

Reason for Recall

The Heartstart FR2+ AED may contain a memory chip that has a higher than expected rate of failure. Failure of this chip could render the AED inoperable and prevent it from delivering therapy when indicated.

Trade Name

HeartStart MRx DC Power Module

Recall Posting Date

2010-01-18

Manufacturer

Philips Medical Systems

Recall Start Date

2009-12-01

Recall Number

51950

Hazard Classification

Type II

Model or Catalog #

M5529A

Lot or Serial #

N/A

Reason for Recall

With regard to accessories for the HeartStart MRx portable external defibrillator (M5528A - MRx vehicle wall mount and M5529A - DC Power Module), it was determined that under certain conditions, a smoke or fire hazard to patients or caregivers in proximity to the vehicle wall mount could occur. This happens only when both the vehicle wall mount and DC Power Module are installed together and, if the user modifies the product. More specifically, it was found this only occurs if the user modifies the DC output cable from either the DC Power Module and/or the electrical connector on the wall mount by cutting/splicing or soldering.

Trade Name

hm550OVP Cryostat

Recall Posting Date

2010-03-29

Manufacturer

Thermo Anatomical Pathology Microm

Recall Start Date

2009-12-04

Recall Number

53235

Hazard Classification

Type II

Model or Catalog #

36 101 3493

Lot or Serial #

45847

Reason for Recall

Cryostat serial 45847 may have been built using an incorrect cable with undersized diameter. It could potentially cause cable to overheat and to break. If instrument not grounded according to IFU a severe risk of electric shock may result.

Trade Name

Immage Alpha2-Macroglobulin AMG Reagent

Recall Posting Date

2010-01-04

Manufacturer

Beckman Coulter Inc.

Recall Start Date

2009-09-15

Recall Number

50959

Hazard Classification

Type II

Model or Catalog #

447790

Lot or Serial #

M806252 ,M901414

Reason for Recall

The Immage AMG Reagent shows a possible prozone affect for samples within the extended measuring range.

Trade Name

Implant Extraction Set

Recall Posting Date

2010-03-29

Manufacturer

Stryker Trauma GMBH

Recall Start Date

2010-02-09

Recall Number

53127

Hazard Classification

Type II

Model or Catalog #

1806-6150, 1806-6151, 1806-6162

Lot or Serial #

Brochure Lot # A3507, B2208, Device Lot # All

Reason for Recall

Stryker has become aware that there is potential for the brochure to mislead the user into choosing a non-suitable extraction instrument.

Trade Name

In-Situ Bender/Cutter

Recall Posting Date

2010-02-15

Manufacturer

Synthes (Canada) Ltd.

Recall Start Date

2010-01-14

Recall Number

52185

Hazard Classification

Type I

Model or Catalog #

530.521S

Lot or Serial #

N/A

Reason for Recall

The In-Situ bender/cutter, wide, sterile has been found to have a potential for the attachment to continue heating after release of the power button.

Trade Name

Internal Defibrillation Paddles

Recall Posting Date

2010-03-29

Manufacturer

Philips Medical Systems

Recall Start Date

2010-01-19

Recall Number

53041

Hazard Classification

Type II

Model or Catalog #

M4741A, M4742A, M4743A, M4744A

Lot or Serial #

0908, 1008, 1108, 1208

Reason for Recall

The discharge switch on the handle in affected devices may stick or fail to actuate and prevent the user from delivering defibrillation therapy. This was caused by a manufacturing defect in the paddle switch assembly. This only affects units with date codes (mmyy) of 0908, 1008, 1108, 1208 (units manufactured between September 1, 2008 and December 30, 2008).

Trade Name

Internal Indirect Transfer Copings

Recall Posting Date

2010-03-29

Manufacturer

Biohorizons Implant Systems, Inc.

Recall Start Date

2010-03-04

Recall Number

53487

Hazard Classification

Type III

Model or Catalog #

PBRIC, PGRIC, PYRIC

Lot or Serial #

0902025, 0900980, 0902585, 0903089, 0901112

Reason for Recall

The parts were manufactured with the external flat aligned with the point of the hex instead of the flat of the hex.

Trade Name

Internal Oxygen Sensor

Recall Posting Date

2010-01-04

Manufacturer

Teleflex Medical

Recall Start Date

2009-11-25

Recall Number

51957

Hazard Classification

Type III

Model or Catalog #

5804

Lot or Serial #

906003

Reason for Recall

Teleflex Medical has been notified by their supplier of a premature "low sensor" indication on the internal oxygen sensor, catalogue number #5804. The defect will prematurely indicate a "low sensor" reading causing the end user to conduct preventative maintenance earlier than necessary.

Trade Name

i-Stat 1 Analyzer

Recall Posting Date

2010-01-18

Manufacturer

Abbott Point Of Care Inc.

Recall Start Date

2009-09-14

Recall Number

52261

Hazard Classification

Type II

Model or Catalog #

06F16-10

Lot or Serial #

N/A

Reason for Recall

The storage temperature on the label on the side of analyzer box does not match product specification. Label indicates storage condition of -20c to 50c. Product specification is -10c to 46c. Damage may occur to some components of the analyzer should the unit be stored at the extremes of temperature indicated on the incorrect label.

