Medical Device Recall Listings - Sorted by Manufacturer

(From July 2010 - September 2010)

Manufacturer

Abbott Laboratories Diagnostic Division

Recall Posting Date

2010-08-30

Trade Name

A) Cell-Dyn 4000 Vent Needle and Accessory Kit
B) Cell-Dyn Sapphire Vent Head Assembly and Accessory Kit

Recall Start Date

2010-08-06

Recall Number

56047

Hazard Classification

Type III

Model or Catalog #

A) 01H01-01
B) 08H00-01

Lot or Serial #

A) N/A
B) N/A

Reason for Recall

During manufacturing, the aspiration probe was hitting the top portion of the vent head assembly and would not go all the way down. Upon further evaluation, it was found that the vent needle was not manufactured correctly by the supplier.

Manufacturer

Abbott Laboratories Diagnostic Division

Recall Posting Date

2010-09-27

Trade Name

A) Cell-Dyn 3700 Haematology System-SL Analyser
B) Cell-Dyn 3200SL System
C) Cell-Dyn 3700 Haematology System-CS Analyser

Recall Start Date

2010-08-31

Recall Number

56461

Hazard Classification

Type III

Model or Catalog #

A) 02H31-01
B) 4H60-01
C) 02H30-01

Lot or Serial #

A) All serial numbers
B) All serial numbers
C) All serial numbers

Reason for Recall

Cell-Dyn 3700 customers had reported occurrences of visible fire and smoke from the analyzer. In addition, a Cell-Dyn 3200 customer reported smoke from the analyzer. Returned power supply units were analysed and were identified to contain the incorrect fuse for the electrical configuration at the customer site.

Manufacturer

Abbott Point of Care Inc.

Recall Posting Date

2010-08-30

Trade Name

i-Stat Level 2 Control Value Assignment Sheet (VAS)

Recall Start Date

2010-08-02

Recall Number

55982

Hazard Classification

Type III

Model or Catalog #

06F13-01

Lot or Serial #

B09342, B09154

Reason for Recall

Abbott has determined that the i-Stat level 2 Control Value Assignment Sheets contain the incorrect range for PCO2, blood urea nitrogen (BUN) and glucose for the i-Stat cartridges. Abbott has made the decision to update the affected value assignment sheets to ensure the performance of their products.

Manufacturer

Accuray, Inc.

Recall Posting Date

2010-08-02

Trade Name

CyberKnife Robotic Radiosurgery System - Base CyberKnife

Recall Start Date

2010-07-06

Recall Number

55783

Hazard Classification

Type II

Model or Catalog #

028000, 030000, 032000

Lot or Serial #

C0231, C0202

Reason for Recall

When the cosmetic linac cover (the 'nose' cover) is reattached to the linac after removal, the rotating latches that secure the cover may not be properly engaged with the connection pins on the linac. If the latches are not fully engaged, the linac cover can become loose and may unexpectedly drop off the linac. If a patient treatment is initiated while the cover is loose, there is potential for it to contact the patient and lead to injury depending on the position and height of the linac at that time.

Manufacturer

Acumed, LLC

Recall Posting Date

2010-07-05

Trade Name

Trial Gage

Recall Start Date

2010-05-11

Recall Number

54806

Hazard Classification

Type III

Model or Catalog #

TR-TG01

Lot or Serial #

211365, 214346, 220365, 222678, 224183

Reason for Recall

These parts are being recalled as they were manufactured from a different grade of aluminum than required. The part therefore has an increased risk of breaking which could occur during a surgery.

Manufacturer

Advanced Neuromodulation Systems, Inc.

Recall Posting Date

2010-07-19

Trade Name

A) Genesis IPG Neurostimulator - Lamitrode (Surgical) Leads
B) Lamitrode S-4 Lead Kits
C) Lamitrode S-8 Lead Kits
D) Lamitrode C Series Leads
E) Lamitrode Neurostimulation Lead Kit
F) Lamitrode S-Series Neurostimulation Lead Kit
G) Lamitrode Tripole 8 Lead Kit
H) Lamitrode Tripole 8C Lead Kit
I) Lamitrode Tripole 16C Lead Kit
J) Lamitrode Exclaim Lead Kit
K) Lamitrode Tripole 16 Lead Kit

Recall Start Date

2010-06-18

Recall Number

55435

Hazard Classification

Type III

Model or Catalog #

A) 3240, 3244, 3280
B) 3243, 3246
C) 3283, 3286
D) 3245
E) 3254, 3255, 3262, 3263, 3264, 3265
F) 3266, 3267, 3268, 3269
G) 3208
H) 3210
I) 3214
J) 3224
K) 3219

Lot or Serial #

A) N/A
B) N/A
C) N/A
D) N/A
E) N/A
F) N/A
G) N/A
H) N/A
I) N/A
J) N/A
K) N/A

Reason for Recall

St. Jude Medical (SJM) has identified the potential for the rare occurrence of neurological deficit adverse events such as autonomic symptoms, pain (manifesting itself as chest or abdominal pain) or paralysis associated with implanting the paddle leads listed above.

Manufacturer

AGFA Healthcare N.V.

Recall Posting Date

2010-08-16

Trade Name

A) NX8000 workstations used in combination with 19'' Barco monitor and mounting stand
B) NX8200 workstations used in combination with 19'' Barco monitor and mounting stand

Recall Start Date

2010-06-30

Recall Number

55730

Hazard Classification

Type II

Model or Catalog #

A) E5LHV, E5LJX
B) X.0.8200

Lot or Serial #

A) N/A
B) N/A

Reason for Recall

Attempt to reposition the monitor by pulling or pushing the monitor housing will cause strain on the monitor. Depending on the extent of stress and after an extended period of time the monitor may fail at or near the mounting bracket pins.

Manufacturer

American Medical Systems

Recall Posting Date

2010-09-27

Trade Name

GreenLight HPS fibers, P/N 0010-2090

Recall Start Date

2010-01-29

Recall Number

53499

Hazard Classification

Type III

Model or Catalog #

0010-2090A, 0010-2090B, 0010-2090C,
0010-2090D

Lot or Serial #

>10 Numbers, Contact Manufacturer

Reason for Recall

The laser fibres had intermittent packaging and labelling issues. Three scenarios: HPS 0010-2090 as PV2079, HPS0010-2090 as PV 0010-2090, and product insert may be missing.

Manufacturer

Amo Manufacturing USA, LLC

Recall Posting Date

2010-09-13

Trade Name

Wavescan Wavefront System and Offline Programming Module (OPM)

Recall Start Date

2010-08-04

Recall Number

56048

Hazard Classification

Type III

Model or Catalog #

HS-1

Lot or Serial #

N/A

Reason for Recall

An incorrect patient treatment table may be generated by a coding error within the Wavescan Wavefront system software. The field correction is in regard to the software upgrade of Wavescan Wavefront system and offline programming module (OPM), which is used to determine patient treatment.

Manufacturer

Arrow International, Inc.

Recall Posting Date

2010-08-16

Trade Name

Central Venous Catheterization Kit

Recall Start Date

2010-07-23

Recall Number

55893

Hazard Classification

Type II

Model or Catalog #

CA-22702

Lot or Serial #

RF0033779

Reason for Recall

Arrow has received complaints regarding the introducer needle being "flimsy" and being difficult to insert into the blood vessel. It was determined that some finished products lots had incorrect cannula with a blunt bevel.

Manufacturer

B. Braun Medical Inc.

Recall Posting Date

2010-08-02

Trade Name

AddEase Binary Connector

Recall Start Date

2010-07-06

Recall Number

55733

Hazard Classification

Type I

Model or Catalog #

N7990, N7993

Lot or Serial #

60984562, 61019650, 61031167, 61057867

Reason for Recall

B.Braun pab bags demonstrate coring when used with AddEase connectors and third party needles. The incidence rate appears to be higher with the use of AddEase connectors.

Manufacturer

B. Braun Medical Inc.

Recall Posting Date

2010-08-16

Trade Name

Addease Binary Connector

Recall Start Date

2010-07-22

Recall Number

55733

Hazard Classification

Type I

Model or Catalog #

N7990, N7993

Lot or Serial #

60984562, 61019650, 61031167, 61057867

Reason for Recall

B.Braun pab bags demonstrate coring when used with Addease connectors and third party needles. The incidence rate appears to be higher with the use of Addease connectors.

Manufacturer

Baxter Healthcare Corporation

Recall Posting Date

2010-09-27

Trade Name

A) Micro-Volume Extension Sets with Filter
B) Micro-Volume Extension Set

Recall Start Date

2010-09-07

Recall Number

56507

Hazard Classification

Type III

Model or Catalog #

A) 2N3350
B) 2N3347

Lot or Serial #

A) UR07I25092, UR08B04109, UR08B09058, UR09E12013, UR09F04083, UR192179X, UR242057, UR253450, UR261362
B) UE103267

Reason for Recall

Baxter has identified a labelling issue affecting all lots of extension sets 2N3347 and 2N3350, whereby the product configuration and label illustration have the slide clamp above the filter, but the written instructions tell the user to close the clamp below filter when set is not in use. The current clamp configuration could result in the unintended fluid administration of approximately 0.2ml.

Manufacturer

Beckman Coulter, Inc.

Recall Posting Date

2010-07-05

Trade Name

A) P3, P4 Plates for the PK7200 Automated Microplate System-Microplate Reader
B) P3, P4 Plates for the PK7200 Automated Microplate System-Analyzer Class 3
C) P3, P4 Plates for the PK7300 Automated Microplate System-Instrument Class 3
D) P3, P4 Plates for the PK7300 Automated Microplated System-Instrument

Recall Start Date

2010-04-26

Recall Number

55300

Hazard Classification

Type II

Model or Catalog #

A) PK7200
B) PK7200
C) PK7300
D) PK7300

Lot or Serial #

A) P3-91A,92A,93A,95D,96D, P4-93B,94B,99C
B) P3-91A,92A,93A,95D,96D, P4-93B,94B,99C
C) P3-91A,92A,93A,95D,96D, P4-93B,94B,99C
D) P3-91A,92A,93A,95D,96D, P4-93B,94B,99C

Reason for Recall

Beckman Coulter has confirmed the presence of deformed well terraces in the PK Microplate wells may cause fold over or slip down of positive reaction patterns in the PK7200 and PK7300 Automated Microplate System.

Manufacturer

Beckman Coulter, Inc.

Recall Posting Date

2010-07-19

Trade Name

Access Thyroglobulin Antibody II Reagent

Recall Start Date

2010-05-17

Recall Number

55500

Hazard Classification

Type II

Model or Catalog #

A32898

Lot or Serial #

916271, 917073, 918433

Reason for Recall

Beckman Coulter has confirmed that the three lots of Access Thyroglobulin Antibody II Reagent may produce significantly different results in a small subset of patient samples when compared to previously released reagent lots.

Manufacturer

Beckman Coulter, Inc.

Recall Posting Date

2010-08-02

Trade Name

A) Unicel DXI 600 Access Immunoassay System - Instrument Class 2
B) Unicel DXI 600 Access Immunoassay System - Instrument Class 3
C) Unicel DXI 800 Access Immunoassay - Analyzer-Class 3
D) Unicel DXI 800 Access Immunoassay System - Analyzer - Class II

Recall Start Date

2010-07-05

Recall Number

55603

Hazard Classification

Type II

Model or Catalog #

A) A30260
B) A30260
C) 973100
D) 973100

Lot or Serial #

A) All lots
B) All lots
C) All lots
D) All lots

Reason for Recall

Beckman Coulter has confirmed the following issue with the software version 4.3 being used in the Unicel DXI 600 and DXI 800 Access Immunoassay Systems. If a laboratory changed a default sample type setting on the tests screen while running Unicel DXI System software version 4.3, the new setting would not be saved to the system database. The changed sample type setting would reset to the previously saved setting when power was interrupted to the system, or if an operator rebooted the system.

Manufacturer

Beckman Coulter, Inc.

Recall Posting Date

2010-08-30

Trade Name

Sex Hormone Binding Globulin (SHBG) Reagent

Recall Start Date

2010-07-26

Recall Number

55983

Hazard Classification

Type II

Model or Catalog #

A48617

Lot or Serial #

009046, 010202, 829586, 909837, 914557, 915628, 917613, 919184

Reason for Recall

The instruction for use (IFU) for access Sex Hormone Binding Globulin (SHBG) does not specify the units of measure to be used when calculating the free androgen index (FAI %). Access SHBG (nmol/l) values and access testosterone (ng/ml) values are reported in different default units. The testosterone value (when reported in ng/ml) requires conversion to nmol/l before the FAI % can be calculated..

Manufacturer

Beckman Coulter, Inc.

Recall Posting Date

2010-08-30

Trade Name

Synchron System(s) Creatine Reagent

Recall Start Date

2010-08-03

Recall Number

55984

Hazard Classification

Type II

Model or Catalog #

472525

Lot or Serial #

M911428, M911519

Reason for Recall

Beckman Coulter Inc. has confirmed reports that black/brown particulates were observed in some bottles of the creatinine alkaline buffer in modular Creatinine Reagent Kit lots M911428 and M911519.

Manufacturer

Beckman Coulter, Inc.

Recall Posting Date

2010-08-30

Trade Name

Synchron Systems Glucose Reagent (GLU)

Recall Start Date

2010-08-09

Recall Number

56165

Hazard Classification

Type II

Model or Catalog #

442640

Lot or Serial #

All non-expired lots

Reason for Recall

Synchron Systems Glucose Reagent (GLU) when used in conjunction with Unicel DXC and Synchron LX instruments may give falsely high results for moderately hemolysed samples.

Manufacturer

Beckman Coulter, Inc.

Recall Posting Date

2010-09-13

Trade Name

Navios Flow Cytometer

Recall Start Date

2010-06-21

Recall Number

55631

Hazard Classification

Type III

Model or Catalog #

A52101, A52102, A52103

Lot or Serial #

AN29103-AS15099, AN06024-AS03008, AM51001-AS15102

Reason for Recall

Beckman Coulter has confirmed an issue with the Navios Flow Cytometer with version 1.0 software: red and violet laser related errors are not displayed in the event of a laser failure. The blue laser is not impacted by this issue.

Manufacturer

Beckman Coulter, Inc.

Recall Posting Date

2010-09-13

Trade Name

Synchron Systems Enzymatic CO2 (CO2E) Reagent

Recall Start Date

2010-07-12

Recall Number

55665

Hazard Classification

Type III

Model or Catalog #

A60290

Lot or Serial #

M907574

Reason for Recall

Blank rate high (SH) instrument flag may be generated when less than 30 tests left in the CO2E cartridge and recalibration attempts may fail or may not be maintained.

Manufacturer

Beckman Coulter, Inc.

Recall Posting Date

2010-09-13

Trade Name

A) Access System - Immunoassay Aanalyzers Class 2
B) Unicel DXC 600I Synchron Access Clinical Analyzer
C) Unicel DXI 600 Access Immunoassay System - Instrument Class 2
D) Unicel DXI 600 Access Immunoassay System - Instrument Class 3
E) Unicel DXC 880I Synchron Access Clinical Analyzer
F) Access Immunoassay Analyzers - Class 3
G) Access Immunoassay System - Analyzer Class 3
H) Access System Access 2 Analyzer - Class 2
I) Unicel DXI 800 Access Immunoassay System - Analyzer - Class III
J) Unicel DXI 800 Access Immunoassay System - Analyzer - Class II
K) Synchron LXI 725
L) Unicel DXC 660I Synchron Access Clinical Analyzer
M) Unicel DXC 680I Synchron Access Clinical Analyzer
N) Unicel DXC 860I Synchron Access Clinical Analyzer

Recall Start Date

2010-08-09

Recall Number

56259

Hazard Classification

Type II

Model or Catalog #

A) 81600
B) 4767
C) A30260
D) A30260
E) 4768
F) 81600
G) 81600N
H) 81600N
I) 973100
J) 973100
K) 476501
L) 4771
M) 4772
N) 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
H) All lots
I) All lots
J) All lots
K) All lots
L) All lots
M) All lots
N) All lots

Reason for Recall

If a reagent pack is not loaded onto Access and DXI instruments in accordance with the instrument operator's guide, it is possible for the instrument to pipette insufficient or incorrect reagents and generate erroneous quality control or patient results.

