Medical Device Recall Listings - Sorted by Recall Posting Date

(From July 2009 - September 2009)

Recall Posting Date

2009/09/28

Trade Name

A) Advia Centaur System Software Class 3
B) Advia Centaur XP System Software Class 2
C) Advia Centaur XP System Software Class 4
D) Advia Centaur XP System Software Class 3
E) Advia Centaur System Software Class 2
F) Advia Centaur System Software Class 4

Manufacturer

Siemens Healthcare Diagnostics Inc.

Recall Start Date

2009/08/28

Recall Number

50676

Hazard Classification

Type III

Model or Catalog #

A) 04911855, 078-A001-14
B) 078-A010-07, 09066916
C) 078-A010-07, 09066916
D) 078-A010-07, 09066916
E) 04911855, 078-A001-14
F) 04911855, 078-A001-14

Lot or Serial #

A) Version 4.0 Software
B) Version 6.0 Software
C) Version 6.0 Software
D) Version 6.0 Software
E) Version 4.0 Software
F) Version 4.0 Software

Reason for Recall

Internal testing conducted by the manufacturer has determined that Advia Centaur V. 4.0 and Advia Centaur XP V. 6.0 system software is missing range flags and no reflex testing after restoring definition files and reflex for Hepatitis B surface antigen (HBSAG) is not updated.

Recall Posting Date

2009/09/28

Trade Name

A) Aria Software
B) Aria Offline Review Software
Updated recall # 49074 previously posted on 2009-06-22.

Manufacturer

Varian Medical Systems, Inc.

Recall Start Date

2009/05/09

Recall Number

49074

Hazard Classification

Type II

Model or Catalog #

A) 8.1.15, 8.5.11, 8.6.07, HIT
B) 8.1.15, 8.5.11, 8.6.07, HIT

Lot or Serial #

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

Reason for Recall

An anomaly exists in the software, which leads to a record save fail in the case that a partially treated fraction has zero dose accumulation. If the change to the plan had been to parameters other than dose per fraction, treatment to incorrect volume could result, potentially leading to serious injury.

Recall Posting Date

2009/09/28

Trade Name

A) I-Stat Kaolin Act Cartridge
B) I-Stat Act Celite Cartridge

Manufacturer

Abbott Point Of Care Inc.

Recall Start Date

2009/08/11

Recall Number

50427

Hazard Classification

Type II

Model or Catalog #

A) 07G81-01, 07G81-02
B) 07G01-01, 07G01-02

Lot or Serial #

A) All Lots
B) All Lots

Reason for Recall

An inconsistency was noted in the i-Stat System manuals regarding the volume of saline used to flush an indwelling line and the volume of blood to be discarded for clearing the line when testing coagulation cartridges.

Recall Posting Date

2009/09/28

Trade Name

A) PCR Eleva S
B) PCR Compano Eleva

Manufacturer

Philips Medical Systems DMC GMBH

Recall Start Date

2009/02/23

Recall Number

46769

Hazard Classification

Type II

Model or Catalog #

A) PCR ELEVA S
B) PCR ELEVA PLUS

Lot or Serial #

A) N/A
B) N/A

Reason for Recall

Possibility that choice of patient will be changed when using filtered work lists. Normally problem detected because the "active" name of patient is displayed. This affects PCR Eleva system connected to a RIS.

Recall Posting Date

2009/09/28

Trade Name

A) PowerProMax Battery Modular Handpiece
B) PowerProMax Battery 2-Trigger/Full F HP
C) PowerProMax Oscilator Handpiece
D) PowerProMax Reciprocator Saw Handpiece
E) MPower Battery Two Trigger
F) MPower Battery Sternum Saw
G) MPower Battery Handpieces
H) PowerPro Battery Trigger Handpiece

Manufacturer

Linvatec Corporation D.B.A. Conmed Linvatec

Recall Start Date

2009/08/14

Recall Number

50403

Hazard Classification

Type II

Model or Catalog #

A) PRO5100M
B) PRO5200M
C) PRO5300M
D) PRO5400M
E) PRO6202
F) PRO6450
G) PRO6200, PRO6300, PRO6400
H) PRO5200, PRO5100, PRO5300, PRO5400

Lot or Serial #

A) BBB97037, BBB97730, BBB97731, BBB97734, BBB98124, BBB98125, BBB99622, BBB99925, BBC07409, BBC07410
B) >10 Numbers, Contact Manufacturer
C) >10 Numbers, Contact Manufacturer
D) >10 Numbers, Contact Manufacturer
E) >10 Numbers, Contact Manufacturer
F) BBC98784, BBC98787, BBD08568
G) >100 Numbers, Contact Manufacturer
H) >10 Numbers, Contact Manufacturer

Reason for Recall

The manufacturer has determined there is a remote possibility that certain handpieces may self activate.

Recall Posting Date

2009/09/28

Trade Name

A) Unipolar Intramuscular Leads
B) Enterra Gastric Stimulation Leads
C) Enterra Therapy GastricC Stimulation IPG

Manufacturer

Medtronic Inc.

Recall Start Date

2009/09/04

Recall Number

50734

Hazard Classification

Type II

Model or Catalog #

A) 4300-35, 4300-50
B) 4351
C) 3116, 7425G

Lot or Serial #

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

Reason for Recall

The recall is initiated to provide important new safety information and patient management recommendations related to the potential for bowel obstruction and/or perforation in a small percentage of Medtronic Enterra Therapy System patients. Enterra Therapy leads may wrap around or perforate the bowel.

Recall Posting Date

2009/09/28

Trade Name

A) Virtuoso Dual Chamber ICD
B) Concerto CRT-D
C) Virtuoso Single Chamber ICD

Manufacturer

Medtronic Inc.

Recall Start Date

2009/09/09

Recall Number

50790

Hazard Classification

Type II

Model or Catalog #

A) D164AWG
B) C174AWK
C) D164VWC

Lot or Serial #

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

Reason for Recall

Affected devices may not meet expected device longevity due to gradually increasing current drain caused by low voltage capacitor degradation. This issue may present in the affected devices as reaching the recommended replacement time (RRT) earlier than expected.

Recall Posting Date

2009/09/28

Trade Name

C0R36 15x100mm Kii Optical Access Sys

Manufacturer

Applied Medical Resources Corporation

Recall Start Date

2009/06/09

Recall Number

50115

Hazard Classification

Type II

Model or Catalog #

C0R36

Lot or Serial #

1084426, 1085506, 1082348

Reason for Recall

A cannula tip had fractured during a gastric bypass procedure. The resulting fragments were recovered and the event did not directly result in patient injury. However, the surgeon converted the laparoscopic procedure to "open" to confirm all fragments were recovered. The identity of other medical devices or accessories used in the event is unknown.

Recall Posting Date

2009/09/28

Trade Name

Galileo 1000 Microliter Syringe

Manufacturer

Immucor Inc.

Recall Start Date

2009/08/24

Recall Number

50713

Hazard Classification

Type III

Model or Catalog #

65051

Lot or Serial #

>10 Numbers, Contact Manufacturer

Reason for Recall

The glue joint between the glass and the metal can be insufficient on some syringes, which, over the time, can lead to leaking and possibly to breakage of the glass barrel.

Recall Posting Date

2009/09/28

Trade Name

Galileo Echo Blood Bank Analyzer

Manufacturer

Immucor Inc.

Recall Start Date

2009/08/28

Recall Number

50717

Hazard Classification

Type II

Model or Catalog #

87000

Lot or Serial #

N/A

Reason for Recall

QC may not be reset after reported QC failure. This occurs because QC passed but was repeated and failed prior to the 24-hour expiration period established for the first QC.

Recall Posting Date

2009/09/28

Trade Name

Immulite 2000 System-Androstenedione AS

Manufacturer

Siemens Healthcare Diagnostics Products Limited

Recall Start Date

2009/09/04

Recall Number

50731

Hazard Classification

Type III

Model or Catalog #

L2KAO2

Lot or Serial #

217

Reason for Recall

Lot numbers exhibit a positive bias with quality controls and patient results (average about +20%).

Recall Posting Date

2009/09/28

Trade Name

Immulite System-Total T4 Assay

Manufacturer

Siemens Healthcare Diagnostics Products Ltd.

Recall Start Date

2009/09/14

Recall Number

50818

Hazard Classification

Type III

Model or Catalog #

LKT41, LKT45

Lot or Serial #

351

Reason for Recall

Siemens Healthcare Diagnostics received customer complaints regarding Immulite / Immulite 1000 total T4 kit assay where the barcode did not correspond to the kit barcode lot number.

Recall Posting Date

2009/09/28

Trade Name

MCS+Mobile Collection System, LN 9000

Manufacturer

Haemonetics Corporation

Recall Start Date

2009/08/31

Recall Number

50666

Hazard Classification

Type II

Model or Catalog #

09000-100-E, 09000-110-EWC

Lot or Serial #

>10 Numbers, Contact Manufacturer

Reason for Recall

The rare possibility exists for a pump encoder failure to go undetected and cause a pump to spin rapidly and possibly infuse anticoagulant to a donor. This has occurred just one time in over fifteen million procedures in the past 10 years.

Recall Posting Date

2009/09/28

Trade Name

R Series Defibrillator/Pacemaker/Monitor

Manufacturer

Zoll Medical Corporation

Recall Start Date

2009/09/02

Recall Number

50795

Hazard Classification

Type II

Model or Catalog #

Zoll R Series

Lot or Serial #

S/N AF07F001253, S/N AF08G005269, S/N AF08J005776, S/N AF08L006574, S/N AF09B006789, S/N AF09B006791

Reason for Recall

R series may display an ECG fault 7 message and fail to display the ECG baseline. Failure to display the patient's ECG could delay delivery of defibrillation or pacing therapy.

Recall Posting Date

2009/09/28

Trade Name

Search-Cyte Duo Reagent Red Blood Cells

Manufacturer

Biotest Medical Diagnostics GMBH

Recall Start Date

2009/08/24

Recall Number

50727

Hazard Classification

Type III

Model or Catalog #

70226

Lot or Serial #

169053

Reason for Recall

Cell II of this product tests positive with the direct coombs test which interferes with antibody screening procedures causing false positive results.

Recall Posting Date

2009/09/28

Trade Name

Sequencer

Manufacturer

Impac Medical Systems Inc.

Recall Start Date

2009/08/27

Recall Number

50644

Hazard Classification

Type III

Model or Catalog #

10-0020

Lot or Serial #

Sequencer for MOSAIQ 1.30, Sequencer for MOSAIQ 1.40, Sequencer for MOSAIQ 1.41, Sequencer for MOSAIQ 1.50, Sequencer for MOSAIQ 1.60, Sequencer for MOSAIQ 2.00

Reason for Recall

The problem is a defect in the RTP Import functionality (SEQUENCER) during the import of an RTP plan, which converts the Field between coordinate systems that swap the X and Y axes (e.g., from IEC1217 to IEC601). The subject defect did not impair the accuracy of or the ability to use QA mode.

Recall Posting Date

2009/09/28

Trade Name

Spinnaker Elite Flow Directed Catheter

Manufacturer

Boston Scientific Cork Ltd.

Recall Start Date

2009/08/05

Recall Number

50289

Hazard Classification

Type II

Model or Catalog #

549015-2, 549020-2, 549030-2, 559010-2, 559020-2, 559030-2

Lot or Serial #

N/A

Reason for Recall

Boston is sending safety alert to customers to re-emphasize the device's approved indications and remind that this product is not intended or indicated for use with glue or glue mixtures.

Recall Posting Date

2009/09/28

Trade Name

Staph Xtra Latex Kit

Manufacturer

Pro-Lab Diagnostics

Recall Start Date

2009/06/30

Recall Number

49925

Hazard Classification

Type II

Model or Catalog #

PL.1080, PL.1081

Lot or Serial #

PL1080 Lot 6066, PL1080 LOT 6087, PL1080 LOT 6240, PL1081 LOT 5927, PL1081 LOT 6067, PL1081 LOT 6088, PL1081 LOT 6127, PL1081 LOT 6237, PL1081 LOT C6340, PL1081 LOT C6375

Reason for Recall

The affected lot numbers of the reagent, may display graininess that could be mis-interpreted as a false positive result.

Recall Posting Date

2009/09/28

Trade Name

Sutureless Connector Intrathecal Catheters and Revision Kits

Manufacturer

Medtronic Inc.

Recall Start Date

2009/08/27

Recall Number

50614

Hazard Classification

Type I

Model or Catalog #

8578, 8709SC, 8731SC, 8596SC

Lot or Serial #

>10 Numbers, Contact Manufacturer

Reason for Recall

Medtronic has determined that Sutureless Connector (SC) Intrathecal Catheters and Revision Kits are not compatible with Isomed Infusion Pumps. A physical interference between the SC Catheter Connector and the Isomed Pump prevents the SC Catheter from completely connecting to the Isomed Pump even though it may appear to be connected and feel secure.

Recall Posting Date

2009/09/28

Trade Name

TDX SR Power Wheelchair

Manufacturer

Invacare Corporation

Recall Start Date

2009/09/02

Recall Number

50704

Hazard Classification

Type II

Model or Catalog #

TDXSR, TDXSR-CG, TDXSR-CG-HD, TDXSR-HD, TDXSR-MCG, TDXSR-MCG-HD, TDXSRV-HD

Lot or Serial #

N/A

Reason for Recall

On some chairs the stability lock feature may not be engaging properly or consistently. If the stability lock feature does not engage properly, the wheelchair may exhibit a tendency to do one or more of the following: 1) veer to one side, 2) rock forward onto its front riggings, 3) drive in an unintended circular motion, and/or 4)fall forward or to one side and injure the user.

Recall Posting Date

2009/09/28

Trade Name

TempBond Clear with Triclosan

Manufacturer

Kerr Corporation

Recall Start Date

2009/09/09

Recall Number

50813

Hazard Classification

Type III

Model or Catalog #

33351

Lot or Serial #

3257280, 3229807, 3268505, 3277455, 3258772, 3269811

Reason for Recall

Manufacturer received 21 complaints that catalyst portion of TempBond Clear with Triclosan syringes was polymerized and therefore unusable. An investigation confirmed the complaints.

Recall Posting Date

2009/09/28

Trade Name

TestOxidase Reagent

Manufacturer

Pro-Lab Diagnostics

Recall Start Date

2009/06/30

Recall Number

49922

Hazard Classification

Type III

Model or Catalog #

PL.390

Lot or Serial #

5824, 5884, 5971, 6038, 6136

Reason for Recall

The affected lot numbers of the reagent, normally clear or tan in colour, have shown a purple discolouration. Product performance is not affected.

