Medical Device Recall Listings - Sorted by Trade Name

(From October 2009 - December 2009)

Trade Name

070 Neuron Delivery Catheter

Recall Posting Date

2009/11/09

Manufacturer

Penumbra Inc.

Recall Start Date

2009/09/17

Recall Number

51330

Hazard Classification

Type II

Model or Catalog #

N/A

Lot or Serial #

>10 Numbers, Contact Manufacturer

Reason for Recall

Design modifications were made to the Neuron Delivery Catheter in March 2009 to improve the catheter kink resistance. Penumbra initiated voluntary field removal of the original catheter design from the marketplace.

Trade Name

A Locus High Resolution SSP Unitray

Recall Posting Date

2009/11/23

Manufacturer

Invitrogen Corporation

Recall Start Date

2009/07/24

Recall Number

51366

Hazard Classification

Type III

Model or Catalog #

47290-10, 47291-10

Lot or Serial #

1145687

Reason for Recall

Lane 23 in the 'A' high resolution SSP Unitray, lot and batch number identified, will produce a false positive band at the correct base pair size in the presence of A*0301 samples. This will affect typing results on samples that are Aa*0301 homozygote, since they could be erroneously reported as A*0301/A*1101.

Trade Name

A) Access Immunoassay System - Troponin
B) Unicel DXI600 Access Immunoassay System
C) Unicel DXI800 Access Immunoassay System

Recall Posting Date

2009/12/07

Manufacturer

Beckman Coulter Inc.

Recall Start Date

2009/10/23

Recall Number

51585

Hazard Classification

Type III

Model or Catalog #

A) A78803
B) A78803
C) A78803

Lot or Serial #

A) 915417
B) 915417
C) 915417

Reason for Recall

The reagents in wells three (RLC) and four (RLD) of the reagent pack were inadvertently switched during manufacturing. Lot number 915417 contains reagent RLD in well three and RLC in well four.

Trade Name

A) Accura Breast Localisation Needles
B) Hawkins II Breast Localisation Needles
C) Hawkins I Breast Localization Needles
D) Homer Mammalok Breast Localisation Needles
E) Manan Co-Axial Introducer Needles
F) Manan Introducer Sheath Needles
G) Manan Guidewire Introducer Needles
H) Manan Seldinger Needles
I) Manan Modified Potts/Cournand Needles
J) Manan Galactography Trays
K) Skater-Centesis Catheter
L) Chiba Style Manual
M) Franseen Style
N) Green Style
O) Spinal Style
P) Westcott Style
Q) Hawkins III Breast Localization Needles
R) Pro-Mag Disposable Biopsy Needles
S) Maxi-Cell Biopsy Needles
T) Ultracore Disposable Biopsy Needles
U) Lorad Needle Guide

Recall Posting Date

2009/12/07

Manufacturer

Medical Device Technologies, Inc. DBA Angiotech

Recall Start Date

2009/09/01

Recall Number

50935

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
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

Lot or Serial #

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

Reason for Recall

The complaints were reported as "run off" (non-contiguous) seals. A run off seal is a seal in which the Angiotech applied seal is mis-aligned.

Trade Name

A) Acuson Antares Software Version 4.0
B) Acuson Antares Main Unit/5.0 Upgrades

Recall Posting Date

2009/11/09

Manufacturer

Siemens Medical Solutions USA, Inc.

Recall Start Date

2009/10/08

Recall Number

51249

Hazard Classification

Type III

Model or Catalog #

A) 05936518
B) 10032746

Lot or Serial #

A) 112267, 10134
B) 114573, 113469

Reason for Recall

Potential software problem with Acuson and Sonoline Antares systems product version 5.0 with cardiac option installed below software version 200.0.079.

Trade Name

A) Antistreptolysin O Assay
B) Antistrepolysin O Assay
C) IGM Flex Assay
D) ASL Flex Reagent

Recall Posting Date

2009/10/26

Manufacturer

Siemens Healthcare Diagnostics Products GMBH

Recall Start Date

2009/09/24

Recall Number

50979

Hazard Classification

Type III

Model or Catalog #

A) K7058
B) K7022
C) 10445904
D) 10445888

Lot or Serial #

A) 07310MA, 08029MA, 08252MA, 08336MA
B) 07311MA, 08043MA, 09077MA, 07177MA
C) 07310MA, 08029MA, 08252MA, 08336MA
D) 07177MA, 07311MA, 08043MA, 09077MA

Reason for Recall

Under certain conditions the software falsely elevated the results particularly if the preceding serum sample has a higher volume and concentration of beta2-microglobulin, anti-strepolysin o, or immunoglobulin M analytes.

Trade Name

A) Artiste MV-Syngo RT Therapist Assist
B) Artiste MV-Syngo RT Therapist

Recall Posting Date

2009/12/07

Manufacturer

Siemens Medical Solutions USA, Inc. Oncology Care Systems

Recall Start Date

2009/11/05

Recall Number

51605

Hazard Classification

Type III

Model or Catalog #

A) 08162807
B) 08162815

Lot or Serial #

A) 10024
B) 10040

Reason for Recall

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

Trade Name

A) Artiste Syngo RT Therapist Assist
B) Artiste Syngo RT Therapist

Recall Posting Date

2009/11/09

Manufacturer

Siemens Medical Solutions USA, Inc.
Oncology Care Systems

Recall Start Date

2009/09/23

Recall Number

51246

Hazard Classification

Type III

Model or Catalog #

A) 08162807
B) 08162815

Lot or Serial #

A) 10024
B) 10040

Reason for Recall

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

Trade Name

A) AW Volumeshare
B) AW Volumeshare2

Recall Posting Date

2009/10/12

Manufacturer

GE Medical Systems SCS

Recall Start Date

2009/09/15

Recall Number

49927

Hazard Classification

Type II

Model or Catalog #

A) S30321ZK
B) 5183859-3, 5183859-4, 5183859-5

Lot or Serial #

A) >10 Numbers, Contact Manufacturer
B) S/N'S A8177079, A9062007, 9093001, A7274009, M8281004, 8354008

Reason for Recall

Measurement values provided by Seno Advantage Workstations 1x. 2.0 & 2.1 may be incorrect when applied to magnification images acquired on non-GE digital mammography systems, which could lead to overestimate of size of breast lesion.

Trade Name

A) BD Q-Syte Extension Set
B) MPS Acadia Extension Set With Rightbore
C) MPS Acadia Specialty Tri-Extension Set

Recall Posting Date

2009/12/07

Manufacturer

Becton Dickinson Infusion Therapy Systems Inc.

Recall Start Date

2009/11/02

Recall Number

51661

Hazard Classification

Type I

Model or Catalog #

A) 385102
B) 385150, 385151
C) 385164

Lot or Serial #

A) 8308330
B) A1967, A2399
C) A1951

Reason for Recall

Product may function improperly. This may result in the risk of air bubbles leaking into the infusion system through the BD Q-Syte Luer access split septum. This may lead to complications should the air bubbles not be detected.

Trade Name

A) Calcar Planer Surgical Protocols
B) Accolade Surgical Protocol

Recall Posting Date

2009/10/12

Manufacturer

Howmedica Osteonics Corporation

Recall Start Date

2009/09/14

Recall Number

50823

Hazard Classification

Type II

Model or Catalog #

A) LSP42, LSP46, LSP47M, LSP48
B) LASST

Lot or Serial #

A) N/A
B) N/A

Reason for Recall

Stryker has identified a need to provide specific instructions for initiating power to the Calcar Planer prior to engagement with bone in the cutting edge, Omnifit HFX, Secur-Fit Max/Secur-Fit Plus Max, and Omnifit Eon Surgical Protocols, as well as to provide specific instructions for rasping dense bone and/or narrow intra medullary canals for the Accolade Surgical Protocol.

Trade Name

A) C-Series Clinac, Trilogy & Novalis Tx
B) Trilogy Radiotherapy Delivery System
C) Novalis TX Linear Accelerator

Recall Posting Date

2009/12/07

Manufacturer

Varian Medical Systems, Inc.

Recall Start Date

2009/10/08

Recall Number

51773

Hazard Classification

Type II

Model or Catalog #

A) H18, H27, H29
B) H14, H29
C) H14, H29

Lot or Serial #

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

Reason for Recall

SRS treatments occurred with conical collimator accessory not inserted, or with conical collimator accessory correctly mounted, but with a primary collimator field size setting exceeding outside diameter of that conical collimator. With wrong field size, unintended radiation is given to patient outside the outer edge of cone.

Trade Name

A) Definium 8000 Digital Radiographic System
B) Proteus XR/A General Purpose Radiographic
C) Revolution XR/D Digital Radiographic System

Recall Posting Date

2009/10/12

Manufacturer

GE Healthcare

Recall Start Date

2009/09/21

Recall Number

47780

Hazard Classification

Type II

Model or Catalog #

A) 2259988-2, 5131070
B) 2259973-3, 2259976, 2259988, S3918KD/KE
C) 2351505, 5131070, S3918LD

Lot or Serial #

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

Reason for Recall

Table locks may not actuate, causing tabletop to unexpectedly float in either the lateral axes or both the longitudinal and lateral axes, which could result in patient or operator injury.

Trade Name

A) Imager II Angiographic Catheters
B) Imager II Catheters BERN
C) Imager II Catheters SIM
D) Imager II Catheters Contra2
E) Imager II Catheters C
F) Imager II Catheters RC
G) Imager II Catheters RDC
H) Imager II Catheters Pigtail
I) Imager II Catheters Contralateral

Recall Posting Date

2009/12/21

Manufacturer

Boston Scientific Corporation

Recall Start Date

2009/11/03

Recall Number

51535

Hazard Classification

Type II

Model or Catalog #

A) 31-400, 31-402, 31-510, 31-516, 31-520, 31-602
B) 31-407, 31-408, 31-409, 31-410, 31-607, 31-609
C) 31-430, 31-631
D) 31-458, 31-459, 31-658
E) 31-466, 31-467, 31-468, 31-469, 31-669
F) 31-485, 31-486, 31-685
G) 31-488, 31-489, 31-491
H) 31-509, 31-513, 31-519
I) 31-525, 31-528, 31-531

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

Reason for Recall

The sterile barrier in the packaging (pouch) that contains the catheter may be breached. The breach of sterility could lead to a contamination of the device with subsequent transfer of infectious agents to the patient.

Trade Name

A) Immulite System-Reactive Protein (CRP) Assay
B) Immulite 2500 System-HIH Sensit CRP Assay
C) Immulite 1000 System-Cardiac HSCRP Assay
D) Immulite System-Cardiac HSCRP Assay
E) Immulite 2000 System-Cardiac HSCRP Assay
F) Immulite 2500 System-HSCRP Assay
G) Immulite 1000 System-High Sens CRP Assay
H) Immulite 3000 Systems-High Sens CRP Assay
I) Immulite System-High Sensitivity CRP Assay
J) Immulite 1000 System-C-Reactive Protein

Recall Posting Date

2009/10/26

Manufacturer

Siemens Healthcare Diagnostics Products Limited

Recall Start Date

2009/09/11

Recall Number

50797

Hazard Classification

Type II

Model or Catalog #

A) LCRCM
B) LCRCM
C) LCRCM
D) LCRCM
E) L2KCRP2
F) LCRCM
G) LCRCM
H) L2KCRP2
I) LCRCM
J) LCRCM

Lot or Serial #

A) 022L, 025L
B) 022L, 025L
C) 022L, 025L
D) 022L, 025L
E) 243
F) 022L, 025L
G) 022L, 025L
H) 243
I) 022L, 025L
J) 022L, 025L

Reason for Recall

Siemens Healthcare Diagnostics received customer complaints regarding instabilities of high sensitivity C-reactive protein adjusters and controls giving an average positive bias of 20% compared with results from previous lots.

Trade Name

A) Intravenous Infusion Accessory IVMED20
B) Intravenous Infusion Accessory IVMED60

Recall Posting Date

2009/12/07

Manufacturer

Medxl Inc.

Recall Start Date

2009/11/06

Recall Number

51696

Hazard Classification

Type II

Model or Catalog #

A) N/A
B) N/A

Lot or Serial #

A) N/A
B) N/A

Reason for Recall

A warning letter was sent to the distributor requesting that sales be suspended until a licence has been obtained.