Manufacturer

Beckman Coulter, Inc.

Recall Posting Date

2010-09-13

Trade Name

SYNCHRON System(s) Immunoglobulin A (Ig-A) Reagent

Recall Start Date

2010-06-28

Recall Number

55480

Hazard Classification

Type II

Model or Catalog #

467920

Lot or Serial #

M812164, M902345

Reason for Recall

Ig-A Reagent lots M812164 and M902345 contain an unidentified cross reacting antibody that may yield falsely high Ig-A results in survey samples for immunoglobulins which are formulated with Ig-M monoclonal antibodies.

Manufacturer

Beckman Coulter, Inc.

Recall Posting Date

2010-09-27

Trade Name

A) AU5400 Clinical Chemistry Analyzer
B) AU2700 Clinical Chemistry Analyzer
C) AU400/AU400E Clinical Chemistry Analyzers
D) AU600/AU640/AU640E Clinical Chemistry Analyzers
E) AU680 Clinical Chemistry Analyzer
F) AU480 Clinical Chemistry Analyzer

Recall Start Date

2010-07-12

Recall Number

56411

Hazard Classification

Type I

Model or Catalog #

A) AU5400
B) AU2700
C) AU400, AU400E
D) AU600, AU640, AU640E
E) AU680
F) AU480

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

Reason for Recall

Company has received reports of incorrect results generated by analyzers as a result of cuvette overflow. Current system software unable to complete real-time monitoring of reaction profiles to identify impact of cuvette overflow on results, yielding incorrect results without any flags or alarms to alert operator.

Manufacturer

Becton Dickinson and Company

Recall Posting Date

2010-09-13

Trade Name

BD Gaspak EZ Large Incubation Container

Recall Start Date

2010-08-17

Recall Number

56228

Hazard Classification

Type III

Model or Catalog #

260672

Lot or Serial #

7110573

Reason for Recall

Product may not maintain air tight environment due to a manufacturing defect. The defect is a missing clear plastic post on the inside of the container lid that is found in the middle position.

Manufacturer

Becton Dickinson and Company

Recall Posting Date

2010-09-27

Trade Name

BBL Staphyloslide Latex Test Kit

Recall Start Date

2010-07-19

Recall Number

56555

Hazard Classification

Type III

Model or Catalog #

240952, 240953

Lot or Serial #

16605410, 16640910, 16679310, 16778710, 16781210, 16781510,
16821684

Reason for Recall

Kits may exhibit false agglutination with non-staphylococcus aureus colonies as well as the negative control reagent. Quality control should be performed each day the kit is used. The kit should not be used if the reactions with the control organisms are incorrect.

Manufacturer

Becton Dickinson Diagnostic Instrument Systems

Recall Posting Date

2010-09-13

Trade Name

Bactec FX

Recall Start Date

2010-08-12

Recall Number

56174

Hazard Classification

Type III

Model or Catalog #

441385

Lot or Serial #

FT001 to FT0906, FT0922

Reason for Recall

Patient sample database on the Bactec FX are sometimes found to be unusable upon rebooting the instrument. The reboot proceeds normally until it tries to load the database file, at which point the instrument reboots and then repeats this cycle indefinitely or customers see a message on the display that says "please insert a bootable device". The system will continue to agitate and incubate the samples.

Manufacturer

Becton Dickinson Infusion Therapy Systems Inc.

Recall Posting Date

2010-08-30

Trade Name

A) BD Q-Syte Extension Set
B) MPS Acadia Extension Set With Rightbore
C) MPS Acadia Specialty Tri-Extension Set
D) Dual Port BD Nexiva Closed IV Catheter
Updated recall #51661 previously posted on 2009-12-07.

Recall Start Date

2009-11-02

Recall Number

51661

Hazard Classification

Type I

Model or Catalog #

A) 385102
B) 385150, 385151
C) 385164
D) 383530, 383531

Lot or Serial #

A) 8308330
B) A1967, A2399
C) A1951
D) 8238450, 8345951, 9013867

Reason for Recall

Potential risk of end-users inadvertently taking a BD Q-Syte device from BD Nexiva product or package, and placing it on a central venous catheter.

Manufacturer

Biomerieux SA

Recall Posting Date

2010-08-16

Trade Name

Vidas System Rub IGG II Assay

Recall Start Date

2010-07-21

Recall Number

55865

Hazard Classification

Type II

Model or Catalog #

30221

Lot or Serial #

837810801

Reason for Recall

One or the two pouch of lot #837810801 may contain out-of-specification cones that were affected by a manufacturing incident.

Manufacturer

Biomerieux, Inc.

Recall Posting Date

2010-08-30

Trade Name

A) Vitek 2 Compact 30 System - Test Cards
B) Vitek 2 Compact 60 System - Test Cards
C) Vitek 2 System - Test Cards

Recall Start Date

2010-08-02

Recall Number

55961

Hazard Classification

Type II

Model or Catalog #

A) 22225
B) 22225
C) 22225

Lot or Serial #

A) 345158910
B) 345158910
C) 345158910

Reason for Recall

There are small slits on the backsides of Vitek 2 AST-N085 lot 345158910 foil pouches near the seam separating the desiccant from the main body of the pouch.

Manufacturer

Biomerieux, Inc. Portland

Recall Posting Date

2010-08-16

Trade Name

O-F Dextrose Tubed Media

Recall Start Date

2010-06-08

Recall Number

55201

Hazard Classification

Type III

Model or Catalog #

T7141

Lot or Serial #

313295-1

Reason for Recall

O-F Dextrose labelling information on the tubes incorrectly described the product as O-F Staph.

Manufacturer

Biomet Microfixation, Inc.

Recall Posting Date

2010-09-13

Trade Name

Rees Insulated Forceps

Recall Start Date

2010-06-30

Recall Number

55527

Hazard Classification

Type II

Model or Catalog #

02-0461

Lot or Serial #

042308D08, 112108D08, 031309C09, 041009D09, 042310B10, 021910B10, 092707I07, 103607J07, 032607C07, 041607D07

Reason for Recall

Cracking or peeling off of the insulation of the forceps, causing burns to the patients.

Manufacturer

Biomet Sports Medicine Inc.

Recall Posting Date

2010-07-05

Trade Name

Artificial Ligament Fixation Device

Recall Start Date

2010-03-31

Recall Number

53910

Hazard Classification

Type II

Model or Catalog #

904755

Lot or Serial #

050400, 089710, 648470, 192250, 228610

Reason for Recall

The ziploop extended toggleloc device may contain an out of specification saddle length (too long), which could result in insufficient graft being introduced into the surgical tunnel.

Manufacturer

Bio-Rad

Recall Posting Date

2010-07-05

Trade Name

Strep B Select

Recall Start Date

2010-06-08

Recall Number

55233

Hazard Classification

Type II

Model or Catalog #

63750

Lot or Serial #

0D0039

Reason for Recall

The lot 0D0039 gives an abnormal rate of blue colonies that were not further confirmed as GBS (group B streptococcus). On this particular lot, some enterococci could produce blue colonies instead of the pink to violet colonies that are expected for these organisms.

Manufacturer

Bio-Rad Laboratories Deeside

Recall Posting Date

2010-08-30

Trade Name

IN2IT - A1C Test Cartridges

Recall Start Date

2010-08-10

Recall Number

56054

Hazard Classification

Type II

Model or Catalog #

2810001EX

Lot or Serial #

All lots

Reason for Recall

Bio-Rad notifies in2it users that when performing in2it testing at altitudes above 1 000 meters (3 280 feet) they may obtain high results. This problem can occur on all lots of A1C test cartridges.

Manufacturer

Boston Scientific Corporation

Recall Posting Date

2010-07-19

Trade Name

A) Synchro 2 Soft Guidewire
B) Synchro 2 Standard Guidewire
C) Synchro PVS 1300 Neuro Guidewire

Recall Start Date

2010-06-07

Recall Number

55223

Hazard Classification

Type II

Model or Catalog #

A) M00326010, M00326310
B) M00326410, M00326510
C) M00313010, M00313020, M00313310

Lot or Serial #

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

Reason for Recall

Product may exhibit a PTFE coating issue that could impact patient safety, more specifically, Boston Scientific Corporation has identified scrapes on the coating during production of the affected lots, which could lead to flaking.

Manufacturer

Boston Scientific Corporation

Recall Posting Date

2010-08-30

Trade Name

A) Sterling Monorail PTA Balloon
B) Sterling Over-The-Wire PTA Balloon

Recall Start Date

2010-05-11

Recall Number

54721

Hazard Classification

Type III

Model or Catalog #

A) H74939135152010, H74939135202010, H74939135203010, H74939135204010, H74939135252010, H74939135253010, H74939135254010, H74939135302010, H74939135303010, H74939135304010, H74939135352010, H74939135354010, H74939135402010, H74939135403010, H74939135404010
B) H74939134152010, H74939134202010, H74939134203010, H74939134204010, H74939134252010, H74939134253010, H74939134254010, H74939134302010, H74939134303010, H74939134304010, H74939134352010, H74939134353010, H74939134354010, H74939134402010, H74939134403010, H74939134404010

Lot or Serial #

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

Reason for Recall

Directions for use for the affected lots do not include certain language previously requested.

Manufacturer

Boston Scientific Corporation

Recall Posting Date

2010-09-13

Trade Name

Ultraflex Precision Colonic Stent

Recall Start Date

2010-07-16

Recall Number

55796

Hazard Classification

Type II

Model or Catalog #

M00557360

Lot or Serial #

>10 Numbers, Contact Manufacturer

Reason for Recall

Boston Scientific has identified an issue that may potentially result in the failure to deploy the stent due to the deployment suture breaking.

Manufacturer

Brainlab AG

Recall Posting Date

2010-09-13

Trade Name

A) Kolibri Navigation Station 2.0 with Mobile Camera Stand 2.0
B) Kolibri Mobile Camera Stand 2.0

Recall Start Date

2010-08-18

Recall Number

56243

Hazard Classification

Type II

Model or Catalog #

A) 19506C
B) 19801A

Lot or Serial #

A) 000000005042210001, 000000005042310001, 000000003934009001, 000000002185609001, 000000004809910001, 000000003509109001, 000000004367509001
B) N/A

Reason for Recall

For the Spectra camera interfaces assembled within the Kolibri Mobile Camera Stand, a long-term reliable fixation of the camera unit cannot be guaranteed due to a manufacturing error.

Manufacturer

Brentwood Medical Technology, Corp. DBA Midmark Diagnostics Group

Recall Posting Date

2010-07-19

Trade Name

IQmanager Diagnostic Workstation

Recall Start Date

2010-05-26

Recall Number

55107

Hazard Classification

Type III

Model or Catalog #

4-100-1200

Lot or Serial #

Versions 8.3, 8.3.1, 8.3.2

Reason for Recall

When the user access the QT dialogue box to manually accept or edit the QT interval, the software recalculates the QTC value using Hodges equation for all patients rather than for only patients 16 years and older.

Manufacturer

Cardiac Pacemakers Incorporated

Recall Posting Date

2010-09-13

Trade Name

A) Contak Renewal 3 RF CRT-D
B) Contak Renewal 3 RF HE CRT-D
C) Contak Renewal 4 CRT-D
D) Contak Renewal 4 HE CRT-D

Recall Start Date

2010-07-23

Recall Number

55829

Hazard Classification

Type III

Model or Catalog #

A) H215
B) H217
C) H190
D) H-197, H-199

Lot or Serial #

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

Reason for Recall

Application of a magnet (typically in a clinic hospital environment) may cause a magnetic reed switch located within the device to become permanently stuck in a closed position and prevent delivery of programmed tachy therapy.

Manufacturer

Cardinal Health

Recall Posting Date

2010-08-30

Trade Name

A) Sterile Craniotomy Pack
B) Sterile Ear Pack

Recall Start Date

2010-08-04

Recall Number

56051

Hazard Classification

Type II

Model or Catalog #

A) SNE30CRXXX
B) SEN30EAXXX, SEN30MEXXX

Lot or Serial #

A) 887069, 905131, 909364, 919774, 926904, 933512, 953095, 885710, 890855, 894055, 900358, 918868, 933456, 940554, 945788
B) 887885, 908312, 912899, 916104, 916587, 890561, 906447, 935731, 953954

Reason for Recall

The possibility of reduced adhesion between the patties and the blue radio-opaque x-ray stripe. This may result in the x-ray stripe becoming detached from the pattie during use and remaining in surgical site.

Manufacturer

Cardinal Health

Recall Posting Date

2010-09-27

Trade Name

Medi-Vac Non Conductive Suction Tubing

Recall Start Date

2010-08-18

Recall Number

56305

Hazard Classification

Type II

Model or Catalog #

PN510, PN512, PN56A, PN610, PN612, PN66A, PN710, PN712, PN76A

Lot or Serial #

All Lot Numbers Prior to Y10KXXXX (10K is August 2010)

Reason for Recall

The recall has been initiated due to the possibility that packaging seals on the referenced lot numbers may be compromised.

Manufacturer

CaridianBCT, Inc.

Recall Posting Date

2010-08-02

Trade Name

A) COBE Spectra White Blood Cell Sets
B) COBE Spectra Therapeutic Plasma Exchange Sets

Recall Start Date

2010-07-16

Recall Number

55784

Hazard Classification

Type II

Model or Catalog #

A) 70620
B) 70600

Lot or Serial #

A) 01S15239
B) 01S15238

Reason for Recall

Potential leaking at the return luer connection on two manufacturing lots of COBE Spectra White Blood Cell Disposable Tubing Sets.

Manufacturer

CaridianBCT, Inc.

Recall Posting Date

2010-08-30

Trade Name

COBE Spectra White Blood Cell Sets
Updated recall # 55784 previously posted 2010-08-02. / Mise … jour du retrait # 55784 afflich‚ le 2010-08-02.

Recall Start Date

2010-07-16

Recall Number

55784

Hazard Classification

Type II

Model or Catalog #

70620

Lot or Serial #

01S15239

Reason for Recall

Potential leaking at the return luer connection on two manufacturing lots of COBE Spectra White Blood Cell Disposable Tubing Sets.Note that COBE Spectra Therapeutic Plasma Exchange Sets has been removed from this recall.

Manufacturer

CaridianBCT, Inc.

Recall Posting Date

2010-09-27

Trade Name

Cobe Spectra Apheresis System wbc

Recall Start Date

2010-07-16

Recall Number

55784

Hazard Classification

Type II

Model or Catalog #

70620

Lot or Serial #

01S15239, 01S15238

Reason for Recall

Leak at the return luer connection on 2 MFR lots of Cobe Spectra white blood cell disposable tubing sets. Leak is observed as a very small fluid leak originating between the male Luer on the return line and the attached customer needle or as an observation of air in the line when blood warmer tubing is attached to the male Luer.

Manufacturer

Ciba Vision Corporation

Recall Posting Date

2010-09-13

Trade Name

Softperm

Recall Start Date

2010-07-03

Recall Number

55841

Hazard Classification

Type II

Model or Catalog #

Softperm

Lot or Serial #

>100 Numbers, Contact Manufacturer

Reason for Recall

Out-of-specification in a product stability study resulting from a change in the vial stopper.

Manufacturer

Codman & Shurtleff Inc.

