Health Canada
www.hc-sc.gc.ca
Common menu bar links
Institutional links
Drugs and Health Products
Medical Device Recall Listings - Sorted by Trade Name
(From July 2009 - September 2009)
- Trade Name
- 2.0 Compression L Plate, 6 Hole Left
- Recall Posting Date
- 2009/08/03
- Manufacturer
- Walter Lorenz Surgical, Inc. Also Trading As: Biomet Microfixation
- Recall Start Date
- 2009/06/29
- Recall Number
- 49529
- Hazard Classification
- Type III
- Model or Catalog #
- 62-5442
- Lot or Serial #
- 24180
- Reason for Recall
- The possibility of part number 62-5442 2.0 Compression l Plate, 6 Holes Left package may have contained a similar part 62-5441 2.0 Compression l Plate Right instead of the 62-5442 part.
Top of Page- Trade Name
- 3.0T Signa HDX MR System - Hardware
- Recall Posting Date
- 2009/08/31
- Manufacturer
- GE Healthcare
- Recall Start Date
- 2009/08/04
- Recall Number
- 48251
- Hazard Classification
- Type II
- Model or Catalog #
- M3335PF
- Lot or Serial #
- WB0029
- Reason for Recall
- Contrast-enhanced 3D TOF MRA peripheral run-off studies show significant vasculature shading and right/left asymmetry, which could subject the patient to additional non-invasive examinations.
- Trade Name
- 4.0mm Direct Measuring Gauge
- Recall Posting Date
- 2009/08/17
- Manufacturer
- Smith & Nephew, Inc.
- Recall Start Date
- 2009/07/15
- Recall Number
- 49969
- Hazard Classification
- Type II
- Model or Catalog #
- 71117083
- Lot or Serial #
- All Prior To 2009 Excluding 08KM20464 & Excluding 08KM12521
- Reason for Recall
- The markings on the gauge are incorrect. The discrepancy may not be apparent to the user and could result in incorrect placement of the K-wire.
- Trade Name
- '903' Newborn Screening Cards
- Recall Posting Date
- 2009/08/03
- Manufacturer
- Whatman, Part Of GE Healthcare
- Recall Start Date
- 2009/05/27
- Recall Number
- 49796
- Hazard Classification
- Type III
- Model or Catalog #
- N/A
- Lot or Serial #
- Lot # 6828908, 6829008, 6818808
- Reason for Recall
- Partial or complete detachment of the '903' paper from the demographic portion of the '903' newborn screening card may occur, which may necessitate a re-screening.
- Trade Name
- A) 0.8% Resolve Panel A Reagent RBC
B) 0.8% Resolve Panel B Reagent RBC
C) 0.8% Resolve Panel C Reagent RBC - Recall Posting Date
- 2009/07/20
- Manufacturer
- Ortho-Clinical Diagnostics Inc.
- Recall Start Date
- 2009/06/11
- Recall Number
- 49448
- Hazard Classification
- Type III
- Model or Catalog #
- A) 6902317
B) 6902318
C) 6902319 - Lot or Serial #
- A) VRA124, VRA125, VRA126, VRA127, VRA128
B) VRB123, VRB124, VRB125, VRB126, VRB127
C) VRC123, VRC125, VRC126, VRC127 - Reason for Recall
- OCD has received complaints from customers reporting that caps on several reagent red blood cell product vials are too tight. In some of those complaints, customers reported breaking or cracking of the glass reagent vial while attempting to unscrew the cap prior to use.
- Trade Name
- A) Advia Centaur System Software Class 3
B) Advia Centaur XP System Software Class 2
C) Advia Centaur XP System Software Class 4
D) Advia Centaur XP System Software Class 3
E) Advia Centaur System Software Class 2
F) Advia Centaur System Software Class 4 - Recall Posting Date
- 2009/09/28
- Manufacturer
- Siemens Healthcare Diagnostics Inc.
- Recall Start Date
- 2009/08/28
- Recall Number
- 50676
- Hazard Classification
- Type III
- Model or Catalog #
- A) 04911855, 078-A001-14
B) 078-A010-07, 09066916
C) 078-A010-07, 09066916
D) 078-A010-07, 09066916
E) 04911855, 078-A001-14
F) 04911855, 078-A001-14 - Lot or Serial #
- A) Version 4.0 Software
B) Version 6.0 Software
C) Version 6.0 Software
D) Version 6.0 Software
E) Version 4.0 Software
F) Version 4.0 Software - Reason for Recall
- Internal testing conducted by the manufacturer has determined that Advia Centaur V. 4.0 and Advia Centaur XP V. 6.0 system software is missing range flags and no reflex testing after restoring definition files and reflex for Hepatitis B surface antigen (HBSAG) is not updated.