Trade Name

A) Intro-Flex Introducer Sets
B) Percutaneous Sheath Introducer Kit

Recall Posting Date

2009/12/21

Manufacturer

Edwards Lifesciences LLC

Recall Start Date

2009/05/21

Recall Number

48857

Hazard Classification

Type II

Model or Catalog #

A) 1350BF85
B) I652BF85H, S5507BF85

Lot or Serial #

A) >10 Numbers, Contact Manufacturer
B) 58511631, 58549300, 58606253, 58648812, 58496258, 58535112, 58604814, 58644423

Reason for Recall

Blue connector proximal to Tuohy-Borst hemostasis valve may fatigue, crack or separate, resulting in patency failure & potential blood loss where Intro-Flex Introducer secures a venous catheter.

Trade Name

A) Navigation Software Knee Zimmer
B) Brainlab Knee Essential Software
C) Brainlab Knee Unlimited Software

Recall Posting Date

2009/12/21

Manufacturer

Brainlab AG

Recall Start Date

2009/09/11

Recall Number

50954

Hazard Classification

Type III

Model or Catalog #

A) 22086-03D, 22086-03E
B) 21100-01(2.0), 21100-01C(2.1)
C) 70001A, 70002A(2.1)

Lot or Serial #

A) Version 2.1.1 & All Previous
B) Version 2.1.1 & All Previous
C) Version 2.1.1 & All Previous

Reason for Recall

Incorrect Zimmer implant data in Brainlab Software Knee leads to incorrect information for Zimmer Innex implants.

Trade Name

A) Nexgen Rotating Hinge Knee - Femoral
B) Nexgen Rotating Hinge Knee - Tibial
C) Nexgen Rotating Hinge Knee,Tibial Plate
D) Nexgen Rotating Hinge Knee - Femoral, B

Recall Posting Date

2009/12/07

Manufacturer

Zimmer Inc.

Recall Start Date

2009/11/06

Recall Number

51622

Hazard Classification

Type III

Model or Catalog #

A) 00-5880-013-01, 00-5880-014-01, 00-5880-014-02, 00-5880-015-01, 00-5880-015-02, 00-5880-016-01, 00-5880-016-02
B) 00-5880-002-00, 00-5880-003-00, 00-5880-004-00, 00-5880-005-00, 00-5880-006-00
C) 00-5880-001-02
D) 00-5880-012-01

Lot or Serial #

A) >10 Numbers, Contact Manufacturer
B) >10 Numbers, Contact Manufacturer
C) 60433397, 60461749
D) 60186249 H5

Reason for Recall

This action is being conducted because these components are labelled with a 10 year expiry period when in fact these components expire 5 years after manufacture. Expiration dating refers to 'use by' dates. There is no risk to patients who receive these implants prior to January 2010, when devices from the affected lots begin to expire.

Trade Name

A) Online TDM Gentamicin for Roche/Hitachi
B) Online TDM Gentamicin (GENT2) for Cobas

Recall Posting Date

2009/11/09

Manufacturer

Roche Diagnostics GMBH

Recall Start Date

2009/10/07

Recall Number

51194

Hazard Classification

Type II

Model or Catalog #

A) 03800504190
B) 04490843190

Lot or Serial #

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

Reason for Recall

The online TDM Gentamicin assays may generate falsely elevated control and patient results when used with the current lot of Preciset TDM 1 Calibrator on the Roche/Hitachi analyzers.

Trade Name

A) PDS II Absorbable Sutures
B) Coated Vicryl Absorbable Sutures

Recall Posting Date

2009/11/23

Manufacturer

Ethicon Inc.

Recall Start Date

2009/10/26

Recall Number

51428

Hazard Classification

Type II

Model or Catalog #

A) Z316H
B) J318H

Lot or Serial #

A) ACM008
B) ACM473

Reason for Recall

Specific lots of PDS II (polydioxanone) Absorbable Sutures are being recalled because some of these products may have a small void in the foil outer package. The void in the foil may lead to suture degradation and the potential for a compromise in the sterility of the product.

Trade Name

A) Powerhart G3 Automated External Defibrillator
B) Powerhart AED G3 Pro
C) Powerhart AED G3 Plus
D) Powerhart G3 Plus Automatic
E) Powerhart - AED G3 (Biphasic)

Recall Posting Date

2009/12/21

Manufacturer

Cardiac Science Corporation

Recall Start Date

2009/10/08

Recall Number

51818

Hazard Classification

Type II

Model or Catalog #

A) 9300A-501PPC
B) 9300P-601
C) 9390E-501
D) 9390A-501
E) 9300E-501

Lot or Serial #

A) 4230260ppc
B) 4226121
C) 4237595
D) 4183220
E) 4218441, 4153329, 4153683

Reason for Recall

Review of test records indicated that the seven impacted Powerhart G3 AEDS manufactured by Cardiac Science Corporation (CSC) may not have received adequate testing prior to being shipped from the factory.

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
Updated recall # 50403 previously posted on
2009-09-28.

Recall Posting Date

2009/10/26

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

Update: The manufacturer now requests return of the affected devices. The manufacturer has determined there is a remote possibility that certain handpieces may self activate.

Trade Name

A) Renegade Fiber Braided Microcatheter
B) Renegade Hi-Flow Microtainer

Recall Posting Date

2009/10/12

Manufacturer

Boston Scientific Cork Ltd.

Recall Start Date

2009/08/26

Recall Number

50811

Hazard Classification

Type II

Model or Catalog #

A) 18-251, 18-252, 18-253
B) 18-285, 18-286, 18-288, 18-289, 18-290, 18-291, 18-298, 18-299, 18-300, 18-302, 18-303

Lot or Serial #

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

Reason for Recall

Sterile barrier in the packaging of affected product may be compromised. Pouch seal (top seal) may be breached.

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
Updated recall # 50598 previously posted on 2009-09-14.

Recall Posting Date

2009/11/09

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. Testing indicates the integrity of the packaging was maintained by an inner o-ring seal. The date range of distribution for the affected products is 2007/04/26 to 2007/08/01.

Trade Name

A) SDC HD Capture Recorder
B) SDC HD Capture Device

Recall Posting Date

2009/12/07

Manufacturer

Stryker Endoscopy

Recall Start Date

2009/10/30

Recall Number

51583

Hazard Classification

Type II

Model or Catalog #

A) 240-050-888
B) 240-050-890

Lot or Serial #

A) All Lot Numbers
B) All Lot Numbers

Reason for Recall

Stryker Endoscopy was aware that the SDC HD picture/video capture device would not be able to assign the correct time/date stamp for saved files after December 31st 2009. On January 1st 2010, the system date for all SDC HD units would re-start from October 1st 2001 and begin incrementing from that point onwards. This event would not affect how pictures or videos were captured using SDC HD during surgery, however the system date would be incorrect and users would not be able to correct this issue without a software upgrade.

Trade Name

A) Signa 1.5T Excite HD - Gradients
B) 3.0T Signa HDX MR System - Main Unit
C) 1.5T Signa HDX MR System - Hardware
D) Discovery MR750 MR System - Main Unit
E) 1.5T Signa Infinity Twinspeed Excite
F) Signa 1.5T Infinity Excite MR System
G) Signa Excite 3.0T Electronics
H) Signa HDXT 1.5T MR System - Main Unit

Recall Posting Date

2009/12/07

Manufacturer

GE Medical Systems LLC

Recall Start Date

2009/11/05

Recall Number

50777

Hazard Classification

Type II

Model or Catalog #

A) M3000LF
B) M3335JK
C) M3335PB
D) M7000BF
E) M3000TD
F) 2294302
G) M3333TA
H) SIGNA HDXT 1.5T MR SYSTEM

Lot or Serial #

A) HDMR10368, 7547YR3, 278606MR9, 266072MR8, 274168MR4, 270572MR1
B) 7555YR6
C) >10 Numbers, Contact Manufacturer
D) 291192MR3, 290992MR7
E) >10 Numbers, Contact Manufacturer
F) 243409MR0, 239046MR6, 253630MR8, 239043MR3, 256216MR3, 246610MR0, 258415MR9, 247728MR9, 242181MR6
G) 6690YR2, 266690MR7
H) 30BD4960

Reason for Recall

Use of CADstream with "pure" software for Dynamic MRI imaging may require a modification to the study preference settings to present colour overlays equivalent to non-pure studies.

Trade Name

A) TCD Drainage Catheters
B) SKATER Single Step Drainage Set

Recall Posting Date

2009/11/09

Manufacturer

PBN Medical Denmark A/S

Recall Start Date

2009/09/22

Recall Number

51091

Hazard Classification

Type II

Model or Catalog #

A) 716084020
B) 756007025, 756008025, 756010025, 756012025, 756506025, 756507025, 756508020, 756512020

Lot or Serial #

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

Reason for Recall

Packaging integrity may be compromised as a result of transportation and distribution of the products.

Trade Name

A) Tegaderm Hydrocolloid Dressing
B) Medipore Soft Cloth Surgical Tape

Recall Posting Date

2009/12/21

Manufacturer

3M Health Care

Recall Start Date

2009/11/23

Recall Number

51873

Hazard Classification

Type III

Model or Catalog #

A) 90002
B) 2961

Lot or Serial #

A) 2012-06 AA
B) 2012-10 XT

Reason for Recall

The master carton and the individual dressing packages are labelled correctly, however the boxes that contain the individual dressing packages were labelled for Tegaderm Hydrocolloid thin dressing, catalogue # 90022.

Trade Name

A) Therakair Visio
B) InfoV.A.C. Therapy Unit
C) First Step All in One
D) ActiV.A.C. Therapy Unit
E) First Step Select - Pump
F) Kinair IV
G) V.A.C. ATS Therapy Unit
H) Proficare Pump Unit
I) Therapulse ATP

Recall Posting Date

2009/12/07

Manufacturer

KCI USA, Inc.

Recall Start Date

2009/11/09

Recall Number

51634

Hazard Classification

Type II

Model or Catalog #

A) M6257763
B) M8260027
C) 227500
D) 340013
E) 215200
F) 216050
G) M8259994
H) M8259988
I) 227080.S, 227800

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

Reason for Recall

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

Trade Name

A) Transport Stretcher
B) M-Series Stretcher
C) Trauma Stretcher
D) Eye Surgery Stretcher

Recall Posting Date

2009/10/12

Manufacturer

Stryker Medical

Recall Start Date

2009/08/31

Recall Number

50938

Hazard Classification

Type II

Model or Catalog #

A) 0737-000-000, 0738-000-000
B) 1007-000-000 (SM104)
C) 1027-000-000
D) 1079-000-000

Lot or Serial #

A) >10 Numbers, Contact Manufacturer
B) >100 Numbers, Contact Manufacturer
C) >10 Numbers, Contact Manufacturer
D) 0811100540, 0812101547, 0812102798, 0901034284, 0901034285

Reason for Recall

The stretchers have the potential for the bushing in the braking system to fracture, which could result in the brake/steer pedal seizing. If the pedal seizes, the braking system may become inoperable and/or steering around corners may become more difficult.

Trade Name

A) Triporteur Star 3
B) Quadriporteur Star 4

Recall Posting Date

2009/11/09

Manufacturer

Orthofab Inc.

Recall Start Date

2009/09/22

Recall Number

50934

Hazard Classification

Type II

Model or Catalog #

A) 180-32040-22
B) 180-32000-07, 180-32000-22

Lot or Serial #

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

Reason for Recall

Lack of surface treatment on one of the gears of the transmission gearbox.

Trade Name

A) Unicel DXC600I Synch.Acc.Clin. Analyzer
B) Unicel DXC880I Synch.Acc.Clin. Analyzer
C) Unicel DXC660I Synch.Acc.Clin. Analyzer
D) Unicel DXC680I Synch.Acc.Clin. Analyzer
E) Unicel DXC860I Synch.Acc.Clin. Analyzer

Recall Posting Date

2009/12/07

Manufacturer

Beckman Coulter, Inc.

Recall Start Date

2009/10/22

Recall Number

51584

Hazard Classification

Type III

Model or Catalog #

A) 4767
B) 4768
C) 4771
D) 4772
E) 4773

Lot or Serial #

A) Cup Lot Numbers Starting With "09" Or Later
B) Cup Lot Numbers Starting With "09" Or Later
C) Cup Lot Numbers Starting With "09" Or Later
D) Cup Lot Numbers Starting With "09" Or Later
E) Cup Lot Numbers Starting With "09" Or Later

Reason for Recall

The access 1.0 ml insert cup, used on Unicel DXC Synchron Clinical Systems, might be the cause of some sample wheel motion errors when run using 13x100 sample tubes.