Trade Name

Jam Shidi Needles

Recall Posting Date

2010-02-01

Manufacturer

Stryker Spine SAS

Recall Start Date

2009-12-30

Recall Number

52532

Hazard Classification

Type II

Model or Catalog #

N/A

Lot or Serial #

48237105, 48237110, 48237115, 48237135, Serial Number: All

Reason for Recall

Stryker Spine was made aware of the potential for the packaging of the Jam Shidi Needles to fail during shipment. Product experience reports (PER) indicate the peel pouch may be scratched which may compromise sterility of the product.

Trade Name

Koordinat M/MP
Updated Recall # 50747 previously posted on 2009-12-21.
A) Neurostar
B) Coroskop
C) Angiostar
D) Multistar

Recall Posting Date

2010-03-01

Manufacturer

Siemens AG

Recall Start Date

2009-08-13

Recall Number

50747

Hazard Classification

Type III

Model or Catalog #

05294003, 06239003, 4414905
A) 44 14 731
B) 4415019
C) 4413642
D) 4416058

Lot or Serial #

>10 Numbers, Contact Manufacturer
A) 1489
B) 1442
C) 1491
D) 1492

Reason for Recall

If the swivel locking mechanism is not completely engaged into position, during patient transfer, the table may unintentionally swivel, could result in uncontrolled patient movement during transfer, patient falling to the floor.

Trade Name

K-Tips on Cobas Ampliprep

Recall Posting Date

2010-03-01

Manufacturer

Roche Diagnostics Ltd

Recall Start Date

2009-08-06

Recall Number

50275

Hazard Classification

Type III

Model or Catalog #

03287343001

Lot or Serial #

09004108, 09005108

Reason for Recall

The affected lots contain K-Tips that are completely closed (near the pipetting end of the K-Tips), which prevents the Cobas Ampliprep instrument from pipetting the processed sample from the sample processing unit into the K-tube.

Trade Name

Lantis

Recall Posting Date

2010-01-04

Manufacturer

Siemens Medical Solutions USA, INC. Oncology Care Systems

Recall Start Date

2009-08-26

Recall Number

50982

Hazard Classification

Type III

Model or Catalog #

4503178

Lot or Serial #

93-0083, 93-1091

Reason for Recall

When editing the note type of a previously entered note and then changing the note type again back to the original note type, the other notes defined with that same note type may 'disappear' from the echart navigator view.

Trade Name

Leveen Coaccess Electrode System

Recall Posting Date

2010-01-04

Manufacturer

Boston Scientific Corporation

Recall Start Date

2009-07-10

Recall Number

50071

Hazard Classification

Type II

Model or Catalog #

26-216, 26-217

Lot or Serial #

>100 Numbers, Contact Manufacturer

Reason for Recall

During a procedure, the umbrella of the Leveen Needle Electrode- 5cm may become detached from the core wire.

Trade Name

Lifecycle For Prenatal Screening

Recall Posting Date

2010-03-01

Manufacturer

Wallac OY

Recall Start Date

2010-02-02

Recall Number

52863

Hazard Classification

Type II

Model or Catalog #

5002-0020

Lot or Serial #

V3.0 REV2, REV3, REV4

Reason for Recall

A false screening risk score can be potentially reported when users try to correct originally misentered data.

Trade Name

Lumenis One

Recall Posting Date

2010-01-04

Manufacturer

Lumenis Ltd.

Recall Start Date

2009-12-03

Recall Number

52100

Hazard Classification

Type II

Model or Catalog #

GAL 150000

Lot or Serial #

>10 Numbers, Contact Manufacturer

Reason for Recall

To address a found computer glitch, which when adjusting the default settings in intense pulse light triple pulse mode, it has been found that the GUI display does not accurately display the true adjusted power.

Trade Name

Mammomat Inspiration

Recall Posting Date

2010-01-04

Manufacturer

Siemens AG

Recall Start Date

2009-10-27

Recall Number

51424

Hazard Classification

Type III

Model or Catalog #

10140000

Lot or Serial #

1151, 1164, 1423, 1466, 1474, 1468, 1384

Reason for Recall

Modification of the software operating the procedure for stereotactic biopsy because when executed with a compression factor force less than 15 newtons the required accuracy cannot be assured.

Trade Name

Martel Printer Accessory to i-Stat 1

Recall Posting Date

2010-02-15

Manufacturer

Abbott Point Of Care Inc.

Recall Start Date

2010-01-04

Recall Number

52533

Hazard Classification

Type II

Model or Catalog #

06F16-10, 06F21-35(Printer)

Lot or Serial #

N/A

Reason for Recall

Martel Printers used with the i-Stat System may become damaged due to the use of rechargeable battery packs that do not contain a fuse which have been purchased from suppliers other than Abbott Point of Care. This notice reminds customers to only use the recommended battery available through Abbott Point of Care.

Trade Name

Martel Printer Accessory To i-Stat 1

Recall Posting Date

2010-01-04

Manufacturer

Abbott Point Of Care Inc.

Recall Start Date

2009-11-09

Recall Number

51869

Hazard Classification

Type II

Model or Catalog #

06F16-10, 06F23-91(Printer)

Lot or Serial #

>10 Numbers, Contact Manufacturer

Reason for Recall

Although there have been no reported incidents, there is a possibility that the significant overheating of the printer due to a tantalum capacitor component failure could lead to a potential fire hazard. To date there have been no reported incidents related to a capacitor failure.

Trade Name

Medline Self Sealing Sterilization Pouches

Recall Posting Date

2010-03-01

Manufacturer

Medline Industries Inc.