- Trade Name
- A) Advia Centaur
B) Advia Centaur XP - Recall Posting Date
- 2009/07/06
- Manufacturer
- Siemens Healthcare Diagnostics Inc.
- Recall Start Date
- 2009/06/10
- Recall Number
- 49196
- Hazard Classification
- Type III
- Model or Catalog #
- A) 07566733
B) 07566733 - Lot or Serial #
- A) > 10, Contact Manufacturer
B) > 10, Contact Manufacturer - Reason for Recall
- Manufacturer has determined that specific lots have shown decreased specificity for negative populations. The positive bias of approximately 0.3 index units and specimens with 0.5 to 0.8 index may be incorrectly identified as reactive for total antibodies to the core antigen of Hepatitis B virus.
- Trade Name
- A) Advia Centaur
B) Advia Centaur XP
Updated recall # 49196 previously posted on 2009-07-06. - Recall Posting Date
- 2009/08/17
- Manufacturer
- Siemens Healthcare Diagnostics Inc.
- Recall Start Date
- 2009/06/10
- Recall Number
- 49196
- Hazard Classification
- Type III
- Model or Catalog #
- A) 07566733
B) 07566733 - Lot or Serial #
- A) 37820027, 38129027, 38386027, 39195027
B) 37820027, 38129027, 38386027, 39195027 - Reason for Recall
- Manufacturer has determined that specific lots have shown decreased specificity for negative populations. The positive bias of approximately 0.3 index units and specimens with 0.5 to 0.8 index may be incorrectly identified as reactive for total antibodies to the core antigen of Hepatitis B virus.
- Trade Name
- A) Aeroset System - Total Bilirubin Assay
B) Architect System - Total Bilirubin Assay - Recall Posting Date
- 2009/08/03
- Manufacturer
- Abbott Laboratories Diagnostic Division
- Recall Start Date
- 2009/07/10
- Recall Number
- 49921
- Hazard Classification
- Type III
- Model or Catalog #
- A) 6L45-20, 6L45-40
B) 6L45-20, 6L45-40 - Lot or Serial #
- A) All Lots
B) All Lots - Reason for Recall
- Abbott Clinical Chemistry Total Bilirubin (6L45) demonstrated under-recovery on one clinical neonatal specimen resulting in a value less than the linear limit. A linear high flag (LH) was therefore not generated. The specimen was known to have a bilirubin concentration higher than the linear limit.
- Trade Name
- A) Alaris Patient Care System-ID Module
B) Alaris Patient Care System-Server Module
C) Alaris Patient Care System-PCA Module
D) Alaris Patient Care System-ENTDAL CO2
E) Alaris Patient Care System-Pump
F) Alaris Patient Care System-SPO2 Module
G) Alaris Patient Care System-Syringe Pump - Recall Posting Date
- 2009/08/17
- Manufacturer
- Cardinal Health
- Recall Start Date
- 2009/07/28
- Recall Number
- 49979
- Hazard Classification
- Type II
- Model or Catalog #
- A) 8600, 8650
B) 8015
C) 8120
D) 8300
E) 8000APM, 8100LVP
F) 8210, 8220
G) 8110 - Lot or Serial #
- A) > 10 Numbers, Contact Manufacturer
B) > 10 Numbers, Contact Manufacturer
C) > 10 Numbers, Contact Manufacturer
D) > 10 Numbers, Contact Manufacturer
E) > 10 Numbers, Contact Manufacturer
F) > 10 Numbers, Contact Manufacturer
G) > 10 Numbers, Contact Manufacturer - Reason for Recall
- 1) Occluded tubing may cause medication not to be delivered. 2) Misprogrammed infusion caused by ignoring the warning message. 3) Specific ESD protection circuitry may result in an over or under infusion. 4) Certain fluids solidify in the pumping mechanism. 5) IUI connector failure when they become corroded or contaminated.
- Trade Name
- A) Amplilink Software V 3.1.1
B) Amplilink Software V 3.1.2 Build 0502
C) Amplilink Software V 3.2
D) Amplilink Software V 3.2.1
E) Amplilink Software V 3.2.2 - Recall Posting Date
- 2009/07/20
- Manufacturer
- Roche Diagnostics Ltd.
- Recall Start Date
- 2009/06/16
- Recall Number
- 48878
- Hazard Classification
- Type II
- Model or Catalog #
- A) CAT #04807197001
B) CAT #04855094001
C) CAT# 04862392001
D) CAT #05093236001
E) CAT# 05201357001 - Lot or Serial #
- A) All Lots
B) All Lots
C) All Lots
D) All Lots
E) All Lots - Reason for Recall
- While running the AmpliLink software, there are possibilities (under certain circumstances) that an assay is being performed with the test file parameters of another assay.