Trade Name

A) Unicel DXI600 Access Immunoassay System Class 2
B) Unicel DXI600 Access Immunoassay System Class 3
C) Unicel DXC880I Access Clinical Analyzer
D) Unicel DXI800 Access Analyzer Class 3
E) Unicel DXI800 Access System Analyzer Class 2
F) Unicel DXC660I Access Clinical Analyzer
G) Unicel DXC680I Access Clinical Analyzer
H) Unicel DXC860I Access Clinical Analyzer

Recall Posting Date

2009/12/07

Manufacturer

Beckman Coulter Inc.

Recall Start Date

2009/10/26

Recall Number

51422

Hazard Classification

Type II

Model or Catalog #

A) A30260, A71461
B) A71461
C) 4768
D) 973100, A71457
E) 973100, A71457
F) 4771
G) 4772
H) 4773

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

Reason for Recall

A software issue was identified in system software 4.2 and 4.2.1, which may result in the incorrect handling of a wash arm dispense plate motion failure. Instead of generating a red 'warning' event and stopping sample processing, the system will post a yellow 'caution' event and continue to operate with the dispense plate in an elevated position until the instrument is reinitialized. Potentially affected results are not flagged.

Trade Name

A) VNS Therapy Demipulse Programmable Generator
B) VNS Therapy Demipulse Duo Generator

Recall Posting Date

2009/12/21

Manufacturer

Cyberonics Inc.

Recall Start Date

2009/12/03

Recall Number

52025

Hazard Classification

Type II

Model or Catalog #

A) N/A
B) N/A

Lot or Serial #

A) All Lot Numbers
B) All Lot Numbers

Reason for Recall

Enhanced labelling to prevent end of service (EOS) warning messages & reduced battery life resulting from electromagnetic induction (EMI), electrostatic discharge (ESD), or electro cautery exposure during surgery.

Trade Name

A) Voluson E8 Ultrasound System Main Unit
B) Voluson E8 Expert Ultrasound System

Recall Posting Date

2009/11/09

Manufacturer

GE Medical Systems Kretztechnik GMBH & CO OHG

Recall Start Date

2009/10/21

Recall Number

51227

Hazard Classification

Type III

Model or Catalog #

A) H48651PT
B) H48661N

Lot or Serial #

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

Reason for Recall

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

Trade Name

Acuson S2000

Recall Posting Date

2009/10/12

Manufacturer

Siemens Medical Solutions USA, Inc.

Recall Start Date

2009/09/08

Recall Number

50793

Hazard Classification

Type II

Model or Catalog #

10041461

Lot or Serial #

200252, 200288, 200334, 200926, 200979, 200995

Reason for Recall

There is an intermittent series of events in which a print or store event failure may cause the following to occur: A) The last image of a patient study can be stored with the next new patient study performed. B) If the first patient's last image had measurement results they will appear on the next patient's image. C) When a distance ratio or area ratio measurement is performed with L Testis Mass 2 measurement label, it appears in the report as R Testis Mass 2 in English only. D) When more than 4 measurements of the same label are performed they will not appear on-screen or on the printed report.

Trade Name

A-Dec Decade Plus 1221 Dental Chair

Recall Posting Date

2009/11/23

Manufacturer

A-Dec, Inc.

Recall Start Date

2009/04/06

Recall Number

51399

Hazard Classification

Type III

Model or Catalog #

1221

Lot or Serial #

>10 Numbers, Contact Manufacturer

Reason for Recall

When the chair back was returned up to the 'patient entry / exit' position, a pinch existed between the moving chair back support and the stationary underside of the armrest.

Trade Name

AdvanSync Orthodontic Device

Recall Posting Date

2009/10/26

Manufacturer

Ormco Corporation

Recall Start Date

2009/10/05

Recall Number

51125

Hazard Classification

Type III

Model or Catalog #

600-4000

Lot or Serial #

080901333, 080902356, 070981416, 060971299, 060976084, 080902357, 080901335, 070981417, 060971304, 060976079

Reason for Recall

Five complaints involving braze joint failures of AdvanSync Telescopic Rod Assemblies resulting in a recall.

Trade Name

Advantage, 2-Button Turbo Handpiece

Recall Posting Date

2009/12/07

Manufacturer

Linvatec Corporation D.B.A. Conmed Linvatec

Recall Start Date

2009/11/09

Recall Number

51507

Hazard Classification

Type II

Model or Catalog #

D9924

Lot or Serial #

>10 Numbers, Contact Manufacturer

Reason for Recall

The manufacturer has determined there is a remote possibility that the device may self activate.

Trade Name

Advent 4.5mmd Platform Tapered Abutment

Recall Posting Date

2009/12/07

Manufacturer

Zimmer Dental Inc.

Recall Start Date

2009/11/06

Recall Number

51588

Hazard Classification

Type II

Model or Catalog #

AVACT

Lot or Serial #

61233652, 61238956, 61245049, 61252577, 61256798, 61263053, 61314067, 61341224

Reason for Recall

Zimmer Dental has received field complaints reporting that during application of torque to the abutment, the upper portion of the abutment had fractured and separated from the lower shaft. The investigation has determined that the product is not manufactured to specification. The pilot broach for threading the internal threads of the implant is too deep and extends into the shaft of the screw.

Trade Name

Amplatz PTFE-Coated Guidewire

Recall Posting Date

2009/11/09

Manufacturer

Gyrus Acmi, Inc.

Recall Start Date

2009/08/25

Recall Number

50973

Hazard Classification

Type III

Model or Catalog #

13BX

Lot or Serial #

96158DB

Reason for Recall

Amplatz PTFE-Coated Guidewires, part number 13BX, sold as lot 96158DB, may have been mis-packaged with product from lot number 96159DB. In this case, the outer box is labelled with the errant 96158DB lot number while the inner pouches are correctly labelled as lot 96159DB.

Trade Name

Amplicor STD Specimen & Transport Kit

Recall Posting Date

2009/12/21

Manufacturer

Roche Molecular Systems, Inc.

Recall Start Date

2009/11/27

Recall Number

51858

Hazard Classification

Type II

Model or Catalog #

20753920122

Lot or Serial #

K13333, K13334, K15491, K15492, 2036

Reason for Recall

Potential for the male swab to present a defectiveness where the cotton head of the swab may dislodge and/or unravel with minimal force. This could result in having cotton fibres remaining within the urethra during specimen collection of male patients.

Trade Name

Apexpro Telemetry System - Clinical Info.

Recall Posting Date

2009/11/23

Manufacturer

GE Medical Systems Information Technologies

Recall Start Date

2009/10/26

Recall Number

48250

Hazard Classification

Type II

Model or Catalog #

418779-010, APRSRVR16=XXX, CICV3APRO=XXX, CICV3APRO=XXX/XXX , CICV4APRO=XXX

Lot or Serial #

>100 Numbers, Contact Manufacturer

Reason for Recall

Operator's manual does not warn against the unintended use of Apexpro Telemetry to monitor SPO2 without concurrent ECG monitoring and does not identify correct alarms and messages during loss of SPO2 data condition.

Trade Name

ASP Automatic Endoscope Reprocessor

Recall Posting Date

2009/11/23

Manufacturer

Advanced Sterilization Products,
A Division Of Ethicon

Recall Start Date

2009/09/28

Recall Number

51459

Hazard Classification

Type III

Model or Catalog #

20300, 20301

Lot or Serial #

>10 Numbers, Contact Manufacturer

Reason for Recall

Advanced Sterilization Products (ASP) is sending a letter to all Automated Endoscope Reprocessor (AER) customers to reinforce the importance of properly setting the disinfectant cycle time when using the ASP AER and to remind users to observe the illuminated temperature light during the cycle. ASP has received user reports about improper times set for each disinfectant cycle.

Trade Name

Auto D Dimer Kit CRS 126B

Recall Posting Date

2009/12/07

Manufacturer

Trinity Biotech PLC

Recall Start Date

2009/08/19

Recall Number

51650

Hazard Classification

Type II

Model or Catalog #

CRS126-B

Lot or Serial #

T065095, T082003, T119007

Reason for Recall

The response of the two highest points of the kit's calibration curve are the same and consequently very high D dimer values may be underestimated.

Trade Name

Bard Magnum Core Tissue Biopsy Needle

Recall Posting Date

2009/11/23

Manufacturer

Bard Peripheral Vascular, Inc.

Recall Start Date

2009/10/16

Recall Number

51391

Hazard Classification

Type II

Model or Catalog #

MN1610, MN1613, MN1616, MN1620

Lot or Serial #

>10 Numbers, Contact Manufacturer

Reason for Recall

Some of the needles may exhibit an exposed sample chamber due to extended stylet length from a loose hub connection, resulting in an inability to obtain the biopsy sample.

Trade Name

BCI 9015 4-Channel Analog Output Cable

Recall Posting Date

2009/11/09

Manufacturer

Smiths Medical PM, Inc.

Recall Start Date

2009/10/19

Recall Number

51331

Hazard Classification

Type III

Model or Catalog #

9015

Lot or Serial #

W72407

Reason for Recall

When interfaced via A 9015 cable to an external data collection device, A 9004 monitor configured with CCAP 1.13 software will not communicate reliably through either channel 3 or 4. This issue only occurs when the monitor's analog output is set to external.

Trade Name

BD 30ml Luer-Lok Syringes

Recall Posting Date

2009/12/21

Manufacturer

Becton Dickinson Canada Inc.

Recall Start Date

2009/11/26

Recall Number

51921

Hazard Classification

Type II

Model or Catalog #

309650

Lot or Serial #

9175046

Reason for Recall

BD has determined that a small number of unit packages may have open seals which can adversely impact product package integrity/product sterility.

Trade Name

BHR Streamline Cup Introducers

Recall Posting Date

2009/12/07

Manufacturer

Smith & Nephew, Inc.

Recall Start Date

2009/11/11

Recall Number

51665

Hazard Classification

Type II

Model or Catalog #

90128285

Lot or Serial #

S811270

Reason for Recall

The identified lot number may mechanically seize up, preventing release of the cable tightening mechanism, during surgery or before use. As a result, this could prolong surgery time. Also, if implanted, this could cause a possibility of malpositioning of the cup due to use of the device in a mechanically seized condition.

Trade Name

Bioflex 2200- 665-1850 Vasculitis Kit

Recall Posting Date

2009/12/07

Manufacturer

Bio-Rad Laboratories Diagnostics Group

Recall Start Date

2009/11/06

Recall Number

51677

Hazard Classification

Type II

Model or Catalog #

6651850

Lot or Serial #

950759, 959261, 961363

Reason for Recall

Bioplex 2200 vasculitis reagent kits could produce false results when analyzing diluted samples.

Trade Name

Bryan Cervical Disk System

Recall Posting Date

2009/11/09

Manufacturer

Medtronic Sofamor Danek USA, Inc.

Recall Start Date

2009/10/09

Recall Number

51184

Hazard Classification

Type II

Model or Catalog #

6470114, 6470115, 6470116, 6470117,
6470118

Lot or Serial #

>10 Numbers, Contact Manufacturer

Reason for Recall

There is a slight possibility of outer pouch failure during shipping, which could result in the introduction of an inner pouch having non-sterile outer surfaces into the sterile field. The innermost packaging has been shown to remain intact. Proper dispensing technique must be followed, placing the product, rather than the inner pouch, into the sterile field.

Trade Name

Buretrol IV Solution Adm.Sets Clearlink

Recall Posting Date

2009/12/07

Manufacturer

Baxter Healthcare Corporation

Recall Start Date

2009/11/05

Recall Number

51663

Hazard Classification

Type II

Model or Catalog #

2C8864

Lot or Serial #

UR09E21238

Reason for Recall

Separation of tubing from Distal Clearlink Y-site could occur, which may result in blood loss, infection, interruption of or delay in the start of intravenous therapy.

Trade Name

Carto 3 EP Mapping System

Recall Posting Date

2009/12/21

Manufacturer

Biosense Webster (Israel) Ltd.

Recall Start Date

2009/11/25

Recall Number

51915

Hazard Classification

Type II

Model or Catalog #

FG540000

Lot or Serial #

3257, 2246, 4203, 4166, 4184

Reason for Recall

Biosense Webster, Inc. has recently become aware of a potential hazard that may occur during the operation of the bloom DTU-215b cardiac stimulator (not a Johnson & Johnson device) in conjunction with RF generators and EP equipment, including the Carto 3 system. If RF energy and pacing stimuli are delivered simultaneously, across the same electrode pair, a DC voltage may be generated. This can cause micro-bubbles in the blood within the heart chamber.