Recall Start Date

2010-01-22

Recall Number

52864

Hazard Classification

Type II

Model or Catalog #

MPP100520, MPP100525, MPP100545, MPP100546, MPP100550, MPP100555, MPP100558, MPP100565

Lot or Serial #

All lots

Reason for Recall

The self seal adhesive strip of the sterilization pouch may lose partial strength during steam sterilization which may compromise the seal in isolated areas of the adhesive. This could create a non-sterile pathway into the pouch after sterile processing.

Trade Name

Millex 33 Syringe Filter Unit

Recall Posting Date

2010-01-04

Manufacturer

Millipore Ireland B.V.

Recall Start Date

2009-11-24

Recall Number

52075

Hazard Classification

Type II

Model or Catalog #

SLGVM33RS

Lot or Serial #

R8PN37631

Reason for Recall

Millipore Corporation has determined that one lot (lot number: R8PN37631) of Millex 33 Syringe Filter Units, catalogue number SLGVM33RS may have potential membrane integrity defects, and thus does not meet Millipore's specifications.

Trade Name

Neoblue Mini LED Phototherapy System

Recall Posting Date

2010-01-04

Manufacturer

Natus Medical Inc.

Recall Start Date

2009-10-08

Recall Number

51237

Hazard Classification

Type II

Model or Catalog #

10101

Lot or Serial #

61048, 61049, 62311, 62312, 60001-62656

Reason for Recall

The clamp that connects the Neoblue Mini Phototherapy light to the accessory pole stand has shown stress fractures or broken when tightened with excessive force.

Trade Name

Nexgen Complete Knee Solution, MIS

Recall Posting Date

2010-01-04

Manufacturer

Zimmer Inc.

Recall Start Date

2009-12-10

Recall Number

52161

Hazard Classification

Type II

Model or Catalog #

00-5954-057-02

Lot or Serial #

61225562, 61235612, 61240323, 61248321, 61259184, 61272449, 61280371, 61315873, 61319581, 61068388

Reason for Recall

The bond strength between the trabecular metal and the titanium substrate of affected units of the Nexgen Complete Knee Solution MIS procedures trabecular metal technology tibial tray fixed bearing (size 8) may not be to specification and the two components could disassociate in some areas of the construct.

Trade Name

Nexgen Complete Knee, Stemmed Tibial

Recall Posting Date

2010-03-01

Manufacturer

Zimmer Inc.

Recall Start Date

2010-01-27

Recall Number

52954

Hazard Classification

Type II

Model or Catalog #

00598004702

Lot or Serial #

61246477

Reason for Recall

This action is being conducted because the affected lot of Nexgen Complete Solution Stemmed Tibial component implants may have incorrectly seated or loose flange plugs.

Trade Name

Nexus 3

Recall Posting Date

2010-02-01

Manufacturer

Dana Douglas Inc.

Recall Start Date

2009-12-21

Recall Number

52174

Hazard Classification

Type II

Model or Catalog #

4500185F, 4500225F, 4500245F

Lot or Serial #

>10 Numbers, Contact Manufacturer

Reason for Recall

Manufacturer has received a large number of complaints and has determined that the Nexus 3 product may experience weakening just below the weld on the rear frame which could result in breakage below the weld. No injuries have been reported.

Trade Name

Nexus 3

Recall Posting Date

2010-02-01

Manufacturer

Dana Douglas Inc.

Recall Start Date

2009-12-14

Recall Number

52171

Hazard Classification

Type III

Model or Catalog #

4500185F, 4500225F, 4500245F

Lot or Serial #

>10 Numbers, Contact Manufacturer

Reason for Recall

A dealer called to report that a rollator returned by a customer had a faulty brake that would not lock - it was "jammed". They could not determine the cause of the problem and asked us to inspect.

Trade Name

Nexus 3
Updated recall # 52174 previously posted on 2010-02-01

Recall Posting Date

2010-03-29

Manufacturer

Dana Douglas Inc.

Recall Start Date

2009-12-21

Recall Number

52174

Hazard Classification

Type II

Model or Catalog #

4500185F, 4500225F, 4500245F

Lot or Serial #

>10 Numbers, Contact Manufacturer

Reason for Recall

Rollators manufactured prior to September 18, 2008 may experience a weakening just below the weld on the rear frame which could result in breakage when used by consumers above 187 pounds to a maximum of 250 pounds. If breakage occurs the user could fall and suffer injury including broken bones and bruising. 145 incidents with no injuries have been reported.

Trade Name

OEC 9800 Plus Mobile Digital Imaging

Recall Posting Date

2010-01-18

Manufacturer

GE OEC Medical Systems Inc.

Recall Start Date

2009-12-18

Recall Number

51836

Hazard Classification

Type II

Model or Catalog #

00-870632-05, 2274023

Lot or Serial #

>100 Numbers, Contact Manufacturer

Reason for Recall

A replacement Hitachi 160GB hard drive, when installed on certain GE OEC 9800 models, is susceptible of causing unanticipated system shut downs, no boots, data loss or data mix or hard drive corruption.

Trade Name

One Way Valve

Recall Posting Date

2010-01-04

Manufacturer

Teleflex Medical

Recall Start Date

2009-04-12

Recall Number

52132

Hazard Classification

Type II

Model or Catalog #

1665

Lot or Serial #

02J0901967

Reason for Recall

Packaging error where a One Way Valve catalogue number #1664 was incorrectly labelled as a One Way Valve catalogue number #1665. The error is limited to lot number 02J0901967.