Recall Posting Date

2010-08-16

Trade Name

Codman Surgical Patties, X-Ray Detectable

Recall Start Date

2010-07-22

Recall Number

55895

Hazard Classification

Type II

Model or Catalog #

80-1396, 80-1399

Lot or Serial #

>10 Numbers, Contact Manufacturer

Reason for Recall

Codman Surgical Patties, which are labelled with a radio-opaque marker, and were distributed by Codman between May 2009 and May 2010, may have reduced adhesion between the patty and the blue radio-opaque x-ray stripe due to a recently discovered processing problem. This reduced adhesion may result in the x-ray stripe becoming detached from the patty during use and remaining in the surgical site inadvertently.

Manufacturer

Cook Urological Inc.

Recall Posting Date

2010-08-02

Trade Name

Modified Novy Cornual Cannualtion Set

Recall Start Date

2010-01-09

Recall Number

52817

Hazard Classification

Type II

Model or Catalog #

J-NCS-503570

Lot or Serial #

U1799467

Reason for Recall

The curved tip of the introducing catheter has the potential to separate during use. If the affected product has already been used successfully, there is not additional patient risk.

Manufacturer

Cook, Inc.

Recall Posting Date

2010-09-13

Trade Name

A) Ciaglia Blue Rhino Percutaneous
B) Ciaglia Blue Dolphin Percutaneous

Recall Start Date

2010-04-23

Recall Number

54482

Hazard Classification

Type I

Model or Catalog #

A) C-PTIS-100-HC-PERC6, C-PTIS-100-HC-PERC6-CA, C-PTIS-100-HC-PERC8, C-PTIS-100-HC-PERC8-CA
B) C-PTBS-2600-PERC6, C-PTBS-2800-PERC8, C-PTBSY-2600-PERC6, C-PTBSY-2800-PERC8

Lot or Serial #

A) G12403, G12566, G13165, G36037, G13166, G12523, G36038, G12565, G53178, G53169, G53170
B) G36116, G36118, G51971, G36117, G49507, G51972

Reason for Recall

Certain cuffed Shiley tracheostomy tubes, in which the cuff does not hold air as a result of leaks in the pilot balloon inflation assembly.

Manufacturer

Coopersurgical Inc.

Recall Posting Date

2010-08-16

Trade Name

A) INCA Infant Nasal Cannulae Assembly for CPAP
B) INCA Infant Nasal Cannulae Assembly for CPAP Replacement Set

Recall Start Date

2010-07-27

Recall Number

55932

Hazard Classification

Type III

Model or Catalog #

A) 44-2707, 44-2709, 44-2710, 44-2712, 44-2715
B) 44-0707, 44-0709, 44-0710, 44-0712, 44-0715

Lot or Serial #

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

Reason for Recall

As a result of Coopersurgical's voluntary recall for the Infant Nasal Cannulae (CPAP)(INCA) assembly the classification of the device was reviewed by Health Canada. Subsequently, Coopersurgical is recalling the INCA since it was sold in Canada without a license.

Manufacturer

Depuy International Ltd.

Recall Posting Date

2010-09-27

Trade Name

A) Depuy ASR Cup System - Heads
B) ASR XL Acetabular Cup System - Heads
C) ASR XL Acetabular Cup - Sleeve Adaptors
D) Depuy ASR Acetabular Cup System - Shells
E) ASR 300 Spiked Acetabular Shells

Recall Start Date

2010-08-25

Recall Number

56326

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
E) 999830744, 999830746, 999830748, 999830750, 999830752, 999830754, 999830756, 999830758, 999830760, 999830762, 999830764, 999830766, 999830768, 999830770

Lot or Serial #

A) >500 Numbers, Contact Manufacturer
B) >100 Numbers, Contact Manufacturer
C) >500 Numbers, Contact Manufacturer
D) >500 Numbers, Contact Manufacturer
E) >100 Numbers, Contact Manufacturer

Reason for Recall

Depuy issued a field safety notice in March 2010 (recall number 53553) after receiving data that demonstrated the ASR system had a higher than expected revision rate at three years when used with smaller head sizes. New data now shows a higher than expected revision rate at five years, across the entire size range. The manufacturer is therefore issuing a voluntary recall of all ASR products.

Manufacturer

Depuy Mitek

Recall Posting Date

2010-07-05

Trade Name

A) VAPR S90 Suction Electrode (Integrated)
B) VAPR S50 Knee Electrode (Integrated)
C) VAPR Premiere90 Electrode (Integrated)
D) VAPR Premiere50 Electrode (Integrated)

Recall Start Date

2010-06-09

Recall Number

55222

Hazard Classification

Type II

Model or Catalog #

A) 225370
B) 227355
C) 227204
D) 227504

Lot or Serial #

A) >100 Numbers, Contact Manufacturer
B) 805107, 904050, 904051, 904056, 904061
C) >10 Numbers, Contact Manufacturer
D) 906032

Reason for Recall

Some of the products within the recall list did not meet the required packaging specifications for pouch seal width dimensions, which could potentially lead to a breach in sterility. The recall applies to all non-expired inventory with the exception of inventory that is designated with round green stickers.

Manufacturer

Depuy Orthopaedics, Inc.

Recall Posting Date

2010-08-02

Trade Name

Summit Broach Handle

Recall Start Date

2010-07-14

Recall Number

55756

Hazard Classification

Type III

Model or Catalog #

2750-00-000

Lot or Serial #

A1109, A1209, A0210, A0310

Reason for Recall

Some of Depuy's straight broach handles are experiencing early failure due to a weakened handle locking mechanism (leaf spring).

Manufacturer

Diasorin Inc.

Recall Posting Date

2010-08-30

Trade Name

Liason Analyzer

Recall Start Date

2010-08-10

Recall Number

56139

Hazard Classification

Type II

Model or Catalog #

15970

Lot or Serial #

All Serial Numbers

Reason for Recall

During system initialization when pipettors are washing, if sample or reagent area flap are opened, the shaker rod may stop moving. This will affect the suspension of magnetic particles resulting in low RLU values for calibrators, controls & patient samples giving unexpected positive or negative results or incorrect dose.

Manufacturer

Draeger Medical AG & Co. KG

Recall Posting Date

2010-08-02

Trade Name

NBP Cuffs NEO Sizes 1 to 5

Recall Start Date

2010-06-29

Recall Number

55447

Hazard Classification

Type I

Model or Catalog #

MP00901, MP00902, MP00903, MP00904, MP00905

Lot or Serial #

Devices Delivered Between 12-01-2010 and 12-06-2010.

Reason for Recall

Cases where measurements with the affected neonatal blood pressure cuffs deviate from the actual values. This deviation can be up to 50%, meaning the measured and displayed value can be 50% higher than the actual one.

Manufacturer

Draeger Medical AG & Co. KG

Recall Posting Date

2010-09-13

Trade Name

Oxylog 3000

Recall Start Date

2010-08-16

Recall Number

56204

Hazard Classification

Type I

Model or Catalog #

2M86955

Lot or Serial #

SRZB-0059, SRZA-0128, SRYK-0134, SRYK-0133, SRYK-0132, SRYK-0131, SRYK-0069, SRYK-0068, SRYB-0074, SRYA-0195, SRYA-0014

Reason for Recall

Patients have been inadequately ventilated because the dead space of the breathing circuit was not completely considered by the user when setting the ventilation parameters. The information for use (IFU) for the Oxylog 3000 devices delivered from September 2008 contains additional warnings and cautions. A safety notice with the IFU amendment will be sent out to users who own affected Oxylog 3000. No patient injury has been reported in relation to that dead space issue.

Manufacturer

Draeger Medical AG & Co. KG

Recall Posting Date

2010-09-13

Trade Name

Fabius GS Anesthesia System

Recall Start Date

2010-08-25

Recall Number

56304

Hazard Classification

Type II

Model or Catalog #

8604700

Lot or Serial #

>10 Numbers, Contact Manufacturer

Reason for Recall

The Fabius GS or Fabius Tiro delivered between June 2005 and June 2006 could have been equipped with a power cord of the manufacturer Electri-Cord Manufacturing Corporation (ECM). The US Food and Drug Administration (FDA) has associated a risk of sparks, fire, device failures or electrical shocks with these power cords. Although Draeger Medical has not received any reports of failures of power cords manufactured by ECM, Draeger Medical will replace the possible affected power cords.

Manufacturer

Draeger Medical Systems, Inc.

Recall Posting Date

2010-07-19

Trade Name

A) Gamma XXL
B) Delta Monitor

Recall Start Date

2010-05-24

Recall Number

55089

Hazard Classification

Type II

Model or Catalog #

A) MS18852
B) MS18597

Lot or Serial #

A) 5399463952, 5399468849, 5399469251, 5399494054, 5399498745, 5399532156, 5399532753, 5399533850, 5399662354, 5399664949, 6000446771, 6000796170
B) >10 Numbers, Contact Manufacturer

Reason for Recall

Investigation determined that the monitor's fixed keys may become inoperative or activate without user interaction due to a contamination present in the fixed key panel material. This is a concern because the worst case scenario of this malfunction could be that the monitor may discharge to a patient automatically.

Manufacturer

Elekta Business Area Software Systems ATA Computerized Medical Systems Inc.

Recall Posting Date

2010-07-05

Trade Name

Focal Software

Recall Start Date

2010-06-10

Recall Number

55234

Hazard Classification

Type II

Model or Catalog #

N/A

Lot or Serial #

Release 4.40.00 & Up

Reason for Recall

The couch position can be moved (X or Y direction) between scans of the same CT study. When images are imported, the software is not checking the Dicom image position (patient) tag & is not aligning the image sets. A shift between image sets will exist of the same amount that the CT couch was moved.

Manufacturer

Excelsior Medical Corporation

Recall Posting Date

2010-09-27

Trade Name

Prefilled Flush Syringe

Recall Start Date

2010-09-02

Recall Number

56438

Hazard Classification

Type II

Model or Catalog #

S-5

Lot or Serial #

>10 Numbers, Contact Manufacturer

Reason for Recall

During a routine test for the syringe integrity, a possible integrity failure was discovered.

Manufacturer

Focus Medical, LLC

Recall Posting Date

2010-09-27

Trade Name

Naturalase 1064 Laser

Recall Start Date

2010-09-01

Recall Number

55902

Hazard Classification

Type II

Model or Catalog #

LT100

Lot or Serial #

N/A

Reason for Recall

The recall is being conducted because the licence to market and sell these systems in Canada had expired at the time the units were sold

Manufacturer

Fujirebio Diagnostics, Inc.

Recall Posting Date

2010-08-16

Trade Name

Mesomark Kits

Recall Start Date

2010-07-08

Recall Number

55955

Hazard Classification

Type II

Model or Catalog #

801-900

Lot or Serial #

57K04510, 57K04409 (Already Expired)

Reason for Recall

Certain lots of Mesomark Kits may generate inaccurate absorbance values due to the presence of a residue on the underside of some microtiter wells that can be detected visually.

Manufacturer

GE Healthcare

Recall Posting Date

2010-07-05

Trade Name

A) Prospeed Scanner System
B) SYTEC6000

Recall Start Date

2009-03-26

Recall Number

47109

Hazard Classification

Type II

Model or Catalog #

A) B7970YZ
B) P9183AH

Lot or Serial #

A) 298920YMO & 455302YMO
B) 121615YM9

Reason for Recall

The x-ray leakage from the diagnostic source assembly (tube+collimator) of the Zj/Qj families of computed tomography systems exceeded 21 CFR regulatory requirement and IEC standard.

Manufacturer

GE Healthcare IT

Recall Posting Date

2010-07-19

Trade Name

Centricity Ultra Laboratory Information System

Recall Start Date

2010-06-15

Recall Number

55072

Hazard Classification

Type II

Model or Catalog #

CORE

Lot or Serial #

All Software Versions

Reason for Recall

Under specific conditions, the laboratory system may report incorrect results such as truncating a value after a comma is encountered. For example, a result of 1,234 would be reported as 1.0.

Manufacturer

GE Healthcare Japan Corporation

Recall Posting Date

2010-08-16

Trade Name

HiSpeed DX/I LX/I CT System

Recall Start Date

2010-07-26

Recall Number

55695

Hazard Classification

Type III

Model or Catalog #

B7510ZZ

Lot or Serial #

00000532977YM6, 00000715131YM9

Reason for Recall

Computed tomography dose index (CTDI) values on dose display & in operator manual are incorrect for scan settings over 3mm slice thickness. The provided CTDI value may be more than 20% higher than actual CTDI value.

Manufacturer

GE Medical Systems Information Technologies, Inc.

Recall Posting Date

2010-09-27

Trade Name

A) Transport Pro V2 Patient Monitor
B) Transport Pro Patient Monitor (PDM Compatible)

Recall Start Date

2010-08-30

Recall Number

56100

Hazard Classification

Type II

Model or Catalog #

A) TRANS-AC-HXXX
B) TRANS-BC-HXXX

Lot or Serial #

A) AAD05360553GA, AAD06031134GA, AAD06131474GA, AAD06352093GA, AAD06352095GA, AAD05350491GA
B) >10 Numbers, Contact Manufacturer

Reason for Recall

Transport Pro stops communication with Carescape patient data modules after 414 days of continuous run time, resulting in the loss of the displayed parameter info. (Eg: waveforms, numerical data, alarms).

Manufacturer

GE Medical Systems Kretztechnik GMBH & CO OHG

Recall Posting Date

2010-07-05

Trade Name

A) Voluson E8 Ultrasound System Main Unit
B) Voluson E8 Expert Ultrasound System
Updated reall # 51227 previously posted on 2009/11/09

Recall Start Date

2009-10-21

Recall Number

51227

Hazard Classification

Type II

Model or Catalog #

A) H48651PT
B) H48661N

Lot or Serial #

A) S/N D00229
B) S/N D04842, D05589 & D50233

Reason for Recall

When using combination of 2D-compound resolution imaging (CRI) and a pulsed wave Doppler single gate (PW) with steered Doppler angle, the displayed velocity scale is incorrect, which could delay treatment.

Manufacturer

GE Medical Systems SCS

Recall Posting Date

2010-07-05

Trade Name

Innova 2000 Cardiovascular System

Recall Start Date

2010-06-09

Recall Number

54810

Hazard Classification

Type II

Model or Catalog #

S1872LC

Lot or Serial #

>10 Numbers, Contact Manufacturer

Reason for Recall

Source to image distance (SID) failure could occur, which may result in loss of x-ray generation. An error message may or may not be displayed, depending on certain conditions.

Manufacturer

GE Medical Systems Ultrasound & Primary Care Diagnostics LLC

Recall Posting Date

2010-09-27

Trade Name

Logiq E9 Ultrasound System-Sector Transducer

Recall Start Date

2010-09-02

Recall Number

56175

Hazard Classification

Type III

Model or Catalog #

H4908SC

Lot or Serial #

94900496

Reason for Recall

Rating plate of S1-5 probe identifies name and model number of S4-10 probe. Correct S1-5 name appears on transducer handle and packaging.

Manufacturer

Gyrus Acmi, Inc.

Recall Posting Date

2010-08-30

Trade Name

Pleatman Sac Tissue Removal System

Recall Start Date

2010-08-04

Recall Number

56025

Hazard Classification

Type II

Model or Catalog #

004942-903

Lot or Serial #

186540FC

Reason for Recall

Trays used to package the Pleatman Sac product had cracks and/or dimples on them. Further investigation revealed that the dimples could form cracks when the tray is manipulated. This could lead to a breach in the sterile barrier which could compromise sterility of the product.

Manufacturer

Gyrus ACMI, Inc.