Trade Name

CBC II Blood Conservation Kit

Recall Posting Date

2009/12/07

Manufacturer

Stryker Instruments

Recall Start Date

2009/11/13

Recall Number

51764

Hazard Classification

Type II

Model or Catalog #

225-414-000

Lot or Serial #

>10 Numbers, Contact Manufacturer

Reason for Recall

There is a potential that the package pouch in the CBC II Blood Conservation Kits may have a pin hole, a weakened seal, or an opened seal that could result in the product not being sterile.

Trade Name

Centricity PACS Workstation - Software

Recall Posting Date

2009/12/07

Manufacturer

GE Healthcare IT

Recall Start Date

2009/10/30

Recall Number

51228

Hazard Classification

Type II

Model or Catalog #

K2020YS, K2030JN

Lot or Serial #

>100 Numbers, Contact Manufacturer

Reason for Recall

If Dicom node config. is set to accept, user may unintentionally add new images to an approved exam, under certain conditions images will be deleted from PACS or from dictated, transcribed or completed status exam.

Trade Name

Colleague Volumetric Infusion Pumps
Updated recall # 44735 previously posted on 2008-11-24.

Recall Posting Date

2009/12/07

Manufacturer

Baxter Healthcare Corporation

Recall Start Date

2008/11/24

Recall Number

44735

Hazard Classification

Type III

Model or Catalog #

2M9163

Lot or Serial #

>10 Numbers, Contact Manufacturer

Reason for Recall

Customers were erroneously provided with version 0719H0166 of the operator's manual instead of the correct version 0719I0166.

Trade Name

Complement Control Cells

Recall Posting Date

2009/11/23

Manufacturer

Immucor Inc.

Recall Start Date

2009/10/26

Recall Number

51502

Hazard Classification

Type III

Model or Catalog #

N/A

Lot or Serial #

32616

Reason for Recall

There is evidence of potential microbial contamination in some vials of complement control cells (lot # 32616), based on gram stain results.

Trade Name

Connection Bracket 1180.36AO

Recall Posting Date

2009/10/26

Manufacturer

Maquet GMBH & Co. KG

Recall Start Date

2009/09/30

Recall Number

51053

Hazard Classification

Type II

Model or Catalog #

1180.360AO

Lot or Serial #

N/A

Reason for Recall

The Connection Bracket show too much mechanical play at the operating room table interface for some procedures. The cause of this play, is that the hole in the lock washer, which is responsible for locking the accessory to the operating room table interface, is too large.

Trade Name

Contour SE Microspheres

Recall Posting Date

2009/11/09

Manufacturer

Boston Scientific Corporation

Recall Start Date

2009/08/28

Recall Number

50810

Hazard Classification

Type II

Model or Catalog #

M001761101, M001761122, M001761141, M001761162, M001761201, M001761222, M001761241, M001761262, M001761301, M001761322, M001761341, M001761362, M001761401, M001761422, M001761441, M001761462, M001761501, M001761522, M001761541, M001761562

Lot or Serial #

>100 Numbers, Contact Manufacturer

Reason for Recall

All affected product is packaged within a vial. Boston Scientific has determined that, for affected products, the sterile barrier in the packaging (pouch) that contains the vial may be breached.

Trade Name

CyberKnife Robotic Radiosurgery System

Recall Posting Date

2009/12/21

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.

Trade Name

CyberKnife Robotic Radiosurgery System
Updated recall # 50252 previously posted on 2009-08-31.

Recall Posting Date

2009/12/07

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. Recalls 50114 and 50252 are identical. For future reference, refer to recall 50252.

Trade Name

Da Vinci S Surgical System, Model IS2000

Recall Posting Date

2009/10/26

Manufacturer

Intuitive Surgical Inc.

Recall Start Date

2009/07/01

Recall Number

51026

Hazard Classification

Type III

Model or Catalog #

IS2000

Lot or Serial #

N/A

Reason for Recall

Intuitive Surgical Inc. observed an electronics subsystem failure that resulted in partial intermittent closure of the instrument grip (IS2000 system). A software coding error in P7 caused the error for the MTM grip.

Trade Name

Dade Hepzyme (B4240-10)

Recall Posting Date

2009/12/21

Manufacturer

Siemens Healthcare Diagnostics Products GMBH

Recall Start Date

2009/12/02

Recall Number

51994

Hazard Classification

Type III

Model or Catalog #

B4240-10

Lot or Serial #

528752

Reason for Recall

Customer complaints regarding incorrect high APTT values that may be observed on heparin and heparin-free samples treated with lot 528752 of Dade Hepzyme when using lot 528752 of Dade Hepzyme with non-Siemens APTT reagents.

Trade Name

Diagnostic Ultrasound Transducers / Probe

Recall Posting Date

2009/12/21

Manufacturer

Toshiba Medical Systems Corporation

Recall Start Date

2009/10/30

Recall Number

51870

Hazard Classification

Type II

Model or Catalog #

PVT-681MV

Lot or Serial #

>10 Numbers, Contact Manufacturer

Reason for Recall

In ultrasound systems using the Ultrasound Convex Transducer PVT-681MV, the volume image acquired in 'plane C' is reversed horizontally.

Trade Name

Dimension Vista System-Chem Calibrators

Recall Posting Date

2009/12/21

Manufacturer

Siemens Healthcare Diagnostics Inc.

Recall Start Date

2009/10/19

Recall Number

51373

Hazard Classification

Type III

Model or Catalog #

KC130

Lot or Serial #

9ED058

Reason for Recall

Customer complaints regarding Dimension Vista Amon method. Siemens has confirmed a negative bias of up to 35% for level 1 quality control when calibrated with Chem 3 Calibrator lot 9ED058 vs. 9BD064.

Trade Name

Dimension Vista System-Urea Nitrogen Assay

Recall Posting Date

2009/10/26

Manufacturer

Siemens Healthcare Diagnostics Inc.

Recall Start Date

2009/09/28

Recall Number

51016

Hazard Classification

Type III

Model or Catalog #

K1021

Lot or Serial #

09187AA

Reason for Recall

Received customer complaints regarding inaccurate results with the Bun Flex Reagent cartridge lots 09154AE and 09187AA.The test results may be falsely depressed or elevated.

Trade Name

Dimension V-Lyte Integrated Multisensor

Recall Posting Date

2009/12/07

Manufacturer

Siemens Healthcare Diagnostics Inc.

Recall Start Date

2009/10/29

Recall Number

51421

Hazard Classification

Type III

Model or Catalog #

K800, K820, K825, K835

Lot or Serial #

>10 Numbers, Contact Manufacturer

Reason for Recall

Received customer complaints regarding Dimension Vista V-Lyte. Siemens confirms that urine sodium results become elevated as urine specimens are run on a sensor.

Trade Name

Dupaque X-Ray Detectable Sponges

Recall Posting Date

2009/12/07

Manufacturer

Derma Sciences, Inc.

Recall Start Date

2009/10/27

Recall Number

51464

Hazard Classification

Type II

Model or Catalog #

94675-5

Lot or Serial #

4408

Reason for Recall

Received two complaints from a customer indicating that the sponge separated at the end during surgery and was left behind.

Trade Name

Duralite Pyramid Receiver Prox. Adaptor

Recall Posting Date

2009/12/07

Manufacturer

The Ohio Willow Wood Company

Recall Start Date

2009/11/09

Recall Number

51740

Hazard Classification

Type II

Model or Catalog #

N/A

Lot or Serial #

All Lot Numbers

Reason for Recall

There is a potential for the adapter to crack or break while in use by active amputees.

Trade Name

Durom Acetabular Cup

Recall Posting Date

2009/12/07

Manufacturer

Zimmer GMBH

Recall Start Date

2009/11/15

Recall Number

51631

Hazard Classification

Type II

Model or Catalog #

01.00214.044, 01.00214.046, 01.00214.048, 01.00214.050, 01.00214.052, 01.00214.054, 01.00214.056, 01.00214.058, 01.00214.060, 01.00214.062, 01.00214.064, 01.00214.066

Lot or Serial #

>1000 Numbers, Contact Manufacturer

Reason for Recall

There have been reports of revisions of Zimmer's Durom Acetabular Cup and the Metasul LDH (large diameter head) femoral head in certain European markets. Based on Zimmer's investigation, the most probable cause is using a surgical technique which differs from that prescribed in the surgical technique for the Durom Acetabular Cup. This field safety notice updates surgical technique instructions.

Trade Name

Endo Femoral Aimers

Recall Posting Date

2009/11/09

Manufacturer

Smith & Nephew, Inc., Endoscopy Division

Recall Start Date

2009/09/22

Recall Number

50942

Hazard Classification

Type I

Model or Catalog #

72201714, 72201716

Lot or Serial #

For product code 72201714: (L) 50278012
For product code 72201716: (L)502780141 and (L)50278014

Reason for Recall

Specific product codes and lot numbers of the Endo Femoral Aimers may have been improperly marked indicating the wrong size and part number. The actual 4mm Aimer is marked as 6mm and the actual 6mm Aimer is marked as 4mm.

Trade Name

Endoclamp Aortic Catheter

Recall Posting Date

2009/11/09

Manufacturer

Edwards Lifesciences

Recall Start Date

2009/10/01

Recall Number

51118

Hazard Classification

Type II

Model or Catalog #

EC1001

Lot or Serial #

>10 Numbers, Contact Manufacturer

Reason for Recall

Possibility of the balloon rupturing during use.

Trade Name

Engen Automated Sample Handling System

Recall Posting Date

2009/10/26

Manufacturer

Thermo Fisher Scientific OY

Recall Start Date

2009/10/06

Recall Number

51117

Hazard Classification

Type I

Model or Catalog #

ENGEN

Lot or Serial #

JCT20Q3J

Reason for Recall

Ortho Clinical Diagnostics is aware of one confirmed report of misreported patient results with the Engen Laboratory Automation System. When used with TCAutomation software versions 2.8.2 or below, incorrect sample ID’s may be electronically written to the radio frequency ID tags on the sample carriers.

Trade Name

Equalizer Balloon Catheter

Recall Posting Date

2009/11/09

Manufacturer

Boston Scientific Cork Ltd.

Recall Start Date

2009/09/30

Recall Number

51119

Hazard Classification

Type II

Model or Catalog #

M001171060, M001171080, M001171100, M001171120

Lot or Serial #

>100 Numbers, Contact Manufacturer

Reason for Recall

Sterile barrier in the packaging of the affected product may be compromised. It has been reported that the outer pouch seal may be breached.

Trade Name

Excor System-Connecting Set For Cannula

Recall Posting Date

2009/12/21

Manufacturer

Berlin Heart GMBH

Recall Start Date

2009/10/02

Recall Number

51703

Hazard Classification

Type I

Model or Catalog #

A06-009, A09-012, A12-016

Lot or Serial #

526337

Reason for Recall

It was observed that a too short cut of the adapter cannula combined together with certain conditions of stress may have a effect of leakage of the cannula.

Trade Name

Express SD Premounted Stent System

Recall Posting Date

2009/10/12

Manufacturer

Boston Scientific Corporation

Recall Start Date

2009/04/14

Recall Number

48011

Hazard Classification

Type III

Model or Catalog #

H74937911515900, H74937911614900, H74937911715900, H74937912519900, H74937912618150, H74937912618900

Lot or Serial #

12045170, 12070363, 12073173, 12054585, 12054587, 12054580, 12082319, 12082341, 12045167, 12085875, 12089749, 12089752, 12129028

Reason for Recall

Packaging for the applicable devices may not include a written copy of the product directions for use.

Trade Name

EZManager Max Diabetes Management Software

Recall Posting Date

2009/12/21

Manufacturer

Animas Corporation

Recall Start Date

2009/11/16

Recall Number

51762

Hazard Classification

Type III

Model or Catalog #

100-467-23, 100-467-50

Lot or Serial #

2937776 for EZManager Max CD, French
2936068, 2938247, 2962490 for EZManager Max CD, English

Reason for Recall

Compact discs received for EZManager Max Diabetes Management Software packages were identified as being blank when used in a computer.

Trade Name

Galileo Echo Blood Bank Analyzer

Recall Posting Date

2009/12/07

Manufacturer

Immucor Inc.

Recall Start Date

2009/11/06

Recall Number

51706

Hazard Classification

Type I

Model or Catalog #

87000

Lot or Serial #

N/A

Reason for Recall

Two lot numbers of reagents or strips are allowed to be tested while performing QC testing on the echo. The result is that the final lot tested will pass QC even though it did not undergo complete QC testing.

Trade Name

Galileo Echo Blood Bank Analyzer

Recall Posting Date

2009/12/07

Manufacturer

Immucor Inc.