Recall Posting Date

2009/09/28

Trade Name

Uniglide Tibia, Cementless Size 7

Manufacturer

Corin Limited

Recall Start Date

2009/08/06

Recall Number

50619

Hazard Classification

Type III

Model or Catalog #

525.07

Lot or Serial #

NACN

Reason for Recall

Insufficient process control of the sterile barrier (blister lid) sealing process. The devices have been sealed in blister packs. Pack test results from one day's production met minimum requirements of the testing regime but there was a step change in the test results indicating a change to the validated process.

Recall Posting Date

2009/09/14

Trade Name

A) Anesthesia Manager
B) PACU Manager
C) Critical Care Manager

Manufacturer

Picis Inc.

Recall Start Date

2009/08/10

Recall Number

50507

Hazard Classification

Type II

Model or Catalog #

A) Model/Catalog #: 4220
B) Model/Catalog #: 4245
C) Model/Catalog #: 1110

Lot or Serial #

A) S/W version 7.1
B) S/W version 7.1
C) S/W version 7.1

Reason for Recall

A problem may occur when an order of long duration (those continuing for several days) is discontinued. Due to the configuration of the buffer storage in local memory it may not set the status of the future tasks to "done". In this rare instance it will continue to appear on the flowsheet and the pending orders list.

Recall Posting Date

2009/09/14

Trade Name

A) Brainscan Radiotherapy System-Software
B) iPlan RT Dose-Planning Software

Manufacturer

Brainlab AG

Recall Start Date

2009/08/12

Recall Number

50497

Hazard Classification

Type I

Model or Catalog #

A) 20630
B) 20630

Lot or Serial #

A) N/A
B) N/A

Reason for Recall

Failure to apply and verify an adequate jaw-shaped field size and field position at the linac for the used conical collimator(s) or the failure to mount and verify the correct, intended conical collimator may lead to serious injury or death of the patient.

Recall Posting Date

2009/09/14

Trade Name

A) Expo Angiographic Catheters, amplatz
B) Impulse Angiographic Catheter, amplatz
C) Impulse Angiographic Catheter, brachial
D) Impulse Angiographic Catheters,femoral
E) Impulse Angiographic Catheters,internal
F) Impulse Angiographic Catheters,left
G) Impulse Angiographic Catheters, multi
H) Impulse Angiographic Catheters, radial
I) Impulse Angiographic Catheters, ventri.
J) Impulse Angiographic Catheters, kimny
K) Impulse Angiographic Catheters, cummings
L) Expo Angiographic Catheters, brachial
M) Expo Aangiographic Catheters, femoral
N) Expo Angiographic Catheters, femoral r.
O) Expo Angiographic Catheters intermal
P) Expo Angiographic Catheters L/R coronar
Q) Expo Angiographic Catheters, multipurpose
R) Expo Angiographic Catheters, ventricular
S) Expo Angiographic Catheters, multipack
T) Expo Angiographic Catheters, kimny famil
U) Expo ANgiographic Catheters, cummings FA
V) Wiseguide Guide Catheters, femoral
W) Wiseguide Guide Catheters, allright
X) Wiseguide Guide Catheters, voda
Y) Wiseguide Guide Catheters, amplatz

Manufacturer

Boston Scientific Corporation

Recall Start Date

2009/08/07

Recall Number

50383

Hazard Classification

Type II

Model or Catalog #

A) 08526-01
B) 16391-100
C) 16391-11
D) 16391-02
E) 16391-201
F) 16391-190
G) 16391-117
H) 16391-174
I) 16391-40
J) 16391-180
K) 16391-203
L) 08526-150
M) 08526-21
N) 08526-01
O) 08526-201
P) 08526-190
Q) 08526-146
R) 08526-40
S) H749085263002
T) 08526-180
U) H749085263031
V) 16320-01
W) 16320-496
X) 16320-230
Y) 16320-103

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
L) N/A
M) N/A
N) N/A
O) N/A
P) N/A
Q) N/A
R) N/A
S) N/A
T) N/A
U) N/A
V) N/A
W) N/A
X) N/A
Y) N/A

Reason for Recall

Sterile barrier in the packaging may be compromised.

Recall Posting Date

2009/09/14

Trade Name

A) Gyroscan Intera ACS 1.5 Tesla MR System
B) Intera 1.5T MR Systems - Coils

Manufacturer

Philips Medical Systems Nederland B.V.

Recall Start Date

2009/08/14

Recall Number

50406

Hazard Classification

Type II

Model or Catalog #

A) N/A
B) N/A

Lot or Serial #

A) 5354, 5220, 5418, 99220, 5572, 5465, 5438
B) 8985, 10236, 8256, 22658, 8672, 8442, 8379, 8240, 10183, 10566

Reason for Recall

The combined use of the Synergy Flex-M/Shoulder Coil 1.5T with other coils increases the chance of RF interaction and heating up of the coil. This may result in possible burns of the patient. This applies to all Intera 1.5T and Gyroscan Intera ACS 1.5T MR systems with a Synergy Flex M/Shoulder Coil 1.5T initially delivered as release 5.1.7, 6, 7, 8, 9, or 10.

Recall Posting Date

2009/09/14

Trade Name

A) Oximetrix 3 System SO2/CO Computer
B) Lifecare PCA 4100 Plus Infuser
C) Lifecare 5000 Plum Infusion Pump System
D) Plum XL
E) Omni Flow 4000 Plus IV Medication MS
F) Plum XL Micro/Macro With Data Port XLD
G) Plum XL Micro/Macro Infusion (XLM)
H) Plum XL Multiline Infusion Sys. XL3
I) Plum XL 3 Micro/Macro Infusion Sys.XL3M
J) Gemstar Docking Station
K) Lifecare PCA 3 Infusion System
L) Plum A+ Volumetric Infusion Pump
M) Plum A+3 Infusion Pumps

Manufacturer

Hospira Inc.

Recall Start Date

2009/08/20

Recall Number

50517

Hazard Classification

Type II

Model or Catalog #

A) 50130
B) 1950
C) 2507
D) 11555
E) 40051
F) 11859
G) 11846
H) 11781
I) 186706
J) 13075
K) 12384, 20709
L) 11971, 12391, 20679, 20792
M) 12618, 20678

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
L) N/A
M) N/A

Reason for Recall

Power cords may crack and fail leading to potential risks of electrical shock. Delay in setup and therapy interruption and fires which may also occur in an oxygen-rich environment.

Recall Posting Date

2009/09/14

Trade Name

A) PKS Seal Open Forceps, Curved Jaw With Cord
B) Plasmakinetic Curved Jaw Open Forceps
C) Plasmakinetic Straight Jaw Open Forceps
D) Plasmakinetic Angle Jaw Open Forceps

Manufacturer

Gyrus Acmi, Inc.

Recall Start Date

2009/08/18

Recall Number

50595

Hazard Classification

Type II

Model or Catalog #

A) 915000PK, 915005PK, 915010PK
B) 3103PK
C) 3104PK
D) 3105PK

Lot or Serial #

A) All Lots Prior To 2009-08-14
B) All Lots Prior To 2009-08-14
C) All Lots Prior To 2009-08-14
D) All Lots Prior To 2009-08-14

Reason for Recall

The metal shim between the jaws may detach during the procedure and fall into the surgical field. It has been reported that the detached shim may be undetected and be left behind in the patient.

Recall Posting Date

2009/09/14

Trade Name

A) Portex Tracheal Tube, Oral/Nasal, Ivory
B) Portex Tracheal Tube, Siliconised
C) Portex Tracheal Tube,Murphy,Siliconised
D) Portex Polar Preformed Tracheal Tube
E) Portex Tracheal Tube, Oral/Nasal
F) Portex Tracheal Tube, Oral/Nasal, Murphy Eye, Clear

Manufacturer

Smiths Medical International Ltd.

Recall Start Date

2009/09/14

Recall Number

50611

Hazard Classification

Type I

Model or Catalog #

A) 100-105-025, 100-105-030, 100-105-035
B) 100-111-020, 100-111-025, 100-111-030, 100-111-035, 100/126/025, 100/126/030, 100/126/035
C) 100-141-025, 100-141-030, 100-141-035
D) 100/134/030, 100/134/035
E) 100/112/030, 100/112/035
F) 100/127/025, 100/127/030, 100/127/035

Lot or Serial #

A) All lots prior to Sept 2009
B) All lots prior to Sept 2009
C) All lots prior to Sept 2009
D) All lots prior to Sept 2009
E) All lots prior to Sept 2009
F) All lots prior to Sept 2009

Reason for Recall

Smiths Medical International Ltd. has become aware that certain Portex uncuffed paediatric tracheal tubes were manufactured with an internal diameter slightly smaller than specifications. There is a remote potential for a suction catheter to become lodged in a tracheal tube which may require extubation.

Recall Posting Date

2009/09/14

Trade Name

A) Screwplant Implants
B) Screwplant Healing Collars
C) Legacy Healing Collars
D) Screwindirect Implants
E) Screwplus Implants
F) Screwdirect Implants
G) Replant Implants
H) Replus Implants

Manufacturer

Implant Direct LLC

Recall Start Date

2009/08/18

Recall Number

50598

Hazard Classification

Type II

Model or Catalog #

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

Lot or Serial #

A) > 100 Numbers, Contact Manufacturer
B) > 10 Numbers, Contact Manufacturer
C) > 10 Numbers, Contact Manufacturer
D) > 10 Numbers, Contact Manufacturer
E) > 10 Numbers, Contact Manufacturer
F) > 10 Numbers, Contact Manufacturer
G) > 10 Numbers, Contact Manufacturer
H) > 10 Numbers, Contact Manufacturer

Reason for Recall

Cover caps exhibited visible cracks post sterilization.

Recall Posting Date

2009/09/14

Trade Name

A) Unicel DXI800 Thyroglobulin Antibody II
B) Access System Thyroglobulin Antibody II
C) Unicel DXI600 Thyroglobulin Antibady II

Manufacturer

Beckman Coulter Inc.

Recall Start Date

2009/08/24

Recall Number

50639

Hazard Classification

Type III

Model or Catalog #

A) A32898
B) A32898
C) A32898

Lot or Serial #

A) >618967
B) >618967
C) >618967

Reason for Recall

The Access Thyroglobulin Antibody II (THGAB II) assay demonstrates increased low-end imprecision and false positive rate when run in conjunction (i.e. random access mode) with the Access Accutnl assay.

Recall Posting Date

2009/09/14

Trade Name

A) Van Sonnenberg
B) Flexima Hydrophilic All Purpose
C) Flexima Hydrophilic Drainage
D) Flexima Hydrophilic Biliary Drainage
E) Flexima Hydrophilic Drainage Kit
F) Flexima Hydrophilic Nephrostomy
G) Flexima Hydrophilic Nephrostomy Catheter
H) VTC Nephrostomy System
I) Nephroureteral Stent System
J) Vansonnenberg Chest Drain Set

Manufacturer

Boston Scientific Corporation

Recall Start Date

2009/03/23

Recall Number

47710

Hazard Classification

Type III

Model or Catalog #

A) 20-307, 21-306, 21-307, 27-303, 27-304, 27-315, 27-316
B) 27-124, 27-131, 27-132, 27-133, 27-134, 27-135
C) 27-196, 27-197, 27-198, 27-199
D) 27-154, 27-155, 27-156, 27-157, 27-158, 27-159, 27-160, 27-161, 27-162, 27-260, 27-261, 27-262, 27-263, 27-264, 27-265, 27-266, 27-267, 28-260, 28-261
E) 27-163, 27-164, 27-165, 27-166
F) 27-177, 27-178, 27-179, 27-180, 27-181, 27-182, 27-183, 27-184, 27-185
G) 27-186, 27-187, 27-188, 27-189, 27-190, 27-191
H) 22-514, 22-524
I) 22-136, 22-137, 22-138, 22-139, 22-140, 22-141, 22-142, 22-143, 23-136, 23-137, 23-138, 23-139, 23-140, 23-141, 23-142, 23-143
J) 24-506, 24-507

Lot or Serial #

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

Reason for Recall

Boston scientific has decided to revise the DFU for all affected products to include more detailed info about sutures separating from catheter.

Recall Posting Date

2009/09/14

Trade Name

A) VNS Demipulse SYS Programming
B) VNS Demipulse SYS Programming Software

Manufacturer

Cyberonics Inc.

Recall Start Date

2009/08/11

Recall Number

50356

Hazard Classification

Type II

Model or Catalog #

A) 250 (Versions 6.1 And Less)
B) 250, 250 V7.1.4

Lot or Serial #

A) All Versions And Lot Numbers
B) All Versions And Lot Numbers

Reason for Recall

In rare instances, a system diagnostic test using model 250 programming software (v 7.1 and earlier) may report "lead impedance: ok" when, in fact, normal wear and trauma has resulted in a short-circuit condition that prevents the lead from delivering therapy to the vagus nerve.

Recall Posting Date

2009/09/14

Trade Name

A) VNS Model 250 Programming Software
B) VNS Demipulse System Programming Software

Manufacturer

Cyberonics Inc.

Recall Start Date

2009/07/31

Recall Number

50356

Hazard Classification

Type II

Model or Catalog #

A) 250, 250 V7.1.4
B) 250 (Versions 6.1 And Less)

Lot or Serial #

A) All Versions And Lot Numbers
B) All Versions And Lot Numbers

Reason for Recall

In rare instances, a system diagnostic test using model 250 programming software (v 7.1 and earlier) may report "lead impedance: ok" when, in fact, normal wear and trauma has resulted in a short-circuit condition that prevents the lead from delivering therapy to the vagus nerve.

Recall Posting Date

2009/09/14

Trade Name

A) Wiseguide Guide Catheters, bypass
B) Wiseguide Guide Catheters, multipurpose
C) Wiseguide Guide Catheters, q-curve
D) Wiseguide Guide Catheters, radial
E) Wiseguide Guide Catheters, contralateral
F) Wiseguide Guide Catheters, cls
G) Wiseguide Guide Catheters, kimny

Manufacturer

Boston Scientific Corporation

Recall Start Date

2009/08/07

Recall Number

50383

Hazard Classification

Type II

Model or Catalog #

A) 16320-122
B) 16320-131
C) 16320-293
D) 19500-474
E) 16320-573
F) 16320-573
G) 16320-583

Lot or Serial #

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

Reason for Recall

Sterile barrier in the packaging may be compromised.

Recall Posting Date

2009/09/14

Trade Name

Aquesure Disposable Filters

Manufacturer

Bomimed Inc.

Recall Start Date

2009/04/30

Recall Number

50420

Hazard Classification

Type II

Model or Catalog #

N/A

Lot or Serial #

042709, 042309, 042209

Reason for Recall

A customer could not get a CO2 tracing while the anesthesia circuit was in use because the CO2 port on the filter was blocked with the plastic mould. Lot numbers listed are the affected anesthesia circuits.