Recall Posting Date

2010-08-16

Trade Name

Dissector PlasmaKnife (DPK)

Recall Start Date

2010-07-15

Recall Number

55925

Hazard Classification

Type II

Model or Catalog #

7035-3005

Lot or Serial #

>10 Numbers, Contact Manufacturer

Reason for Recall

A non conformance report (NCR) was initiated at Gyrus ACMI facility because a qualification run of fluid electrodes failed International Safe Transit Association (ISTA) testing due to a failure of the seal on the sterile packaging. A breach in the sterile barrier would compromise the sterility of the product.

Manufacturer

Haemonetics Corporation

Recall Posting Date

2010-07-05

Trade Name

Plasma Bowl, 0625B-00

Recall Start Date

2010-06-10

Recall Number

55256

Hazard Classification

Type II

Model or Catalog #

0625B-00

Lot or Serial #

>10 Numbers, Contact Manufacturer

Reason for Recall

There is a defect in a very small number of plasma bowls in which a portion of the wall of the bowl may be too thin. There is a potential that a defective bowl may leak or fail within the centrifuge chamber during a plasma collection procedure. If a leak or failure were to occur, the PCS2 system is designed to detect the problem and safely terminate the collection procedure. However, it is possible that blood could escape from the device and spray into the surrounding environment and onto surrounding objects or people.

Manufacturer

Heine Optotechnik GMBH & Co. KG

Recall Posting Date

2010-08-16

Trade Name

XP Laryngoscope Blabe Mac 3

Recall Start Date

2010-07-08

Recall Number

55909

Hazard Classification

Type III

Model or Catalog #

F-000.22.763

Lot or Serial #

62117

Reason for Recall

There is a tolerance issue on a certain production batch from April 2010. The result is that the heel of the blade may be too wide to be inserted into the head of laryngoscope handles manufactured to the "green standard".

Manufacturer

Hill-Rom, Inc.

Recall Posting Date

2010-07-05

Trade Name

Hill-Rom 100 Low Bed

Recall Start Date

2010-05-03

Recall Number

54548

Hazard Classification

Type II

Model or Catalog #

P3930

Lot or Serial #

N/A

Reason for Recall

Potential for siderails used on the Hill-Rom 100 Low Bed to operate incorrectly (false latching, unintentional lowering) or become inoperate.

Manufacturer

Hill-Rom, Inc.

Recall Posting Date

2010-07-05

Trade Name

A) Hill-Rom 1000 Beds
B) Care Assist P1170

Recall Start Date

2009-07-13

Recall Number

54567

Hazard Classification

Type II

Model or Catalog #

A) P1600
B) P1170

Lot or Serial #

A) N/A
B) N/A

Reason for Recall

There is a potential for a shearing action between the siderail arm and the bracket used to secure the siderail to the bed.

Manufacturer

Hill-Rom, Inc.

Recall Posting Date

2010-07-19

Trade Name

A) Hill-Rom 1000 Beds
B) Careassist Hospital Bed

Recall Start Date

2010-06-10

Recall Number

55218

Hazard Classification

Type II

Model or Catalog #

A) P1160
B) P1170

Lot or Serial #

A) N/A
B) N/A

Reason for Recall

Failure of the plastic housing used to support the trapeze handle from the patient helper.

Manufacturer

Hologic, Inc.

Recall Posting Date

2010-09-13

Trade Name

A) Atec Breast Biopsy & Excision System Sapphire
B) Atec Breast Biopsy & Excision System Emerald
C) Atec Breast Biopsy & Excision System Pearl

Recall Start Date

2010-08-09

Recall Number

56247

Hazard Classification

Type II

Model or Catalog #

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

Lot or Serial #

A) 003016
B) 003016
C) 003016

Reason for Recall

The aperture of the needle may be a 20mm size, versus the 12mm size indicated on the label.

Manufacturer

Hospira Inc.

Recall Posting Date

2010-08-30

Trade Name

Gemstar Pump Set (110 Yellow)(AMB.INFU)

Recall Start Date

2010-08-10

Recall Number

56130

Hazard Classification

Type II

Model or Catalog #

13261, 13273

Lot or Serial #

740545H, 680295H, 770878H

Reason for Recall

Under delivery reports occurring during clinical use under low rate settings (less than 10ml/hr).

Manufacturer

Howmedica Osteonics Corporation

Recall Posting Date

2010-08-30

Trade Name

Osteonics Series 7000 Total Knee Standard Tibial Tray

Recall Start Date

2010-08-04

Recall Number

56012

Hazard Classification

Type II

Model or Catalog #

7115-0007

Lot or Serial #

MJK68N

Reason for Recall

Stryker Howmedica Osteonics has become aware that there was a cross mix between the Osteonics Series 7000 Total Knee Standard Tibial Tray and the Triathlon Total Knee System Primary Cemented Tibial Base-Plate. The packaging was labelled as a Series 7000 Total Knee Standard Tibial Tray, while the package actually contained a Triathlon Total Knee System Primary Cemented Tibial Base-Plate.

Manufacturer

Immucor Inc.

Recall Posting Date

2010-07-19

Trade Name

Anti-FY Blood Grouping Reagent

Recall Start Date

2010-06-16

Recall Number

55381

Hazard Classification

Type III

Model or Catalog #

0007594

Lot or Serial #

613007, 613007-1

Reason for Recall

Lots 613007 and 613007-1 demonstrate weaker reactivity than previous lots of Anti-FY.

Manufacturer

Immucor Inc.

Recall Posting Date

2010-08-16

Trade Name

Panoscreen I, II and III

Recall Start Date

2010-07-16

Recall Number

55873

Hazard Classification

Type I

Model or Catalog #

0002377

Lot or Serial #

24223

Reason for Recall

Panoscreen I, II and III lot 24223 does not include an S positive donor cell.

Manufacturer

Immucor Inc.

Recall Posting Date

2010-08-16

Trade Name

Galileo Blood Bank Analyzer

Recall Start Date

2010-07-28

Recall Number

55949

Hazard Classification

Type II

Model or Catalog #

0064999

Lot or Serial #

N/A

Reason for Recall

If an unrecognized rack is removed, and a sample is than removed or switched in the rack, followed by reinserting the rack into the lane, it is possible for the sample ID that originally occupied the position to be assigned to the newly loaded sample or the empty position. Under these conditions, it is possible that results will be associated with the wrong sample.

Manufacturer

Immucor Inc.

Recall Posting Date

2010-09-13

Trade Name

Galileo Echo Blood Bank Analyzer

Recall Start Date

2010-08-12

Recall Number

56238

Hazard Classification

Type II

Model or Catalog #

0087000

Lot or Serial #

N/A

Reason for Recall

When a sample rack is partially removed after testing is complete and another rack is inserted into an adjacent position, it is possible for the partially removed rack to be inadvertently loaded ahead of the second rack. In this instance, the second rack's sample ID's will be incorrectly assigned to the original rack.

Manufacturer

Immucor Inc.

Recall Posting Date

2010-09-27

Trade Name

Panocell-20

Recall Start Date

2010-08-30

Recall Number

56415

Hazard Classification

Type II

Model or Catalog #

0005020

Lot or Serial #

29304

Reason for Recall

Cell 5 (donor B3907) of lot 29304 is demonstrating weak positive reactions in direct antiglobulin testing (DAT). Tests performed with this cell may produce unexpected positive reactions at the anti-human globulin (AHG) phase of testing.

Manufacturer

Immunotech A.S.

Recall Posting Date

2010-08-02

Trade Name

Estrone Radioimmunoassay (RIA) Kit

Recall Start Date

2010-07-05

Recall Number

55630

Hazard Classification

Type II

Model or Catalog #

DSL 8700

Lot or Serial #

992637, 100226A, 100319A, 100409A

Reason for Recall

Beckman Coulter has determined that the Estrone RIA Kit lots identified were inaccurately calibrated to their internal reference calibrator.

Manufacturer

Immuontech A.S.

Recall Posting Date

2010-08-30

Trade Name

IGFBP-3 Immunoradiometric Assay (IRMA)

Recall Start Date

2010-08-09

Recall Number

56099

Hazard Classification

Type II

Model or Catalog #

DSL-6600

Lot or Serial #

100115A, 100319A, 100409A, 100430A, 991225, 991694, 991938, 992171, 992372

Reason for Recall

Beckman Coulter has confirmed that IGFBP-3 measurements using IGFBP-3 IRMA Kit (REF DSL-6600) lots identified may result in IGFBP-3 levels that are not in agreement with simultaneously measured levels of IGF-1.

Manufacturer

INO Therapeutics, LLC DBA IKARIA

Recall Posting Date

2010-08-16

Trade Name

INOMAX DS Drug Delivery-System

Recall Start Date

2010-07-23

Recall Number

55907

Hazard Classification

Type II

Model or Catalog #

DS 20050006

Lot or Serial #

>10 Numbers, Contact Manufacturer

Reason for Recall

A component within the pressure switch which monitors for loss of drug supply may tear, causing Inomax to leak from the rear of the system. As a result, the Inomax cylinder empties more quickly than normal. An interruption or delay in the administration of Inomax therapy may cause worsening of systemic oxygenation indices (i.e. hypoxemia, especially manifested as decreased arterial oxygenation saturation), hypotension, and/or increase in pulmonary arterial pressure.

Manufacturer

Institut Straumann AG

Recall Posting Date

2010-07-19

Trade Name

Impression Set for WN Solid Abutment

Recall Start Date

2010-06-15

Recall Number

55311

Hazard Classification

Type III

Model or Catalog #

040.38

Lot or Serial #

Y4021

Reason for Recall

The product name on the label incorrectly identifies the product as "Impression Set for RN (regular neck) Solid Abutment" when it should read "Impression set for WN (wide neck) Solid Abutment".

Manufacturer

Instrumentation Laboratory Co.

Recall Posting Date

2010-09-27

Trade Name

A) ACL Top 500 CTS
B) ACL Top, ACL Top 700 LAS, ACL Top CTS

Recall Start Date

2010-06-01

Recall Number

56433

Hazard Classification

Type II

Model or Catalog #

A) 0000280040
B) 0000280000, 0000280020, 0000280030

Lot or Serial #

A) 08010100 to 10061231
B) 03110101 to 1006111, 08120100 to 10020126, 06020101 to 10030659

Reason for Recall

Software V4.3.0 (with test parameters P-14.6) introduces an additional data check designed to minimize performance issues from factors such as patient condition and improper sample or reagent preparation by the user. Specifically, a new data CJECL, "multiple threshold check" was added to identify and fail abnormal (bimodal) clot curves for hemosil synthasil (APTT reagent, K060688) and hemosil recombiplastin 2g (PT reagent, K070005). The flag will recognize any APTT/PT curve that has a signal that increases in absorbance to a certain threshold level more than once.

Manufacturer

Integra Neurosciences Implants S.A.

Recall Posting Date

2010-08-02

Trade Name

Neuro Balloon Catheter

Recall Start Date

2010-07-07

Recall Number

55602

Hazard Classification

Type II

Model or Catalog #

7CBD10

Lot or Serial #

0151870, 0158739, 0159938

Reason for Recall

Certain Integra Neuro Balloon Catheters have the potential to improperly inflate or deflate under certain conditions. It was determined that this condition could exist during pre-implant testing or during the procedure with some lots of Integra Neuro Balloon Catheter products.

Manufacturer

International Technidyne Corp.

Recall Posting Date

2010-07-05

Trade Name

Hemochron Response Instrument, IDMS

Recall Start Date

2010-06-14

Recall Number

55307

Hazard Classification

Type III

Model or Catalog #

HRS.110

Lot or Serial #

72900321, 72900376, 72900367

Reason for Recall

There is a tabulation error in the integrated data management system (IDMS) software, product code 464100, versions 7.1 through 7.3, used with the Hemochron Response Instrument, that affects the operator and the device performance summary reports for two electronic quality control (EQC) tests.

Manufacturer

International Technidyne Corp.

Recall Posting Date

2010-08-16

Trade Name

Directcheck Whole Blood Control

Recall Start Date

2010-07-19

Recall Number

55897

Hazard Classification

Type III

Model or Catalog #

DCJPT-A

Lot or Serial #

G9DPA005

Reason for Recall

The acceptable performance range published in the Directcheck microcoagulation quality control (product code DCJPT-A, lot number G9DPA005 only) package insert is inaccurate. The posted range printed on the package insert reads "3.7 - 6.5 INR". The correct range is 4.1 - 8.7 INR.

Manufacturer

Inviro Medical, Inc.

Recall Posting Date

2010-07-19

Trade Name

Invirosnap Safety Syringe

Recall Start Date

2010-05-14

Recall Number

55079

Hazard Classification

Type III

Model or Catalog #

100002, 100018, 100019, 100017, 100038, 100047, 100034

Lot or Serial #

2006-06, 2006-09, 061911, 2006-10

Reason for Recall

When the plunger is retracted after an injection, the plunger with needle can be pulled out of the back of the syringe.

Manufacturer

Inviro Medical, Inc.

Recall Posting Date

2010-07-19

Trade Name

Invirosnap Safety Syringe

Recall Start Date

2010-05-14

Recall Number

55085

Hazard Classification

Type III

Model or Catalog #

100019, 100038, 100032, 100034

Lot or Serial #

063804, 061911, 2006-08

Reason for Recall

The needle length is out the specifications.

Manufacturer

Johnson & Johnson Vision Care, Inc.

Recall Posting Date

2010-08-30

Trade Name

Acuvue Oasys Brand Contact Lenses for Astigmatism

Recall Start Date

2010-08-02

Recall Number

56160

Hazard Classification

Type III

Model or Catalog #

N/A

Lot or Serial #

B006X641

Reason for Recall

Some product may have been mislabeled on the secondary carton (yellow carton) and there is a discrepancy with the primary package (blister pack).

Manufacturer

Levo AG

Recall Posting Date

2010-08-02

Trade Name

Levo C3 Wheelchair

Recall Start Date

2010-06-25

Recall Number

55674

Hazard Classification

Type II

Model or Catalog #

N/A

Lot or Serial #

913021

Reason for Recall

A quality problem was discovered with the stand-up wheelchair model Levo C3. When using the stand-up mechanism after a short time a screw may break at the support or the stand-up actuator unit propping up the seat to a 45 degree angle position.

Manufacturer

Lifescan Inc.

Recall Posting Date

2010-09-27

Trade Name

A) OneTouch DataLink Data Management System
B) OneTouch DataLink Management System

Recall Start Date

2010-10-23

Recall Number

56430

Hazard Classification

Type I

Model or Catalog #

A) 021-323, 021-969
B) 021-309, 021-970

Lot or Serial #

A) All lots
B) All lots

Reason for Recall

Possibility of data loss at healthcare facilities when downloading Surestep Flexx Meters to the OneTouch Datalink Data Management System under very specific circumstances (including having more than one meterlink instance installed & a meter that has not downloaded within 25 hrs).

Manufacturer

Liko AB

Recall Posting Date

2010-07-19

Trade Name

Viking M Patient Lift

Recall Start Date

2010-05-25

Recall Number

54859

Hazard Classification

Type II

Model or Catalog #

2040015

Lot or Serial #

7500401 to 7503472

Reason for Recall

Failure of the Viking M Lift as it relates to the control box (CBL 20)and the battery (BAL 20). The product will stop functioning. Note that there is a mechanical means to safely lower the patient during transfer.

Manufacturer

Liko AB

Recall Posting Date

2010-08-02

Trade Name

Scale Adapters

Recall Start Date

2010-07-12

Recall Number

55601

Hazard Classification

Type II

Model or Catalog #

200, 350, 400

Lot or Serial #

N/A

Reason for Recall

If you twist the sling bar when using the scale and scale adapter at a right angle in the lifting direction, the adapter can get locked in this position when the lift has a flexlink. If patient is lifted with the equipment while adapter is in this position, adapter may be damaged or break, allowing a patient to fall.