Recall Start Date

2009/11/06

Recall Number

51708

Hazard Classification

Type I

Model or Catalog #

87000

Lot or Serial #

N/A

Reason for Recall

Under some circumstances, a manually entered sample ID could be assigned to the wrong sample.

Trade Name

Galileo Echo Blood Bank Analyzer

Recall Posting Date

2009/12/21

Manufacturer

Immucor Inc.

Recall Start Date

2009/11/25

Recall Number

51956

Hazard Classification

Type II

Model or Catalog #

87000

Lot or Serial #

N/A

Reason for Recall

The instrument may generate a negative well interpretation for capture-R ready-screen or capture-R ready-ID assays and subsequent visual interpretation of those reactions are weak positive or questionable (equivocal).

Trade Name

Gammacoat Plasma Renin Activity 123I RIA Kit

Recall Posting Date

2009/11/09

Manufacturer

Diasorin Inc./S.R.L.

Recall Start Date

2009/10/19

Recall Number

51278

Hazard Classification

Type II

Model or Catalog #

N/A

Lot or Serial #

123574, 123612, 123620

Reason for Recall

The Renin Activity Control provided with the kit has an incorrect range printed on the label. Printed range on the label is 5.5 - 10.3 ng/ml/hr. The correct range is 4.0 -7.6 ng/ml/hr.

Trade Name

Getinge Steam Sterilizer

Recall Posting Date

2009/12/07

Manufacturer

Getinge Sourcing LLC.

Recall Start Date

2009/09/01

Recall Number

50976

Hazard Classification

Type II

Model or Catalog #

422HC, 433HC, 522HC, 533HC, 633HC, 733HC, 833HC

Lot or Serial #

>10 Numbers, Contact Manufacturer

Reason for Recall

RTD temperature sensor component was failing prematurely. Temperature control of the sterilization process is maintained through the use of the sensor used in the sterilizer jacket and chamber.

Trade Name

Giraffe & Panda T-Piece Resuscitation System

Recall Posting Date

2009/10/26

Manufacturer

Ohmeda Medical,
A Division Of Datex Ohmeda Inc.

Recall Start Date

2009/09/22

Recall Number

51025

Hazard Classification

Type II

Model or Catalog #

M1091316, M1091335, M1091365

Lot or Serial #

N/A

Reason for Recall

1. Moulding flash during manufacturing of T-piece at supplier caused out of specification aperture. 2. Severity in risk analysis control document (RAC) scored low leading to less strict supplier inspection and process control requirements.

Trade Name

Goldmann Applanation Tonometer Prism

Recall Posting Date

2009/11/09

Manufacturer

Haag-Streit, AG

Recall Start Date

2009/10/13

Recall Number

51262

Hazard Classification

Type III

Model or Catalog #

1000855

Lot or Serial #

>100 Numbers, Contact Manufacturer

Reason for Recall

In Europe, Hagg-Streit received 3 reports concerning leaking Tonometer Prisms. A known reason of failing Tonometer Prisms is the use of disinfectants not approved and not released by Haag-Streit, mainly cool wipes. This might lead to irritation of cornea and in rare cases to reversible corneal erosions.

Trade Name

GT Obturators

Recall Posting Date

2009/10/12

Manufacturer

Dentsply Tulsa Dental Specialties Trading As Dentsply Endodontics

Recall Start Date

2009/09/25

Recall Number

50931

Hazard Classification

Type III

Model or Catalog #

GTOB20042

Lot or Serial #

12709123

Reason for Recall

The product, GT Obturators, GTOB20042, lot 012709123 was found to contain mixed instruments, size 20, taper .04 (20/.04) and size 20, taper .08 (20/.08) obturators.

Trade Name

Guider Softip Guiding Catheter

Recall Posting Date

2009/11/09

Manufacturer

Medi-Tech Boston Scientific Corporation

Recall Start Date

2009/10/07

Recall Number

51219

Hazard Classification

Type II

Model or Catalog #

10042, 10043, 10044, 10046, 10047, 10048, 10050, 10051, 10052, 10062, 10063, 10064, 10142, 10143, 10144, 10146, 10147, 10148, 10150, 10151, 10152, 10162, 10163, 10164

Lot or Serial #

>10 Numbers, Contact Manufacturer

Reason for Recall

It is believed that vast swings in environmental conditions can impact catheter products over time. Improper storage may cause polymer degradation in portions of the catheter. Use of degraded catheters can expose patients to potential adverse events including a delay in procedure time due to catheter exchange, vessel trauma and stroke. Boston Scientific Corp. is issuing a safety alert reminding users to follow directions for use.

Trade Name

Gynecare Morcellex Tissue Morcellator

Recall Posting Date

2009/11/09

Manufacturer

Ethicon Inc. Also Trading As Ethicon Women's
Health And Urology

Recall Start Date

2009/10/09

Recall Number

51327

Hazard Classification

Type II

Model or Catalog #

MX0100

Lot or Serial #

>10 Numbers, Contact Manufacturer

Reason for Recall

Ethicon is conducting a voluntary product recall of all lots of Gynecare Morcellex Tissue Morcellator due to the potential for the duckbill seal to become dislodged, and a confirmed event in which the seal was retained in a patient.

Trade Name

Heartmate XVE And II LVAS Battery Clip

Recall Posting Date

2009/11/23

Manufacturer

Thoratec Corporation

Recall Start Date

2009/10/14

Recall Number

51438

Hazard Classification

Type II

Model or Catalog #

N/A

Lot or Serial #

>100 Numbers, Contact Manufacturer

Reason for Recall

The threaded connector of the battery clip housing can become loose from the battery clip housing thereby creating a potential to interrupt pump function.

Trade Name

Heater Wire Adaptors

Recall Posting Date

2009/10/12

Manufacturer

Fisher And Paykel Healthcare Ltd.

Recall Start Date

2009/07/23

Recall Number

50850

Hazard Classification

Type II

Model or Catalog #

900MR800

Lot or Serial #

All Lot Numbers

Reason for Recall

Manufacturer is replacing these adaptors with new, more advanced product, which include surge protection hardware that will reduce the risk of breathing circuit heater wire malfunction.

Trade Name

Heater Wire Adaptors
Updated recall # 50850 previously posted on 2009-10-12.

Recall Posting Date

2009/11/09

Manufacturer

Fisher And Paykel Healthcare Ltd.

Recall Start Date

2009/07/23

Recall Number

50850

Hazard Classification

N/A

Model or Catalog #

N/A

Lot or Serial #

N/A

Reason for Recall

After further review it has been determined that this action by the manufacturer is not considered a recall under the definition of recall, but is considered a product withdrawal by the manufacturer.

Trade Name

Hintegra Talar Cutting Guides

Recall Posting Date

2009/12/21

Manufacturer

New Deal SA

Recall Start Date

2009/10/20

Recall Number

51435

Hazard Classification

Type II

Model or Catalog #

Left Cutting Guide, Right Cutting Guide

Lot or Serial #

>10 Numbers, Contact Manufacturer

Reason for Recall

The width of the defective Talar Cutting Guides is too large, thus the medio-lateral cuts are too large compared to the Talar trial implant dimensions.

Trade Name

Histopaque 1077-1

Recall Posting Date

2009/10/12

Manufacturer

Sigma Diagnostics

Recall Start Date

2009/09/21

Recall Number

50914

Hazard Classification

Type III

Model or Catalog #

1077-1

Lot or Serial #

038K6170

Reason for Recall

Bacterial contamination (Pseudomonas mendocina) in the affected device.The device is a cell separation media and in the reported instance was used to isolate stem cells from bone marrow specimens. The isolated cells were placed into cell culture for further testing and contamination was evident after 14 days of culture. The laboratory confirmed the source of contamination was the device.

Trade Name

Hypergel 5 Gram

Recall Posting Date

2009/10/12

Manufacturer

Molnlycke Health Care AB

Recall Start Date

2009/09/22

Recall Number

50961

Hazard Classification

Type III

Model or Catalog #

360500

Lot or Serial #

08D22-156-32913, 08D22-157

Reason for Recall

Hypergel 5 gram, product code 360500, lot numbers 08d22-156-32913 and 08d22-157, have been distributed with a lot number deficiency wherein the lot number listed on the packaging does not match the lot number on the individual piece.

Trade Name

i-CAT 3D Dental Imaging System

Recall Posting Date

2009/12/21

Manufacturer

Imaging Sciences International, Inc.

Recall Start Date

2009/10/30

Recall Number

51709

Hazard Classification

Type II

Model or Catalog #

9140-0000-0000

Lot or Serial #

ICU070488, ICU070518, ICU070519

Reason for Recall

Fault in the brake system may result in gantry-overhead dropping quickly when the overhead is lowered. i-CAT classic containing electrical brake.

Trade Name

i-CAT 3D Dental Imaging System

Recall Posting Date

2009/12/21

Manufacturer

Imaging Sciences International, Inc.

Recall Start Date

2009/10/30

Recall Number

51944

Hazard Classification

Type II

Model or Catalog #

9140-0000-0000

Lot or Serial #

>10 Numbers, Contact Manufacturer

Reason for Recall

i-CAT classic units containing mechanical brake or containing dual brake system- fault in brake system may result in the gantry-overhead carriage moving below its limits.

Trade Name

Ilumavision Software Ver. 2.1.0

Recall Posting Date

2009/10/12

Manufacturer

Imtec Imaging, LLC

Recall Start Date

2009/08/03

Recall Number

50774

Hazard Classification

Type II

Model or Catalog #

N/A

Lot or Serial #

Version 2.1.0

Reason for Recall

1. Incorrect imaging resulting from 3rd party digital image (Dicom) incompatibility. 2. Potential incorrect patient identification on report. Both may result in inaccurate or inappropriate treatment.

Trade Name

Imager II Urology Torque Catheters

Recall Posting Date

2009/12/21

Manufacturer

Boston Scientific Corporation

Recall Start Date

2009/11/03

Recall Number

51536

Hazard Classification

Type II

Model or Catalog #

M0064003031

Lot or Serial #

57271, 57616, 57269, 57613

Reason for Recall

The sterile barrier in the packaging (pouch) that contains the catheter may be breached. The breach of sterility could lead to a contamination of the device with subsequent transfer of infectious agents to the patient.

Trade Name

Impression Coping Closed Tray

Recall Posting Date

2009/10/26

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

Nobel Biocare received several complaints from customers. After investigation it was determined that one batch of Impression Coping Closed Tray Nobelactive INT RP Q6x9mm was mis-packaged.

Trade Name

Innova 2121IQ Bi-Plane Cardio Imaging

Recall Posting Date

2009/11/23

Manufacturer

GE Medical Systems SCS

Recall Start Date

2009/10/30

Recall Number

51374

Hazard Classification

Type II

Model or Catalog #

S18821AM

Lot or Serial #

S/N 553918BU4

Reason for Recall

Potential limit switch failure could occur due to collision between lateral plane of Innova positioner and other equipment, which may break x-ray and positioning switches and may not allow exam completion.

Trade Name

Insight Software Revision H,Bioview REV5.5.1

Recall Posting Date

2009/11/23

Manufacturer

Sandhill Scientific Inc.

Recall Start Date

2009/02/23

Recall Number

47672

Hazard Classification

Type III

Model or Catalog #

S98-1925-2H

Lot or Serial #

All lots are affected

Reason for Recall

The Revision "H" software calculated esophageal amplitudes incorrectly when the user generated a report. There were no issues with the acquisition of the data. Users could still acquire data, however there was a requirement to install the revision 'I' software upgrade before reports were printed to ensure data was reported (printed) correctly.

Trade Name

Intertan Hex Screw

Recall Posting Date

2009/11/09

Manufacturer

Smith & Nephew, Inc.

Recall Start Date

2009/10/15

Recall Number

51245

Hazard Classification

Type III

Model or Catalog #

71642220

Lot or Serial #

>10 Numbers, Contact Manufacturer

Reason for Recall

This recall was initiated as the product description included the word 'captured' and this was not a 'captured' screw. This could cause intra operative confusion due to the mislabeling. The problem originated in 2007 and all internal product was corrected, however the product in the field was not corrected.

Trade Name

IW900 Series Infant Warmer

Recall Posting Date

2009/11/09

Manufacturer

Fisher And Paykel Healthcare Ltd.

Recall Start Date

2009/09/07

Recall Number

51309

Hazard Classification

Type III

Model or Catalog #

IW910, IW920, IW930, IW932, IW934, IW950,
IW980, WITH SUFFIX JEU

Lot or Serial #

All Infant Warmers in Canada.