Recall Posting Date

2009/09/14

Trade Name

Bond-1 Primer/Adhesive

Manufacturer

Pentron Clinical Technologies, LLC

Recall Start Date

2009/08/25

Recall Number

50640

Hazard Classification

Type III

Model or Catalog #

N01IAB

Lot or Serial #

186620, 190582, 190985, 183847

Reason for Recall

Some of the bottles had already gelled and were unusable.

Recall Posting Date

2009/09/14

Trade Name

Capture-R Ready Screen (4)

Manufacturer

Immucor Inc.

Recall Start Date

2009/08/18

Recall Number

50618

Hazard Classification

Type II

Model or Catalog #

0066802, 0066812

Lot or Serial #

K226

Reason for Recall

Unexpected positive reactivity with this lot of product. Invalid test result due to unexpected negative reactions with the positive control observed with this lot.

Recall Posting Date

2009/09/14

Trade Name

Clay Adams Dynac III Centrifuge

Manufacturer

Becton Dickinson And Company

Recall Start Date

2009/08/17

Recall Number

50475

Hazard Classification

Type III

Model or Catalog #

420104

Lot or Serial #

8192744, 8288054

Reason for Recall

Latch bar on centrifuges may have been improperly assembled. May become loose, disabling safety feature which prevents customers from opening centrifuge while it is spinning.

Recall Posting Date

2009/09/14

Trade Name

Cobra Electrosurgical System

Manufacturer

Boston Scientific EP Technologies

Recall Start Date

2009/08/05

Recall Number

50601

Hazard Classification

Type II

Model or Catalog #

M00448100, M00448110, M0048400

Lot or Serial #

> 10 Numbers, Contact Manufacturer

Reason for Recall

Potential to deliver RF energy without depressing the foot switch. If foot switch is not depressed, and the audible sound is heard and/or the indicator light is on, the foot switch is not functioning properly.

Recall Posting Date

2009/09/14

Trade Name

Cook Sydney IVF Culture Oil

Manufacturer

William A. Cook Australia, PTY. Ltd.

Recall Start Date

2009/03/31

Recall Number

47702

Hazard Classification

Type II

Model or Catalog #

K-SICO-200

Lot or Serial #

A833541

Reason for Recall

Higher than usual viscosity of culture oil may lead to difficulty in culturing. Communication issued to affected facilities but no product return requested.

Recall Posting Date

2009/09/14

Trade Name

Datex Ohmeda Carestations Interface

Manufacturer

GE Healthcare Finland OY

Recall Start Date

2009/04/14

Recall Number

47422

Hazard Classification

Type II

Model or Catalog #

M1079844

Lot or Serial #

> 10 Numbers, Contact Manufacturer

Reason for Recall

The N-DISVENT-02 acts as an interface between the anesthesia machine or ventilator and the patient monitor. Because of incorrect patient weight and/or height synchronization between anesthesia machine/ventilator and the patient monitor through the N-DISVENT-02 interface, there is the possibility of incorrect patient weight and/or height recorded in the patient monitor.

Recall Posting Date

2009/09/14

Trade Name

Emax 2 Plus System - Foot Pedal

Manufacturer

The Anspach Effort Inc.

Recall Start Date

2009/08/17

Recall Number

50456

Hazard Classification

Type II

Model or Catalog #

EPLUS-FP

Lot or Serial #

SN C08301701901

Reason for Recall

The foot control cable lacks the shield connection from the cable to the connector body. The lack of shielding may result in radiated emissions exceeding CISPR11.

Recall Posting Date

2009/09/14

Trade Name

G40, X150, X300 Ultrasound System

Manufacturer

Siemens Medical Solutions USA, Inc.

Recall Start Date

2009/08/12

Recall Number

50581

Hazard Classification

Type III

Model or Catalog #

8648375

Lot or Serial #

302351, 303316, 300477

Reason for Recall

Letter to inform all customers on how volume flow calculations are calculated on the affected ultrasound systems and that the formulas determining flow volume are described in the included manual addendum.

Recall Posting Date

2009/09/14

Trade Name

Galileo 500ul Syringes

Manufacturer

Immucor Inc.

Recall Start Date

2009/08/11

Recall Number

50526

Hazard Classification

Type II

Model or Catalog #

64999, 65050 (Syringe)

Lot or Serial #

N/A

Reason for Recall

The glue joint between the glass and the metal can be insufficient on some syringes, which can lead to leaking and possibly to breakage of the glass barrel.

Recall Posting Date

2009/09/14

Trade Name

HeartStart MRx Defibrillator/Monitor

Manufacturer

Philips Medical Systems

Recall Start Date

2009/08/18

Recall Number

50623

Hazard Classification

Type II

Model or Catalog #

M3535A, M3536A

Lot or Serial #

Serial numbers US00533518 - US00535118

Reason for Recall

The devices were shipped with an incorrect configuration file, disarming the 'flashing red x' and audible alarms when they are powered by AC or DC power and have no battery or low battery capacity. This also causes a weekly self diagnostic test to run hourly depleting batteries faster than normal when stored without an external power source.

Recall Posting Date

2009/09/14

Trade Name

Hi-Art System

Manufacturer

Tomotherapy Incorporated

Recall Start Date

2009/08/13

Recall Number

50472

Hazard Classification

Type II

Model or Catalog #

101264

Lot or Serial #

10037, 10169, 10014, 10072, 10130, 101212, 110009, 110129

Reason for Recall

During radiation treatment the usual data were not visible on the operator station display, even though the rad on indicators were active. The treatment was then stopped at around the 4min mark, but the system did not mark the treatment as interrupted. When the treatment was re-run, the entire treatment was delivered instead of starting at the 4min mark.

Recall Posting Date

2009/09/14

Trade Name

HTA System

Manufacturer

Boston Scientific Microvasive

Recall Start Date

2009/08/05

Recall Number

50466

Hazard Classification

Type II

Model or Catalog #

M006550160, M006550161, M006560200, M006560201

Lot or Serial #

> 10 Numbers, Contact Manufacturer

Reason for Recall

Possibility of thermal injury to patient resulting from fluid leakage at the cervix around the sheath.

Recall Posting Date

2009/09/14

Trade Name

Hydrodissector Cannulas

Manufacturer

Hurricane Medical

Recall Start Date

2009/05/14

Recall Number

50440

Hazard Classification

Type II

Model or Catalog #

4027

Lot or Serial #

90402

Reason for Recall

It was discovered during final review of the product 4027, lot 090402 that the wrong product was issued for packaging. A similar ophthalmic cannula, product 2027 was inadvertently retrieved and packed as a product 4027.

Recall Posting Date

2009/09/14

Trade Name

InterDry Ag

Manufacturer

Coloplast A/S

Recall Start Date

2009/07/28

Recall Number

50228

Hazard Classification

Type II

Model or Catalog #

7910

Lot or Serial #

1789435

Reason for Recall

Coloplast became aware of an InterDry AG stability test failure in that a sample submitted for testing contained no silver. Only a portion of 1 lot did not meet product specifications for silver content.

Recall Posting Date

2009/09/14

Trade Name

Magna-FX Cannulated Screw Fixation

Manufacturer

Zimmer Inc.

Recall Start Date

2009/08/14

Recall Number

50432

Hazard Classification

Type III

Model or Catalog #

114607000

Lot or Serial #

60471710

Reason for Recall

Some units in the affected lot of Magna-FX Cannulated Screw Fixation System cannulated bone screws may not have the hex broached into the head of the screw, making driver engagement impossible.

Recall Posting Date

2009/09/14

Trade Name

MC5057 Universal Cable

Manufacturer

Linvatec Corporation D.B.A. Conmed Linvatec

Recall Start Date

2009/08/14

Recall Number

50401

Hazard Classification

Type II

Model or Catalog #

MC5057

Lot or Serial #

N/A

Reason for Recall

The possibility that a sufficiently worn/damaged Universal Cable MC5057, when used with various Conmed Linvatec electric handpieces may cause the handpiece to self activate.

Recall Posting Date

2009/09/14

Trade Name

Pedicap / Pedicap 6

Manufacturer

Covidien LP - Respiratory & Monitoring Solutions GBU

Recall Start Date

2009/08/18

Recall Number

50527

Hazard Classification

Type I

Model or Catalog #

Pedicap, Pedicap 6

Lot or Serial #

> 10 Numbers, Contact Manufacturer

Reason for Recall

A recent modification to Pedicap end-tidal co2 detector may result in increased resistance to airflow through Pedicap and may cause ineffective ventilation of patient and inadequate detection of co2 levels, so that the indicator paper will not change colour.

Recall Posting Date

2009/09/14

Trade Name

Phenobarbital And Drug Calibrator 1

Manufacturer

Beckman Coulter Inc.

Recall Start Date

2009/08/28

Recall Number

50663

Hazard Classification

Type II

Model or Catalog #

469600, 469785

Lot or Serial #

Reagent part # 469785 lots M810083 and earlier, Drug Calibrator part # 469600 lots M810440 and earlier.

Reason for Recall

There is variability in results of Phenobarbital (PHE) Reagent and Drug Calibrator 1. Results may vary from -3% to +17% with different reagent and calibrator lot combinations when measured against the established gas chromatography flame ionization detection (GC-FID) method traceable to certified phenobarbital standards.

Recall Posting Date

2009/09/14

Trade Name

Sireskop SX/SD
Updated recall # 47071 previously posted on 2009-06-22.

Manufacturer

Siemens AG

Recall Start Date

2009/02/11

Recall Number

47071

Hazard Classification

Type III

Model or Catalog #

10093754, 31 11 676, 3111668

Lot or Serial #

21005, 21040, 21087, 21107, 21110, 31036, 34170, 36103, 41021

Reason for Recall

Penetrating liquids or sprays entering the system may lead to malfunction of the system, resulting in unintentional movement, unintentional radiation, extended radiation or useless image, endangering the patient or operator.

Recall Posting Date

2009/09/14

Trade Name

Stratus OCT Tomographer Vers. 6.0 Software

Manufacturer

Carl Zeiss Meditec Inc.

Recall Start Date

2009/08/14

Recall Number

50625

Hazard Classification

Type II

Model or Catalog #

Stratus OCT

Lot or Serial #

Software Version 6.0.0

Reason for Recall

A defect in Version 6.0.0 of Stratus OCT instrument and review software, in certain situations reports generated will have incorrectly labelled OD (right eye) or OS (left eye).

Recall Posting Date

2009/09/14

Trade Name

Synchron CX Immuno-Protein Calibrator

Manufacturer

Beckman Coulter Inc.

Recall Start Date

2009/08/24

Recall Number

50657

Hazard Classification

Type II

Model or Catalog #

442840

Lot or Serial #

M901330 And Higher

Reason for Recall

The recovery of the standard has shifted. Standardizaton of the Immuno Protein Calibrator Set has been re-established to IFCC reference preparation for plasma proteins, BCD-470. This has caused a shift in quality control results and patient results for IgG, IgA, TRF and IgM.

Recall Posting Date

2009/09/14

Trade Name

Ultrapower Diamond Wheel Bur

Manufacturer

Linvatec Corporation D.B.A. Conmed Linvatec

Recall Start Date

2009/08/04

Recall Number

50380

Hazard Classification

Type II

Model or Catalog #

7021-092, 7021-292, 7021-393

Lot or Serial #

> 10 Numbers, Contact Manufacturer

Reason for Recall

This device ID was included because of the error on device ID #23037. The catalogue # 7021-392 was wrongly listed under device ID 406636 instead of 406639. Company already have send corrective fax-back to MDB.

Recall Posting Date

2009/09/14

Trade Name

Warmer, Infant Radiant

Manufacturer

Draeger Medical Systems, Inc.

Recall Start Date

2009/07/20

Recall Number

50549

Hazard Classification

Type I

Model or Catalog #

1250, 1500, 200, 2000, 2000/3000, 2200/3200, 300, 3000, 3200, 79 FMT

Lot or Serial #

All Serial Numbers

Reason for Recall

After a brief intense fire in a neonatal unit in the United States, an ECRI investigations concluded the stabilet was the ignition source for the fire.

Recall Posting Date

2009/08/31

Trade Name

3.0T Signa HDX MR System - Hardware

Manufacturer

GE Healthcare

Recall Start Date

2009/08/04

Recall Number

48251

Hazard Classification

Type II

Model or Catalog #

M3335PF

Lot or Serial #

WB0029

Reason for Recall

Contrast-enhanced 3D TOF MRA peripheral run-off studies show significant vasculature shading and right/left asymmetry, which could subject the patient to additional non-invasive examinations.

Recall Posting Date

2009/08/31

Trade Name

A) CoaguCheck XS Instrument
B) CoaguCheck XS Plus Monitor

Manufacturer

Roche Diagnostics GMBH

Recall Start Date

2009/08/13

Recall Number

50168

Hazard Classification

Type II

Model or Catalog #

A) 3666794
B) 04800842190

Lot or Serial #

A) All Serial Numbers
B) All Serial Numbers

Reason for Recall

The cleaning procedure as recommended in the instrument's manual can lead to falsely elevated PT/INR results. This procedure may include liquid into the meters which can lead to the creation of electrical bridging between heater pins.

Recall Posting Date

2009/08/31

Trade Name

A) Dyonics Powermax Elite Motor Drive Unit
B) Dyonics Mini-Motor Drive Unit
C) Dyonics Power Ultralight Motor Drive

Manufacturer

Smith & Nephew, Inc., Endoscopy Division

Recall Start Date

2009/07/26

Recall Number

50208

Hazard Classification

Type III

Model or Catalog #

A) 72200616
B) 7205357
C) 7205971

Lot or Serial #

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

Reason for Recall

A customer has reported that pieces of tissue remained within a Smith & Nephew shaver motor drive unit (hand piece) after the cleaning process had been completed prior to sterilization.

Recall Posting Date

2009/08/31

Trade Name

A) Integrated Power Console (ENT)
B) Integrated Power Console (NT)

Manufacturer

Medtronic Xomed

Recall Start Date

2009/07/27

Recall Number

50207

Hazard Classification

Type III

Model or Catalog #

A) 1898001
B) EC300

Lot or Serial #

A) 71358, 71360, 71357, 71361
B) 51033, 51356, 51508

Reason for Recall

An error code (code 13) is displayed on some of the consoles when a stylus or EHS hand piece is connected to the integrated power console (IPC) indicating that the hand piece has not been recognized by the console. When this happens the stylus or EHS HP is inoperative.