Manufacturer

Linvatec Corporation D.B.A. Conmed Linvatec

Recall Posting Date

2010-08-16

Trade Name

87K Arthroscopy Tubing Set

Recall Start Date

2010-07-06

Recall Number

55704

Hazard Classification

Type II

Model or Catalog #

87100

Lot or Serial #

Lot # date codes beginning with 0904151 to 1005201

Reason for Recall

A possibility the product may have a breach in the packaging seal that potentially could compromise the product sterility.

Manufacturer

Luxottica North America Distribution LLC

Recall Posting Date

2010-08-02

Trade Name

Sport Goggles - Liberty Sport

Recall Start Date

2010-07-02

Recall Number

55657

Hazard Classification

Type II

Model or Catalog #

MAXMORPHEUS, REC SPEC MAXX

Lot or Serial #

N/A

Reason for Recall

Some Sport Goggles may have prescription lens which do not meet the lens thickness specifications established by the frame manufacturer. Potential for lens breakage or disengagement from frame in event of impact.

Manufacturer

Maquet Cardiopulmonary AG

Recall Posting Date

2010-09-27

Trade Name

Straight Connector

Recall Start Date

2010-08-30

Recall Number

56358

Hazard Classification

Type II

Model or Catalog #

HG0286

Lot or Serial #

70045443, 70050983

Reason for Recall

A leak has been found at the shank during priming before perfusion, a manufacturer issue was detected at the supplier level.

Manufacturer

Medical Device Technologies, Inc. DBA Angiotech

Recall Posting Date

2010-08-02

Trade Name

Tru-Core II

Recall Start Date

2010-07-02

Recall Number

55562

Hazard Classification

Type II

Model or Catalog #

MD763114200X, MD763118100X, MD763118200X

Lot or Serial #

92661WY0, 93491YG7, 00621ZQ1, 011720OQ, 93431YBI, 92661WY7

Reason for Recall

Pouch holes at the chevron edge on the polyethylene side of the pouch or along the chevron side of the seal can compromise the sterile barrier of the packaging.

Manufacturer

Medline Industries Inc

Recall Posting Date

2010-09-27

Trade Name

A) Nygh Dental Pack
B) Nygh Minor and Major Pack
C) C-Section Pack
D) Nygh T & A Pack
E) Nygh Septoplasty Pack
F) Nygh Laparoscopy Pack
G) Grace Total Hip Pack
H) Nygh Vascular Pack
I) Cardiac Pack

Recall Start Date

2010-08-23

Recall Number

56350

Hazard Classification

Type II

Model or Catalog #

A) DYNJ23545
B) DYNJ23312, DYNJ23313
C) OBT242X
D) DYNJ28887
E) DYNJ23314
F) DYNJ23528
G) DYNJ23234
H) DYNJ23547
I) DYNJ31903X

Lot or Serial #

A) 07AD1212, 07AD4192, 07GD1673
B) 07AD1541, 07ED3906, 07AD2649, 07BD3551
C) 10FD0997, 10FD1415, 10GD0786, 10GD2489, 09CD2228, 09CD02261, 10DD0174, 09ED0001, 09ED0887, 09ED3576, 09GD2287, 09HD3244, 09JD3472, 08DD0257, 08ED1747, 08GD4104, 08HD1333, 08KD1091, 09KD3436
D) 07AD2162, 07BD0755, 07CD1423, 07DD1506, 07DD4242
E) 07AD2160, 07BD2175, 07BD2537, 07CD1090, 07DD3113
F) 07AD2290, 07BD0186, 07FD2924, 07GD3752
G) 10BD2818, 10AD0648, 09LD1851, 09HD1616, 09GD0515, 09FD3755, 09FD3241, 09FD0698, 08FD1984, 08FD1109, 08ED3801, 08DD1563, 08DD0368, 08CD2385, 08AD0583, 07LD0379, 07KD0907, 07KD0906, 07JD1514, 07ID1730, 07FD2226
H) 07AD4449, 07AD4545, 07BD1859, 07FD0509, 07GD3003
I) 09ED0655, 09ED3002, 09FD0041, 09FD3115, 09JD1513, 09KD1837, 09LD0272, 09LD2807, 10AD0647, 10AD3494

Reason for Recall

These custom procedure packs contain the Cardinal Medi-Vac Non-Conductive Suction Tubing that has been recalled by Cardinal Health. Medline Industries was alerted by Cardinal regarding a product recall for their Sterile Medi-Vac Non-Conductive Suction Tubing due to the possibility that packaging seals may be compromised.

Manufacturer

Medtronic Inc.

Recall Posting Date

2010-07-19

Trade Name

Carelink - Monitor

Recall Start Date

2010-06-10

Recall Number

55207

Hazard Classification

Type II

Model or Catalog #

2490C

Lot or Serial #

>10 Numbers, Contact Manufacturer

Reason for Recall

During an update, a subset of Carelink monitors of a previous design received firmware intended for monitors of a newer design. This mismatch makes affected monitors non-functional & unable to transmit data.

Manufacturer

Medtronic Inc.

Recall Posting Date

2010-08-02

Trade Name

Enrhythm Dual Chamber Rate Responsive Pacemaker

Recall Start Date

2010-02-11

Recall Number

53125

Hazard Classification

Type II

Model or Catalog #

P1501DR

Lot or Serial #

>1000 Numbers, Contact Manufacturer

Reason for Recall

1) Battery voltage at device interrogation lower than what is tracked to provide data for elective replacement indicator notification. 2) Battery voltage could decrease sooner than expected.

Manufacturer

Medtronic Inc.

Recall Posting Date

2010-08-02

Trade Name

HMS System - Instrument

Recall Start Date

2010-03-08

Recall Number

53511

Hazard Classification

Type III

Model or Catalog #

305-14

Lot or Serial #

>10 Numbers, Contact Manufacturer

Reason for Recall

Control test for heparin assay (HPT) cartridges may run longer than normal & in some cases time out after setting instrument parameters to "IU".

Manufacturer

Medtronic Inc.

Recall Posting Date

2010-08-02

Trade Name

Sutureless Unipolar Myocardial Lead

Recall Start Date

2010-02-25

Recall Number

53385

Hazard Classification

Type II

Model or Catalog #

5071

Lot or Serial #

>100 Numbers, Contact Manufacturer

Reason for Recall

Possible inadequate sterile packaging seals that could potentially affect product sterility.

Manufacturer

Medtronic Navigation Israel Ltd.

Recall Posting Date

2010-08-16

Trade Name

Polestar N-20 - Magnetic Resonance Diagnostic Device

Recall Start Date

2010-07-16

Recall Number

55746

Hazard Classification

Type II

Model or Catalog #

Flexicoil - 9733063

Lot or Serial #

7110519203, 8051519694, 9210040532

Reason for Recall

Electronics box on some flexicoils can overheat and may cause a skin burn when in direct contact with the patient.

Manufacturer

Medtronic Navigation, Inc.

Recall Posting Date

2010-07-19

Trade Name

Stealthstation S7 - Stealth 3D

Recall Start Date

2010-06-21

Recall Number

55374

Hazard Classification

Type II

Model or Catalog #

9734046

Lot or Serial #

S/N's 4500883854, 4500961922, 4500816943, 4500816944, 4501132005, 4500707425

Reason for Recall

Numerous electrical issues related to the power cord retractors.

Manufacturer

Medtronic Navigation, Inc.

Recall Posting Date

2010-08-02

Trade Name

Orthopedic Dovetail Clamp

Recall Start Date

2010-02-10

Recall Number

53129

Hazard Classification

Type II

Model or Catalog #

9730289

Lot or Serial #

200304080750, 200308061080, 2003040807, 2003080610, 200308061080 & 5081710533

Reason for Recall

Current IFU does not indicate that the clamp is designed for exclusive use with Zimmer brand acetabular cup positioner/impactor. Otherwise the clamp can slip axially, resulting in movement of the reference frame.

Manufacturer

Medtronic Sofamor Danek USA, Inc.

Recall Posting Date

2010-07-19

Trade Name

Nim-Eclipse System - Module, Surface Preamp

Recall Start Date

2010-07-02

Recall Number

55529

Hazard Classification

Type II

Model or Catalog #

945SPM608

Lot or Serial #

0923052D

Reason for Recall

Under worst case conditions, such as sweating under warming blankets and long term contact periods, the patient's skin can become discoloured at the electrode contact site.

Manufacturer

Metrex Research Corporation

Recall Posting Date

2010-09-27

Trade Name

Curing Light Sleeves

Recall Start Date

2010-08-09

Recall Number

56429

Hazard Classification

Type III

Model or Catalog #

4500, 4513

Lot or Serial #

100622, 100733

Reason for Recall

Part no. 4500 labelled as 7mm/8mm curing light sleeves actually contained 13mm sleeves. Part no. 4513 labelled as 13mm curing light sleeves actually contained 7mm/8mm sleeves.

Manufacturer

Minntech Corporation

Recall Posting Date

2010-08-02

Trade Name

Endoscope Disinfector

Recall Start Date

2010-07-08

Recall Number

55606

Hazard Classification

Type II

Model or Catalog #

DSD-110-HU0109

Lot or Serial #

N/A

Reason for Recall

Misprinted DSD hookup application guide that recommended the use of the DSD-110-HU0109 hookup rather than DSD-110-HU0144 hookup. May result in inadequate high-level disinfection of either the balloon filling channel or the elevator wire channel depending on the method of connection.

Manufacturer

Mizuho America, Inc.

Recall Posting Date

2010-07-05

Trade Name

Mizuha Doppler Probe

Recall Start Date

2010-03-22

Recall Number

53996

Hazard Classification

Type III

Model or Catalog #

07-150-10

Lot or Serial #

9781-34600, 9782-34598, 9785-34634, 9780-34586

Reason for Recall

The affected lots contain probes that may produce no audio signal. The lack of audio signal will be apparent to the user once the probe is connected to the Doppler transceiver and there is not a reasonable probability that the use of, or exposure to, the product will cause serious adverse health consequences.

Manufacturer

Ohmeda Medical, A Division of Datex Ohmeda Inc.

Recall Posting Date

2010-07-05

Trade Name

Giraffe In-Bed Scales

Recall Start Date

2010-06-08

Recall Number

55120

Hazard Classification

Type II

Model or Catalog #

N/A

Lot or Serial #

>10 Numbers, Contact Manufacturer

Reason for Recall

During the weighing procedure, the scale is programmed to give only 6 seconds to place the baby on the mattress, if it takes more than 6 seconds to place the baby on the mattress, the scale will display an inaccurate weight.

Manufacturer

Oridion Medical 1987 Ltd.

Recall Posting Date

2010-08-16

Trade Name

A) Filterline Set
B) Smart Capnoline Plus ADU/INT 25/100 UN
C) Smart Capnoline Plus O2 ADU/INT 25UN
D) Smart Capnoline H Plus O2 ADU/INT 25UN
E) Niv-Line Adult 25UN

Recall Start Date

2010-05-26

Recall Number

55493

Hazard Classification

Type II

Model or Catalog #

A) XS04620
B) 009818, 010209
C) 009822
D) 010433
E) 008174

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

Reason for Recall

As a result of a production issue, Microstream Filterlines may not be recognized by the monitor when connected to the Microstream Filterline input connector and co2 monitoring will not commence unless the filterline is replaced. No co2 readings will be displayed and no alarms will appear until co2 monitoring starts.

Manufacturer

Ortho-Clinical Diagnostics Inc.

Recall Posting Date

2010-08-30

Trade Name

Vitros Chemistry Products MALB Reagent

Recall Start Date

2010-08-10

Recall Number

56101

Hazard Classification

Type II

Model or Catalog #

6801740

Lot or Serial #

Generation 2, 3 & 4

Reason for Recall

Ortho Clinical Diagnostics has received several customer complaints of lower than expected albumin results for samples that were expected to generate results significantly above the measuring (reportable) range of 0.6 - 19.0 mg/dl. These samples may be negatively biassed and give values within the reportable range without an initial dilution.

Manufacturer

Ortho-Clinical Diagnostics Inc.

Recall Posting Date

2010-09-27

Trade Name

A) Vitros 5600 System Software 1.4 & Below
B) Vitros 3600 System Software 1.4 & Below

Recall Start Date

2010-07-28

Recall Number

55916

Hazard Classification

Type II

Model or Catalog #

A) 680 2863, 680 2864
B) 680 2865, 680 2866

Lot or Serial #

A) >10 Numbers, Contact Manufacturer
B) 36000264, 36000130, 36000116

Reason for Recall

Ortho-Clinical Diagnostics has identified two scenarios on the Vitros 5600 Integrated System (software version 1.4 and below) and Vitros 3600 Immunodiagnostic System (software version 1.4 and below) in which Microwell and/or Microtip reagent inventory may not be properly updated, resulting in misidentified reagent packs and incorrect results or 'no result' being reported by the system.

Manufacturer

Ortho-Clinical Diagnostics Inc.

Recall Posting Date

2010-09-27

Trade Name

Ortho HTLV-I/II AB-Capture Elisa Test

Recall Start Date

2010-09-09

Recall Number

56514

Hazard Classification

Type III

Model or Catalog #

934200

Lot or Serial #

HTV208

Reason for Recall

Ortho-Clinical Diagnostics has received customer complaints regarding intermittent invalid plates due to elevated optical densities (OD) for the negative calibrator when using Ortho HTLV-I/II AB-Capture Elisa Test System, lot HTV208. A negative calibrator OD that is outside the package insert specification would cause an invalid plate. If this occurs the entire plate is aborted and no results are reported.

Manufacturer

Pelton and Crane

Recall Posting Date

2010-08-02

Trade Name

Dental Chair Magnetic Headrest Assembly

Recall Start Date

2010-03-15

Recall Number

54641

Hazard Classification

Type II

Model or Catalog #

N/A

Lot or Serial #

Option - 40R501-XX

Reason for Recall

Magnetic headrest may temporarily affect the function or programming of some implantable pacemakers or defibrillators if the device is programmed to respond to a magnet. People with such devices should avoid using magnetic headrests.

Manufacturer

Philips Medical Systems

Recall Posting Date

2010-07-05

Trade Name

Heartstart FR2+ Semi-Automatic Defibrillator - Main Unit

Recall Start Date

2010-04-23

Recall Number

55119

Hazard Classification

Type II

Model or Catalog #

M3860A, M3861A

Lot or Serial #

>10 Numbers, Contact Manufacturer

Reason for Recall

Certain Heartstart FR2+ Automated External Defibrillators (AEDS) may contain a component called a voltage detector that may have a higher than expected rate of failure. Failure of the voltage detector can cause the AED battery to drain more rapidly than normal or to render the AED unusable.

Manufacturer

Philips Medical Systems

Recall Posting Date

2010-08-02

Trade Name

A) Philips Heartstart HS1 Onsite Defibrillator
B) Philips Heartstart HS1 Home Defibrillator

Recall Start Date

2010-04-23

Recall Number

55525

Hazard Classification

Type II

Model or Catalog #

A) M5066A
B) M5068A

Lot or Serial #

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

Reason for Recall

There is a potential for users to misread the quick reference guide (QRG) and render the device ineffective.

Manufacturer

Philips Medical Systems

Recall Posting Date

2010-08-30

Trade Name

Heartstart MRX Defibrillator / Monitor

Recall Start Date

2010-07-12

Recall Number

56084

Hazard Classification

Type II

Model or Catalog #

M3535A, M3536A

Lot or Serial #

>100 Numbers, Contact Manufacturer

Reason for Recall

Philips has become aware that users may not fully understand the advanced features related to primary ECG lead configuration settings and the automatic lead selection behaviour of the Heartstart MRX.

Manufacturer

Philips Medical Systems (Cleveland), Inc.