Reason for Recall

Notifying users in Canada of updating cleaning instructions for the IW900 Series Infant Radiant Warmers. The inclusion of the recommended and non-recommended proprietary cleaning products supplements the current operating instructions and technical manual held by Canadian customers which already cautions against using solutions containing specifically named chemicals.

Trade Name

IW900 Series Infant Warmer

Recall Posting Date

2009/11/09

Manufacturer

Fisher And Paykel Healthcare Ltd.

Recall Start Date

2009/09/07

Recall Number

51383

Hazard Classification

Type III

Model or Catalog #

Series With Suffix > IW910, IW920, IW930, IW932, IW934, IW950, IW980

Lot or Serial #

All Infant Warmers in Canada.

Reason for Recall

Notifying users in Canada of an updated test procedure for the power-fail alarm of the IW900 Series Infant Radiant Warmer. The service manual already includes a requirement for an annual check of the power-fail alarm. The test procedure has been revised to check that the power-fail alarm operates for at least 12 minutes. The revised test procedure accounts for any unexpected degradation over time of the supercapacitor that operates the power-fail alarm.

Trade Name

IW900 Series Infant Warmer

Recall Posting Date

2009/12/21

Manufacturer

Fisher And Paykel Healthcare Ltd.

Recall Start Date

2009/09/07

Recall Number

51309

Hazard Classification

Type III

Model or Catalog #

IW910, IW920, IW930, IW932, IW934, IW950, IW980, WITH SUFFIX JEU

Lot or Serial #

All Infant Warmers in Canada.

Reason for Recall

Notifying users in Canada of updating cleaning instructions for the IW900 series infant radiant warmers. The inclusion of the recommended and non-recommended proprietary cleaning products supplements the current operating instructions and technical manual held by Canadian customers which already cautions against using solutions containing specifically named chemicals.

Trade Name

Koordinat M/MP

Recall Posting Date

2009/12/21

Manufacturer

Siemens AG

Recall Start Date

2009/08/13

Recall Number

50747

Hazard Classification

Type III

Model or Catalog #

05294003, 06239003

Lot or Serial #

>10 Numbers, Contact Manufacturer

Reason for Recall

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

Trade Name

Kryptonite Bone Cement

Recall Posting Date

2009/12/07

Manufacturer

Doctors Research Group Inc.

Recall Start Date

2009/09/17

Recall Number

51492

Hazard Classification

Type III

Model or Catalog #

KRYP-X-03, KRYP-X-10, KRYP-Z-03, KRYP-Z-10

Lot or Serial #

05072009, 05272009, 06292009, 03102009, 07142008, 10232008, 10272008, 10312008, 10282009

Reason for Recall

As a result of increased viscosity of component "A" in some Kryptonite Bone Cement Kits, the end user may observe difficulty in discharging component "A" from the syringe that it is packaged in.

Trade Name

Kyphx HV-R Bone Cement

Recall Posting Date

2009/12/07

Manufacturer

Medtronic Spine LLC

Recall Start Date

2009/11/09

Recall Number

51643

Hazard Classification

Type II

Model or Catalog #

C01A, C01B

Lot or Serial #

>10 Numbers, Contact Manufacturer

Reason for Recall

Medtronic Spine LLC is recalling specific lots of Kyphx HV-R bone cement following complaints regarding extended time to reach the proper viscosity (doughy state) and inconsistency or lack of homogeneity during cement preparation, as well as when waiting to deliver the bone cement with the delivery device (e.g. bone filler device).

Trade Name

LabPro V3.01 Panel Update-01

Recall Posting Date

2009/12/21

Manufacturer

Siemens Healthcare Diagnostics Inc.

Recall Start Date

2009/11/30

Recall Number

51937

Hazard Classification

Type III

Model or Catalog #

9800-3771

Lot or Serial #

Software Version 3.01

Reason for Recall

Siemens Healthcare Diagnostics received customer complaints regarding QC isolates when tested on the walkaway instrument. Following the installation of LabPro 3.01 panel update -01 and utilization of the panel type POS combo 33 (PC33), an issue has been confirmed for QC isolates when tested on the walkaway instrument. This issue only applies to those that have installed the LP V3.01 panel update-01 (9800-3768 compact disk). QC issue affects combo type panels.

Trade Name

Leksell gamma Knife Perfexion

Recall Posting Date

2009/12/07

Manufacturer

Elekta Instruments AB

Recall Start Date

2009/08/18

Recall Number

51437

Hazard Classification

Type II

Model or Catalog #

715000

Lot or Serial #

Serial Number 6005

Reason for Recall

When incorrectly used the frame adapter may become damaged which in worst case could make it possible to lock the adapter so it does not properly fixate the frame.

Trade Name

Leksell Stereotactic System - Fixation Post

Recall Posting Date

2009/12/07

Manufacturer

Elekta Instruments AB

Recall Start Date

2009/10/02

Recall Number

51522

Hazard Classification

Type II

Model or Catalog #

1003935, 1003937

Lot or Serial #

N/A

Reason for Recall

Excessive heating of the tip of the fixation screws with the standard non-insulated posts may cause minor burning of the contact point of patients during certain higher energy MRI usage.

Trade Name

Lexicon K-File

Recall Posting Date

2009/10/26

Manufacturer

Dentsply Tulsa Dental Specialties Trading As Dentsply Endodontics

Recall Start Date

2009/09/29

Recall Number

51017

Hazard Classification

Type III

Model or Catalog #

KF01025

Lot or Serial #

811000105

Reason for Recall

The product is labelled as 25 mm in length but the files are actually 31 mm in length.

Trade Name

Manual Pulmonary Resuscitator (MPR)

Recall Posting Date

2009/11/09

Manufacturer

Unomedical Inc.

Recall Start Date

2009/10/08

Recall Number

51151

Hazard Classification

Type I

Model or Catalog #

724-E

Lot or Serial #

03-25

Reason for Recall

On some units of the Manual Pulmonary Resuscitator (MPR), the duckbill valve and retention ring inside the patient valve housing may become dislodged and fall into the MPR bag/body. If this were to occur, the MPR may loose its ability to generate the positive pressure necessary to function properly.

Trade Name

Maquet Hanaulux Model Blue 130

Recall Posting Date

2009/11/09

Manufacturer

Maquet S.A.

Recall Start Date

2009/09/22

Recall Number

50980

Hazard Classification

Type III

Model or Catalog #

56077943

Lot or Serial #

00001717, 00001719

Reason for Recall

There is potential for a crack on the front pivot of the Acrobat 2000 spring arm installed with a Blue 130 series surgical light that could cause the surgical light to swing freely. Defect rate is 0.35%.

Trade Name

MC5057 Universal Cable
Updated recall # 50401 previously posted on
2009-09-14.

Recall Posting Date

2009/10/26

Manufacturer

Linvatec Corporation D.B.A. Conmed Linvatec

Recall Start Date

2009/08/14

Recall Number

50401

Hazard Classification

Type II

Model or Catalog #

537702

Lot or Serial #

N/A

Reason for Recall

Update: The manufacturer now requests return of the affected devices. A sufficiently worn/damaged Universal Cable MC5057, used with Conmed Linvatec Electric Handpieces may cause the handpiece to self activate.

Trade Name

Medfusion Syringe Infusion Pumps

Recall Posting Date

2009/12/07

Manufacturer

Smiths Medical MD Inc.

Recall Start Date

2009/11/16

Recall Number

51668

Hazard Classification

Type II

Model or Catalog #

3010A, 3500-306, 3500-415, 3500-500

Lot or Serial #

>100 Numbers, Contact Manufacturer

Reason for Recall

Smiths Medical has become aware of an increased trend in reports of "motor not running" ("MNR") and "motor rate error" ("MRE") alarm message events with certain Medfusion Syringe Infusion Pumps, models 3010a and 3500 ("pump"). These are high priority alarm messages which can occur for a variety of reasons as part of the usual self-test functionality of these pumps. The pump stops delivery when an MNR/MRE alarm message event occurs.

Trade Name

Medical Grade Flat Panel Display

Recall Posting Date

2009/12/07

Manufacturer

Spacelabs Medical, Inc.

Recall Start Date

2009/10/30

Recall Number

51662

Hazard Classification

Type II

Model or Catalog #

94260-19

Lot or Serial #

>10 Numbers, Contact Manufacturer

Reason for Recall

A potential safety hazard associated with the use of Spacelabs Medical 19" Flat Panel Displays, model 94260-19. There is a possibility that the internal power distribution circuit board will fail prematurely, causing the display to go blank. Audio alarms will continue to function normally.

Trade Name

Midas Touch Needle Electrode

Recall Posting Date

2009/11/09

Manufacturer

Olsen Medical

Recall Start Date

2009/09/24

Recall Number

51204

Hazard Classification

Type II

Model or Catalog #

30-1014

Lot or Serial #

011668, 011970

Reason for Recall

The recall was initiated due to recent tests that indicated some Midas Touch Needle Electrodes with modified tip might have an insulation breach and could generate a risk of superficial burn to the patient and/or end-user.

Trade Name

Model 7600 - Oximeter Pod

Recall Posting Date

2009/12/07

Manufacturer

Nonin Medical Inc.

Recall Start Date

2009/10/23

Recall Number

51731

Hazard Classification

Type II

Model or Catalog #

Model 7600

Lot or Serial #

500849356, 500849358, 500849360, 500549361, 500823174, 500857064, 500874926

Reason for Recall

A malfunction with one of the components that may result in the overheating of the Oximeter pod has the potential to cause a burn if the pod is in direct contact with the patient.

Trade Name

MRSASelect Referance 63747 Coffret 20 Plaque

Recall Posting Date

2009/12/21

Manufacturer

Bio-Rad

Recall Start Date

2009/10/23

Recall Number

51525

Hazard Classification

Type II

Model or Catalog #

63747

Lot or Serial #

9H2414, 9H2417, 9H2425, 9J2429, 9J2432, 9J2435, 9J2437

Reason for Recall

Decrease of medium selectivity for methicillin-sensitive Saphyloccus aureus strains before medium’s expiration date.

Trade Name

neoBLUE mini LED Phototherapy System

Recall Posting Date

2009/12/07

Manufacturer

Natus Medical Inc.

Recall Start Date

2009/10/01

Recall Number

51237

Hazard Classification

Type II

Model or Catalog #

10101

Lot or Serial #

60001-62656 serial number

Reason for Recall

There has been a trend observed in failure of the pole mount clamp shipped with a neoBlue mini LED Phototherapy Systems. When tightened with excessive force, some of these clamps have shown stress fractures or broken. The pole mount clamp has been redesigned by the manufacturer and customers of record are being advised to inspect their systems and to order a replacement clamp if necessary.

Trade Name

Neptune 2 Ultra Rover

Recall Posting Date

2009/10/26

Manufacturer

Stryker Instruments

Recall Start Date

2009/10/06

Recall Number

51120

Hazard Classification

Type II

Model or Catalog #

0702-001-000

Lot or Serial #

>10 Numbers, Contact Manufacturer

Reason for Recall

The company has become aware that there is the potential that over time, a buildup of surgical waste on the receptacle bearing surfaces may increase the force required to rotate the suction manifold. If the force becomes too high the manifold cannot be rotated - therefore it cannot be inserted or removed. Once this occurs there will be no vacuum applied to the suction manifold so the primary function of the affected rover canister is lost.

Trade Name

OneTouch SureStep Test Strips

Recall Posting Date

2009/12/21

Manufacturer

Lifescan Inc.

Recall Start Date

2009/09/24

Recall Number

51926

Hazard Classification

Type III

Model or Catalog #

Part # 010-665

Lot or Serial #

2749789

Reason for Recall

Expired OneTouch SureStep Test Strips (lot#274789) were shipped to four Canadian wholesalers.

Trade Name

Oxidase Touch Sticks

Recall Posting Date

2009/12/07

Manufacturer

Oxoid Limited

Recall Start Date

2009/07/07

Recall Number

51737

Hazard Classification

Type II

Model or Catalog #

BR0064A

Lot or Serial #

702079

Reason for Recall

May produce weak positive or false negative results.

Trade Name

Periarticular Locking Plate System

Recall Posting Date

2009/11/23

Manufacturer

Zimmer Inc.

Recall Start Date

2009/10/20

Recall Number

51408

Hazard Classification

Type III

Model or Catalog #

00-2357-009-06

Lot or Serial #

60594607

Reason for Recall

This action is being conducted because the part number on the locking plate (Zimmer Periarticular Locking Plate System distal lateral tibial plate) is incorrect. The part was etched as '2357-09-07', when it should have been etched '2357-09-06'.