- Trade Name
- A) Anesthesia Manager
B) PACU Manager
C) Critical Care Manager - Recall Posting Date
- 2009/09/14
- Manufacturer
- Picis Inc.
- Recall Start Date
- 2009/08/10
- Recall Number
- 50507
- Hazard Classification
- Type II
- Model or Catalog #
- A) Model/Catalog #: 4220
B) Model/Catalog #: 4245
C) Model/Catalog #: 1110 - Lot or Serial #
- A) S/W version 7.1
B) S/W version 7.1
C) S/W version 7.1 - Reason for Recall
- A problem may occur when an order of long duration (those continuing for several days) is discontinued. Due to the configuration of the buffer storage in local memory it may not set the status of the future tasks to "done". In this rare instance it will continue to appear on the flowsheet and the pending orders list.
- Trade Name
- A) Aria Software
B) Aria Offline Review Software
Updated recall # 49074 previously posted on 2009-06-22. - Recall Posting Date
- 2009/09/28
- Manufacturer
- Varian Medical Systems, Inc.
- Recall Start Date
- 2009/05/09
- Recall Number
- 49074
- Hazard Classification
- Type II
- Model or Catalog #
- A) 8.1.15, 8.5.11, 8.6.07, HIT
B) 8.1.15, 8.5.11, 8.6.07, HIT - Lot or Serial #
- A) >10 Numbers, Contact Manufacturer
B) >10 Numbers, Contact Manufacturer - Reason for Recall
- An anomaly exists in the software, which leads to a record save fail in the case that a partially treated fraction has zero dose accumulation. If the change to the plan had been to parameters other than dose per fraction, treatment to incorrect volume could result, potentially leading to serious injury.
- Trade Name
- A) BHS 301
B) BHS 202
C) BHS 102
D) BHS 130
E) BHS 301 SCULPTOR
F) BHS 302
G) BHS 135
H) BHS 140 - Recall Posting Date
- 2009/08/03
- Manufacturer
- Body Health S.A.
- Recall Start Date
- 2009/07/01
- Recall Number
- 49781
- Hazard Classification
- Type II
- Model or Catalog #
- A) BHS 301
B) BHS 202
C) BHS 102
D) BHS 130
E) BHS 301 SCULPTOR
F) BHS 302
G) BHS 135
H) BHS 140 - Lot or Serial #
- A) 131108-0471, 131108-0472, 131108-0474
B) 160708-0134, 090408-0090
C) 080408-0082, 080408-0094, 120508-0112, 120508-0113, 120508-0114, 120508-0115, 120508-0107, 120508-0116, 120508-0106
D) 201207-0137
E) 181108-0179
F) 050208-0087
G) 140108-0238
H) 070607-0021 - Reason for Recall
- A notification was sent to the distributor informing them that the medical devices that were sold to them by Body Health S.A. were not licensed in accordance with the medical devices regulations.
- Trade Name
- A) Brainscan Radiotherapy System-Software
B) iPlan RT Dose-Planning Software - Recall Posting Date
- 2009/09/14
- Manufacturer
- Brainlab AG
- Recall Start Date
- 2009/08/12
- Recall Number
- 50497
- Hazard Classification
- Type I
- Model or Catalog #
- A) 20630
B) 20630 - Lot or Serial #
- A) N/A
B) N/A - Reason for Recall
- Failure to apply and verify an adequate jaw-shaped field size and field position at the linac for the used conical collimator(s) or the failure to mount and verify the correct, intended conical collimator may lead to serious injury or death of the patient.
- Trade Name
- A) Brilliance 40/64 Slice CT System
B) Gemini TF PET/CT System - Recall Posting Date
- 2009/08/03
- Manufacturer
- Philips Medical Systems (Cleveland), Inc.
- Recall Start Date
- 2009/07/16
- Recall Number
- 46654
- Hazard Classification
- Type II
- Model or Catalog #
- A) 4550 110 02031
B) 4550 110 09021 - Lot or Serial #
- A) N/A
B) N/A - Reason for Recall
- There is potential for data to be lost during reconstruction of images in which slices can either be disregarded or interleaved based upon their series ID.
- Trade Name
- A) Bypass TGH Kit
B) Valve TGH Kit - Recall Posting Date
- 2009/08/03
- Manufacturer
- Cardinal Health
- Recall Start Date
- 2009/07/13
- Recall Number
- 49952
- Hazard Classification
- Type II
- Model or Catalog #
- A) PC30CG'XXX'
B) PC30VP'XXX' - Lot or Serial #
- A) 870139, 878608, 866059, 874187, 876386, 882391, 888414
B) 878586, 866060, 874182, 874678, 884383 - Reason for Recall
- The unit package seals on the BD 60 ml Luer lock syringes, a component of the Cardinal Health custom sterile packs may have been adversely affected as a result of an issue during the packaging process.