Recall Posting Date

2009/08/31

Trade Name

A) Sheri-I-Bronch Endobronchial Tube Kit
B) Sher-I-SWIV Double Swivel Tracheal Tube

Manufacturer

Teleflex Medical

Recall Start Date

2009-07-31

Recall Number

50274

Hazard Classification

Type I

Model or Catalog #

A) 5-16028, 5-16035, 5-16037, 5-16039, 5-16041, 5-16128, 5-16135, 5-16137, 5-16139, 5-16141
B) 5-15301, 5-15401

Lot or Serial #

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

Reason for Recall

It has come to the attention of Teleflex that the tether attaching to the double swivel cap may partially or completely break at the attachment points. The broken tether may lodge inside the dual swivel tubing or body during shipment to the end user resulting in the potential for the accidental aspiration of the tether into the patient's lungs.

Recall Posting Date

2009/08/31

Trade Name

A) Stryker Pain Pump 120cc Catheters
B) Infusion Sets For Stryker Pain Pumps
C) Stryker Pain Pump 270cc Catheters
D) Exfen Catheters
E) Stryker Pain Pump II Infusion Sets
F) Stryker Pain Pump2 Kits

Manufacturer

Stryker Instruments

Recall Start Date

2009/06/23

Recall Number

49458

Hazard Classification

Type II

Model or Catalog #

A) 0500-100-000, 0500-110-000, 0500-120-000, 0500-120-025, 0500-140-000
B) 0500-200-000, 0500-250-000
C) 0501-100-000, 0501-120-000, 0501-140-050, 0501-416-050
D) 0500-050-000, 0525-010-000
E) 525-250-000, 525-500-000
F) 0525-125-000, 540-155-000

Lot or Serial #

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

Reason for Recall

There is the potential for the catheter to break. Additionally there is the potential for the pain-pump to under-infuse pain medication.

Recall Posting Date

2009/08/31

Trade Name

A) Tube Assembly 142, V2, V12, For DXC 600
B) Tube Assembly 142, V2, V12, For DXC 800
C) Tube Assembly 142,V2,V12, For DXC 600i

Manufacturer

Beckman Coulter Inc.

Recall Start Date

2009/07/27

Recall Number

50231

Hazard Classification

Type II

Model or Catalog #

A) 4764, A10038
B) 4764, A10038
C) 4767, A10038

Lot or Serial #

A) All Serial Numbers
B) All Serial Numbers
C) All Serial Numbers

Reason for Recall

The wash concentrate tube assembly may fail to deliver the appropriate amount of wash concentrate on some Synchron DXC systems due to an accumulation of crystals.

Recall Posting Date

2009/08/31

Trade Name

Active Cortisol Enzyme Immunoassay Kit

Manufacturer

Diagnostic Systems Laboratories Inc., DSL

Recall Start Date

2009/07/20

Recall Number

50075

Hazard Classification

Type II

Model or Catalog #

DSL-10-2000

Lot or Serial #

> 10 Numbers, Contact Manufacturer

Reason for Recall

Active Cortisol Elisa Kits will result in falsely high values for patient samples due to a shift in the calibration of the assigned standard values.

Recall Posting Date

2009/08/31

Trade Name

Anti-Cardiolipin IGM Test Kit

Manufacturer

Bio-Rad Laboratories Diagnostics Group

Recall Start Date

2009/07/27

Recall Number

50175

Hazard Classification

Type II

Model or Catalog #

425-2020

Lot or Serial #

CL-863

Reason for Recall

Microbial contamination of Anti-Cardiolipin IGM positive control (lot CPM-591). Calibrator 3, lot CLM3-156, may also be affected. These lots are included in Anti-Cardiolipin IGM Test Kit, lot CL-863 only.

Recall Posting Date

2009/08/31

Trade Name

Aquillion One

Manufacturer

Toshiba Medical Systems Corporation

Recall Start Date

2009/08/11

Recall Number

50342

Hazard Classification

Type II

Model or Catalog #

TSX-301A/2

Lot or Serial #

> 10 Numbers, Contact Manufacturer

Reason for Recall

In Aquilion One System, due to the problem of software and other, a part of the image-related information may be abnormal, or an error may occur at the time of scan setup when sure exposure 3D is used.

Recall Posting Date

2009/08/31

Trade Name

Clearview HCG

Manufacturer

Unipath Limited

Recall Start Date

2009/06/29

Recall Number

50405

Hazard Classification

Type II

Model or Catalog #

506788

Lot or Serial #

All Lot Numbers.

Reason for Recall

The manufacturer has updated the instructions for use to state "read the result at 3 minutes. Do not interpret the result after 3 minutes". Previously the instructions allowed tests to be read up to 10 minutes.

Recall Posting Date

2009/08/31

Trade Name

Conmed Linvatec Arthro-Knife

Manufacturer

Linvatec Corporation D.B.A. Conmed Linvatec

Recall Start Date

2009/08/05

Recall Number

50381

Hazard Classification

Type II

Model or Catalog #

70-0071-103, 70-0071-113, 70-0072-003, 70-0073-003, 70-0074-103, 70-0075-003, 70-0076-003, 70-0077-103, 70-0078-103

Lot or Serial #

> 10 Numbers, Contact Manufacturer (Lot #'s With Expiration Dates Of July 2009 to August 2013)

Reason for Recall

Manufacturer has determined there is the possibility that the device may not fully retract once it is deployed.

Recall Posting Date

2009/08/31

Trade Name

CyberKnife Robotic Radiosurgery System

Manufacturer

Accuray, Inc.

Recall Start Date

2009/06/22

Recall Number

50252

Hazard Classification

Type II

Model or Catalog #

28000

Lot or Serial #

C202

Reason for Recall

A healthcare facility reported their end-to-end targeting accuracy was out of specification. The position of one of the robotic manipulator axes differed from the position determined by the robotic controller. Error 103 (karel e-stop detected) and error 342 (Deviation in absolute position value DSE - RDC) were displayed.

Recall Posting Date

2009/08/31

Trade Name

Elecsys Anti-CCP reagent Kit

Manufacturer

Roche Diagnostics GMBH

Recall Start Date

2009/07/31

Recall Number

50171

Hazard Classification

Type III

Model or Catalog #

5031656190

Lot or Serial #

Lots #153989 And Above

Reason for Recall

Reduction on the measuring range from 7-100 u/ml to 7-500 u/ml for the product Anti-CCP Reagent Kit.

Recall Posting Date

2009/08/31

Trade Name

Heartstart MRX Defibrillator/Monitor

Manufacturer

Philips Medical Systems

Recall Start Date

2009/07/02

Recall Number

50290

Hazard Classification

Type II

Model or Catalog #

M3536A

Lot or Serial #

> 100 Numbers, Contact Manufacturer

Reason for Recall

In certain external transport use environments, the mechanical/electrical connection between the pads therapy cable (including pads/CPR cable) and the Heartstart MRX Defibrillator/Monitor may wear at an increased rate. Without routine operational checks, wear of the connection could ultimately prevent the device from sensing that the pads therapy cable is connected, or, cause the device to inappropriately identify external paddles or internal paddles when the pads therapy cable is connected.

Recall Posting Date

2009/08/31

Trade Name

Lasertek 5000

Manufacturer

Scalp Laser

Recall Start Date

2009/07/10

Recall Number

50348

Hazard Classification

Type III

Model or Catalog #

N/A

Lot or Serial #

N/A

Reason for Recall

The Lasertek 5000 has been classified as a class II device in Canada. This device is not currently licenced for use in Canada.

Recall Posting Date

2009/08/31

Trade Name

Lightwave Ablator IA-2000-S

Manufacturer

Linvatec Corporation D.B.A. Conmed Linvatec

Recall Start Date

2009/08/05

Recall Number

50376

Hazard Classification

Type II

Model or Catalog #

IA-2000-S

Lot or Serial #

> 10 Numbers, Contact Manufacturer (Numbers With Expiration Dates From July 2009 to Sept. 2013)

Reason for Recall

The manufacturer has determined there is a possibility that the device may not shut off if the ablate button is released.

Recall Posting Date

2009/08/31

Trade Name

Oxidase Touch Sticks

Manufacturer

Oxoid Limited

Recall Start Date

2009/04/20

Recall Number

50095

Hazard Classification

Type II

Model or Catalog #

N/A

Lot or Serial #

657819, 660081, 669024, 680190, 682455

Reason for Recall

May produce weak positive or false negative results.

Recall Posting Date

2009/08/31

Trade Name

Staphaurex Plus 150/450 Test Kits

Manufacturer

Remel Europe Ltd.

Recall Start Date

2009/03/27

Recall Number

50094

Hazard Classification

Type II

Model or Catalog #

N/A

Lot or Serial #

J477610, J359510

Reason for Recall

A potential for false positive reactions with some strains of staphylococcus epidermidis which may result in misidentification as taphylococcus aureus.

Recall Posting Date

2009/08/31

Trade Name

TDWorkstation Working With Sebia Hyris

Manufacturer

Technidata S.A.S.

Recall Start Date

2009/07/26

Recall Number

50203

Hazard Classification

Type II

Model or Catalog #

TD-WST-01

Lot or Serial #

V.11.11.A, V.12.51.A, V.12.61.A

Reason for Recall

In a specific case, the TDWorkstation sends the total protein result to the instrument for a wrong patient. Software defect 24578.

Recall Posting Date

2009/08/31

Trade Name

Teleflex Medical Surgical Scissors

Manufacturer

Teleflex Medical

Recall Start Date

2009/07/06

Recall Number

49787

Hazard Classification

Type II

Model or Catalog #

352164, 352165, 352166, 352167, 352168, 352169, 352178

Lot or Serial #

RR8, SS8, TT8, UU8, VV8, WW8, XX8, MM9, WW7, XX7, MM8, NN8, OO8, PP8, QQ8

Reason for Recall

Manufacturer has identified a defect, a rough square finish to the scissor tips rather than a smooth tip, could cause damage to the inner wall of the blood vessel rendering it unsuitable for bypass graft.

Recall Posting Date

2009/08/31

Trade Name

Versys Hip System Femoral Head

Manufacturer

Zimmer Inc.

Recall Start Date

2009/08/06

Recall Number

50277

Hazard Classification

Type II

Model or Catalog #

801802802

Lot or Serial #

60378581

Reason for Recall

This action is being conducted because the potential exists for residual buffing compound to be present on the surfaces of the femoral head.

Recall Posting Date

2009/08/31

Trade Name

VGM 19" Monitor
Updated recall # 48079 previously posted on 2009-05-25.

Manufacturer

Welch Allyn Protocol, Inc.

Recall Start Date

2009/04/21

Recall Number

48079

Hazard Classification

Type II

Model or Catalog #

VG930M

Lot or Serial #

S/NS > QC2082880001

Reason for Recall

48 complaints reporting that the monitors lost power unexpectedly or when they attempted to power up which resulted in loss of both visual and secondary alarm enunciation from the LCD flat panel.

Recall Posting Date

2009/08/31

Trade Name

Wellcolex Colour Salmonella

Manufacturer

Remel Europe Ltd.

Recall Start Date

2009/04/03

Recall Number

50093

Hazard Classification

Type II

Model or Catalog #

RE30858301, RE30858302

Lot or Serial #

J438110, J438910

Reason for Recall

Potential of false positive reactions (blue agglutination) for salmonella E or G serogroups with reagent # 2 included in the kits.

Recall Posting Date

2009/08/17

Trade Name

4.0mm Direct Measuring Gauge

Manufacturer

Smith & Nephew, Inc.

Recall Start Date

2009/07/15

Recall Number

49969

Hazard Classification

Type II

Model or Catalog #

71117083

Lot or Serial #

All Prior To 2009 Excluding 08KM20464 & Excluding 08KM12521

Reason for Recall

The markings on the gauge are incorrect. The discrepancy may not be apparent to the user and could result in incorrect placement of the K-wire.

Recall Posting Date

2009/08/17

Trade Name

A) Advia Centaur
B) Advia Centaur XP
Updated recall # 49196 previously posted on 2009-07-06.

Manufacturer

Siemens Healthcare Diagnostics Inc.

Recall Start Date

2009/06/10

Recall Number

49196

Hazard Classification

Type III

Model or Catalog #

A) 07566733
B) 07566733

Lot or Serial #

A) 37820027, 38129027, 38386027, 39195027
B) 37820027, 38129027, 38386027, 39195027

Reason for Recall

Manufacturer has determined that specific lots have shown decreased specificity for negative populations. The positive bias of approximately 0.3 index units and specimens with 0.5 to 0.8 index may be incorrectly identified as reactive for total antibodies to the core antigen of Hepatitis B virus.

Recall Posting Date

2009/08/17

Trade Name

A) Alaris Patient Care System-ID Module
B) Alaris Patient Care System-Server Module
C) Alaris Patient Care System-PCA Module
D) Alaris Patient Care System-ENTDAL CO2
E) Alaris Patient Care System-Pump
F) Alaris Patient Care System-SPO2 Module
G) Alaris Patient Care System-Syringe Pump

Manufacturer

Cardinal Health

Recall Start Date

2009/07/28

Recall Number

49979

Hazard Classification

Type II

Model or Catalog #

A) 8600, 8650
B) 8015
C) 8120
D) 8300
E) 8000APM, 8100LVP
F) 8210, 8220
G) 8110

Lot or Serial #

A) > 10 Numbers, Contact Manufacturer
B) > 10 Numbers, Contact Manufacturer
C) > 10 Numbers, Contact Manufacturer
D) > 10 Numbers, Contact Manufacturer
E) > 10 Numbers, Contact Manufacturer
F) > 10 Numbers, Contact Manufacturer
G) > 10 Numbers, Contact Manufacturer

Reason for Recall

1) Occluded tubing may cause medication not to be delivered. 2) Misprogrammed infusion caused by ignoring the warning message. 3) Specific ESD protection circuitry may result in an over or under infusion. 4) Certain fluids solidify in the pumping mechanism. 5) IUI connector failure when they become corroded or contaminated.

Recall Posting Date

2009/08/17

Trade Name

A) Cancellous Bone Screws
B) Gap Plate Screw
Update recall # 49712 previously posted on 2009-08-03.

Manufacturer

Howmedica Osteonics Corporation

Recall Start Date

2009/07/03

Recall Number

49712

Hazard Classification

Type II

Model or Catalog #

A) 2080-0015, 2080-0020, 2080-0025, 2080-0030, 2080-0035, 2080-0040, 2080-0045, 2080-0050, 2080-0055, 2080-0060
B) 2030-6516, 2030-6520, 2030-6525, 2030-6530, 2030-6535, 2030-6540, 2030-6545, 2030-6550, 2030-6555, 2030-6560

Lot or Serial #

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

Reason for Recall

Stryker has become aware that the third party supplier, for material used to manufacture the Cancellous Bone Screws and Gap Plate Screw, did not comply with metallurgical requirements outlined in the ASTM standards for titanium surgical implants. As such, areas of modified material properties may result, which may affect the intended use of the product. Although testing demonstrated the affected lots to have shear strength equivalent to screws manufactured from non-affected material, the potential for variability of the material used in manufacturing the affected lots could compromise the strength.