Trade Name

OneTouch Ping Insulin Infusion Pump

Recall Posting Date

2010-01-18

Manufacturer

Animas Corporation

Recall Start Date

2009-12-22

Recall Number

52349

Hazard Classification

Type III

Model or Catalog #

100-430-51, 100-431-51, 100-432-51, 100-434-51, 100-435-51

Lot or Serial #

>100 Numbers, Contact Manufacturer

Reason for Recall

Incorrect configuration setting cause incompatibility between the OneTouch Ping Insulin Pump and EZmanager Max Diabetes Management Software, affecting the ability to download, view, and print pump information.

Trade Name

Onetouch Ultra Test Strips (Lot # 2953920)

Recall Posting Date

2010-02-15

Manufacturer

Lifescan Inc.

Recall Start Date

2010-01-10

Recall Number

52899

Hazard Classification

Type III

Model or Catalog #

020-384

Lot or Serial #

2953920

Reason for Recall

A hole in the outer test strip container exposing the desiccant sleeve.

Trade Name

OneTouch UltraSmart Blood Glucose Meter

Recall Posting Date

2010-03-01

Manufacturer

Lifescan Inc.

Recall Start Date

2010-02-12

Recall Number

53142

Hazard Classification

Type II

Model or Catalog #

020-720

Lot or Serial #

V0909034X

Reason for Recall

Twenty-three Canadian OneTouch UltraSmart meters were set to the incorrect unit of measurement (mg/dl instead of mmol/l).

Trade Name

Orthodontic Liquid DP-Ortho (Crystal)

Recall Posting Date

2010-03-15

Manufacturer

DenPlus Inc.

Recall Start Date

2009-11-11

Recall Number

52948

Hazard Classification

Type III

Model or Catalog #

DP-ORTHO-C

Lot or Serial #

091028A

Reason for Recall

DP-Ortho Crystal orthodontic liquid, lot 091028A, may have decreased efficiency in terms of polymerisation.

Trade Name

Philips Eclipse 1.5T MRI System

Recall Posting Date

2010-02-15

Manufacturer

Philips Medical Systems (Cleveland), Inc.

Recall Start Date

2009-11-20

Recall Number

52913

Hazard Classification

Type II

Model or Catalog #

OFF-ML-1

Lot or Serial #

N34528, N11963

Reason for Recall

The RF connector block on the tabletop has the potential to smoke and ignite during scanning due to a combination of arcing of electrical components below the connector and the flame rating of the connector block material.

Trade Name

Piccolo Comprehensive Metabolic Panel

Recall Posting Date

2010-02-01

Manufacturer

Abaxis Inc.

Recall Start Date

2009-11-17

Recall Number

52289

Hazard Classification

Type II

Model or Catalog #

36 101 4431

Lot or Serial #

9284AC2

Reason for Recall

Bar code rings were mistakenly used in the manufacture of a small number of lot 9284AC2 Comprehensive Metabolic Panel rotors at the very end of the manufacture run. This resulted in incorrect calibration factors being applied to the calculation of the measured values for serum creatinine on a sub-set of rotors. Serum levels will be slightly lower.

Trade Name

Pneumo Sure Heated Tube Set

Recall Posting Date

2010-03-15

Manufacturer

Stryker Endoscopy

Recall Start Date

2010-02-09

Recall Number

53130

Hazard Classification

Type III

Model or Catalog #

0620-040-690

Lot or Serial #

102008W, 011609W, 011709W, 003109W, 003809W, 010509W, 011909W, 089608W, 003609W, 095009W

Reason for Recall

Stryker Endoscopy has become aware that the Pneumo Sure Heated Tube Set has the potential to display an error message stating "check/change tube set" and then the flow drops to a maximum of 11 liters/minute. If the issue is not resolved, pneumoperitoneum may take longer to establish due to the limited flow.

Trade Name

Powerheart AED G3

Recall Posting Date

2010-02-15

Manufacturer

Cardiac Science Corporation

Recall Start Date

2009-12-23

Recall Number

52710

Hazard Classification

Type II

Model or Catalog #

9390A-501

Lot or Serial #

Serial # 4261416, 4261417, 4261123, 4261144, 4261383, 4261387,4261403, 4261408, 4261411

Reason for Recall

Cardiac Science identified 65 reported early failures of contact resistance in the K302 relay of the G3 series AED product line over a 3 year time period ending May 2009. These failures occur within 200 days of shipment. The shipment date corresponds to the date at which the device is activated and an automated daily self-test begins.

Trade Name

Rapidpoint 405 System Cartridges

Recall Posting Date

2010-01-04

Manufacturer

Siemens Healthcare Diagnostics Inc.

Recall Start Date

2009-11-12

Recall Number

51667

Hazard Classification

Type II

Model or Catalog #

10283221, 130520, 130521

Lot or Serial #

>10 Numbers, Contact Manufacturer

Reason for Recall

Advising customers that a software update installation will be required to prevent a bias with outliers ranging from -0.08 to -0.1 units.

Trade Name

RELI SSO HLA-B Typing Kit

Recall Posting Date

2010-03-15

Manufacturer

Invitrogen Ltd.

Recall Start Date

2010-02-12

Recall Number

53159

Hazard Classification

Type III

Model or Catalog #

840.01

Lot or Serial #

4920335D, 5325725D, 4992705D

Reason for Recall

Complaint was received reporting incorrect typing result when using RELI SSO HLA-B Typing Kit with known sample which had been high resolution SSP typed as B*51 & B*4038. Possible false negative with probe 45 gave RELI SSO result B*51 & B*4001. This problem will also affect B*0835, B*4814, B*5163, and B*5532. The labelling of the affected kits incorrectly includes a high resolution listing for these five rare alleles.