- Trade Name
- A) Cancellous Bone Screws
B) Gap Plate Screw - Recall Posting Date
- 2009/08/03
- Manufacturer
- Howmedica Osteonics Corporation
- Recall Start Date
- 2009/07/03
- Recall Number
- 49712
- Hazard Classification
- Type II
- Model or Catalog #
- A) N/A
B) N/A - Lot or Serial #
- A) > 10 Numbers, Contact Manufacturer
B) > 10 Numbers, Contact Manufacturer - Reason for Recall
- Stryker has become aware that the third party supplier, for material used to manufacture the Cancellous Bone Screws and Gap Plate Screw, did not comply with metallurgical requirements outlined in the ASTM standards for titanium surgical implants. As such, areas of modified material properties may result, which may affect the intended use of the product. Although testing demonstrated the affected lots to have shear strength equivalent to screws manufactured from non-affected material, the potential for variability of the material used in manufacturing the affected lots could compromise the strength.
- Trade Name
- A) Cancellous Bone Screws
B) Gap Plate Screw
Update recall # 49712 previously posted on 2009-08-03. - Recall Posting Date
- 2009/08/17
- Manufacturer
- Howmedica Osteonics Corporation
- Recall Start Date
- 2009/07/03
- Recall Number
- 49712
- Hazard Classification
- Type II
- Model or Catalog #
- A) 2080-0015, 2080-0020, 2080-0025, 2080-0030, 2080-0035, 2080-0040, 2080-0045, 2080-0050, 2080-0055, 2080-0060
B) 2030-6516, 2030-6520, 2030-6525, 2030-6530, 2030-6535, 2030-6540, 2030-6545, 2030-6550, 2030-6555, 2030-6560 - Lot or Serial #
- A) > 10 Numbers, Contact Manufacturer
B) > 10 Numbers, Contact Manufacturer - Reason for Recall
- Stryker has become aware that the third party supplier, for material used to manufacture the Cancellous Bone Screws and Gap Plate Screw, did not comply with metallurgical requirements outlined in the ASTM standards for titanium surgical implants. As such, areas of modified material properties may result, which may affect the intended use of the product. Although testing demonstrated the affected lots to have shear strength equivalent to screws manufactured from non-affected material, the potential for variability of the material used in manufacturing the affected lots could compromise the strength.
- Trade Name
- A) Cell-Dyn 1700 Analyzer/1700CS Analyzer
B) Cell-Dyn 1800 Analyzer - Recall Posting Date
- 2009/07/06
- Manufacturer
- Abbott Laboratories Diagnostic Division
- Recall Start Date
- 2009/06/12
- Recall Number
- 49223
- Hazard Classification
- Type III
- Model or Catalog #
- A) 03H53-01, 03H57-01, 03H57-03
B) 07H77-01 - Lot or Serial #
- A) N/A
B) N/A - Reason for Recall
- Use of the current available version of the 10ml diluent syringe, part number (p/n) 9212368 (without spacer), on a Cell-Dyn 1700, Cell-Dyn 1700cs, or Cell-Dyn 1800 with a die-cast syringe drive may result in diluent leakage during initialization of the analyzer, resulting in "diluent empty" faults.
- Trade Name
- A) Central Venous Catheterization Set
B) Central Venous Catheter - Recall Posting Date
- 2009/08/03
- Manufacturer
- Arrow International, Inc.
- Recall Start Date
- 2009/05/11
- Recall Number
- 48476
- Hazard Classification
- Type II
- Model or Catalog #
- A) CS-12123-E, CS-15123-E
B) MC-12123, MC-15123 - Lot or Serial #
- A) > 10 Numbers, Contact Manufacturer
B) > 10 Numbers, Contact Manufacturer - Reason for Recall
- The catheters have a deformity in the lumen at the catheter juncture hub which can cause difficulty in passing the spring wire guide through the hub of the catheter or removing the spring wire guide from the catheter.
- Trade Name
- A) CoaguCheck XS Instrument
B) CoaguCheck XS Plus Monitor - Recall Posting Date
- 2009/08/31
- Manufacturer
- Roche Diagnostics GMBH
- Recall Start Date
- 2009/08/13
- Recall Number
- 50168
- Hazard Classification
- Type II
- Model or Catalog #
- A) 3666794
B) 04800842190 - Lot or Serial #
- A) All Serial Numbers
B) All Serial Numbers - Reason for Recall
- The cleaning procedure as recommended in the instrument's manual can lead to falsely elevated PT/INR results. This procedure may include liquid into the meters which can lead to the creation of electrical bridging between heater pins.