Recall Posting Date

2010-07-05

Trade Name

1.5T Edge Eclipse System - Main Unit

Recall Start Date

2010-04-12

Recall Number

55221

Hazard Classification

Type II

Model or Catalog #

OFF-ML-1

Lot or Serial #

N/A

Reason for Recall

There is a potential for misdiagnosis - slice grids associated with images acquired after couch movement will be shown in an incorrect position when viewed on images acquired before the couch was moved.

Manufacturer

Philips Medical Systems (Cleveland), Inc.

Recall Posting Date

2010-09-27

Trade Name

Mx8000 IDT Multislice CT Imaging System

Recall Start Date

2010-07-14

Recall Number

56344

Hazard Classification

Type II

Model or Catalog #

OFF-EI-590

Lot or Serial #

3056

Reason for Recall

The Mx8000 IDT Multislice CT Imaging System may become inoperable if the user does not adjust the site specific protocols manually after the software upgrade.

Manufacturer

Philips Medizin Systeme Boeblingen GMBH

Recall Posting Date

2010-08-02

Trade Name

A) Intellivue MP70 Patient Monitor System - Main Unit
B) Intellivue MP60 Patient Monitor System - Main Unit

Recall Start Date

2010-06-24

Recall Number

55526

Hazard Classification

Type II

Model or Catalog #

A) M8007A
B) M8005A

Lot or Serial #

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

Reason for Recall

Philips has recently received reports of monitors becoming loose and detaching from the variable height mount, with the potential of causing injury.

Manufacturer

Philips Medzin Systeme Boeblingen GMBH

Recall Posting Date

2010-08-30

Trade Name

Anesthetic Gas Monitor Water Trap

Recall Start Date

2010-07-15

Recall Number

56013

Hazard Classification

Type II

Model or Catalog #

M1657B

Lot or Serial #

>100 Numbers, Contact Manufacturer

Reason for Recall

Philips has received reports that when changing the anaesthetic gas monitor water trap (M1657B), the manifold seals on the Philips gas analysers, models M1013A, M1019A and M1026B, may be unintentionally removed. A missing seal results in leakage and may cause incorrect monitor readings of inspiratory or expiratory gas levels.

Manufacturer

Prollenium Medical Technologies Inc.

Recall Posting Date

2010-08-30

Trade Name

Dermal Roller SR

Recall Start Date

2010-08-09

Recall Number

56052

Hazard Classification

Type III

Model or Catalog #

DR10, DR5

Lot or Serial #

10-1209, 05-1209

Reason for Recall

The Dermal SR Roller (transdermal delivery microneedle therapy) is being recalled because of lack of assurance of sterility.

Manufacturer

Rehabilitation Centre for Children

Recall Posting Date

2010-08-02

Trade Name

Tilt Standing Frame

Recall Start Date

2010-06-23

Recall Number

55699

Hazard Classification

Type I

Model or Catalog #

N/A

Lot or Serial #

Contact Manufacturer

Reason for Recall

If an individual on the frame is moved to an upright position without the safety straps, knee blocks and tray in place, the individual may fall forward, tipping the tilt standing frame, posing a risk of serious injury.

Manufacturer

Remel Inc.

Recall Posting Date

2010-07-19

Trade Name

TB Potassium Permanganate Counterstain

Recall Start Date

2010-06-15

Recall Number

55303

Hazard Classification

Type II

Model or Catalog #

RE40092, RE40192

Lot or Serial #

152898, 152899

Reason for Recall

Product deterioration, may affect the ability of the counterstain to quench background fluorescent during performance of staining procedure.

Manufacturer

Roche Diagnostics GMBH

Recall Posting Date

2010-08-16

Trade Name

IgG-2 (Tina Quant IgG Gen.2)

Recall Start Date

2010-07-15

Recall Number

55734

Hazard Classification

Type III

Model or Catalog #

03507432190

Lot or Serial #

63009201

Reason for Recall

Quality control release of the Cobas C501 IgG-2 (Tina Quant IgG Gen. 2) cassette showed a too low recovery of the precinorm PUC control target value while using the cerebrospinal fluid (CSF) application.

Manufacturer

Roche Diagnostics GMBH

Recall Posting Date

2010-08-16

Trade Name

Anti-CCP for Elecsys and Cobas E

Recall Start Date

2010-07-21

Recall Number

55874

Hazard Classification

Type III

Model or Catalog #

05031656190

Lot or Serial #

157557

Reason for Recall

The manufacturer identified a potential decreased recovery of the precicontrol Anti-CCP in combination with the Cobas E-Elecsys Anti-CCP Reagent Kit.

Manufacturer

Roche Diagnostics GMBH

Recall Posting Date

2010-08-30

Trade Name

Elecsys Vitamin D3 assay

Recall Start Date

2010-08-03

Recall Number

55964

Hazard Classification

Type III

Model or Catalog #

03314847190

Lot or Serial #

159526

Reason for Recall

Elecsys Vitamin D3 Monoclonal Assay shows deteriorating traceability to the reference method and a negative bias when compared to the previous polyclonal antibody based version.

Manufacturer

Roche Diagnostics GMBH

Recall Posting Date

2010-08-30

Trade Name

Elecsys Free T4

Recall Start Date

2010-08-06

Recall Number

56041

Hazard Classification

Type III

Model or Catalog #

11731297122

Lot or Serial #

155674, 157677

Reason for Recall

A calibration factor close to or even below 0.8 can be observed with reagent kits stored on-board for more than four weeks. In such case, the rack pack calibration cannot be released by the system.

Manufacturer

Roche Diagnostics GMBH

Recall Posting Date

2010-08-30

Trade Name

A) Coaguchek XS Monitor
B) Coaguchek XS Plus Monitor

Recall Start Date

2010-07-07

Recall Number

56053

Hazard Classification

Type II

Model or Catalog #

A) 3666794
B) 04800842190

Lot or Serial #

A) All lots
B) All lots

Reason for Recall

The recommended cleaning procedures for the Coaguchek XS and Coaguchek XS Plus systems may cause a meter malfunction which could lead to falsely elevated PT/INR results.

Manufacturer

Roche Diagnostics GMBH

Recall Posting Date

2010-08-30

Trade Name

A) Tina-Quant D-Dimer Gen.2 for Cobas Integra and Cobas C-System
B) Tina-Quant D-Dimer Gen.2 for Roche/Hitachi 917 and Modular P Analyzers
C) Tina-Quant D-Dimer Gen.2 for Roche Cobas C111 Analyzers

Recall Start Date

2010-08-12

Recall Number

56170

Hazard Classification

Type I

Model or Catalog #

A) 04912551190
B) 04912497190
C) 05077753190

Lot or Serial #

A) 62837701
B) 62838001
C) 62841101

Reason for Recall

The impacted lots show unusual systematic negative bias of 15% when used together with serum based calibrators and controls. The false negative result could pose a patient at risk of not being timely diagnosed for thrombosis and embolism.

Manufacturer

Roche Diagnostics GMBH

Recall Posting Date

2010-08-30

Trade Name

Precicontrol Universal

Recall Start Date

2010-06-25

Recall Number

55469

Hazard Classification

Type II

Model or Catalog #

11731416190

Lot or Serial #

15418301, 15418305

Reason for Recall

The package insert for the Precicontrol Universal has been modified to exclude the TG component from the storage stability of 3 days at 2-8c after reconstitution due to instability related to an aging effect.

Manufacturer

Roche Diagnostics GMBH

Recall Posting Date

2010-09-27

Trade Name

MagNa Pure LC 2.0 Instrument

Recall Start Date

2010-08-27

Recall Number

56376

Hazard Classification

Type III

Model or Catalog #

05197686001

Lot or Serial #

All lots

Reason for Recall

There is potential for wrong error handling by the MagNa Pure LC 2.0 Instrument software where the extraction protocol is performed only during a portion of the estimated run time and then exits out of the extraction process.

Manufacturer

Roche Diagnostics GMBH

Recall Posting Date

2010-09-27

Trade Name

Cobas Integra Glucose HK Gen. 3

Recall Start Date

2010-08-31

Recall Number

56482

Hazard Classification

Type III

Model or Catalog #

N/A

Lot or Serial #

All lots

Reason for Recall

A change must be made to the glucose urine application of the Cobas C501 unit of Cobas 6000 analyzer due to precision problems and outliers when using aqueous urine control materials at a concentration level of 1.4 mmol/l.

Manufacturer

Roche Diagnostics Ltd.

Recall Posting Date

2010-07-19

Trade Name

MagNa Pure Compact Instrument

Recall Start Date

2010-06-07

Recall Number

55083

Hazard Classification

Type III

Model or Catalog #

03730964001, 03730972001, 03731146001, 04802993001

Lot or Serial #

>10 Numbers, Contact Manufacturer

Reason for Recall

Manufacturer internal investigation revealed that the transfer of the nucleic acid contained in the eluates from the reagent cartridge to the elution tube was impacted with a frequency of 5%. Only a certain portion of the eluated material was transferred to the elution tubes.

Manufacturer

Roche Diagnostics Ltd.

Recall Posting Date

2010-08-16

Trade Name

A) Amplilink Software Version 3.1.1
B) Amplilink Software Version 3.1.2
C) Amplilink Software Version 3.2
D) Amplilink Software Version 3.2.1
E) Amplilink Software Version 3.2.2
F) Amplilink Software Version 3.2.3

Recall Start Date

2010-06-18

Recall Number

55272

Hazard Classification

Type II

Model or Catalog #

A) 04807197001
B) 04855094001
C) 04862392001
D) 05093236001
E) 05201357001
F) 05666678001

Lot or Serial #

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

Reason for Recall

Out-of-range control failures flagged as failed did not invalidate patient samples in the batch for the customers using the Amplilink SW 3.1.X & 3.2X in combination with Cobas Amplicor assays.

Manufacturer

Roche Diagnostics Ltd.

Recall Posting Date

2010-09-13

Trade Name

A) Amplilink Software Version 3.1.1
B) Amplilink Software Version 3.1.2
C) Amplilink Software Version 3.2
D) Amplilink Software Version 3.2.1
E) Amplilink Software Version 3.2.2
F) Amplilink Software Version 3.2.3
Updated recall # 55272 previously posted on 2010-08-16.

Recall Start Date

2010-06-18

Recall Number

55272

Hazard Classification

Type II

Model or Catalog #

A) 04807197001
B) 04855094001
C) 04862392001
D) 05093236001
E) 05201357001
F) 05666678001

Lot or Serial #

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

Reason for Recall

Out-of-range control failures flagged as failed did not invalidate patient samples in the batch for the customers using the Amplilink SW 3.1.X & 3.2X in combination with COBAS© AmpliPrep / COBAS© TaqMan©.

Manufacturer

Roche Diagnostics Ltd.

Recall Posting Date

2010-09-27

Trade Name

Cobas IT 3000 Software

Recall Start Date

2010-09-01

Recall Number

56465

Hazard Classification

Type I

Model or Catalog #

05161401001

Lot or Serial #

Version 2.03.09

Reason for Recall

Critical software issue when using automatic medical validation for Cobas IT 3000 version 2.03.09. A programming error was notice which causes the automatic medical validation to release results which should be held for review.

Manufacturer

Sequal Technologies Inc.

Recall Posting Date

2010-09-13

Trade Name

Sequal Eclipse Oxygen System

Recall Start Date

2009-12-07

Recall Number

53321

Hazard Classification

Type I

Model or Catalog #

N/A

Lot or Serial #

073002972, 063005184, 073006282, 073000585, 073007840, 073006062, 073002301, 073004651,073003155,073004456

Reason for Recall

Eclipse oxygen system units may experience premature wear on electrical connector between battery bridge printed circuit board and power manager printed circuit board that could lead to temporary power interruption when operating from power cartridge, causing unit to sound an alarm and shut down.

Manufacturer

Siemens AG

Recall Posting Date

2010-08-02

Trade Name

Syngo Imaging

Recall Start Date

2010-06-21

Recall Number

55479

Hazard Classification

Type III

Model or Catalog #

10 014 063

Lot or Serial #

1094, 1200, 1262

Reason for Recall

Potential malfunction and hence hazard to patients when using Syngo Imaging version lines VB20, VB30, VB35 in combination with RIS (radiology information system) that is violating dicoms (digital imaging and communication in medicine) standard by creating non-unique study instance UIDS (unique identifiers).

Manufacturer

Siemens AG

Recall Posting Date

2010-08-16

Trade Name

A) Artis Zee Ceiling
B) Artis Zee Biplane

Recall Start Date

2010-07-15

Recall Number

55780

Hazard Classification

Type III

Model or Catalog #

A) 10094137
B) 10094141

Lot or Serial #

A) 146288, 146314
B) 153275

Reason for Recall

A potential malfunction and a possible hazard to patients when using the Artis systems with motor controller failures caused by tolerances on the electronic parts.

Manufacturer

Siemens AG

Recall Posting Date

2010-08-30

Trade Name

A) Mevatron Linear Accelerators
B) Artiste MV-Linear Accelerator-Main Unit

Recall Start Date

2010-08-11

Recall Number

56152

Hazard Classification

Type III

Model or Catalog #

A) 1940035
B) 8139789

Lot or Serial #

A) 2473, 2559, 2618, 3235, 3236, 3376, 2459, 2616, 3291, 3356, 3378, 3382, 3406, 3742, 2239, 2267, 2264
B) 5414, 5485

Reason for Recall

Siemens received a report on a system with 160MLC, where a misalignment of treatment fields was detected during quality assurance. This misalignment was caused by a defective bearing of the collimator.

Manufacturer

Siemens AG

Recall Posting Date

2010-09-13

Trade Name

A) Axiom Artis DTA
B) Axiom Artis FA Alpha
C) Axiom Artis MP Diagnostic

Recall Start Date

2010-08-18

Recall Number

56246

Hazard Classification

Type III

Model or Catalog #

A) 7008605
B) 5904441
C) 5904466

Lot or Serial #

A) 32070
B) 25006, 25055, 25076, 25147
C) 20069, 20070, 20151, 20163, 20215

Reason for Recall

A potential danger by the image intensifier system with perivision options. During perivision the image system can sporadically crash. The customer has to repeat the perivision and to apply contrast media and x-ray to the patient.

Manufacturer

Siemens Healthcare Diagnostics Inc.

Recall Posting Date

2010-07-05

Trade Name

Dimension Tacrolimus Flex Reagent Cartridge, DF107

Recall Start Date

2010-06-16

Recall Number

55304

Hazard Classification

Type III

Model or Catalog #

DF107

Lot or Serial #

DA0334

Reason for Recall

Siemens has confirmed customer complaints regarding low recovery of the Tacrolimus Flex Reagent Cartridge DF107.

Manufacturer

Siemens Healthcare Diagnostics Inc.

Recall Posting Date

2010-08-02

Trade Name

Dimension Vista System-Enzymatic Creatinine Assay (ECREA)

Recall Start Date

2010-06-25

Recall Number

55520

Hazard Classification

Type II

Model or Catalog #

K1270

Lot or Serial #

09350AC, 10011AF, 10131AC

Reason for Recall

Siemens Healthcare Diagnostics received customer complaints regarding the Dimension Vista Assay Enzymatic Creatinine Flex Reagent Cartridge. Siemens has confirmed an issue which may cause enzymatic creatinine (ECREA) results to be falsely depressed up to 0.4 mg/dl or falsely elevated up to 0.6 mg/dl across the assay range.

Manufacturer

Siemens Healthcare Diagnostics Inc.