Trade Name

Restoration Modular Plasma Distal Stem

Recall Posting Date

2010-02-01

Manufacturer

Howmedica Osteonics Corporation

Recall Start Date

2010-01-13

Recall Number

52681

Hazard Classification

Type II

Model or Catalog #

6276-5-014

Lot or Serial #

20568201

Reason for Recall

Stryker was aware of a labelling issue associated with the Restoration Modular Plasma Distal Stem, part # 6276-5-026, lot code # 20503201 and part # 6276-5-014, lot code # 20568201. The implant [part # 6276-5-026] was discovered with two different labels on the box. The box had the correct size #26 label at one end and a different size #14 label- part # 6276-5-014, lot code 20568201 at the other end. It was determined that there was a possibility that qty 1 of the size #14 may have a size #14 label at one end and a size #26 label at the other end.

Trade Name

Safesheath CSG Hemostatic Introducer

Recall Posting Date

2010-02-15

Manufacturer

Thomas Medical Products, A GE Healthcare Company

Recall Start Date

2010-01-12

Recall Number

52816

Hazard Classification

Type II

Model or Catalog #

CSG/WORLEY-2-09, CSG/WORLEY/BCOR-1-09, CSG/WORLEY/BCOR-2-09

Lot or Serial #

>10 Numbers, Contact Manufacturer

Reason for Recall

Thomas Medical Products has recently become aware that in some instances the Safesheath CSG (coronary sinus guide) Hemostatic Introducer with radiopaque/soft tip may fracture during in vivo use resulting in device fragments that will remain in the patient's vasculature.

Trade Name

SDC PRO 2

Recall Posting Date

2010-01-18

Manufacturer

Stryker Endoscopy

Recall Start Date

2009-12-23

Recall Number

52295

Hazard Classification

Type II

Model or Catalog #

240-050-810

Lot or Serial #

All lots

Reason for Recall

Stryker Endoscopy has become aware that the SDC PRO 2 picture/video capture device will not be able to assign the correct time/date stamp for saved files after 31 December 2009. On January 1st 2010, the system date for all SDC PRO 2 units will re-start from October 1st 2001 and begin incrementing from that point onwards. This problem will not affect how pictures or videos are captured using SDC PRO 2 during surgery. The system date will be incorrect and users will not be able to correct this issue.

Trade Name

Seno Advantage 2.2 Software AW Volumeshare 4

Recall Posting Date

2010-03-01

Manufacturer

GE Medical Systems SCS

Recall Start Date

2010-02-08

Recall Number

53072

Hazard Classification

Type I

Model or Catalog #

5341143

Lot or Serial #

S/N'S 000000Q9356005, 00000ZA9260001

Reason for Recall

When using the print image or print screen feature on Seno Advantage 2.2, the scale factor annotation printed on hard copy images is inaccurate.

Trade Name

Sequenser for MOSAIQ Upgrade

Recall Posting Date

2010-03-29

Manufacturer

Impac Medical Systems Inc.

Recall Start Date

2010-02-09

Recall Number

53447

Hazard Classification

Type III

Model or Catalog #

N/A

Lot or Serial #

MOSAIQ 1.60W (all packs), MOSAIQ 2.00T2 (all packs), MOSAIQ 2.10L5 (all packs), MOSAIQ 2.10M7 (all packs)

Reason for Recall

The database conversion utility used during the Varian 4D sites upgraded to 1.60W3, 2.0T2, 2.10l5 and 2.10M7 errantly changes the start gantry angle to zero thereby leading to mistreatment of targeted area resulting in no treatment or treating a non target area.

Trade Name

SmarTemp Disposable Probe Covers

Recall Posting Date

2010-03-01

Manufacturer

Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

Recall Start Date

2010-01-08

Recall Number

52957

Hazard Classification

Type II

Model or Catalog #

M09A-20-62124

Lot or Serial #

N/A

Reason for Recall

An issue with the SmarTemp disposable probe cover has been identified where the probe cover may contain microscopic holes in the moulded seam. If a probe cover has holes in the moulded seam it would allow liquids or body fluids inside the cover and potentially contaminate the reusable temperature probe.

Trade Name

Soflex UV-Absorbing Chamber IOL

Recall Posting Date

2010-01-18

Manufacturer

Bausch & Lomb Surgical

Recall Start Date

2009-11-19

Recall Number

51900

Hazard Classification

Type II

Model or Catalog #

L161SE

Lot or Serial #

4916928

Reason for Recall

The firm has received 3 complaints of lens opacification immediately after surgery. The opacification is associated with a lens abnormality that was noted by the physician. It was not associated with an adverse reaction.

Trade Name

Solar 8000I System - Patient Monitor
Updated recall # 43880 previously posted on 2009-02-16

Recall Posting Date

2010-01-04

Manufacturer

GE Healthcare

Recall Start Date

2008-08-26

Recall Number

43880

Hazard Classification

Type II

Model or Catalog #

SLR8KI-XXX-XXX-XXX-XXX

Lot or Serial #

>10 Numbers, Contact Manufacturer

Reason for Recall

Loss of monitoring at Solar 8000i for approx. 1-2 minutes as a result of unexpected reset of Solar 8000i monitor. Problem occurred when Solar 8000i, patient data module and telemetry used in combo mode.