Recall Posting Date

2009/08/17

Trade Name

A) Innova 4100 IQ - Main Unit
B) Innova 2000 Cardiovascular System

Manufacturer

GE Medical Systems SCS

Recall Start Date

2009/07/31

Recall Number

49983

Hazard Classification

Type II

Model or Catalog #

A) 2335129
B) S1872LC

Lot or Serial #

A) 417372BU0, 405584BU4, 432687BU2, 406451BU5, 429328BU8, 437542BU4, 398530BU6
B) 409881BU0, 397054BU8, 419496BU5, 427075BU7, 417895BU0

Reason for Recall

A potential power supply failure inside the GE equipment cabinet could occur with no warning & prevent x-ray generation & image processing. If this occurs, the system cannot be restarted.

Recall Posting Date

2009/08/17

Trade Name

A) Innova 4100 IQ - Main Unit
B) Innova 2000 Cardiovascular System

Manufacturer

GE Medical Systems SCS

Recall Start Date

2009/07/31

Recall Number

50099

Hazard Classification

Type II

Model or Catalog #

A) 2335129
B) S1872LC

Lot or Serial #

A) 417372BU0, 405584BU4, 406451BU5, 398530BU6
B) 397054BU8, 349890BU4, 347469BU9, 419496BU5, 354853BU6, 417895BU0, 364939BU9

Reason for Recall

Potential video splitter failure inside GE equipment cabinet could occur with no warning & prevent x-ray image display. System cannot be recovered without service intervention.

Recall Posting Date

2009/08/17

Trade Name

A) Vital-Signs Monitor with Rate and Map
B) Vital-Signs Monitor with Rate/Map Printer
C) Vital-Signs Monitor with Rate/Map/Printer/Temp
D) Vital-Signs Monitor with Temp and Printer
E) Vital-Signs Monitor with Nellcor
F) Vital-Signs Monitor with Nellcor SPO2 and Printer
G) Vital-Signs Monitor with Nellcor SPO2/Temp
H) Vital-Signs Monitor with SPO2/Temp & Printer

Manufacturer

Welch Allyn Protocol, Inc.

Recall Start Date

2009/08/04

Recall Number

49917

Hazard Classification

Type II

Model or Catalog #

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

Lot or Serial #

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

Reason for Recall

Speakers in VSM300 Vital-Signs Monitor failed to produce sound. The failure of the speaker eliminates audio alarm tones for parameter violation, equipment alerts, or error codes, as well as repetitive beeps to indicate pulses when monitoring SP02 (oximetry).

Recall Posting Date

2009/08/17

Trade Name

Compax 40E Table

Manufacturer

GE Medical Systems LLC

Recall Start Date

2009/07/31

Recall Number

49649

Hazard Classification

Type II

Model or Catalog #

2208203, 2225864, 2225881

Lot or Serial #

59658ES5, 63221ES6, 69850MA6, 64076ES3

Reason for Recall

Table lock safety features are not always being utilized by the users and have resulted in unintended lateral movement that may impact patient safety.

Recall Posting Date

2009/08/17

Trade Name

Cyberknife Robotic Radiosurgery System

Manufacturer

Accuray, Inc.

Recall Start Date

2009/06/22

Recall Number

50114

Hazard Classification

Type II

Model or Catalog #

27600

Lot or Serial #

C185

Reason for Recall

A site reported that their End-to-End targeting accuracy was out of specification. The position of one of the robotic manipulator axes differed from the position determined by the robot controller. This discrepancy caused the CyberKnife Treatment Delivery System to post Error 103 (karel e-stop detected). Also, the robot controller detected the inconsistency & reported this error as Error 342: Deviation in absolute position value DSE-RDC". This error is displayed on the computer monitor for the robot controller and on the Teach Pendant display. However, Error 342 did not render the system down.

Recall Posting Date

2009/08/17

Trade Name

Delta Ceramic Ball Heads

Manufacturer

Howmedica Osteonics - Stryker Ireland

Recall Start Date

2009/07/27

Recall Number

50100

Hazard Classification

Type II

Model or Catalog #

18-3200

Lot or Serial #

28635501, 28575801

Reason for Recall

The third party who supplies Delta Ceramic Ball Heads did not comply with its specifications. The spherical diameter feature was measuring out of specification (oversized).

Recall Posting Date

2009/08/17

Trade Name

Easylink Informatics System

Manufacturer

Siemens Healthcare Diagnostics Inc.

Recall Start Date

2009/07/20

Recall Number

49974

Hazard Classification

Type II

Model or Catalog #

100034941

Lot or Serial #

All Versions

Reason for Recall

Inaccurate results reported to the system when a sample is diluted and placed back into the system without assigning the sample a unique, different, sample ID. As a result, patient sample results may be reported with an incorrect result value resulting in inaccuracy, imprecision, or error comment reports together with the result.

Recall Posting Date

2009/08/17

Trade Name

Factor V Leiden Kit on LightCycler 2.0

Manufacturer

Roche Molecular Systems, Inc

Recall Start Date

2009/07/24

Recall Number

49994

Hazard Classification

Type III

Model or Catalog #

36101790001

Lot or Serial #

14674120

Reason for Recall

Possible failure of the factor V Leiden control template (positive control) included in the factor V Leiden Kit for use with the LightCycler 2.0 instrument. The factor V Leiden control template may fail to meet the validity criteria set by the macro component of the LightCycler 2.0 instrument.

Recall Posting Date

2009/08/17

Trade Name

Instatrak 3500 System

Manufacturer

GE OEC Medical Systems Inc.

Recall Start Date

2009/07/23

Recall Number

49926

Hazard Classification

Type II

Model or Catalog #

1006236-001

Lot or Serial #

S/N'S IT35079, IT35214P, IT35226P

Reason for Recall

Proper validation was not performed on using the headset in an inverted (upside down) manner as described in the noted system's operators manual.

Recall Posting Date

2009/08/17

Trade Name

M Series Remstar Heated Humidifier System

Manufacturer

Respironics Inc.

Recall Start Date

2009/07/31

Recall Number

50202

Hazard Classification

Type II

Model or Catalog #

1049109, 1049110, 1049124, 1051157, 1051158, R1049109, R1049110, U1049109, U1049110

Lot or Serial #

N/A

Reason for Recall

Some humidifiers may fail to operate due to a potential malfunction of the internal connection between the heater plate and the circuit board which results in a blinking blue light on the control knob.

Recall Posting Date

2009/08/17

Trade Name

MIS Diamond Burs

Manufacturer

Stryker Instruments

Recall Start Date

2009/07/13

Recall Number

49950

Hazard Classification

Type II

Model or Catalog #

8420-107-120, 8420-107-125, 8420-107-130, 8420-107-135

Lot or Serial #

> 10 Numbers, Contact Manufacturer

Reason for Recall

MIS Diamond Burs have the potential to deform and fracture at speeds above 50,000 rpm.

Recall Posting Date

2009/08/17

Trade Name

Operon D850/750/752/B810 Surgical Table

Manufacturer

Berchtold Medizen-Elektronik GMBH

Recall Start Date

2009/02/03

Recall Number

50000

Hazard Classification

Type III

Model or Catalog #

B 810, D 750, D 752, D 850

Lot or Serial #

3272-O10001, 3270-O10002, 3261-O10036

Reason for Recall

Upgrades initiated to avoid potential problems: pinch points and binding of release mechanism on headrest adaptors, floorlock retracting to unlock position, CPU errors involving involuntary table movements.

Recall Posting Date

2009/08/17

Trade Name

Reusable Metal Needle Guides & Bushings

Manufacturer

GE Healthcare

Recall Start Date

2009/04/30

Recall Number

48986

Hazard Classification

Type I

Model or Catalog #

N/A

Lot or Serial #

> 10 Numbers, Contact Manufacturer

Reason for Recall

Operator manual does not contain description of a re-sterilization process for reusable biopsy metal needle guides for the stereotactic positioner.

Recall Posting Date

2009/08/17

Trade Name

Smartmonitor 2 With PCMCIA

Manufacturer

Respironics Inc.

Recall Start Date

2009/05/11

Recall Number

48114

Hazard Classification

Type I

Model or Catalog #

4002, 4003

Lot or Serial #

S/N: 3000033364 to 3000038740

Reason for Recall

There is a variation in the SmartMonitor 2 manufacturing process that could allow the wire harness attached to the alarm to be pinched between the upper and lower case of the SmartMonitor 2 units. If the wire harness is pinched such that the conductive wires are exposed, they can short to the electrically conductive coating on the inside of the case. This can result in a situation where the alarm will not sound. However, even if the audible alarm fails, the unit will still trigger a visual alert (red lights will come on).
.

Recall Posting Date

2009/08/17

Trade Name

Sonara Transcranial Doppler System

Manufacturer

Cardinal Health 209, Inc. DBA Viasys Healthcare Inc, Viasys Neurocare

Recall Start Date

2009/02/11

Recall Number

49919

Hazard Classification

Type II

Model or Catalog #

982A0470

Lot or Serial #

PWH0201

Reason for Recall

Various forms of system lockup or display screen "freezes" can occur. Surgical monitoring has a remote probability that a lockup could cause any permanent impairment of the body function or permanent damage to a body structure.

Recall Posting Date

2009/08/17

Trade Name

Twin-Pass Dual Access Catheter

Manufacturer

Vascular Solutions, Inc.

Recall Start Date

2009/07/02

Recall Number

49872

Hazard Classification

Type I

Model or Catalog #

5200

Lot or Serial #

> 10 Numbers, Contact Manufacturer

Reason for Recall

3 occurrences of catheters containing a piece of PTFE beading material in the OTW lumen have been reported. The PTFE beading material is a processing aide used during hydrophilic coating. The beading is to be removed followed by a visual inspection prior to packaging. The problem may cause partial or complete blockage of a vessel due to embolization, and/or vessel injury.

Recall Posting Date

2009/08/17

Trade Name

Uniglide Femoral Component, Non-Cemented

Manufacturer

Corin Limited

Recall Start Date

2009/07/20

Recall Number

49985

Hazard Classification

Type II

Model or Catalog #

514.0300, 514.0400

Lot or Serial #

KNRU, KNTK

Reason for Recall

The nonconforming devices were comingled during the manufacturing process. For lot KNRU, there are devices in unit boxes with labels marked size 4 and devices marked '514.0400, size 4', that are actually size 3. For lot KNTK, there are devices in unit boxes with labels marked size 3 and devices marked '514.0300, size 3', that are actually size 4.

Recall Posting Date

2009/08/17

Trade Name

Welch Allyn AED10 Defib, MRL Jumpstart

Manufacturer

Welch Allyn Protocol, Inc.

Recall Start Date

2009/07/30

Recall Number

50054

Hazard Classification

Type II

Model or Catalog #

970300E, 970302E, 970302F, 970308E,
970311-E

Lot or Serial #

> 10 Numbers, Contact Manufacturer

Reason for Recall

If a user experiences a flashing low battery status indicator and does not understand that the device can continue to be used, the user might choose not to continue operating the device, causing therapy to be delayed or

Recall Posting Date

2009/08/03

Trade Name

2.0 Compression L Plate, 6 Hole Left

Manufacturer

Walter Lorenz Surgical, Inc. Also Trading As: Biomet Microfixation

Recall Start Date

2009/06/29

Recall Number

49529

Hazard Classification

Type III

Model or Catalog #

62-5442

Lot or Serial #

24180

Reason for Recall

The possibility of part number 62-5442 2.0 Compression l Plate, 6 Holes Left package may have contained a similar part 62-5441 2.0 Compression l Plate Right instead of the 62-5442 part.

Recall Posting Date

2009/08/03

Trade Name

'903' Newborn Screening Cards

Manufacturer

Whatman, Part Of GE Healthcare

Recall Start Date

2009/05/27

Recall Number

49796

Hazard Classification

Type III

Model or Catalog #

N/A

Lot or Serial #

Lot # 6828908, 6829008, 6818808

Reason for Recall

Partial or complete detachment of the '903' paper from the demographic portion of the '903' newborn screening card may occur, which may necessitate a re-screening.

Recall Posting Date

2009/08/03

Trade Name

A) Aeroset System - Total Bilirubin Assay
B) Architect System - Total Bilirubin Assay

Manufacturer

Abbott Laboratories Diagnostic Division

Recall Start Date

2009/07/10

Recall Number

49921

Hazard Classification

Type III

Model or Catalog #

A) 6L45-20, 6L45-40
B) 6L45-20, 6L45-40

Lot or Serial #

A) All Lots
B) All Lots

Reason for Recall

Abbott Clinical Chemistry Total Bilirubin (6L45) demonstrated under-recovery on one clinical neonatal specimen resulting in a value less than the linear limit. A linear high flag (LH) was therefore not generated. The specimen was known to have a bilirubin concentration higher than the linear limit.

Recall Posting Date

2009/08/03

Trade Name

A) BHS 301
B) BHS 202
C) BHS 102
D) BHS 130
E) BHS 301 SCULPTOR
F) BHS 302
G) BHS 135
H) BHS 140

Manufacturer

Body Health S.A.

Recall Start Date

2009/07/01

Recall Number

49781

Hazard Classification

Type II

Model or Catalog #

A) BHS 301
B) BHS 202
C) BHS 102
D) BHS 130
E) BHS 301 SCULPTOR
F) BHS 302
G) BHS 135
H) BHS 140

Lot or Serial #

A) 131108-0471, 131108-0472, 131108-0474
B) 160708-0134, 090408-0090
C) 080408-0082, 080408-0094, 120508-0112, 120508-0113, 120508-0114, 120508-0115, 120508-0107, 120508-0116, 120508-0106
D) 201207-0137
E) 181108-0179
F) 050208-0087
G) 140108-0238
H) 070607-0021

Reason for Recall

A notification was sent to the distributor informing them that the medical devices that were sold to them by Body Health S.A. were not licensed in accordance with the medical devices regulations.

Recall Posting Date

2009/08/03

Trade Name

A) Brilliance 40/64 Slice CT System
B) Gemini TF PET/CT System

Manufacturer

Philips Medical Systems (Cleveland), Inc.