- Trade Name
- A) Dyonics Powermax Elite Motor Drive Unit
B) Dyonics Mini-Motor Drive Unit
C) Dyonics Power Ultralight Motor Drive - Recall Posting Date
- 2009/08/31
- Manufacturer
- Smith & Nephew, Inc., Endoscopy Division
- Recall Start Date
- 2009/07/26
- Recall Number
- 50208
- Hazard Classification
- Type III
- Model or Catalog #
- A) 72200616
B) 7205357
C) 7205971 - Lot or Serial #
- A) N/A
B) N/A
C) N/A - Reason for Recall
- A customer has reported that pieces of tissue remained within a Smith & Nephew shaver motor drive unit (hand piece) after the cleaning process had been completed prior to sterilization.
- Trade Name
- A) Expo Angiographic Catheters, amplatz
B) Impulse Angiographic Catheter, amplatz
C) Impulse Angiographic Catheter, brachial
D) Impulse Angiographic Catheters,femoral
E) Impulse Angiographic Catheters,internal
F) Impulse Angiographic Catheters,left
G) Impulse Angiographic Catheters, multi
H) Impulse Angiographic Catheters, radial
I) Impulse Angiographic Catheters, ventri.
J) Impulse Angiographic Catheters, kimny
K) Impulse Angiographic Catheters, cummings
L) Expo Angiographic Catheters, brachial
M) Expo Aangiographic Catheters, femoral
N) Expo Angiographic Catheters, femoral r.
O) Expo Angiographic Catheters intermal
P) Expo Angiographic Catheters L/R coronar
Q) Expo Angiographic Catheters, multipurpose
R) Expo Angiographic Catheters, ventricular
S) Expo Angiographic Catheters, multipack
T) Expo Angiographic Catheters, kimny famil
U) Expo ANgiographic Catheters, cummings FA
V) Wiseguide Guide Catheters, femoral
W) Wiseguide Guide Catheters, allright
X) Wiseguide Guide Catheters, voda
Y) Wiseguide Guide Catheters, amplatz - Recall Posting Date
- 2009/09/14
- Manufacturer
- Boston Scientific Corporation
- Recall Start Date
- 2009/08/07
- Recall Number
- 50383
- Hazard Classification
- Type II
- Model or Catalog #
- A) 08526-01
B) 16391-100
C) 16391-11
D) 16391-02
E) 16391-201
F) 16391-190
G) 16391-117
H) 16391-174
I) 16391-40
J) 16391-180
K) 16391-203
L) 08526-150
M) 08526-21
N) 08526-01
O) 08526-201
P) 08526-190
Q) 08526-146
R) 08526-40
S) H749085263002
T) 08526-180
U) H749085263031
V) 16320-01
W) 16320-496
X) 16320-230
Y) 16320-103 - Lot or Serial #
- A) N/A
B) N/A
C) N/A
D) N/A
E) N/A
F) N/A
G) N/A
H) N/A
I) N/A
J) N/A
K) N/A
L) N/A
M) N/A
N) N/A
O) N/A
P) N/A
Q) N/A
R) N/A
S) N/A
T) N/A
U) N/A
V) N/A
W) N/A
X) N/A
Y) N/A - Reason for Recall
- Sterile barrier in the packaging may be compromised.
- Trade Name
- A) Gyroscan Intera ACS 1.5 Tesla MR System
B) Intera 1.5T MR Systems - Coils - Recall Posting Date
- 2009/09/14
- Manufacturer
- Philips Medical Systems Nederland B.V.
- Recall Start Date
- 2009/08/14
- Recall Number
- 50406
- Hazard Classification
- Type II
- Model or Catalog #
- A) N/A
B) N/A - Lot or Serial #
- A) 5354, 5220, 5418, 99220, 5572, 5465, 5438
B) 8985, 10236, 8256, 22658, 8672, 8442, 8379, 8240, 10183, 10566 - Reason for Recall
- The combined use of the Synergy Flex-M/Shoulder Coil 1.5T with other coils increases the chance of RF interaction and heating up of the coil. This may result in possible burns of the patient. This applies to all Intera 1.5T and Gyroscan Intera ACS 1.5T MR systems with a Synergy Flex M/Shoulder Coil 1.5T initially delivered as release 5.1.7, 6, 7, 8, 9, or 10.