Trade Name

Statspin Express 4 Centrifuge

Recall Posting Date

2010-03-15

Manufacturer

Statspin Incorporated DBA Iris Sample Processing

Recall Start Date

2010-02-15

Recall Number

53141

Hazard Classification

Type II

Model or Catalog #

SSH4

Lot or Serial #

Start #00100. Ending #001679

Reason for Recall

There have been two incidents in the USA of a rotor disrupting and pieces of the rotor and sample ejecting from the housing. This may result in serious personal injury and damage to the surrounding area.

Trade Name

Stellaris Vacuum Phaco Pack

Recall Posting Date

2010-02-15

Manufacturer

Bausch & Lomb Inc.

Recall Start Date

2010-01-11

Recall Number

52557

Hazard Classification

Type II

Model or Catalog #

BL5121

Lot or Serial #

U1643

Reason for Recall

Bausch & Lomb had become aware that it is possible to generate particulate from the plastic needle wrench when attaching the needle to the hand piece. Type of injury would be a foreign body reaction.

Trade Name

Steris 9" Urology Extension

Recall Posting Date

2010-03-29

Manufacturer

Steris Corporation

Recall Start Date

2010-02-19

Recall Number

53237

Hazard Classification

Type III

Model or Catalog #

BF578

Lot or Serial #

004876 to 005161

Reason for Recall

Steris has learned that if not used properly an accessory attached to the 9" Urology Extension may become unintentionally detached from the Urology Extension during use.

Trade Name

Stille Sonesta Gynecology & Urology Tables

Recall Posting Date

2010-01-04

Manufacturer

Stille Sonesta

Recall Start Date

2009-10-30

Recall Number

51711

Hazard Classification

Type III

Model or Catalog #

6202, 6302, 6302U, 6303

Lot or Serial #

12-11130, 12-11133, 12-30396, 12-30397, 12-30401, 12-30405, 12-30426, 12-30427

Reason for Recall

Due to inappropriate tempering, the bolts attaching accessories to the Stille Sonesta Gynecology and Urology Tables 6202, 6302, 6302U and 6303 (all of which utilize the bolts) could detach during use.

Trade Name

Surgical Trocars - Separator

Recall Posting Date

2010-03-29

Manufacturer

Applied Medical Resources Corporation

Recall Start Date

2009-12-22

Recall Number

52934

Hazard Classification

Type II

Model or Catalog #

C0R36, C0R37

Lot or Serial #

>10 Numbers, Contact Manufacturer

Reason for Recall

An extension of HC#50115 recall. After filing report 50115, further reports emerged of additional customer experiences for fracturing cannulas that were from different C0R36 lots as well as from model C0R37.

Trade Name

Syndeo PCA Syringe Pump

Recall Posting Date

2010-01-04

Manufacturer

Baxter Healthcare Corporation

Recall Start Date

2009-12-11

Recall Number

50978

Hazard Classification

Type II

Model or Catalog #

2L3113, 2L3113R

Lot or Serial #

All Serial Numbers

Reason for Recall

The controlled withdrawal is intended to allow customers sufficient time to evaluate and implement alternative products options.

Trade Name

Syngo Workflow MLR/Sienet Magicstore

Recall Posting Date

2010-03-01

Manufacturer

Siemens AG

Recall Start Date

2010-02-03

Recall Number

53042

Hazard Classification

Type III

Model or Catalog #

10 019 102

Lot or Serial #

1295

Reason for Recall

This update in combination with server update # IM096/09/S (VB30C_SRV8) will solve a problem with the finalized (correction) report. If the preliminary report was not marked as read, the final report appears now under "new results" correctly.

Trade Name

Syngo Workflow MLR/Sienet Magicstore

Recall Posting Date

2010-03-15

Manufacturer

Siemens AG

Recall Start Date

2010-02-05

Recall Number

53043

Hazard Classification

Type III

Model or Catalog #

10 019 102

Lot or Serial #

1295

Reason for Recall

A problem with the finalized correction report. If preliminary report was not marked as read, the final report appears under "new results".

Trade Name

TD-Synergy software (TD-SYN-01)

Recall Posting Date

2010-03-01

Manufacturer

Technidata S.A.S.

Recall Start Date

2009-12-30

Recall Number

52749

Hazard Classification

Type II

Model or Catalog #

TD-SYN-01

Lot or Serial #

Version V02.01.A to V03.13A

Reason for Recall

"Image viewer" window is not systematically closed when you display the next patient in the val session. So a user could become confused by seeing the graph of the previous patient while working on the next one.

Trade Name

TempSpan Temporary Crown and Bridge Material

Recall Posting Date

2010-03-29

Manufacturer

Pentron Clinical Technologies, LLC

Recall Start Date

2010-01-10

Recall Number

53331

Hazard Classification

Type II

Model or Catalog #

N/A

Lot or Serial #

Part # N69AD, Lot # 200720

Reason for Recall

Product will not set because it was mispackaged with an incorrect catalyst.

Trade Name

Tissue Freeze II

Recall Posting Date

2010-01-18

Manufacturer

Rocky Mountain Surgical

Recall Start Date

2009-10-06

Recall Number

52317

Hazard Classification

Type III

Model or Catalog #

N/A

Lot or Serial #

N/A

Reason for Recall

The sale of class II unlicensed medical device.