Recall Start Date

2009/07/16

Recall Number

46654

Hazard Classification

Type II

Model or Catalog #

A) 4550 110 02031
B) 4550 110 09021

Lot or Serial #

A) N/A
B) N/A

Reason for Recall

There is potential for data to be lost during reconstruction of images in which slices can either be disregarded or interleaved based upon their series ID.

Recall Posting Date

2009/08/03

Trade Name

A) Bypass TGH Kit
B) Valve TGH Kit

Manufacturer

Cardinal Health

Recall Start Date

2009/07/13

Recall Number

49952

Hazard Classification

Type II

Model or Catalog #

A) PC30CG'XXX'
B) PC30VP'XXX'

Lot or Serial #

A) 870139, 878608, 866059, 874187, 876386, 882391, 888414
B) 878586, 866060, 874182, 874678, 884383

Reason for Recall

The unit package seals on the BD 60 ml Luer lock syringes, a component of the Cardinal Health custom sterile packs may have been adversely affected as a result of an issue during the packaging process.

Recall Posting Date

2009/08/03

Trade Name

A) Cancellous Bone Screws
B) Gap Plate Screw

Manufacturer

Howmedica Osteonics Corporation

Recall Start Date

2009/07/03

Recall Number

49712

Hazard Classification

Type II

Model or Catalog #

A) N/A
B) N/A

Lot or Serial #

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

Reason for Recall

Stryker has become aware that the third party supplier, for material used to manufacture the Cancellous Bone Screws and Gap Plate Screw, did not comply with metallurgical requirements outlined in the ASTM standards for titanium surgical implants. As such, areas of modified material properties may result, which may affect the intended use of the product. Although testing demonstrated the affected lots to have shear strength equivalent to screws manufactured from non-affected material, the potential for variability of the material used in manufacturing the affected lots could compromise the strength.

Recall Posting Date

2009/08/03

Trade Name

A) Central Venous Catheterization Set
B) Central Venous Catheter

Manufacturer

Arrow International, Inc.

Recall Start Date

2009/05/11

Recall Number

48476

Hazard Classification

Type II

Model or Catalog #

A) CS-12123-E, CS-15123-E
B) MC-12123, MC-15123

Lot or Serial #

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

Reason for Recall

The catheters have a deformity in the lumen at the catheter juncture hub which can cause difficulty in passing the spring wire guide through the hub of the catheter or removing the spring wire guide from the catheter.

Recall Posting Date

2009/08/03

Trade Name

A) Pediatric Emergency System Kit
B) Pediatric Emergency System Flying Carpet
C) Emergency System Intraosseus Module

Manufacturer

Vital Signs Inc.

Recall Start Date

2009/06/30

Recall Number

49853

Hazard Classification

Type II

Model or Catalog #

A) 7730ALS, 7730BLU5, 7730GRN5, 7730IALS, 7730MOD, 7730ORG5, 7730PUR5, 7730RED5, 7730WHI5, 7730YEL5
B) 7730FLY
C) 7700BIO2, 7700GIO2, 7700OIO2, 7700PIO2, 7700RIO2, 7700WIO2, 7700YIO2

Lot or Serial #

A) 245F to 366F inclusive, 001K to 149K inclusive
B) 001K to 149K inclusive, 245F to 366F inclusive
C) 245F to 366F inclusive, 001K to 149K inclusive

Reason for Recall

The Broselow/Hinkle Intraosseus Module, which is part of the Broselow/Hinkle Pediatric Emergency System, contains a 15g intraosseus needle that is not compatible with the IV extension set that is provided in the module. This may result in a leak at the connection, delaying treatment.

Recall Posting Date

2009/08/03

Trade Name

A) Posey Soft Belt With Crotch Strap
B) Posey Breezeline Pelvic Holder

Manufacturer

J. T. Posey Co.

Recall Start Date

2009/07/08

Recall Number

49840

Hazard Classification

Type II

Model or Catalog #

A) 4125C
B) 4411

Lot or Serial #

A) N/A
B) N/A

Reason for Recall

Label clarification.

Recall Posting Date

2009/08/03

Trade Name

A) Restoration Modular Calcar Bodies
B) Restoration Modular Hip Body/Bolt STD
C) Restoration Hip Body/Bolt
D) Restoration Mod. Hip Broach Body/Bolt
E) Restoration Modular Conical Distal Stem
F) Restoration Modular Conical Bowed Stem

Manufacturer

Howmedica Osteonics - Stryker Ireland

Recall Start Date

2009/07/03

Recall Number

49713

Hazard Classification

Type II

Model or Catalog #

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

Lot or Serial #

A) T80998AA, T80998AC, T80550AA, T81105BA, T55344DA, T80551AA, T80554AA
B) > 10 Numbers, Contact Manufacturer
C) 29054602, 29110402, 28749101, 28932002, 28719201, 28914301, 29054902, 28932601
D) 29389202
E) CAXJ826A, CAXJ827A, CAXJ910A, CAXJ834A, CAXJ834C, CAXJ834J, CAXJA29D
F) CAXJ951A

Reason for Recall

The third party supplier, for material used to manufacture the Restoration Modular Components, has demonstrated poor process control which has raised concerns about the quality of the raw material supplied. As a precaution and due to the potential impact on the mechanical properties of the affected products, Stryker is recalling all products manufactured from material supplied by this supplier.

Recall Posting Date

2009/08/03

Trade Name

A) Sabouraud Dextrose Agar
B) Middlebrook 7H11 Agar
C) TSA + 5% Sheep Blood (BA)
D) Nitrient Agar

Manufacturer

PML Microbiologicals, Inc.

Recall Start Date

2009/06/30

Recall Number

49558

Hazard Classification

Type III

Model or Catalog #

A) 303434
B) P2377
C) P2600
D) P3889

Lot or Serial #

A) 286801-1, 287425-1
B) 286811-1, 287223-1
C) 287232-1
D) 287173-1

Reason for Recall

Specific lots of prepared plated media may be experiencing random fungal contamination.

Recall Posting Date

2009/08/03

Trade Name

Accu-Chek Softclix Lancets

Manufacturer

Roche Diagnostics GMBH

Recall Start Date

2009/06/01

Recall Number

48484

Hazard Classification

Type III

Model or Catalog #

03146693119, 03146707119, 03583031002

Lot or Serial #

> 10 Numbers, Contact Manufacturer

Reason for Recall

There is a potential that a single lancet may miss the protective cap in the Accu-Chek Softclix Lancet boxes and in the bags in blood glucose meter kits.

Recall Posting Date

2009/08/03

Trade Name

Acuson P50 Diagnostic Ultrsound System

Manufacturer

Siemens Medical Solutions USA, Inc.

Recall Start Date

2009/06/19

Recall Number

49589

Hazard Classification

Type III

Model or Catalog #

10041762

Lot or Serial #

10120, 10122

Reason for Recall

1) In versions 1.1 and 1.1, the needle guide feature was to be disabled for all transducers but actually activated for 1215 transducer. 2) In non-cardiac application, can be an error in estimation of velocity when using pulsatility index tool which is sensitive to noise in spectral Doppler waveform causing mis-trace, user is unaware of miscalculations.

Recall Posting Date

2009/08/03

Trade Name

Apexpro Telemetry System - Transmitter

Manufacturer

GE Healthcare

Recall Start Date

2009/02/20

Recall Number

45337

Hazard Classification

Type II

Model or Catalog #

APROCH-XX-XXX-XXX-X

Lot or Serial #

S/N RT908139180GA

Reason for Recall

Potential for intermittent or unpredictable circuit board failures due to insufficient copper plating resulting in loss of communication and patient data.

Recall Posting Date

2009/08/03

Trade Name

AW Volumeshare2 - CT Perfusion 4

Manufacturer

GE Healthcare

Recall Start Date

2009/06/16

Recall Number

48164

Hazard Classification

Type II

Model or Catalog #

5189396

Lot or Serial #

> 10 Numbers, Contact Manufacturer

Reason for Recall

When using CT Perfusion 4 algorithm on data with longer time sampling intervals, under certain conditions, the noise level in the functional maps may prevent user from clearly seeing a subtle perfusion defect.

Recall Posting Date

2009/08/03

Trade Name

Brightview Gamma Camera Sy. w/ 3/8" Crystal & Detector Caudal Cephalic

Manufacturer

Philips Medical Systems (Cleveland), Inc.

Recall Start Date

2009/07/14

Recall Number

49947

Hazard Classification

Type II

Model or Catalog #

2170-3002A

Lot or Serial #

N/A

Reason for Recall

If the radius drive assembly on the detectors of Brightview Gamma Cameras is severely compromised, the detector may slide, under the influence of gravity, to its hardware limit.

Recall Posting Date

2009/08/03

Trade Name

Centricity PACS Workstation - Hardware

Manufacturer

GE Healthcare Integrated IT Solutions

Recall Start Date

2009/05/26

Recall Number

47838

Hazard Classification

Type II

Model or Catalog #

K2033LP

Lot or Serial #

> 100 Numbers, Contact Manufacturer

Reason for Recall

Default configuration may have been modified so that rejected images are included in the retrieved exam, resulting in those images being displayed erroneously on external DICOM device.

Recall Posting Date

2009/08/03

Trade Name

CIC Pro Clinical Information Center

Manufacturer

GE Healthcare

Recall Start Date

2009/06/05

Recall Number

46547

Hazard Classification

Type II

Model or Catalog #

CIC-XXXX-XXXXX-XXXXX*

Lot or Serial #

> 100 Numbers, Contact Manufacturer

Reason for Recall

Large number of time change requests between two or more CARESCAPE devices may result in sluggishness of CIC Pro, loss of waveforms, parameters & alarming and inconsistent time values.

Recall Posting Date

2009/08/03

Trade Name

Clinac IX Radio Therapy Delivery System

Manufacturer

Varian Medical Systems, Inc.

Recall Start Date

2009/05/29

Recall Number

50003

Hazard Classification

Type II

Model or Catalog #

2100C, 21EXS, CLINAC IX H14, CLINAC IX H27, CLINAC IX H29

Lot or Serial #

> 10 Numbers, Contact Manufacturer

Reason for Recall

On Clinacs running C- series version 7.X, the couch can be moved via the float mode when the stereotactic motion disable function is turned on. This may represent a hazard to a stereotactic patient with a head ring mounted on a floor stand or pedestal.

Recall Posting Date

2009/08/03

Trade Name

Damon SS Archwire 227-1043

Manufacturer

Ormco Corporation

Recall Start Date

2009/05/01

Recall Number

49956

Hazard Classification

Type III

Model or Catalog #

227-1043

Lot or Serial #

20994915

Reason for Recall

Damon SS Archwire 227-1029, 26 mm, mislabeled as 227-1043, 40 mm.

Recall Posting Date

2009/08/03

Trade Name

Fetal Bleed Screening Test

Manufacturer

Immucor Inc.

Recall Start Date

2009/07/01

Recall Number

49726

Hazard Classification

Type II

Model or Catalog #

7892

Lot or Serial #

17411

Reason for Recall

Complaints of particulate matter in the indicator cells, positive and negative control components of the test kit. An investigation has confirmed microbial contamination in one vial of indicator cell.

Recall Posting Date

2009/08/03

Trade Name

Fogarty Occlusion Catheter

Manufacturer

Baxter Healthcare Corporation,
Edwards Critical-Care Division

Recall Start Date

2009/06/29

Recall Number

49905

Hazard Classification

Type II

Model or Catalog #

62080822F

Lot or Serial #

> 100 Numbers, Contact Manufacturer

Reason for Recall

Two parts of the tubular packaging could become loose under the shrink wrap that holds the directions for use insert on the packaging tube and could render the product non-sterile.

Recall Posting Date

2009/08/03

Trade Name

Hispeed FXi, LXi System

Manufacturer

GE Healthcare

Recall Start Date

2009/01/13

Recall Number

45604

Hazard Classification

Type III

Model or Catalog #

B7520AZ, B7530AZ

Lot or Serial #

> 10 Numbers, Contact Manufacturer

Reason for Recall

X-ray leakage from diagnostic source (tube + collimator) exceeded 21CFR regulatory requirement and IEC standard. Concerns of increased patient exposure due to leakage of radiation.

Recall Posting Date

2009/08/03

Trade Name

Icelock expulsion valve 551

Manufacturer

OSSUR HF

Recall Start Date

2009/06/25

Recall Number

49594

Hazard Classification

Type II

Model or Catalog #

N/A

Lot or Serial #

CO081010

Reason for Recall

The plastic cap on valve may detach from valve body breaking the vacuum and allowing the prosthesis to loosen or completely detach.

Recall Posting Date

2009/08/03

Trade Name

Kodiak Power Supply

Manufacturer

Breg, Inc.

Recall Start Date

2009/06/18

Recall Number

49511

Hazard Classification

Type II

Model or Catalog #

N/A

Lot or Serial #

3508, 3908, 4308, 4808

Reason for Recall

The power supply have short circuited at the electrical outlet upon initial use of the power supply, causing the circuit breaker for the specific electrical outlet to trip.

Recall Posting Date

2009/08/03

Trade Name

Kuschall K-Junior Manual Wheelchair

Manufacturer

Kuschall AG

Recall Start Date

2009/06/15

Recall Number

49293

Hazard Classification

Type II

Model or Catalog #

K-Junior

Lot or Serial #

806135534

Reason for Recall

A breakage of the pushbuggy handle has been occurring at a calculated weight of 65 kg.

Recall Posting Date

2009/08/03

Trade Name

NX 8000 With V. NX2008 Or NX.x.8000

Manufacturer

AGFA Healthcare N.V.

Recall Start Date

2009/06/22

Recall Number

49490

Hazard Classification

Type II

Model or Catalog #

NX SOFTWARE 2.0.7000, NX SOFTWARE 2.0.8000, NX SOFTWARE 3.0.7000, NX SOFTWARE 3.0.8000

Lot or Serial #

N/A

Reason for Recall

Under certain circumstances, after opening and closing a study on a CMS system while a study is still open on an in-room NX system, a problem of image mis-up can occur on the in-room NX system.

Recall Posting Date

2009/08/03

Trade Name

Paradigm Quick-Set Infusion Sets

Manufacturer

Unomedical A/S

Recall Start Date

2009/07/07

Recall Number

49737

Hazard Classification

Type I

Model or Catalog #

MMT-396, MMT-397, MMT-398, MMT-399

Lot or Serial #

> 10 Numbers, Contact Manufacturer

Reason for Recall

Approximately 2% of infusion sets in the affected lots (lots starting with 8) may not allow the insulin pump to vent properly. Venting is necessary to equalize the pressure in the reservoir compartment with the surrounding atmosphere. If the vent does not work properly, this could result in too much or too little insulin being delivered. / Environ 2 % des dispositifs de perfusion des lots concernés (lots commençant par 8) ne permettent probablement pas à la pompe à insuline de s’aérer convenablement. L’aération est nécessaire pour pressuriser le compartiment de la seringue, où est inséré le réservoir, par rapport à l’air ambiant. Si la bouche d’aération fait défaut, il peut en résulter une administration excessive ou insuffisante d’insuline.