- Trade Name
- A) Immunocap 250 Specific IGE Control
B) Immunocap 100 Specific IGE Control - Recall Posting Date
- 2009/07/06
- Manufacturer
- Phadia AB
- Recall Start Date
- 2009/03/29
- Recall Number
- 49233
- Hazard Classification
- Type III
- Model or Catalog #
- A) 10-9449-01
B) 10-9449-01 - Lot or Serial #
- A) BNMAX, BNMAY, BNMAZ
B) BNMAX, BNMAY, BNMAZ - Reason for Recall
- Phadia AB, (Sweden) voluntarily recallsImmunoCAP Specific IGE Control (art.no 10-949-01) containing vial lot BNMAX, BNMAY, or BNMAZ using ImmunoCAP Allergen E1. Manufacturer updates information on target range values for one of seven ranges stated in the directions for use. Product is a control sample used by laboratory for internal quality assurance. A new range is established for ImmunoCAP Allergen E1. For some customers the results may be out of range and could result in a quality assurance investigation at the customer's site.
- Trade Name
- A) Innova 4100 IQ - Main Unit
B) Innova 2000 Cardiovascular System - Recall Posting Date
- 2009/08/17
- Manufacturer
- GE Medical Systems SCS
- Recall Start Date
- 2009/07/31
- Recall Number
- 49983
- Hazard Classification
- Type II
- Model or Catalog #
- A) 2335129
B) S1872LC - Lot or Serial #
- A) 417372BU0, 405584BU4, 432687BU2, 406451BU5, 429328BU8, 437542BU4, 398530BU6
B) 409881BU0, 397054BU8, 419496BU5, 427075BU7, 417895BU0 - Reason for Recall
- A potential power supply failure inside the GE equipment cabinet could occur with no warning & prevent x-ray generation & image processing. If this occurs, the system cannot be restarted.
- Trade Name
- A) Innova 4100 IQ - Main Unit
B) Innova 2000 Cardiovascular System - Recall Posting Date
- 2009/08/17
- Manufacturer
- GE Medical Systems SCS
- Recall Start Date
- 2009/07/31
- Recall Number
- 50099
- Hazard Classification
- Type II
- Model or Catalog #
- A) 2335129
B) S1872LC - Lot or Serial #
- A) 417372BU0, 405584BU4, 406451BU5, 398530BU6
B) 397054BU8, 349890BU4, 347469BU9, 419496BU5, 354853BU6, 417895BU0, 364939BU9 - Reason for Recall
- Potential video splitter failure inside GE equipment cabinet could occur with no warning & prevent x-ray image display. System cannot be recovered without service intervention.
- Trade Name
- A) Integrated Power Console (ENT)
B) Integrated Power Console (NT) - Recall Posting Date
- 2009/08/31
- Manufacturer
- Medtronic Xomed
- Recall Start Date
- 2009/07/27
- Recall Number
- 50207
- Hazard Classification
- Type III
- Model or Catalog #
- A) 1898001
B) EC300 - Lot or Serial #
- A) 71358, 71360, 71357, 71361
B) 51033, 51356, 51508 - Reason for Recall
- An error code (code 13) is displayed on some of the consoles when a stylus or EHS hand piece is connected to the integrated power console (IPC) indicating that the hand piece has not been recognized by the console. When this happens the stylus or EHS HP is inoperative.
- Trade Name
- A) Isolex 300I Magnetic Cell Separator
B) Isolex 300 Magnetic Cell Separator - Recall Posting Date
- 2009/07/06
- Manufacturer
- Baxter Healthcare Corporation
- Recall Start Date
- 2009/05/04
- Recall Number
- 48344
- Hazard Classification
- Type II
- Model or Catalog #
- A) 4R9734
B) 4R9734 - Lot or Serial #
- A) All Lots
B) All Lots - Reason for Recall
- HSA used to produce this reagent does not comply with the USP monograph as per what the current labelling and package inserts state. It complies with European pharmacopeia instead.
- Trade Name
- A) I-Stat Kaolin Act Cartridge
B) I-Stat Act Celite Cartridge - Recall Posting Date
- 2009/09/28
- Manufacturer
- Abbott Point Of Care Inc.
- Recall Start Date
- 2009/08/11
- Recall Number
- 50427
- Hazard Classification
- Type II
- Model or Catalog #
- A) 07G81-01, 07G81-02
B) 07G01-01, 07G01-02 - Lot or Serial #
- A) All Lots
B) All Lots - Reason for Recall
- An inconsistency was noted in the i-Stat System manuals regarding the volume of saline used to flush an indwelling line and the volume of blood to be discarded for clearing the line when testing coagulation cartridges.
- Trade Name
- A) Nexgen Rotating Hinge Knee-Femoral Component
B) Nexgen Rotating Hinge Knee-Tibial Component - Recall Posting Date
- 2009/07/06
- Manufacturer
- Zimmer Inc.