Trade Name

Power Cord Component Of Sesmoid Plasty

Recall Posting Date

2009/12/07

Manufacturer

Zimmer CAS

Recall Start Date

2009/11/05

Recall Number

51683

Hazard Classification

Type II

Model or Catalog #

500.923 SUB COMP 200.301

Lot or Serial #

SP-122, SP-197

Reason for Recall

1. Female receptacle end: the terminal contact are not sufficiently recessed and protected from access. 2. The cable portion is not certified North America. 3. The male plug that plug to the power supply mains is missing a label.

Trade Name

pRK(Rabbit Kidney)

Recall Posting Date

2009/11/09

Manufacturer

Diagnostic Hybrids, Inc.

Recall Start Date

2009/01/21

Recall Number

51217

Hazard Classification

Type III

Model or Catalog #

48-0600

Lot or Serial #

480109

Reason for Recall

The Rabbit Kidney Culture(pRK), which consisted of a monolayer culture of rabbit kidney cells used to grow viruses from a patient specimen in order to detect or identify the virus, appeared to also contain another type of cells.

Trade Name

Pronto-Short Extraction Catheter

Recall Posting Date

2009/12/21

Manufacturer

Vascular Solutions, Inc.

Recall Start Date

2009/11/20

Recall Number

51819

Hazard Classification

Type II

Model or Catalog #

N/A

Lot or Serial #

Lot 544202, Exp. 11-2009, Lot 545693, Exp. 05-2010, Lot 546614, Exp. 09-2010

Reason for Recall

The expiration date of the sterile pouched guidewire was not considered when expiration dating was calculated for the finished device. Cannot assure sterility or function of the guidewire beyond its expiration date.

Trade Name

Quantiferon-TB Gold In-Tube

Recall Posting Date

2009/10/12

Manufacturer

Cellestis Ltd.

Recall Start Date

2009/09/01

Recall Number

50725

Hazard Classification

Type III

Model or Catalog #

N/A

Lot or Serial #

A090504Z

Reason for Recall

It was observed that there were a higher than expected number of false positive results with lot A090504Z and the presence of higher levels of endotoxins was found.

Trade Name

Rapid Eric Electronic Compendium

Recall Posting Date

2009/12/21

Manufacturer

Remel Inc.

Recall Start Date

2009/10/30

Recall Number

51669

Hazard Classification

Type I

Model or Catalog #

RE8323600

Lot or Serial #

1096277

Reason for Recall

Error limited to the Rapid Yeast Plus Database regarding differentiation of C. albicans from C. dubliniensis potentially leading to false ID of isolate.

Trade Name

Recon Plate 8 X 9mm, 3.5mm

Recall Posting Date

2009/11/23

Manufacturer

Smith & Nephew, Inc.

Recall Start Date

2009/10/14

Recall Number

51369

Hazard Classification

Type III

Model or Catalog #

7114-0108

Lot or Serial #

L06MT04447, L08ET19936

Reason for Recall

Smith & Nephew was made aware that all parts were missing the laser etching as identification information.

Trade Name

Reflex Hybrid Screw Extractor Inner Shaft

Recall Posting Date

2009/11/23

Manufacturer

Stryker Spine SAS

Recall Start Date

2009/10/13

Recall Number

51370

Hazard Classification

Type II

Model or Catalog #

48511905B, 48511905D

Lot or Serial #

All lots

Reason for Recall

The Reflex Hybrid Screw Extractor Inner Shaft was reported to fail at the threaded tip and fracture in the head of the screw. There had been reports of the threaded tip of the inner shaft being left in the screw due to the surgeon being unable to remove the screw. There had also been reports of damage to the screw and/or the plate while attempting to remove the screw.

Trade Name

Removable Magnet Hires 90K

Recall Posting Date

2009/12/07

Manufacturer

Advanced Bionics, LLC

Recall Start Date

2009/08/25

Recall Number

51652

Hazard Classification

Type II

Model or Catalog #

N/A

Lot or Serial #

N/A

Reason for Recall

Advanced Bionics (AB) is notifying all surgeons, clinicians and patients that the removable magnet component of the HiRes 90k cochlear implant (model no. CI-1400-01 and CI-1400-02H) is susceptible to corrosion. The affected units should be monitored and replaced if necessary.

Trade Name

Remstar M Series Heated Humidifier

Recall Posting Date

2009/12/07

Manufacturer

Respironics Inc.

Recall Start Date

2009/11/20

Recall Number

50202

Hazard Classification

Type II

Model or Catalog #

1049109, 1049110, 1049124, 10499110, 1051157, 1051158, R1049109, R1049110, U1049109, U1049110

Lot or Serial #

>10 Numbers, Contact Manufacturer

Reason for Recall

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

Trade Name

Renegade Fiber Braided Microcatheter

Recall Posting Date

2009/10/12

Manufacturer

Boston Scientific Cork Ltd.

Recall Start Date

2009/08/26

Recall Number

50941

Hazard Classification

Type II

Model or Catalog #

18-257, 18-259

Lot or Serial #

>100 Numbers, Contact Manufacturer

Reason for Recall

Sterile barrier in the packaging of affected product may be compromised. Pouch seal (top seal) may be breached.

Trade Name

RET-Search II

Recall Posting Date

2009/12/07

Manufacturer

Sysmex Reagents America

Recall Start Date

2009/11/03

Recall Number

51623

Hazard Classification

Type II

Model or Catalog #

RED-700A

Lot or Serial #

ZY9021

Reason for Recall

Several boxes of RET-Search II (Red-700A) manufactured on July 15, 2009 had an incorrect bar code label applied to the product box. The bar code label identified the product as stromatolyser-NR with the same lot number and expiration date. The box contains a reagent bottle and dye pouch, both of which were correctly labelled, and the contents of the bottle and dye pouch are of the proper chemical composition for RET-Search II and passed all in-process and final inspection test criteria.

Trade Name

Revlite

Recall Posting Date

2009/11/09

Manufacturer

Hoya Conbio

Recall Start Date

2009/03/31

Recall Number

49248

Hazard Classification

Type III

Model or Catalog #

N/A

Lot or Serial #

RL-1094

Reason for Recall

Advisory letter was sent to customers of Revlite System with Revision E1 software, declaring that if PTP keypad is pressed while the wavelength window is green, the system may not complete change to new wavelength as requested.

Trade Name

Revolution Centrifugal Blood Pump

Recall Posting Date

2009/10/26

Manufacturer

Sorin Group Italia S.R.L.

Recall Start Date

2009/09/23

Recall Number

51015

Hazard Classification

Type II

Model or Catalog #

50300700

Lot or Serial #

0905220164, 0906240184

Reason for Recall

Sorin Group Italia has recently identified a weakness in the plastic packaging tray used for the Revolution Centrifugal Blood Pump that might lead the packaging tray to crack. Cracks in the packaging tray can compromise the product sterility.

Trade Name

Sarns Disposable Centrifugal Pump

Recall Posting Date

2009/10/26

Manufacturer

Terumo Cardiovascular System Corporation

Recall Start Date

2009/07/06

Recall Number

51040

Hazard Classification

Type II

Model or Catalog #

164275

Lot or Serial #

KN10, KP08, LA12, LC16, LE15

Reason for Recall

Terumo Cardiovascular Systems has received three reports of tubing disconnecting from the pump inlet of the Sarns Disposable Centrifugal Pump during cardiopulmonary bypass.

Trade Name

Sarns Disposable Centrifugal Pump

Recall Posting Date

2009/10/26

Manufacturer

Termo Cardiovascular System Corporation

Recall Start Date

2009/07/14

Recall Number

51040

Hazard Classification

Type II

Model or Catalog #

164275

Lot or Serial #

KN10, KP08, LA12, LC16, LE15

Reason for Recall

Tubing disconnecting from the pump inlet of the disposable centrifugal pump during cardiopulmonary bypass.

Trade Name

Sequencer For Mosaiq

Recall Posting Date

2009/12/07

Manufacturer

Impac Medical Systems Inc.

Recall Start Date

2009/10/16

Recall Number

51821

Hazard Classification

Type II

Model or Catalog #

N/A

Lot or Serial #

Mosaiq 1.40 (All Builds), Mosaiq 1.41 (All Builds), Mosaiq 1.50
(All Builds), 1.60 (Up To, Including T2SP4), 2.00 (All Builds)

Reason for Recall

Consolidated field sequencing (CFS) feature not working properly as X2 jaw moved when only the X1 jaw should have been moving.

Trade Name

Signa HDE 1.5T MRI System - Magnet

Recall Posting Date

2009/12/07

Manufacturer

GE Healthcare Japan Corporation

Recall Start Date

2009/11/05

Recall Number

51766

Hazard Classification

Type II

Model or Catalog #

M3335SE

Lot or Serial #

HDMR2675, 9948YR1,10833YR2, 11827YR3, 8704YR9, 10685YR6, 7964YR0, 10023YR0

Reason for Recall

Use of CADstream with "pure" software for Dynamic MRI imaging may require a modification to the study preference settings to present colour overlays equivalent to non-pure studies.

Trade Name

Siregraph CF

Recall Posting Date

2009/12/21

Manufacturer

Siemens AG

Recall Start Date

2009/10/08

Recall Number

51376

Hazard Classification

Type III

Model or Catalog #

04 98 717

Lot or Serial #

1987, 3089

Reason for Recall

The potential hazard of fingers or hands getting caught exists when the patient holds on to the tomographic rod between the column/tube assembly and the spotfilm device.

Trade Name

Speedlink 5.5 Transverse Connector

Recall Posting Date

2009/10/12

Manufacturer

Zimmer Spine Austin, Inc.

Recall Start Date

2009/09/22

Recall Number

50964

Hazard Classification

Type III

Model or Catalog #

1302-55M

Lot or Serial #

55QJ

Reason for Recall

This action is being conducted because a small quantity of titanium alloy was discovered to have a discrepancy from the alloying process at another manufacturer. Alloy segregation can affect material strength. It has been suggested that the metal used to manufacture parts from lot 55QJ may have a similar problem, though testing has not shown this.

Trade Name

Staphytect Plus/Dryspot, Test Kits

Recall Posting Date

2009/12/07

Manufacturer

Remel Europe Ltd.

Recall Start Date

2009/07/09

Recall Number

50862

Hazard Classification

Type II

Model or Catalog #

DR0100M, DR0850M

Lot or Serial #

J577910, J055610, J539110, J610610

Reason for Recall

A potential for false positive reactions with some non staphylococcus aureus strains.

Trade Name

Steinmann Pin

Recall Posting Date

2009/11/23

Manufacturer

Zimmer Inc.

Recall Start Date

2009/10/23

Recall Number

51411

Hazard Classification

Type III

Model or Catalog #

18700259

Lot or Serial #

61211489

Reason for Recall

This action is being conducted because packages from the identified lot should contain style 5 (trocar-style three point) Steinmann pins. However, they actually contain style 6 (spade-type diamond point).

Trade Name

Steris Harmony LL500/700 Surgical Light

Recall Posting Date

2009/10/12

Manufacturer

Steris Corporation

Recall Start Date

2009/09/14

Recall Number

50864

Hazard Classification

Type III

Model or Catalog #

YG18568

Lot or Serial #

>10 Numbers, Contact Manufacturer

Reason for Recall

A welded seam at the joint of the spring-loaded arm of the surgical light may brake and the light head may become disengaged and fall.

Trade Name

Streamlab Analytical Workcell

Recall Posting Date

2009/10/12

Manufacturer

Siemens Healthcare Diagnostics Products GMBH

Recall Start Date

2009/09/09

Recall Number

50779

Hazard Classification

Type III

Model or Catalog #

Workcell

Lot or Serial #

N/A

Reason for Recall

Customer complaints regarding Dimension Vista Systems connected to a Streamlab Analytical Workcell where it has been observed on rare occasions an intermittent low result.

Trade Name

Synex II System - Central Body

Recall Posting Date

2009/10/12

Manufacturer

Synthes (Canada) Ltd.

Recall Start Date

2009/09/23

Recall Number

50981

Hazard Classification

Type II

Model or Catalog #

04.808.001, 04.808.002, 04.808.003, 04.808.004, 04.808.005, 04.808.006, 04.808.007, 04.808.008, 04.808.009, 04.808.010, 04.808.011

Lot or Serial #

All Lot Numbers

Reason for Recall

Synthes (Canada), Ltd. was notified by their supplier, Synthes (USA), of six complaints reported outside the US associated with Synex II Implant (Central Body) which fully or partially collapsed in the original implant position after a period of six to fifteen months post operatively.