Recall Posting Date

2009/08/03

Trade Name

PCR AC-500/PCR AC-5000 Basic System

Manufacturer

Philips Medical Systems DMC GMBH

Recall Start Date

2009/02/23

Recall Number

46769

Hazard Classification

Type II

Model or Catalog #

MCR1511

Lot or Serial #

N/A

Reason for Recall

Possibility that choice of patient will be changed when using filtered work lists. Normally problem detected because the "active" name of patient is displayed. This affects PCR Eleva system connected to a RIS.

Recall Posting Date

2009/08/03

Trade Name

Stellant CT Dual Injector Systems P3T

Manufacturer

Medrad Inc.

Recall Start Date

2009/06/19

Recall Number

49618

Hazard Classification

Type II

Model or Catalog #

3007301, 3010432, 3014849

Lot or Serial #

N/A

Reason for Recall

1. When P3T cardiac protocols are programmed with saline test inject and used in conjunction with ISI 700 or ISI 800 products and the Stellant CT Injection system, the pre-diagnostic protocol must include a transit bolus.
2. A defect in SW version 103.0 and 104.0 of the Stellant CT injection systems may cause ISI 700 accessory to incorrectly trigger bolus tracking on a Philips CT system for P3T cardiac protocol.

Recall Posting Date

2009/08/03

Trade Name

Stromatolyser-IM

Manufacturer

Sysmex Reagents America

Recall Start Date

2009/06/26

Recall Number

49463

Hazard Classification

Type III

Model or Catalog #

SIM-220A

Lot or Serial #

c0910, c9011, c9013, c9014, c9015, c9016, c9017

Reason for Recall

Seven lots of Stromatolyser-IM (SIM-220A) manufactured between March 3,2009 and March 26th,2009 have tested positive for a pseudomonas type species of bacteria.

Recall Posting Date

2009/08/03

Trade Name

Synchromed II Implantable Infusion Pump

Manufacturer

Medtronic Inc.

Recall Start Date

2009/07/14

Recall Number

49972

Hazard Classification

Type II

Model or Catalog #

8637

Lot or Serial #

> 100 Numbers, Contact Manufacturer

Reason for Recall

Reduced battery performance (estimated at 2.1% of affected population) has resulted in 8 occurrences of low battery reset between 47 and 56 months, and 1 occurrence of premature elective replacement indicator (ERI) at 54 months post-implant. For affected pumps, the minimum time frame of 90 days between ERI and end of service (EOS) may also be reduced.

Recall Posting Date

2009/08/03

Trade Name

Synchron Rheumatoid Factor (RF) Reagent

Manufacturer

Beckman Coulter Inc.

Recall Start Date

2009/07/08

Recall Number

49912

Hazard Classification

Type II

Model or Catalog #

475136

Lot or Serial #

M802452, M804502, M807345, M808329

Reason for Recall

As the Synchron RF Rreagent ages, it may fail calibration with the condition of "math error" on the calibration report. Real time testing in manufacturing indicates the stability claim of 24 months will not be met for lot numbers: M802452, M804502, M807345 and M808329. Calibration failures occur at 12 months.

Recall Posting Date

2009/08/03

Trade Name

Tina-quant a Apolipoprotein A1

Manufacturer

Roche Diagnostics GMBH

Recall Start Date

2009/07/17

Recall Number

49761

Hazard Classification

Type III

Model or Catalog #

3032612122

Lot or Serial #

All Lot Numbers

Reason for Recall

The manufacturer identified a reduction of the on board stability from 42 days to 14 days for the Hitachi Tina-quant Apolipoprotein A1 reagent when used on the Roche Hitachi 912 and 917 and MODULAR P systems.

Recall Posting Date

2009/08/03

Trade Name

Triage Tox Drug Screen PN 94400

Manufacturer

Biosite Incorporated

Recall Start Date

2009/05/29

Recall Number

50030

Hazard Classification

Type III

Model or Catalog #

94400

Lot or Serial #

> 10 Numbers, Contact Manufacturer

Reason for Recall

Biosite, Inc. initiates notice of correction for Triage TOX Drug Screen Kit, PN 94400. Boxes shipped after August 6, 2008 are misprinted on the right side of the box flap. The misprint incorrectly states "use EDTA whole blood or plasma sample only". The kit is intended for use with urine samples not blood or plasma.

Recall Posting Date

2009/08/03

Trade Name

Trinclot APTT HS, Product Code T1204

Manufacturer

Trinity Biotech PLC

Recall Start Date

2009/05/25

Recall Number

49896

Hazard Classification

Type II

Model or Catalog #

T1204

Lot or Serial #

R324001

Reason for Recall

Precision issues with this lot may result in increased aPTT times across the range of the assay.

Recall Posting Date

2009/08/03

Trade Name

Trinical Reference Plasma T5102

Manufacturer

Trinity Biotech PLC

Recall Start Date

2009/05/21

Recall Number

49894

Hazard Classification

Type II

Model or Catalog #

T5102

Lot or Serial #

R332037, R332037R, S287001

Reason for Recall

Trinity Biotech initiates a corrective field action for TriniCAL Reference Plasma, product code T5102 (lots R332037, R332037R and S287001). The protein C chromogenic value is misassigned in these lots and can result in an erroneous protein C chromogenic activity result.

Recall Posting Date

2009/08/03

Trade Name

Triniclot APPT S, Cat. No. T1202

Manufacturer

Trinity Biotech PLC

Recall Start Date

2009/04/23

Recall Number

49895

Hazard Classification

Type II

Model or Catalog #

T1202

Lot or Serial #

S067009

Reason for Recall

Precision and open vial stability issues with this lot may result in increased or decreased aPTT times across the range of the assay. The lot is not stable for the full 30 day period when opened and stored at 2-8 c as recommended.

Recall Posting Date

2009/08/03

Trade Name

Varelisa MPO ANCA

Manufacturer

Phadia GMBH

Recall Start Date

2009/04/09

Recall Number

49897

Hazard Classification

Type III

Model or Catalog #

17696

Lot or Serial #

32

Reason for Recall

The negative control shows an elevated signal. It can exceed the upper quality control limit of 0.200 OD given in the directions for use.

Recall Posting Date

2009/07/20

Trade Name

A) 0.8% Resolve Panel A Reagent RBC
B) 0.8% Resolve Panel B Reagent RBC
C) 0.8% Resolve Panel C Reagent RBC

Manufacturer

Ortho-Clinical Diagnostics Inc.

Recall Start Date

2009/06/11

Recall Number

49448

Hazard Classification

Type III

Model or Catalog #

A) 6902317
B) 6902318
C) 6902319

Lot or Serial #

A) VRA124, VRA125, VRA126, VRA127, VRA128
B) VRB123, VRB124, VRB125, VRB126, VRB127
C) VRC123, VRC125, VRC126, VRC127

Reason for Recall

OCD has received complaints from customers reporting that caps on several reagent red blood cell product vials are too tight. In some of those complaints, customers reported breaking or cracking of the glass reagent vial while attempting to unscrew the cap prior to use.

Recall Posting Date

2009/07/20

Trade Name

A) Amplilink Software V 3.1.1
B) Amplilink Software V 3.1.2 Build 0502
C) Amplilink Software V 3.2
D) Amplilink Software V 3.2.1
E) Amplilink Software V 3.2.2

Manufacturer

Roche Diagnostics Ltd.

Recall Start Date

2009/06/16

Recall Number

48878

Hazard Classification

Type II

Model or Catalog #

A) CAT #04807197001
B) CAT #04855094001
C) CAT# 04862392001
D) CAT #05093236001
E) CAT# 05201357001

Lot or Serial #

A) All Lots
B) All Lots
C) All Lots
D) All Lots
E) All Lots

Reason for Recall

While running the AmpliLink software, there are possibilities (under certain circumstances) that an assay is being performed with the test file parameters of another assay.

Recall Posting Date

2009/07/20

Trade Name

A) S3 Med/Surg Bed Fowler
B) Secure II Med/Surg Bed Fowler

Manufacturer

Stryker Medical

Recall Start Date

2009/06/11

Recall Number

49199

Hazard Classification

Type II

Model or Catalog #

A) 302S3-000-000
B) 3002-000-000

Lot or Serial #

A) All lots
B) All lots

Reason for Recall

There is potential for the Fowlers (backrests) to drift down to the flat position on the beds. The cause of the drifting Fowler is the Fowler clutch wrapspring having the potential to entangle in between the cup and coupler of the Fowler clutch assembly.

Recall Posting Date

2009/07/20

Trade Name

Architect I System-Total B-HCG Reagent

Manufacturer

Abbott Ireland Diagnostics Division

Recall Start Date

2009/06/30

Recall Number

49556

Hazard Classification

Type III

Model or Catalog #

7K78-20, 7K78-25

Lot or Serial #

74908JN00, EXP 17 DEC. 2009, 74908JN01, EXP 17 DEC. 2009

Reason for Recall

Abbott has observed an increase in complaints for the following error codes when using ARCHITECT Total ?-hCG Reagent with specified lots:
-1109 "assay (X) number (Y) calibration failure, ratio too small for CAL B/CAL A" and /or
- 1005 "result cannot be calculated, final RLU read is outside the specification of the lowest calibrator".

Recall Posting Date

2009/07/20

Trade Name

BD MultiSET Software V.3.0.1

Manufacturer

Becton, Dickinson And Company

Recall Start Date

2009/06/24

Recall Number

49459

Hazard Classification

Type III

Model or Catalog #

643347, 643437, 644459

Lot or Serial #

N/A

Reason for Recall

A multi-sipping issue was found in BD MultiSET Software Version 3.0.1. The software is not adjusting its acquisition criteria for some samples. It only displays the last batch of events acquired.

Recall Posting Date

2009/07/20

Trade Name

BHR Acetabular Cups

Manufacturer

Smith & Nephew Orthopaedics Ltd.

Recall Start Date

2009/06/30

Recall Number

49557

Hazard Classification

Type II

Model or Catalog #

74120152

Lot or Serial #

(L)08CW16248

Reason for Recall

The engraving on the plastic cap does not match the outer label indications for size. The BHR Acetabular Cup and femoral head packages include labelling and colour coding to prevent mismatch in component size selection. The engraved numbers on the impactor cap do not agree with this information and are erroneous. As such, the numbers engraved on the impactor cap could cause some confusion during surgery and lead to surgical delay.

Recall Posting Date

2009/07/20

Trade Name

Carendo Multipurpose Hygiene Chair

Manufacturer

Arjo Hospital Equipment AB

Recall Start Date

2009/06/16

Recall Number

49446

Hazard Classification

Type II

Model or Catalog #

BIB2003-01

Lot or Serial #

> 10 Numbers, Contact Manufacturer

Reason for Recall

A limited number of complaints have been received regarding the Carendo related to skin pinching. If the Carendo is not used in compliance with the device instructions for use. Trending has shown a number of events relating to what has been generally described as clip detachments.

Recall Posting Date

2009/07/20

Trade Name

Coonrad/Morrey Total Elbow System

Manufacturer

Zimmer Inc.

Recall Start Date

2009/06/09

Recall Number

49362

Hazard Classification

Type II

Model or Catalog #

32-8105-038-00

Lot or Serial #

61249897, 61249899

Reason for Recall

Some units in these lots may contain a void in the side seals of the Tyvek/poly pouch.

Recall Posting Date

2009/07/20

Trade Name

Dall Miles Trochanter Cable Grip System

Manufacturer

Howmedica Osteonics - Stryker Ireland

Recall Start Date

2009/06/15

Recall Number

49278

Hazard Classification

Type II

Model or Catalog #

6704-0-210

Lot or Serial #

Serial # 29233201

Reason for Recall

During post-sterilization inspection of the outer blister of the affected lots, it was determined that the outer blister did not meet the required minimum seal width. (Note: the inner blister seal was not affected).

Recall Posting Date

2009/07/20

Trade Name

Digital Radiography Imaging System

Manufacturer

Toshiba Medical Systems Corporation

Recall Start Date

2009/06/12

Recall Number

49202

Hazard Classification

Type II

Model or Catalog #

TFD-3000A1/WV

Lot or Serial #

N/A

Reason for Recall

In rare cases, the target image cannot be displayed or output to an external device after the system is simultaneously operated from the control room and the examination room in the Radrex-i system.

Recall Posting Date

2009/07/20

Trade Name

E-Cylinder Canister Holder

Manufacturer

Stryker Communications

Recall Start Date

2009/06/08

Recall Number

49172

Hazard Classification

Type II

Model or Catalog #

0682-000-449, 0682-001-111

Lot or Serial #

All Lots

Reason for Recall

The older version of the device has a design defect which allows for a fatigue related failure. There are two screws that attach the cage to the bracket which may fatigue over time and fail causing the cage to become detached from the mount and fall.

Recall Posting Date

2009/07/20

Trade Name

Exogen Bone Healing System

Manufacturer

Smith & Nephew, Inc.

Recall Start Date

2009/06/10

Recall Number

49177

Hazard Classification

Type II

Model or Catalog #

71034101

Lot or Serial #

> 10 Numbers, Contact Manufacturer

Reason for Recall

A small percentage of the devices (approximately 1%) may deliver less than the intended amount of ultrasound. This reduction in ultrasound output is the result of partial loosening of internal glued components within the small black cylindrical head, called a transducer. Reduced ultrasound output may affect the progress of patient fracture healing.

Recall Posting Date

2009/07/20

Trade Name

Genesis II Femorals

Manufacturer

Smith & Nephew, Inc.

Recall Start Date

2009/06/10

Recall Number

49201

Hazard Classification

Type II

Model or Catalog #

71420026

Lot or Serial #

08HM17084

Reason for Recall

Smith & Nephew has received complaints of lugs missing from the femorals. The missing lugs are apparent to the user upon opening of the inner sterile tray.

Recall Posting Date

2009/07/20

Trade Name

Laparo-Thoraco Telescopes, Cable Unit

Manufacturer

Olympus Winter & IBE GMBH

Recall Start Date

2009/06/25

Recall Number

49518

Hazard Classification

Type III

Model or Catalog #

A50001A, A50003A, A50021A, A50023A, WA50003L

Lot or Serial #

> 10 Numbers, Contact Manufacturer

Reason for Recall

Due to a geometrical incompatibility between the light guide cable and light source the "high intensity mode" cannot be switched on. Due to a production failure of the manufacturing partner, the distance between the coverglass of the light guide cable and the ledge does not meet specifications. Production between January 2009 and May 28, 2009 was affected.