- Recall Start Date
- 2009/06/08
- Recall Number
- 49105
- Hazard Classification
- Type II
- Model or Catalog #
- A) 00-5880-014-01, 00-5880-014-02, 00-5880-015-01, 00-5880-015-02, 00-5880-016-01
B) 00-5880-002-00, 00-5880-004-00, 00-5880-005-00, 00-5880-006-00 - Lot or Serial #
- A) 60147327, 60230599, 60137094, 60163665, 60173203, 60144695, 60174823, 60186251, 60141825
B) 60195329, 60160461, 60203906, 60206499, 60180540, 60170823, 60191094 - Reason for Recall
- This action is being conducted because these components are labelled with a ten year expiry period when in fact these components expire five years after manufacture.
- Trade Name
- A) Oximetrix 3 System SO2/CO Computer
B) Lifecare PCA 4100 Plus Infuser
C) Lifecare 5000 Plum Infusion Pump System
D) Plum XL
E) Omni Flow 4000 Plus IV Medication MS
F) Plum XL Micro/Macro With Data Port XLD
G) Plum XL Micro/Macro Infusion (XLM)
H) Plum XL Multiline Infusion Sys. XL3
I) Plum XL 3 Micro/Macro Infusion Sys.XL3M
J) Gemstar Docking Station
K) Lifecare PCA 3 Infusion System
L) Plum A+ Volumetric Infusion Pump
M) Plum A+3 Infusion Pumps - Recall Posting Date
- 2009/09/14
- Manufacturer
- Hospira Inc.
- Recall Start Date
- 2009/08/20
- Recall Number
- 50517
- Hazard Classification
- Type II
- Model or Catalog #
- A) 50130
B) 1950
C) 2507
D) 11555
E) 40051
F) 11859
G) 11846
H) 11781
I) 186706
J) 13075
K) 12384, 20709
L) 11971, 12391, 20679, 20792
M) 12618, 20678 - Lot or Serial #
- A) N/A
B) N/A
C) N/A
D) N/A
E) N/A
F) N/A
G) N/A
H) N/A
I) N/A
J) N/A
K) N/A
L) N/A
M) N/A - Reason for Recall
- Power cords may crack and fail leading to potential risks of electrical shock. Delay in setup and therapy interruption and fires which may also occur in an oxygen-rich environment.
- Trade Name
- A) PCR Eleva S
B) PCR Compano Eleva - Recall Posting Date
- 2009/09/28
- Manufacturer
- Philips Medical Systems DMC GMBH
- Recall Start Date
- 2009/02/23
- Recall Number
- 46769
- Hazard Classification
- Type II
- Model or Catalog #
- A) PCR ELEVA S
B) PCR ELEVA PLUS - Lot or Serial #
- A) N/A
B) N/A - Reason for Recall
- Possibility that choice of patient will be changed when using filtered work lists. Normally problem detected because the "active" name of patient is displayed. This affects PCR Eleva system connected to a RIS.
- Trade Name
- A) Pediatric Emergency System Kit
B) Pediatric Emergency System Flying Carpet
C) Emergency System Intraosseus Module - Recall Posting Date
- 2009/08/03
- Manufacturer
- Vital Signs Inc.
- Recall Start Date
- 2009/06/30
- Recall Number
- 49853
- Hazard Classification
- Type II
- Model or Catalog #
- A) 7730ALS, 7730BLU5, 7730GRN5, 7730IALS, 7730MOD, 7730ORG5, 7730PUR5, 7730RED5, 7730WHI5, 7730YEL5
B) 7730FLY
C) 7700BIO2, 7700GIO2, 7700OIO2, 7700PIO2, 7700RIO2, 7700WIO2, 7700YIO2 - Lot or Serial #
- A) 245F to 366F inclusive, 001K to 149K inclusive
B) 001K to 149K inclusive, 245F to 366F inclusive
C) 245F to 366F inclusive, 001K to 149K inclusive - Reason for Recall
- The Broselow/Hinkle Intraosseus Module, which is part of the Broselow/Hinkle Pediatric Emergency System, contains a 15g intraosseus needle that is not compatible with the IV extension set that is provided in the module. This may result in a leak at the connection, delaying treatment.
- Trade Name
- A) PKS Seal Open Forceps, Curved Jaw With Cord
B) Plasmakinetic Curved Jaw Open Forceps
C) Plasmakinetic Straight Jaw Open Forceps
D) Plasmakinetic Angle Jaw Open Forceps - Recall Posting Date
- 2009/09/14
- Manufacturer
- Gyrus Acmi, Inc.
- Recall Start Date
- 2009/08/18
- Recall Number
- 50595
- Hazard Classification
- Type II
- Model or Catalog #
- A) 915000PK, 915005PK, 915010PK
B) 3103PK
C) 3104PK
D) 3105PK - Lot or Serial #
- A) All Lots Prior To 2009-08-14
B) All Lots Prior To 2009-08-14
C) All Lots Prior To 2009-08-14
D) All Lots Prior To 2009-08-14 - Reason for Recall
- The metal shim between the jaws may detach during the procedure and fall into the surgical field. It has been reported that the detached shim may be undetected and be left behind in the patient.