Recall Posting Date

2010-08-30

Trade Name

A) ADVIA Centaur Hepatitis B Core Total (HBCT) Assay
B) ADVIA Centaur XP System-HBC Total (HBCT) assay (donor screening for transplantation)
C) Advia Centaur CP System-HBC Total (HBCT) assay (donor screening for transplantation)

Recall Start Date

2010-07-05

Recall Number

55559

Hazard Classification

Type III

Model or Catalog #

A) 07566733
B) 07566733
C) 07566733

Lot or Serial #

A) 49471033, 50694033, 51071033, 51628033, 52260033, 52809033, 53674033
B) 50694033, 49471033, 51071033, 51628033, 52260033, 52809033, 53674033
C) 49471033, 50694033, 51071033, 51628033, 52260033, 52809033, 53674033

Reason for Recall

Siemens Healthcare Diagnostics confirms lower than expected specificity rates that may increase the frequency of false positive test results for this assay. Siemens believes that false positive results will lead to further investigation, and that the possibility of misinterpretation and incorrect patient management are low.

Manufacturer

Siemens Healthcare Diagnostics Inc.

Recall Posting Date

2010-07-19

Trade Name

Enzymatic Creatinine (EZCR) Flex Reagent Cartridge, DF270B

Recall Start Date

2010-06-24

Recall Number

55437

Hazard Classification

Type II

Model or Catalog #

DF270B

Lot or Serial #

BD1008, CB1050

Reason for Recall

Siemens Healthcare Diagnostics received customer complaints regarding the Dimension Enzymatic Creatinine (EZCR) Flex Reagent Cartridge. Siemens recently confirmed an issue which may cause EZCR elevations across the assay range. This issue may or may not be detected by quality control, as the degree and onset of elevated results may vary and is likely dependent on multiple factors such as method mix or instrument maintenance.

Manufacturer

Siemens Healthcare Diagnostics Products Limited

Recall Posting Date

2010-08-16

Trade Name

Immulite 2500 System-Human Chorionic Gonadotropin (HCG) Assay

Recall Start Date

2010-06-29

Recall Number

55581

Hazard Classification

Type III

Model or Catalog #

L5KCG2, L5KCG6

Lot or Serial #

123, 151

Reason for Recall

Siemens Healthcare Diagnostics Ltd has determined that the dose at which a patient sample may hook for lots 123 and above is lower than indicated in the original instructions for use (no hook effect seen up to 600,000 miu/ml, instead of claimed 2,860,000 miu/ml).

Manufacturer

Siemens Medical Solutions USA, Inc.

Recall Posting Date

2010-08-16

Trade Name

Syngo Dynamics

Recall Start Date

2010-07-27

Recall Number

55938

Hazard Classification

Type III

Model or Catalog #

100 90 480

Lot or Serial #

92241

Reason for Recall

For customers that are using the IHE displayable report profile, signing off (depending on your configuration) a report will result in an automatic upload of that report to your information system. However, if you create an addendum to a report that has been previously uploaded, the addendum must be uploaded manually using the #send to#.# feature in the Syngo Dynamics reporting system. If the addendum is not sent manually, the older report in your information system will not match the more recent report in your Syngo Dynamics system.

Manufacturer

Siemens Medical Solutions USA, Inc.

Recall Posting Date

2010-09-27

Trade Name

A) Acuson Antares Ultrasound System
B) Acuson Antares System with 5.0 Upgrades

Recall Start Date

2010-08-25

Recall Number

56322

Hazard Classification

Type III

Model or Catalog #

A) 5936518
B) 10032746

Lot or Serial #

A) 112267, 10134
B) 113469, 114573

Reason for Recall

Have determined that there is an error in the estimation of mean pressure gradient in the cardiac measurement package available on Antares systems at product versions 4.0 and 5.0.

Manufacturer

Siemens Medical Solutions USA, Inc.

Recall Posting Date

2010-09-27

Trade Name

Acuson S2000

Recall Start Date

2010-08-25

Recall Number

56323

Hazard Classification

Type III

Model or Catalog #

10041461

Lot or Serial #

200252, 200288, 200334, 200926, 200979, 200995, 202301

Reason for Recall

Have determined that there is an error in the estimation of mean pressure gradient in the cardiac measurement package available on Acuson S2000 systems.

Manufacturer

Siemens Medical Solutions USA, Inc.
Molecular Imaging Group

Recall Posting Date

2010-08-16

Trade Name

A) E-Cam Profile Refurbished System
B) Collimators for E Cam
C) E Cam Signature Series

Recall Start Date

2010-07-07

Recall Number

55779

Hazard Classification

Type III

Model or Catalog #

A) 52 44 012
B) 43 55 108
C) 7333243

Lot or Serial #

A) >10 Numbers, Contact Manufacturer
B) 1005, 3005, 3034, 1004
C) >10 Numbers, Contact Manufacturer

Reason for Recall

The possibility for the patient getting injured while holding on the E-Cam patient handling system (PHS) and the technologist puts the PHS to its home position. This could possibly pose a potential safety hazard.

Manufacturer

Smith & Nephew, Inc.

Recall Posting Date

2010-07-05

Trade Name

Gigli Saw Blade, 12 Inch

Recall Start Date

2010-06-15

Recall Number

55302

Hazard Classification

Type II

Model or Catalog #

210482

Lot or Serial #

08KM00086

Reason for Recall

Smith & Nephew has found that the sterile pouches that contain the Gigli Saw Blade are not sealed. One entire end of the package is totally void of a seal.

Manufacturer

Smith & Nephew, Inc., Endoscopy Division

Recall Posting Date

2010-08-30

Trade Name

Dytonics Bonecutter Electroblade

Recall Start Date

2010-08-04

Recall Number

56143

Hazard Classification

Type II

Model or Catalog #

7205962

Lot or Serial #

>10 Numbers, Contact Manufacturer

Reason for Recall

Smith & Nephew has received complaints in which a small number of patients have received skin burns associated with the usage of the Dyonics Bonecutter Electroblade.

Manufacturer

Smith & Nephew, Inc., Endoscopy Division

Recall Posting Date

2010-09-27

Trade Name

BIORAPTOR 2.9mm Suture Anchor

Recall Start Date

2010-08-30

Recall Number

56446

Hazard Classification

Type III

Model or Catalog #

72200774

Lot or Serial #

50306820

Reason for Recall

Smith & Nephew has identified a single lot of the BIORAPTOR 2.9mm Suture Anchor as having been assembled with 2 suture braids rather than 1.

Manufacturer

Smiths Medical ASD, Inc.

Recall Posting Date

2010-07-19

Trade Name

A) Medfusion Syringe Infusion Pump, 3010
B) Medfusion Syringe Infusion Pump, 3010A

Recall Start Date

2010-06-18

Recall Number

55335

Hazard Classification

Type II

Model or Catalog #

A) 3010
B) 3010A

Lot or Serial #

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

Reason for Recall

Smiths Medical has found that pumps with obsolete software versions 2.0.2, 2.0.3, and 2.0.4, may continue to run past the set volume limit, if all of the following occur: 1) the volume over time (delivery method) mode is used, 2) the volume over time mode is re-accessed through the "recall last settings" function, and 3) the syringe is over-filled.

Manufacturer

Southmedic Inc.

Recall Posting Date

2010-09-27

Trade Name

Stainless Safety Scalpel Sterile

Recall Start Date

2010-09-02

Recall Number

56459

Hazard Classification

Type II

Model or Catalog #

73-0610, 73-0611, 73-0615

Lot or Serial #

070610, 071510, 070910

Reason for Recall

Southmedic Inc. is conducting a voluntary recall of specific lot numbers of the Southmedic safety scalpel due to a potential of unsealed sterile pouches.

Manufacturer

Spacelabs Medical, Inc.

Recall Posting Date

2010-09-13

Trade Name

A) Ultraview SL2600 Compact Monitor
B) Ultraview SL2200 Compact Monitor
C) Ultraview SL Compact Monitor

Recall Start Date

2009-11-12

Recall Number

56205

Hazard Classification

Type II

Model or Catalog #

A) 91370
B) 91367
C) 91369

Lot or Serial #

A) >10 Numbers, Contact Manufacturer
B) 1367-000488, 1367-000447, 1367-000448, 1367-000449, 1367-000484
C) >10 Numbers, Contact Manufacturer

Reason for Recall

Affected Spacelabs' portable patient monitors may stop working when on AC power or shut down and do not power on again. The failure mode is caused by the capacitor identified as C329 malfunctioning and initiating a monitor shutdown.

Manufacturer

Sterngold Dental, LLC

Recall Posting Date

2010-09-27

Trade Name

A) ERA Implant Master Prosthetic Kit
B) ERA Mini Dental Implant System,Complete

Recall Start Date

2010-08-31

Recall Number

56385

Hazard Classification

Type III

Model or Catalog #

A) 811914Z
B) 905119Z

Lot or Serial #

A) Z3303
B) Z3561

Reason for Recall

Products do not contain instructions for use. These instructions contain important safety information related to user cleaning and re-sterilization.

Manufacturer

Sterngold Dental, LLC

Recall Posting Date

2010-09-27

Trade Name

Sterngold/Hader Torque Wrench Kit

Recall Start Date

2010-08-31

Recall Number

56387

Hazard Classification

Type III

Model or Catalog #

905104Z

Lot or Serial #

Z3379

Reason for Recall

Product does not contain the correct instructions for use. These instructions contain important safety information related to user cleaning and re-sterilization.

Manufacturer

Stryker Endoscopy

Recall Posting Date

2010-08-02

Trade Name

Stryker Disposable Scope Warmers

Recall Start Date

2010-06-28

Recall Number

55499

Hazard Classification

Type II

Model or Catalog #

0502-360-000

Lot or Serial #

All lots

Reason for Recall

Stryker Endoscopy has become aware that there is potential for a breach in the sterile packaging of the Disposable Scope Warmers.

Manufacturer

Stryker Endoscopy

Recall Posting Date

2010-08-02

Trade Name

Crossfire System - Console

Recall Start Date

2010-07-12

Recall Number

55664

Hazard Classification

Type II

Model or Catalog #

475-000-000

Lot or Serial #

All lots

Reason for Recall

Stryker Endoscopy has become aware that there is potential for the continuous activation of the radio frequency powered shaver handpieces when using the iswitch wireless footswitch with the crossfire console resulting in prolongation of surgery.

Manufacturer

Stryker Instruments

Recall Posting Date

2010-07-05

Trade Name

A) Commandf II Microelectric System
B) Core Drills

Recall Start Date

2010-06-08

Recall Number

55206

Hazard Classification

Type II

Model or Catalog #

A) 2296-301-000
B) 5400-300-000

Lot or Serial #

A) All lots
B) All lots

Reason for Recall

Stryker instruments has become aware that the inner diameter of the bur guards may be out of specification. It was discovered that the injection moulding tool was leaving additional material on the inner surface of the bur guard that is closest to the rotating nose of the impaction drill.

Manufacturer

Stryker Instruments

Recall Posting Date

2010-08-30

Trade Name

Instructions for use (IFU) for Painpump2 Block-Aid

Recall Start Date

2010-08-05

Recall Number

56046

Hazard Classification

Type II

Model or Catalog #

0575-100-000

Lot or Serial #

09355012

Reason for Recall

Stryker Instruments has revised the instructions for use (IFU) for the Painpump2 Block-Aid.

Manufacturer

Stryker Medical

Recall Posting Date

2010-07-19

Trade Name

A) Instruction Manuals for Epic II Critical Care Beds
B) Instruction Manuals for Zoom II Critical Care Beds

Recall Start Date

2010-06-21

Recall Number

55436

Hazard Classification

Type II

Model or Catalog #

A) 2030-000-000
B) 2040-000-000

Lot or Serial #

A) N/A
B) N/A

Reason for Recall

Stryker Medical has become aware that the Stryker Critical Care Beds were reportedly displaying symptoms of unsmooth and noisy fowler motion. Continuous use could potentially result in a situation in which the manual CPR drop on the bed may become inoperable at fowler angles of approximately 45 degrees or more.

Manufacturer

Stryker Medical

Recall Posting Date

2010-08-02

Trade Name

M1 Ambulance Cot

Recall Start Date

2010-06-10

Recall Number

55697

Hazard Classification

Type II

Model or Catalog #

6100-000-000

Lot or Serial #

N/A

Reason for Recall

Stryker Medical has become aware that the head end slide tube, bushings, and head end release rod have the potential to break during use, potentially resulting in the collapse of the head end of the cot.

Manufacturer

Stryker Medtech K.K.

Recall Posting Date

2010-08-16

Trade Name

Stryker Sonopet Ultrasonic Aspirator Console

Recall Start Date

2010-07-19

Recall Number

55828

Hazard Classification

Type II

Model or Catalog #

5450-850-000

Lot or Serial #

All lots

Reason for Recall

Stryker Instruments became aware that the Sonopet console did not meet the IEC 60601-1 standard (electromedical safety standard).

Manufacturer

Stryker Orthopeadics

Recall Posting Date

2010-08-30

Trade Name

Scorpio T72 Insert Tibial Trials

Recall Start Date

2010-07-27

Recall Number

55981

Hazard Classification

Type II

Model or Catalog #

T-72

Lot or Serial #

>100 Numbers, Contact Manufacturer

Reason for Recall

Stryker Orthopaedics has become aware that there is the potential for the Scorpio T72 Insert Tibial Trials to be oversized by a maximum of .024"(0.6mm). It was determined that an oversized Tibial Insert Trial may sit on the anterior edge of the tibial baseplate if used for secondary trialing in a procedure. If there is an inability to seat the insert trial and impaction is used to seat the trial, fracture of the device may occur.

Manufacturer

Sybron Endo

Recall Posting Date

2010-08-16

Trade Name

K3 Gutta Percha

Recall Start Date

2010-07-14

Recall Number

55901

Hazard Classification

Type III

Model or Catalog #

825-0420

Lot or Serial #

020210

Reason for Recall

Mislabeled packages of the K3 Gutta Percha .04/20 points (part number 825-0420) contained the K3 Gutta Percha .04/40.

Manufacturer

Synthes (Canada) Ltd.

Recall Posting Date

2010-09-13

Trade Name

Insight Retractor System Frames

Recall Start Date

2010-08-12

Recall Number

56200

Hazard Classification

Type II

Model or Catalog #

03.615.002, 03.615.100

Lot or Serial #

N/A

Reason for Recall

The holding pin on the retractor frame was reported as unscrewing and falling out. If this were to occur while the retractor is in use, the retraction will not be affected but the fallens screw has the potential to enter the surgical wound undetected. This may result in an un-retrieved device fragment.

Manufacturer

Synthes (Canada) Ltd.

Recall Posting Date

2010-09-13

Trade Name

Implant Holder for Synfix-LR - System Technique Guide

Recall Start Date

2010-08-13

Recall Number

56201

Hazard Classification

Type II

Model or Catalog #

03.802.039

Lot or Serial #

N/A

Reason for Recall

Synthes (Canada), Ltd is initiating a medical device labelling recall related to the Synthes Synfix-LR System Technique Guide, specifically regarding use of the Synfix implant holder. The surgical technique presented in the guide has been revised and emphasizes the importance of ensuring that the Synfix-LR implant holder is not cross threaded when attached to the Synfix-LR implant. The revision also describes the use of holding forceps.

Manufacturer

Sysmex Corporation

Recall Posting Date

2010-09-27

Trade Name

A) XT-2000I Analyzer - Sysmex Hematology Analyzers
B) Sysmex XT-1800I Analayzer - Sysmex Hematology Analyzers
C) XT-4000I Hematology Analyzer

Recall Start Date

2010-08-27

Recall Number

56348

Hazard Classification

Type II

Model or Catalog #

A) 013-2531-8
B) 023-0531-6
C) 013-2553-0

Lot or Serial #

A) >10 Numbers, Contact Manufacturer
B) 16975
C) 11165, 11232

Reason for Recall

A design error introduced in the field programmable gate array (FPGA) was discovered. This FPGA is a logic circuit on a chip embedded on the printed computer board (PCB) in the main unit of the XT-series analyzers. The error can present as an increase in the platelet (PLT) count of up to double the correct count and/or the generation of excessive PLT sampling errors. The increase in count and errors is caused by the circuit seeing a single platelet and creating two pulses that are included in the reported PLT count.