Trade Name

Synex II System - Central Body
Updated recall # 50981 previously posted on 2009-10-12.

Recall Posting Date

2009/11/23

Manufacturer

Synthes (Canada) Ltd.

Recall Start Date

2009/09/23

Recall Number

50981

Hazard Classification

Type I

Model or Catalog #

04.808.001, 04.808.002, 04.808.003, 04.808.004, 04.808.005, 04.808.006, 04.808.007, 04.808.008, 04.808.009, 04.808.010, 04.808.011

Lot or Serial #

All lots

Reason for Recall

Synthes (Canada), Ltd. was notified by their supplier, Synthes (USA), of six complaints reported outside the US associated with Synex II Implant (Central Body) which fully or partially collapsed in the original implant position after a period of six to fifteen months post operatively.

Trade Name

Syngo Dynamics C.S.A.N.-5.X,6.X,7.0

Recall Posting Date

2009/11/09

Manufacturer

Siemens Medical Solutions USA, Inc.

Recall Start Date

2009/04/30

Recall Number

48348

Hazard Classification

Type III

Model or Catalog #

100 90 480

Lot or Serial #

92241, 95243, 93477, 95071, 95248

Reason for Recall

To inform customers about a potential issue, when receiving the multiple PSV measurements from some ultrasound systems, the absolute value is not being used.

Trade Name

Syngo Imaging XS

Recall Posting Date

2009/11/09

Manufacturer

Siemens AG

Recall Start Date

2009/10/13

Recall Number

51220

Hazard Classification

Type III

Model or Catalog #

104 96 279

Lot or Serial #

1225, 1532, 1533

Reason for Recall

A potential of a single image of a series is displayed "distorted" after loading to a viewing application.

Trade Name

Syngo Imaging XS

Recall Posting Date

2009/11/09

Manufacturer

Siemens AG

Recall Start Date

2009/10/13

Recall Number

51221

Hazard Classification

Type III

Model or Catalog #

075 020 29

Lot or Serial #

14630

Reason for Recall

Potential loss of single image data of prior examinations when archived to network-attached storage (NAS) or hierarchical storage management (HSM).

Trade Name

Systeme PhD EIA/IFA (cat# 426-0246)

Recall Posting Date

2009/11/09

Manufacturer

Bio-Rad Laboratories Diagnostics Group

Recall Start Date

2009/10/13

Recall Number

51252

Hazard Classification

Type III

Model or Catalog #

4226-0228, 426-0246

Lot or Serial #

N/A

Reason for Recall

Results passed on integrating lab systems may be erroneous when using competitive tests, if they are located outside of the standard range.

Trade Name

TECNIS 1-Piece Posterior Chamber IOL

Recall Posting Date

2009/12/21

Manufacturer

Advanced Medical Optics, Inc.

Recall Start Date

2009/11/10

Recall Number

51829

Hazard Classification

Type II

Model or Catalog #

ZCB00

Lot or Serial #

N/A

Reason for Recall

The TECNIS 1-Piece Intraocular Lenses (IOLS) are being recalled because the haptics of some TECNIS 1-Piece IOLS (model ZCB00) have adhered to the lens optic after insertion into the eye. This situation can lead to additional manipulation to separate the haptics from the optic during surgery which could lead to an injury.

Trade Name

Tg Gen.2 (Thyroglobulin) Assay

Recall Posting Date

2009/12/07

Manufacturer

Roche Diagnostics GMBH

Recall Start Date

2009/11/12

Recall Number

51712

Hazard Classification

Type II

Model or Catalog #

5118921190

Lot or Serial #

155166

Reason for Recall

The current lot #155166 of TG Gen.2 (Thyroglobulin) Assay shows a premature ageing effect which leads to a positive bias of approximately 1ng/ml TG when used in combination with all current lots # 151605, 152737, 155488 and 157297 of elecsys thyroglobulin calibrator. The manufacturer has determined that customers should not use it for this purpose anymore.

Trade Name

Therascreen K-Ras Mutation Kit

Recall Posting Date

2009/11/23

Manufacturer

DXS Ltd.

Recall Start Date

2009/09/23

Recall Number

50937

Hazard Classification

Type III

Model or Catalog #

KR-41

Lot or Serial #

DK146-01, DK149-01

Reason for Recall

The mixed standard component of the Therascreen Mutation Kit may sporadically generate out-of-range high results when tested with the control assay.

Trade Name

TheraScreen K-Ras Mutation Kit

Recall Posting Date

2009/11/09

Manufacturer

Roche Diagnostics GMBH

Recall Start Date

2009/09/23

Recall Number

50937

Hazard Classification

Type III

Model or Catalog #

5366259190

Lot or Serial #

DK146-01, DK149-01

Reason for Recall

The mixed standard component of the Therascreen Mutation may sporadically generate out-of-range high results when tested with the control assay.

Trade Name

Titan Anchor Accessory Kits

Recall Posting Date

2009/11/23

Manufacturer

Medtronic Inc.

Recall Start Date

2009/10/27

Recall Number

51434

Hazard Classification

Type II

Model or Catalog #

3550-39

Lot or Serial #

>100 Numbers, Contact Manufacturer

Reason for Recall

Medtronic has initiated a field action to notify managing and implanting physicians of Medtronic per cutaneous leads for spinal cord stimulation of the potential for separation of the titanium insert from the silicone portion of the Titan Anchor, model 3550-39. If this occurs it may result in lead migration and compromised therapy for the patient.

Trade Name

Triage Tox Drug Screen PN 94400

Recall Posting Date

2009/12/21

Manufacturer

Biosite Incorporated

Recall Start Date

2009/05/28

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.

Trade Name

Trinest Microplate Incubator And Shaker

Recall Posting Date

2009/11/23

Manufacturer

Wallac OY

Recall Start Date

2009/10/21

Recall Number

51375

Hazard Classification

Type II

Model or Catalog #

1296-0050

Lot or Serial #

12960024, 12960028

Reason for Recall

The protective coating around certain electrical wires inside the Trinest Incubator/Shaker may be worn out due to contact with a round aluminum part rotating during the continuous shaking movement, which would result in a warning message and the instrument would shut down.

Trade Name

Triniclot APPT S, Cat. No. T1202

Recall Posting Date

2009/12/21

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.

Trade Name

Triniclot APTT HS, Product Code T1204

Recall Posting Date

2009/12/21

Manufacturer

Trinity Biotech PLC

Recall Start Date

2009/05/24

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.

Trade Name

Triniclot PT Excel, T1106

Recall Posting Date

2009/12/07

Manufacturer

Trinity Biotech PLC

Recall Start Date

2009/08/06

Recall Number

51651

Hazard Classification

Type III

Model or Catalog #

T1106

Lot or Serial #

S172057

Reason for Recall

Quality control materials not recovering within predefined ranges. Prothrombin times are prolonged in lot S172057 by about 1.2 seconds.

Trade Name

Twist Drill 1.1x50mm 3.5mm stop

Recall Posting Date

2009/12/21

Manufacturer

Walter Lorenz Surgical, Inc. Also trading as: Biomet Microfixation

Recall Start Date

2009/11/18

Recall Number

51857

Hazard Classification

Type III

Model or Catalog #

01-7141

Lot or Serial #

537407, 536306, 535933

Reason for Recall

Three manufacturing lots of Twist Drill 1.1 x 50mm, 3.5mm stop with J notch, part number 01-7141 were packaged and distributed without the instructions for use.

Trade Name

Uric Acid Assay

Recall Posting Date

2009/10/12

Manufacturer

Randox Laboratories Ltd.

Recall Start Date

2009/09/15

Recall Number

50863

Hazard Classification

Type III

Model or Catalog #

UA233

Lot or Serial #

154107

Reason for Recall

UA233, batch 154107, was incorrectly labelled with an expiry date of August 28, 2011. The correct expiry date is November 29, 2010.

Trade Name

Varis 4D Integrated Treatment Console

Recall Posting Date

2009/12/07

Manufacturer

Varian Medical Systems, Inc.

Recall Start Date

2009/10/16

Recall Number

51774

Hazard Classification

Type II

Model or Catalog #

8.0.12, 8.0.23 SP2 , 8.1 SP2, 8.1.1.3, 8.1.1.4,
8.1.2, 8.1.3, 8.1.4, 8.3, 8.6, 8.6.1, 8.6.2,
8.8.0, H51

Lot or Serial #

>10 Numbers, Contact Manufacturer

Reason for Recall

Malfunction when adding CBCT image. Present software has ability to acquire gantry angle when 'treatment approval enforced' and/or 'allow only couch parameter (vert, long, lat) editing & acquiring for approved plans' selected in treatment administration. Therapists can acquire gantry angle into plan, even without system rights to acquire gantry angle. Patient treated with wrong gantry angles one day.

Trade Name

Vertical Surgical Table

Recall Posting Date

2009/12/07

Manufacturer

Stryker Communications

Recall Start Date

2009/11/06

Recall Number

51664

Hazard Classification

Type II

Model or Catalog #

0788-100-000, 0788-100-001, 0788-100-0015

Lot or Serial #

All Lot Numbers

Reason for Recall

The table may experience involuntary movement as a result of fluid intrusion. This hazard can arise especially when the table is in the trendelenburg or anti-trendelenburg position allowing fluids, such as saline or water, to enter the table column.

Trade Name

Vitrax II (Sodium Hyaluronate)

Recall Posting Date

2009/12/21

Manufacturer

Advanced Medical Optics, Inc.

Recall Start Date

2009/11/06

Recall Number

51828

Hazard Classification

Type II

Model or Catalog #

VT465

Lot or Serial #

>10 Numbers, Contact Manufacturer

Reason for Recall

The Vitrax II product is being recalled because during routine stability testing, it was discovered that a sample tested at the three month time point had a ph value of 7.70 which exceeded the ph specification range of 6.8 to 7.5 resulting in a lab investigation. The investigation revealed that some units from different lots post ETO sterilization have a ph greater than the upper ph limit of 7.5. The highest value was found to be 8.29.

Trade Name

Von Willebrand Reagent

Recall Posting Date

2009/11/09

Manufacturer

Siemens Healthcare Diagnostics Products GMBH

Recall Start Date

2009/10/13

Recall Number

51218

Hazard Classification

Type III

Model or Catalog #

OUBD23

Lot or Serial #

537675, 537682

Reason for Recall

An incorrect sensitivity limit has been assigned which is reagent specific and could cause results to be erroneously elevated between 17% and 40%.

Trade Name

Wallach LL 100 Cryosurgery Device

Recall Posting Date

2009/11/09

Manufacturer

Cooper Surgical Inc. Also Trading As Wallach Surgical Devices

Recall Start Date

2009/09/19

Recall Number

51212

Hazard Classification

Type II

Model or Catalog #

REF-900000-900002, REF-900034, REF-900509-5

Lot or Serial #

>10 Numbers, Contact Manufacturer

Reason for Recall

Under certain circumstances a restriction of the flow of carbon dioxide gas within the handle may result in a less than optimal temperature delivery to the treatment site.

Trade Name

Washer Disinfectors

Recall Posting Date

2009/12/21

Manufacturer

Getinge Disinfection AB

Recall Start Date

2009/04/23

Recall Number

51707

Hazard Classification

Type II

Model or Catalog #

9027, 9100, 9120, 9125, 9128

Lot or Serial #

>10 Numbers, Contact Manufacturer

Reason for Recall

The ground wire of the supply transformer exhibited signs of high resistance in a complaint and may give high eddy currents.

Trade Name

XIO Radiation Treatment Planning System

Recall Posting Date

2009/11/09

Manufacturer

Computerized Medical Systems, Inc. (DBA CMS, Inc.) The Elekta Group

Recall Start Date

2009/10/13

Recall Number

51241

Hazard Classification

Type II

Model or Catalog #

N/A

Lot or Serial #

Release 4.3.0 & Higher

Reason for Recall

If an auto port is created for a beam on focal, the plan sent to XIO and the beam edited, it is possible the graphic beam representation and dose display do not agree with the edited field on the text page.

Trade Name

XTEN, HLX 3004, HLX 3005

Recall Posting Date

2009/10/26

Manufacturer

Maquet S.A.

Recall Start Date

2009/09/24

Recall Number

50977

Hazard Classification

Type III

Model or Catalog #

ARD 567801093, ARD 567801094, ARD 567910901, ARD 567910910

Lot or Serial #

>10 Numbers, Contact Manufacturer

Reason for Recall

Excessive strain may cause impairment of the interlocking between the arm joint and surgical light. Inappropriate handling may cause a crack on the front pivot of the Acrobat 2000 spring arm.