Trade Name

Tom Bone Mill

Recall Posting Date

2010-03-01

Manufacturer

Stryker Leibinger GMBH & Co. KG

Recall Start Date

2010-02-05

Recall Number

53083

Hazard Classification

Type II

Model or Catalog #

01-15402

Lot or Serial #

All lots

Reason for Recall

Stryker Leibinger has become aware that the Tom Bone Mill (Stryker Tessier Osseous Microtome) has the potential to fail at the handle ratchet and/or produce metal shavings due to improper inspection, use, and maintenance of the unit.

Trade Name

Tomotherapy Hi-Art System

Recall Posting Date

2010-03-29

Manufacturer

Tomotherapy Incorporated

Recall Start Date

2010-02-22

Recall Number

53493

Hazard Classification

Type II

Model or Catalog #

101264

Lot or Serial #

S/N: 10169, 10037

Reason for Recall

During radiotherapy planning, the Hi-Art system modifies the planning image to replace the couch. In some cases, the patient's diagnostic CT image is narrower than the Hi-Art radiotherapy couch image. In these cases the patient's diagnostic CT must be increased in width to accommodate the Hi-Art radiotherapy couch width. With 4.0 and 4.0.1 version software, this may result in the patient's regions of interest contours being shifted laterally from the intended position by up to 5mm.

Trade Name

TorFlex Transeptal Guiding Sheath

Recall Posting Date

2010-03-15

Manufacturer

Baylis Medical Company Inc.

Recall Start Date

2010-02-10

Recall Number

53153

Hazard Classification

Type I

Model or Catalog #

TF8-38-62-S

Lot or Serial #

S21244, S21903, S21940, S22739, S22739X1

Reason for Recall

In some instances the Transeptal Introducer Sheath Radiopaque/soft tip may fracture or detach during in vivo use resulting in device fragment that can pass into the systemic arterial circulation and lead to an embolic event.

Trade Name

Total Iron Binding Capacity

Recall Posting Date

2010-01-18

Manufacturer

Siemens Healthcare Diagnostics Inc.

Recall Start Date

2009-12-21

Recall Number

52257

Hazard Classification

Type III

Model or Catalog #

DF84

Lot or Serial #

All Lots

Reason for Recall

Siemens Healthcare Diagnostics received customer complaints regarding dimension clinical chemistry system Total Iron Binding Capacity (IBCT) flex reagent cartridges (DF84). Siemens has confirmed an increased incidence in "abnormal reaction" test report messages on some heparinised plasma samples as compared to the matched serum samples.

Trade Name

Total Knee Prosthetic Device

Recall Posting Date

2010-01-04

Manufacturer

Ossur Americas Inc.

Recall Start Date

2009-08-17

Recall Number

50746

Hazard Classification

Type II

Model or Catalog #

TK1100

Lot or Serial #

N/A

Reason for Recall

The Total Knee Junior is rated at 45kg. Ossur initiated internal test limits of 65kg or 144% rated load in 2003. The current balancing unit drawing does not have a sufficient safety margin to assure that the devices will pass the 60kg test when the component is machined to minimum material condition.

Trade Name

Trabecular Metal Reverse Shoulder System

Recall Posting Date

2010-01-04

Manufacturer

Zimmer Inc.

Recall Start Date

2009-12-07

Recall Number

52106

Hazard Classification

Type II

Model or Catalog #

00-4309-037-09, 00-4309-037-12

Lot or Serial #

60936762, 60978339, 61051010, 60943201, 61007945, 61191211, 61237491

Reason for Recall

This action is being conducted because units from these lots may have the male and female locating features misaligned. The full product description is the Trabecular Metal Reverse Shoulder System 6 Instrumentation 9mm and 12mm Spacer Trial.

Trade Name

Tracker Freedom

Recall Posting Date

2010-02-01

Manufacturer

JTech Medical

Recall Start Date

2009-12-18

Recall Number

52268

Hazard Classification

Type III

Model or Catalog #

TF100, TF101, TF102, TF103, TF104, TF105, TF106, TF107

Lot or Serial #

N/A

Reason for Recall

Health Canada notified JTech that Tracker Freedom was reclassified as class II because it was an active diagnostic device and the software monitored the patient. A (Health Canada) letter dated 8-Dec-2009 identified the request for notification to be sent to customers.

Trade Name

Triathlon Total Stabilizer Femur

Recall Posting Date

2010-01-04

Manufacturer

Howmedica Osteonics Corporation

Recall Start Date

2009-12-11

Recall Number

52187

Hazard Classification

Type II

Model or Catalog #

5512-F-301, 5512-F-501

Lot or Serial #

YBTHR1, YEUAR1, XAVN

Reason for Recall

Stryker Orthopedics has become aware that the stem boss of several Triathlon TS Femoral components might have been damaged during manufacturing. The damage could prevent the assembly of a stem extension. The stem extensions aid the fixation femoral component as it is subjected to physiological loads.

Trade Name

Tube Teflon

Recall Posting Date

2010-03-01

Manufacturer

Sysmex Europe GMBH

Recall Start Date

2010-01-22

Recall Number

52855

Hazard Classification

Type III

Model or Catalog #

442-5416-1

Lot or Serial #

>10 Numbers, Contact Manufacturer

Reason for Recall

The CA-1500 series can develop micro holes by mechanical wear in the curved part of the sample arm tubing. The mechanical damage could be the result of a gradual wear out process especially on systems with a high workload or, they might occur if the installation during a tube exchange is executed without a specific orientation of the tube bending and the appropriate fitting to the mechanics of the CA-1500 analyzer.