Manufacturer

Technidata S.A.S.

Recall Posting Date

2010-07-05

Trade Name

TD-Synergy Software

Recall Start Date

2009-12-30

Recall Number

52751

Hazard Classification

Type III

Model or Catalog #

TD-SYN-01

Lot or Serial #

All lots

Reason for Recall

If some microbiology results have not been consolidated yet, and an event triggers replication from the production database to the management database, then the non-consolidated results are overwritten by blank results.

Manufacturer

Technidata S.A.S.

Recall Posting Date

2010-08-30

Trade Name

TD-Synergy

Recall Start Date

2010-07-02

Recall Number

55962

Hazard Classification

Type II

Model or Catalog #

TD-SYN-01

Lot or Serial #

N/A

Reason for Recall

In the ERM session, when results are of coded text type, incorrect data could be displayed in the tool tip on the current result field.

Manufacturer

Technidata S.A.S.

Recall Posting Date

2010-08-30

Trade Name

A) TDLims
B) TD-Synergy

Recall Start Date

2010-07-02

Recall Number

55963

Hazard Classification

Type II

Model or Catalog #

A) TD-LIS-01
B) TD-SYN-01

Lot or Serial #

A) N/A
B) N/A

Reason for Recall

Using F8 key in the ERM session to add a combined test can result in the modification of the value of a result that has already been entered for a test of the request. This could only occur if the combined test added by F8 includes at least one test with the "duplicate result" property set to ?yes?.

Manufacturer

Teleflex Medical

Recall Posting Date

2010-08-02

Trade Name

Rusch Care Premium Drain Bag

Recall Start Date

2010-07-07

Recall Number

55666

Hazard Classification

Type II

Model or Catalog #

390000

Lot or Serial #

20100105

Reason for Recall

During an inspection wet product was found that was due to improper aeration during sterilization of the product and the sterile integrity could not be guaranteed.

Manufacturer

Teleflex Medical

Recall Posting Date

2010-08-16

Trade Name

IMA / ENT Blade Electrode

Recall Start Date

2010-07-30

Recall Number

55952

Hazard Classification

Type II

Model or Catalog #

809335

Lot or Serial #

All lots

Reason for Recall

There is a potential for peeling and melting of the insulation of the cautery tip of the IMA / ENT Blade Electrodes. This can result in the tip losing integrity leading to sparking or arcing of the current at the blade tip and result in a burn or electrical shock.

Manufacturer

Terumo Cardiovascular System Corporation

Recall Posting Date

2010-07-05

Trade Name

Sarns Disposable Centrifugal Pump

Recall Start Date

2010-06-02

Recall Number

55167

Hazard Classification

Type II

Model or Catalog #

164275

Lot or Serial #

N/A

Reason for Recall

Terumo Cardiovascular Systems Corp. received reports of loss of forward with the Sarns Disposable Centrifugal Pump. Terumo CVS investigation determined that in the cases reported that impeller in the disposable shaft separated from the shaft causing it to stop rotating.

Manufacturer

Terumo Cardiovascular System Corporation

Recall Posting Date

2010-07-05

Trade Name

Sarns Cardioplegia Set with MP-4 Module

Recall Start Date

2010-06-10

Recall Number

55224

Hazard Classification

Type II

Model or Catalog #

71032

Lot or Serial #

ME19

Reason for Recall

Terumo Cardiovascular Systems (Terumo CVS) has received four reports of an occluded vent port on the Sarns Cardioplegia Set with MP-4 module. In all reports the defect was evident during priming. Terumo CVS investigation found that for some units in certain lots of MP-4 modules, a damaged pin in the injection mold allowed the vent port to fill with excess plastic.

Manufacturer

Tomotherapy Incorporated

Recall Posting Date

2010-07-19

Trade Name

TomoTherapy HI-ART System

Recall Start Date

2010-06-23

Recall Number

55439

Hazard Classification

Type II

Model or Catalog #

101264

Lot or Serial #

10037, 10169

Reason for Recall

The planning station's printed plan reports may indicate statistics which are not correct. The TomoTherapy Hi-Art treatment planning system presents DVH, isodose and dose statistics information on the user interface (or on-screen) which are accurate and unaffected by this issue. However, if erroneous dose statistics were printed and then provided to third parties to guide therapy in retreatment situations, improper therapy could result.

Manufacturer

Toshiba Medical Systems Corporation

Recall Posting Date

2010-07-19

Trade Name

Kalare

Recall Start Date

2010-06-07

Recall Number

55449

Hazard Classification

Type II

Model or Catalog #

DUA-450F

Lot or Serial #

99A0562042, 99A05X2054, 99A05X2055, 99A05Y2057, 99A0612074, 99A0622078, 99A0672105, A4612006

Reason for Recall

In diagnostic x-ray system Kalare tabletop lateral movement cannot be performed, or tabletop lateral movement is performed at extremely slow speed. As a result, positioning of the patient cannot be performed by tabletop movement.

Manufacturer

Toshiba Medical Systems Corporation

Recall Posting Date

2010-08-16

Trade Name

Aquilion One System - Main Unit

Recall Start Date

2010-07-22

Recall Number

55835

Hazard Classification

Type II

Model or Catalog #

TSX-301A/2

Lot or Serial #

>10 Numbers, Contact Manufacturer

Reason for Recall

In Aquilion One systems, communication between units in the console may be cut off due to failure of a component (hub).

Manufacturer

Toshiba Medical Systems Corporation

Recall Posting Date

2010-09-13

Trade Name

Aquilion One

Recall Start Date

2010-08-06

Recall Number

56173

Hazard Classification

Type II

Model or Catalog #

TSX-301A/2

Lot or Serial #

>10 Numbers, Contact Manufacturer

Reason for Recall

In Aquilion One systems, in some cases the pre-scan dose values displayed in the exam plan editing window is lower than what the displayed value should be when the scanner executes the exam plan.

Manufacturer

Toshiba Medical Systems Corporation

Recall Posting Date

2010-09-13

Trade Name

Aplio Artida

Recall Start Date

2010-08-05

Recall Number

56227

Hazard Classification

Type II

Model or Catalog #

SSH-880CV

Lot or Serial #

W1B0862082, W1F0982235, WIF0982239, WIF0982240

Reason for Recall

In Artida Ultrasound Systems model SSH-880CV, there are two issues noted regarding (1) some measurement values are displayed incorrectly on the report page, and (2) temperature-related warnings are not consistently displayed.

Manufacturer

Trinity Biotech USA

Recall Posting Date

2010-09-13

Trade Name

Captia VZV IgM Kit

Recall Start Date

2010-07-17

Recall Number

56303

Hazard Classification

Type II

Model or Catalog #

2325650

Lot or Serial #

122, 123, 124, 125

Reason for Recall

Disproportionate drop in absorbance of calibrator causes ISR to run out of range. Risk of a false positive.

Manufacturer

Trinity Biotech USA

Recall Posting Date

2010-09-27

Trade Name

Captia EBV VCA IGM

Recall Start Date

2010-07-28

Recall Number

56527

Hazard Classification

Type II

Model or Catalog #

2325760

Lot or Serial #

084

Reason for Recall

Low positive control range for the low positive control (5760-4-003078) included in the Elisa Kit is incorrect. The correct range for the control is (0.91-2.3).

Manufacturer

Tyco Healthcare Liebel-Flarsheim Company

Recall Posting Date

2010-07-05

Trade Name

Hydra Vision DR60/80 System, Generators

Recall Start Date

2010-06-14

Recall Number

55273

Hazard Classification

Type II

Model or Catalog #

700539, 700540

Lot or Serial #

All lots

Reason for Recall

A smell of burning/smoke is emanating from the x-ray generators. This is caused by a failed printed circuit board electronic component and an internal electronic transformer. These failures will cause the generator to become inoperative.

Manufacturer

United States Surgical, A Division of Tyco Healthcare Group

Recall Posting Date

2010-07-19

Trade Name

Auto Suture Protack Fixation Device

Recall Start Date

2010-06-28

Recall Number

55465

Hazard Classification

Type II

Model or Catalog #

174006

Lot or Serial #

P0B0753

Reason for Recall

Certain Protack Fixation devices fire one helical tack and then become inoperable.

Manufacturer

Varian Medical Systems, Inc.

Recall Posting Date

2010-08-16

Trade Name

A) Clinac Linear Accelerator
B) Trilogy Radiotherapy Delivery System
C) Clinac IX Radio Therapy Delivery System
D) Novalis TX Linear Accelerator

Recall Start Date

2010-05-27

Recall Number

55377

Hazard Classification

Type II

Model or Catalog #

A) 2100C, 21EX, 21EXD, 21EXS
B) IX, IXS
C) IX, IXS, TRILOGY
D) NOVALIS TX

Lot or Serial #

A) >10 Numbers, Contact Manufacturer
B) H140836, H291166, H291172, H293787, H293883, H294134, H294403, H294551, H294750
C) >10 Numbers, Contact Manufacturer
D) H294674

Reason for Recall

The auto "goto" or auto "setup" functions in C-series version 7 software ignore couch angle exceeded motion zone unless a tolerance is defined by the user (gantry rotation exclusion now only applies by default if OBI is present and deployed. Customer facilities using both C-series version 6 & 7 may get confused because couch safety zone no longer exists by default in version 7.

Manufacturer

Varian Medical Systems, Inc.

Recall Posting Date

2010-08-16

Trade Name

A) Varian Clinac Linear Accelerator
B) Trilogy Radiotherapy Delivery System
C) Varian Clinac IX Radiotherapy Delivery System
D) Novalis TX Linear Accelerator

Recall Start Date

2010-06-23

Recall Number

55612

Hazard Classification

Type II

Model or Catalog #

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

Lot or Serial #

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

Reason for Recall

Anomalies have been identified with the Clinac Collimator and couches that can result in small patient or field positioning errors that may adversely affect high - dose treatments requiring small positioning tolerances, such as stereotactic radiosurgery (SRS) and stereotactic radiotherapy (SRT). Refer to 'C- series Clinacs when used for hypo-fractioned radiotherapy' dated 06/23/2010 for further information.

Manufacturer

Varian Medical Systems, Inc.

Recall Posting Date

2010-09-13

Trade Name

Eclipse Treatment Planning (BrachyVision)

Recall Start Date

2010-08-01

Recall Number

56293

Hazard Classification

Type II

Model or Catalog #

8.2, 8.5, 8.6, 8.9

Lot or Serial #

N/A

Reason for Recall

When incorrect syntax is used in the template file, a misinterpretation of the desired value can occur.

Manufacturer

Varian Medical Systems, Inc.

Recall Posting Date

2010-07-05

Trade Name

A) Varis Vision or Aria (Version 6.5)
B) Eclipse

Recall Start Date

2010-05-13

Recall Number

55200

Hazard Classification

Type II

Model or Catalog #

A) Version 6.5
B) Version 6.5

Lot or Serial #

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

Reason for Recall

An anomaly was discovered in which a second or subsequent user can access a patient record which is already open at another workstation, and, if they ignore the warning message that the record is being edited by another user, and proceed to edit the plan and save the record, a corrupted but usable patient plan record may result. Errors can include, but are not limited to, incorrect MU, incorrect beam modifiers, incorrect gantry angles, incorrect field sizes, etc.

Manufacturer

Vascular Solutions, Inc.

Recall Posting Date

2010-09-27

Trade Name

Langston Dual Lumen Catheter

Recall Start Date

2010-08-31

Recall Number

56416

Hazard Classification

Type II

Model or Catalog #

5540

Lot or Serial #

548110, 548227, 548364, 548430, 548554, 548723

Reason for Recall

Some lots of the Langston Dual-Lumen Pigtail Catheter, model 5540 are missing a sterile barrier pouch seal.

Manufacturer

Vital Diagnostics, Inc.

Recall Posting Date

2010-08-30

Trade Name

Excyte Sliders

Recall Start Date

2010-04-14

Recall Number

54156

Hazard Classification

Type III

Model or Catalog #

EX-10552

Lot or Serial #

All lots

Reason for Recall

There are Excyte ESR tubes in the field that do not fit properly in the Excyte sliders. The product will not be replaced. This product is discontinued.

Manufacturer

Wilson-Cook Medical, Inc.

Recall Posting Date

2010-09-27

Trade Name

A) Six-Shooter Saeed Multi-Band Ligator
B) Ten-Shooter Saeed Multi-Band Ligator

Recall Start Date

2010-09-07

Recall Number

56462

Hazard Classification

Type II

Model or Catalog #

A) MBL-6-OV, MBL-6-OV-XS
B) MBL-10

Lot or Serial #

A) W2783447, W2758500, W2758501, W2772743, W2753989, W2772759, W2777465
B)W2758472, W2758474, W2764330, W2772073

Reason for Recall

Possibility of a section of the ligator barrel separating from the barrel's friction fit adapter that attaches to patient end of the endoscope, which could in turn result in a section of the ligator barrel detaching inside the patient's gastrointestinal tract.

Manufacturer

Zimmer Inc.

Recall Posting Date

2010-08-02

Trade Name

Versys Hip System Femoral Head 12/14

Recall Start Date

2010-07-09

Recall Number

55632

Hazard Classification

Type II

Model or Catalog #

00801802801, 00801803201

Lot or Serial #

61424803, 61275855

Reason for Recall

This action is being conducted because there is a potential for a package to be labelled as a 28mm femoral head but contain a 32mm femoral head. In addition, there is a potential for the patient record label to be incorrect.

Manufacturer

Zimmer Inc.

Recall Posting Date

2010-08-02

Trade Name

ITST Fixation Locking Bolt Extractor

Recall Start Date

2010-07-09

Recall Number

55641

Hazard Classification

Type II

Model or Catalog #

00-2258-051-01

Lot or Serial #

53951300

Reason for Recall

This action is being conducted because Zimmer has determined the instruments were manufactured using a grade of material that is nonconforming to specifications. As manufactured, the instruments are more brittle, which increases the potential for fracture.

Manufacturer

Zimmer Inc.

Recall Posting Date

2010-09-13

Trade Name

Trabecular Metal Acetabular Porous Shell

Recall Start Date

2010-08-20

Recall Number

56268

Hazard Classification

Type II

Model or Catalog #

00-6202-056-22

Lot or Serial #

61091653

Reason for Recall

This action is being conducted because the threads on the device (Trabecular Metal Modular Acetabular 56mm Porous Shell with Cluster Holes) were not completely machined and therefore will not mate with the corresponding cup positioner.

Manufacturer

Zimmer Inc.

Recall Posting Date

2010-09-13

Trade Name

Bigliani/Flatow Fukuda Retractors

Recall Start Date

2010-08-23

Recall Number

56271

Hazard Classification

Type III

Model or Catalog #

00-4305-019-30, 00-4305-019-40

Lot or Serial #

60795817, 60834923, 60916795, 61017041, 61038697, 60768814, 60806551, 60893241, 60946820, 60999665

Reason for Recall

This action is being conducted due to fractures occurring at the grooves around the perimeter of the blades. The Bigliani/Flatow complete shoulder solution Fukuda Retractors (small and large sizes) are used to gain exposure to the glenoid during surgery.

Manufacturer

Zimmer Trabecular Metal Technology, Inc.

Recall Posting Date

2010-08-02

Trade Name

Trabecular Metal Femoral Cone Augment

Recall Start Date

2010-07-09

Recall Number

55634

Hazard Classification

Type II

Model or Catalog #

00-5450-012-31

Lot or Serial #

60683028

Reason for Recall

This action is being conducted because there is a potential for the packages to be mislabeled. Specifically, the left femoral cone augment component may be labelled as a right and the right femoral cone augment component may be labelled as a left.