Recall Posting Date

2009/07/20

Trade Name

Olympus Mobile Workstation, Transformer

Manufacturer

Keymed (Medical & Industrial Equipment) Ltd.

Recall Start Date

2009/06/16

Recall Number

49339

Hazard Classification

Type III

Model or Catalog #

MAJ-174, MH-787

Lot or Serial #

Serial Numbers Less Than 2810808

Reason for Recall

The fuse holder on the transformers assembled on the bottom of a number of Olympus WM Series Mobile Workstations (WM-NP1, WM-WP1, WM-DP1, WM-SC) can overheat and arc if the fuse carrier is not sufficiently tightened.

Recall Posting Date

2009/07/20

Trade Name

Quinton QStress TM55 Stress Treadmill

Manufacturer

Cardiac Science Corporation

Recall Start Date

2009/03/30

Recall Number

49032

Hazard Classification

Type II

Model or Catalog #

N/A

Lot or Serial #

Serial # 11040079567, 11040079568

Reason for Recall

Review of test records indicated that the two impacted TM55 Stress Treadmills may not have received adequate testing prior to being shipped from the factory.

Recall Posting Date

2009/07/20

Trade Name

Removable Magnet Hires 90K

Manufacturer

Advanced Bionics, LLC

Recall Start Date

2009/06/12

Recall Number

49409

Hazard Classification

Type II

Model or Catalog #

CI 1400-01, CI-1400-01, CI-1400-02H

Lot or Serial #

N/A

Reason for Recall

Advanced Bionics (AB) is notifying implant surgeons about the removable magnet component of the HiRes 90K Cochlear Implant (model no. CI-1400-01 and CI-1400-02h). The magnet is designed to be surgically removable if the Cochlear Implant patient needs to undergo an MRI. AB reports that devices manufactured between May 27 and June 30 of 2005 may have a magnet laser welding defect. The magnets were made such that the metal case surrounding the magnet is not properly welded. A patient implanted with an unwelded magnet could experience a decrease in the strength of the magnet over time, leading to headpiece retention issues. AB is aware of 14 defective magnets. In 7 cases the unwelded magnet resulted in surgery and replacement of the magnet. 2 of the replacements were for devices sold in Canada. An additional 5 potential cases outside of Canada and the USA are under investigation. Based on random sampling AB has determined the weld failure occurred at a rate of 1 in 126 devices. Devices manufactured outside the above time frame were not affected.

Recall Posting Date

2009/07/20

Trade Name

Trident Acetabular Surgical Protocol

Manufacturer

Howmedica Osteonics Corporation

Recall Start Date

2009/06/15

Recall Number

49269

Hazard Classification

Type II

Model or Catalog #

N/A

Lot or Serial #

N/A

Reason for Recall

The Trident Acetabular System surgical protocol (LSP55) needs to be modified to create separate and distinct surgical protocols, one for the Trident PSL Shell (LSP68) and one for the Trident Hemispherical Shell (LSP69) in order to clarify and highlight the differences in reaming technique.

Recall Posting Date

2009/07/06

Trade Name

A) Advia Centaur
B) Advia Centaur XP

Manufacturer

Siemens Healthcare Diagnostics Inc.

Recall Start Date

2009/06/10

Recall Number

49196

Hazard Classification

Type III

Model or Catalog #

A) 07566733
B) 07566733

Lot or Serial #

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

Reason for Recall

Manufacturer has determined that specific lots have shown decreased specificity for negative populations. The positive bias of approximately 0.3 index units and specimens with 0.5 to 0.8 index may be incorrectly identified as reactive for total antibodies to the core antigen of Hepatitis B virus.

Recall Posting Date

2009/07/06

Trade Name

A) Cell-Dyn 1700 Analyzer/1700CS Analyzer
B) Cell-Dyn 1800 Analyzer

Manufacturer

Abbott Laboratories Diagnostic Division

Recall Start Date

2009/06/12

Recall Number

49223

Hazard Classification

Type III

Model or Catalog #

A) 03H53-01, 03H57-01, 03H57-03
B) 07H77-01

Lot or Serial #

A) N/A
B) N/A

Reason for Recall

Use of the current available version of the 10ml diluent syringe, part number (p/n) 9212368 (without spacer), on a Cell-Dyn 1700, Cell-Dyn 1700cs, or Cell-Dyn 1800 with a die-cast syringe drive may result in diluent leakage during initialization of the analyzer, resulting in "diluent empty" faults.

Recall Posting Date

2009/07/06

Trade Name

A) Immunocap 250 Specific IGE Control
B) Immunocap 100 Specific IGE Control

Manufacturer

Phadia AB

Recall Start Date

2009/03/29

Recall Number

49233

Hazard Classification

Type III

Model or Catalog #

A) 10-9449-01
B) 10-9449-01

Lot or Serial #

A) BNMAX, BNMAY, BNMAZ
B) BNMAX, BNMAY, BNMAZ

Reason for Recall

Phadia AB, (Sweden) voluntarily recallsImmunoCAP Specific IGE Control (art.no 10-949-01) containing vial lot BNMAX, BNMAY, or BNMAZ using ImmunoCAP Allergen E1. Manufacturer updates information on target range values for one of seven ranges stated in the directions for use. Product is a control sample used by laboratory for internal quality assurance. A new range is established for ImmunoCAP Allergen E1. For some customers the results may be out of range and could result in a quality assurance investigation at the customer's site.

Recall Posting Date

2009/07/06

Trade Name

A) Isolex 300I Magnetic Cell Separator
B) Isolex 300 Magnetic Cell Separator

Manufacturer

Baxter Healthcare Corporation

Recall Start Date

2009/05/04

Recall Number

48344

Hazard Classification

Type II

Model or Catalog #

A) 4R9734
B) 4R9734

Lot or Serial #

A) All Lots
B) All Lots

Reason for Recall

HSA used to produce this reagent does not comply with the USP monograph as per what the current labelling and package inserts state. It complies with European pharmacopeia instead.

Recall Posting Date

2009/07/06

Trade Name

A) Nexgen Rotating Hinge Knee-Femoral Component
B) Nexgen Rotating Hinge Knee-Tibial Component

Manufacturer

Zimmer Inc.

Recall Start Date

2009/06/08

Recall Number

49105

Hazard Classification

Type II

Model or Catalog #

A) 00-5880-014-01, 00-5880-014-02, 00-5880-015-01, 00-5880-015-02, 00-5880-016-01
B) 00-5880-002-00, 00-5880-004-00, 00-5880-005-00, 00-5880-006-00

Lot or Serial #

A) 60147327, 60230599, 60137094, 60163665, 60173203, 60144695, 60174823, 60186251, 60141825
B) 60195329, 60160461, 60203906, 60206499, 60180540, 60170823, 60191094

Reason for Recall

This action is being conducted because these components are labelled with a ten year expiry period when in fact these components expire five years after manufacture.

Recall Posting Date

2009/07/06

Trade Name

A) System 1000 Dialsate Delivery System - Aurora
B) System 1000 Dialsate Delivery System - Tina
C) Arena SPP Hemodialysis Delivery System
D) Arena SPX Hemodialysis Delivery System

Manufacturer

Baxter Healthcare Corporation

Recall Start Date

2009/04/09

Recall Number

47924

Hazard Classification

Type III

Model or Catalog #

A) SYS1000-L3DPHA, SYS1000-L3P, SYS1000-L3PA, SYS1000-L3PHA
B) SYS1000-L3DPHA, SYS1000-L3P, SYS1000-L3PA, SYS1000-L3PH, SYS1000-L3PHA, SYS1000-L3PHDP
C) ARENASPP-DH, ARENASPP-H
D) ARENASPX-BDH, ARENASPX-HR

Lot or Serial #

A) All Lots
B) All Lots
C) All Lots
D) All Lots

Reason for Recall

An Arena instrument set to deliver 50 ml/min. may deliver between 40 & 60 ml/min., contrary to operator and service manuals. Sys1000 manuals do not specify blood flow accuracy as required by IEC standard.

Recall Posting Date

2009/07/06

Trade Name

Chloride Membrane on ABL 700 & 800 Flex

Manufacturer

Radiometer Medical APS

Recall Start Date

2009/06/05

Recall Number

48585

Hazard Classification

Type III

Model or Catalog #

942-061

Lot or Serial #

177

Reason for Recall

Composition of electrolyte solution in membrane units for the affected lot 177 are incorrect and cause the sensitivity of chloride electrode to be very low and the analyzer rejects calibration.

Recall Posting Date

2009/07/06

Trade Name

Definium 5000 Digital Radiographic System

Manufacturer

GE Healthcare

Recall Start Date

2009/06/11

Recall Number

47773

Hazard Classification

Type II

Model or Catalog #

5220493-2

Lot or Serial #

GEHC00070 & GEHC00096

Reason for Recall

When configured for AEC, after first exposure terminates, subsequent exposures fail to terminate because functionality of ion chamber ramp comparator with low reference voltage is not reliable.

Recall Posting Date

2009/07/06

Trade Name

Delfia Xpress PAPP-A Kit

Manufacturer

Wallac OY

Recall Start Date

2009/05/21

Recall Number

48607

Hazard Classification

Type II

Model or Catalog #

6003-0020

Lot or Serial #

490042, 490656, 503140, 506860, 507311, 516518

Reason for Recall

There is a decrease in the measurement of PAPP-A levels compared to previous lots, leading to the possibility of an increased false positive rate in screening programs.

Recall Posting Date

2009/07/06

Trade Name

Dimension Vista System-Urea Nitrogen Assay

Manufacturer

Siemens Healthcare Diagnostics Inc.

Recall Start Date

2009/06/19

Recall Number

49361

Hazard Classification

Type III

Model or Catalog #

K1021

Lot or Serial #

09061AA

Reason for Recall

Customer complaints received regarding inaccurate results with Dimension Vista Bun Flex Reagent Cartridge in that test results may be falsely elevated or depressed, with a variable error magnitude.

Recall Posting Date

2009/07/06

Trade Name

Dual Offset Broach Handle Left and Right

Manufacturer

Biomet, Inc.

Recall Start Date

2009/03/31

Recall Number

48593

Hazard Classification

Type II

Model or Catalog #

N/A

Lot or Serial #

All Lots

Reason for Recall

Handle body may crack or fracture, which could puncture or rupture the skin of the patient, surgeon or attending nurse and lead to increased risk of infection.

Recall Posting Date

2009/07/06

Trade Name

Flexicair

Manufacturer

Hill-Rom Manufacturing, Inc.

Recall Start Date

2009/05/18

Recall Number

49146

Hazard Classification

Type II

Model or Catalog #

I3000, M4000

Lot or Serial #

N/A

Reason for Recall

It is possible for the identified devices to emit smoke from the blower box assembly. Hazard of smoke inhalation and presence of smoke which can trigger smoke detection alarms.

Recall Posting Date

2009/07/06

Trade Name

Impression Coping Closed Tray Regular Platform 05x9mm

Manufacturer

Nobel Biocare AB

Recall Start Date

2009/05/21

Recall Number

48621

Hazard Classification

Type II

Model or Catalog #

N/A

Lot or Serial #

687218

Reason for Recall

Impression Coping Closed Tray NobelActive Internal Regular Platform (RP) 05x9mm (article no. 34235, lot no. 687218) was incorrectly packaged with the larger size 06x9mm.

Recall Posting Date

2009/07/06

Trade Name

Instrument Manager

Manufacturer

Data Innovations

Recall Start Date

2009/06/18

Recall Number

49308

Hazard Classification

Type III

Model or Catalog #

IM-B02 VX.XX

Lot or Serial #

N/A

Reason for Recall

Previous results retrieved from the specimen management database, which may be used by rules, may not be the most recent previous result.

Recall Posting Date

2009/07/06

Trade Name

LCT-1000 Therapy Laser

Manufacturer

Litecure, LLC

Recall Start Date

2009/05/15

Recall Number

49192

Hazard Classification

Type II

Model or Catalog #

N/A

Lot or Serial #

N/A

Reason for Recall

The LCT-1000 Deep Tissue Laser Therapy is an unlicenced medical device.

Recall Posting Date

2009/07/06

Trade Name

M3 Micro-MLC For Varian With MLC

Manufacturer

Brainlab AG

Recall Start Date

2009/03/19

Recall Number

47235

Hazard Classification

Type II

Model or Catalog #

41600-3, 41600-5, 41600-6

Lot or Serial #

01-006-41600, 01-044-41600, 41600-052-99, E41600-3/30793

Reason for Recall

Potential risk of interference when using BrainLAB M3 on a Varian Linear Accelerator with the Internal Varian Multileaf Collimator not in Park mode during treatment. The Internal Varian F-Collimator could interfere with the intended conformal fields of the BrainLAB M3 during patient treatment. This may cause a critical under-dosage of the target region.

Recall Posting Date

2009/07/06

Trade Name

Powersail Coronary Dilation Catheter

Manufacturer

Abbott Vascular

Recall Start Date

2009/06/18

Recall Number

49279

Hazard Classification

Type II

Model or Catalog #

1005726-08

Lot or Serial #

7112051

Reason for Recall

Received a report of damage to the distal shaft of the catheter. While the issue should be detected during the preparation of the product, it has the potential to cause a leak of contrast material. A leak has the potential to lead to a variety of catheter functional failures and clinical consequences as described in the instructions for use. Patients who have already been treated are not affected by this action and this action does not affect any other part number or lot number of the Powersail product line.

Recall Posting Date

2009/07/06

Trade Name

Stat G3+ Cartridges

Manufacturer

Abbott Point Of Care Inc.

Recall Start Date

2009/05/12

Recall Number

48497

Hazard Classification

Type II

Model or Catalog #

06F03-01, 06F03-02

Lot or Serial #

P08321C

Reason for Recall

Box numbers 1491 and 1534 of this device from lot # P083221C have suboptimal pouch seals. If a cartridge or suboptimal pouch seal is run, there is a possibility that the performance of the cartridge assays may be impacted.

Recall Posting Date

2009/07/06

Trade Name

Sur-Catch No Tip Nitinol Stone Basket

Manufacturer

Gyrus Acmi, Inc.

Recall Start Date

2009/06/04

Recall Number

49030

Hazard Classification

Type II

Model or Catalog #

5711222

Lot or Serial #

89261CB, 89262CB, 91665DB, 91666DB

Reason for Recall

Due to an error, some product was shipped out with a new polyamide sleeve material before the qualifying process was completed. Because of this, Gyrus ACMI cannot ensure that the product's shelf life will meet the expiration date on the label.