Trade Name

Ultrathin Diamond Balloon D. Catheter

Recall Posting Date

2010-03-29

Manufacturer

Boston Scientific Corporation

Recall Start Date

2010-02-17

Recall Number

53228

Hazard Classification

Type II

Model or Catalog #

16-462

Lot or Serial #

0012934317, 0012934318

Reason for Recall

Sterile barrier in the catheter packaging (outer pouch side seal) of the affected products may be compromised.

Trade Name

Unicel DXH800 Coulter Cellular Analyzer

Recall Posting Date

2010-01-04

Manufacturer

Beckman Coulter Inc.

Recall Start Date

2009-12-03

Recall Number

52191

Hazard Classification

Type II

Model or Catalog #

629029

Lot or Serial #

All Lots

Reason for Recall

Beckman Coulter has identified three problems with the Unicel DXH 800 Coulter Cellular Analysis System:
Problem # 1: differential percentages results transmitted to the lab information system (LIS) may not add to 100.0 or 100.00%.
Problem # 2: there was an increased rate of unexpected default test orders due to failure to accept test orders from the LIS.
Problem # 3: 6C and Retic-X were mislabeled in the transmission string to the LIS.

Trade Name

Uniglide Unicondylar Knee, Femoral

Recall Posting Date

2010-02-15

Manufacturer

Corin Limited

Recall Start Date

2009-11-23

Recall Number

52288

Hazard Classification

Type II

Model or Catalog #

514.0300, 514.0400

Lot or Serial #

NKZT, MKCU

Reason for Recall

The nonconforming devices have missed a manufacturing operation resulting in coatings not being applied.

Trade Name

Vanguard Lock-On Impactor

Recall Posting Date

2010-01-18

Manufacturer

Biomet Orthopedics, Inc.

Recall Start Date

2009-12-01

Recall Number

52107

Hazard Classification

Type II

Model or Catalog #

32-486206

Lot or Serial #

433580, 433560, 943990, 296900

Reason for Recall

Locking hook tabs may fracture and fall into patient's joint space, which could result in additional surgery or early revision of knee component.

Trade Name

Variant II Turbo Hemoglobin A1C Program

Recall Posting Date

2010-01-18

Manufacturer

Bio-Rad Laboratories Diagnostics Group

Recall Start Date

2009-12-10

Recall Number

52177

Hazard Classification

Type II

Model or Catalog #

270-2415

Lot or Serial #

70291500, 70292239, 70292240

Reason for Recall

Bio-Rad informs users of Variant II Turbo Hemoglobin A1C Program Reorder Packs batches that they must ensure that the chromatogram baseline is not upward sloping. There is a chance that some samples’ a1c concentration may be underestimated.

Trade Name

Versacell

Recall Posting Date

2010-03-29

Manufacturer

Siemens Healthcare Diagnostics Inc.

Recall Start Date

2010-02-22

Recall Number

53281

Hazard Classification

Type III

Model or Catalog #

10380063

Lot or Serial #

65 to 120

Reason for Recall

Siemens Healthcare Diagnostics received a customer complaint regarding Versacell and the Advia Chemistry 1800 System. If the Versacell is connected to an Advia 1800 Chemistry Analyzer, an incorrect sample tube may be pipetted.

Trade Name

Warmair Cardiac Blanket

Recall Posting Date

2010-02-15

Manufacturer

Cincinnati Sub-Zero Products

Recall Start Date

2009-11-19

Recall Number

52127

Hazard Classification

Type II

Model or Catalog #

542

Lot or Serial #

07424, 08813

Reason for Recall

Cardiac blankets are sealed into bags and sterilized by ethylene oxide. It was observed during production process that the equipment was creating incomplete seals in packaging materials. Sterility of the product inside the package cannot be assured.

Trade Name

Water Caloric Irrigator

Recall Posting Date

2010-03-15

Manufacturer

Micromedical Technologies

Recall Start Date

2009-11-16

Recall Number

52635

Hazard Classification

Type II

Model or Catalog #

Aquastar

Lot or Serial #

1GV 17548 04, 1GV 17548 05

Reason for Recall

One or more electronic components in this Caloric Irrigator may fail due to contact erosion. In the event of failure, unheated tap water will continue to flow through the device back to water drain but LCD display will be garbled and timer will not operate.

Trade Name

Y-Type Blood Solution Sets

Recall Posting Date

2010-02-01

Manufacturer

Baxter Corporation

Recall Start Date

2010-01-08

Recall Number

52558

Hazard Classification

Type II

Model or Catalog #

JC6392, JC7627C, JC7751, JC8750

Lot or Serial #

>10 Numbers, Contact Manufacturer

Reason for Recall

During product inspection of Y-Type Blood Solution Sets, Baxter observed that some blood filter devices contained fibre-like particulate matter consistent with filter material, in the fluid path below the filter.

Trade Name

Zimmer Recon System Tenanculum Instruments

Recall Posting Date

2010-03-15

Manufacturer

Zimmer Inc.

Recall Start Date

2010-02-17

Recall Number

53191

Hazard Classification

Type II

Model or Catalog #

00117902200, 00117902600, 00117902801

Lot or Serial #

60544910, 60544914, 60707686

Reason for Recall

This action is being conducted because Zimmer has determined that certain Zimmer reconstruction system Tenaculum instruments were manufactured using the wrong grade material. As manufactured, the instruments are more brittle, increasing the potential for fracture.