- Trade Name
- A) Portex Tracheal Tube, Oral/Nasal, Ivory
B) Portex Tracheal Tube, Siliconised
C) Portex Tracheal Tube,Murphy,Siliconised
D) Portex Polar Preformed Tracheal Tube
E) Portex Tracheal Tube, Oral/Nasal
F) Portex Tracheal Tube, Oral/Nasal, Murphy Eye, Clear - Recall Posting Date
- 2009/09/14
- Manufacturer
- Smiths Medical International Ltd.
- Recall Start Date
- 2009/09/14
- Recall Number
- 50611
- Hazard Classification
- Type I
- Model or Catalog #
- A) 100-105-025, 100-105-030, 100-105-035
B) 100-111-020, 100-111-025, 100-111-030, 100-111-035, 100/126/025, 100/126/030, 100/126/035
C) 100-141-025, 100-141-030, 100-141-035
D) 100/134/030, 100/134/035
E) 100/112/030, 100/112/035
F) 100/127/025, 100/127/030, 100/127/035 - Lot or Serial #
- A) All lots prior to Sept 2009
B) All lots prior to Sept 2009
C) All lots prior to Sept 2009
D) All lots prior to Sept 2009
E) All lots prior to Sept 2009
F) All lots prior to Sept 2009 - Reason for Recall
- Smiths Medical International Ltd. has become aware that certain Portex uncuffed paediatric tracheal tubes were manufactured with an internal diameter slightly smaller than specifications. There is a remote potential for a suction catheter to become lodged in a tracheal tube which may require extubation.
- Trade Name
- A) Posey Soft Belt With Crotch Strap
B) Posey Breezeline Pelvic Holder - Recall Posting Date
- 2009/08/03
- Manufacturer
- J. T. Posey Co.
- Recall Start Date
- 2009/07/08
- Recall Number
- 49840
- Hazard Classification
- Type II
- Model or Catalog #
- A) 4125C
B) 4411 - Lot or Serial #
- A) N/A
B) N/A - Reason for Recall
- Label clarification.
- 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 - Recall Posting Date
- 2009/09/28
- Manufacturer
- Linvatec Corporation D.B.A. Conmed Linvatec
- Recall Start Date
- 2009/08/14
- Recall Number
- 50403
- Hazard Classification
- Type II
- Model or Catalog #
- A) PRO5100M
B) PRO5200M
C) PRO5300M
D) PRO5400M
E) PRO6202
F) PRO6450
G) PRO6200, PRO6300, PRO6400
H) PRO5200, PRO5100, PRO5300, PRO5400 - Lot or Serial #
- A) BBB97037, BBB97730, BBB97731, BBB97734, BBB98124, BBB98125, BBB99622, BBB99925, BBC07409, BBC07410
B) >10 Numbers, Contact Manufacturer
C) >10 Numbers, Contact Manufacturer
D) >10 Numbers, Contact Manufacturer
E) >10 Numbers, Contact Manufacturer
F) BBC98784, BBC98787, BBD08568
G) >100 Numbers, Contact Manufacturer
H) >10 Numbers, Contact Manufacturer - Reason for Recall
- The manufacturer has determined there is a remote possibility that certain handpieces may self activate.
- Trade Name
- A) Restoration Modular Calcar Bodies
B) Restoration Modular Hip Body/Bolt STD
C) Restoration Hip Body/Bolt
D) Restoration Mod. Hip Broach Body/Bolt
E) Restoration Modular Conical Distal Stem
F) Restoration Modular Conical Bowed Stem - Recall Posting Date
- 2009/08/03
- Manufacturer
- Howmedica Osteonics - Stryker Ireland
- Recall Start Date
- 2009/07/03
- Recall Number
- 49713
- Hazard Classification
- Type II
- Model or Catalog #
- A) N/A
B) N/A
C) N/A
D) N/A
E) N/A
F) N/A - Lot or Serial #
- A) T80998AA, T80998AC, T80550AA, T81105BA, T55344DA, T80551AA, T80554AA
B) > 10 Numbers, Contact Manufacturer
C) 29054602, 29110402, 28749101, 28932002, 28719201, 28914301, 29054902, 28932601
D) 29389202
E) CAXJ826A, CAXJ827A, CAXJ910A, CAXJ834A, CAXJ834C, CAXJ834J, CAXJA29D
F) CAXJ951A - Reason for Recall
- The third party supplier, for material used to manufacture the Restoration Modular Components, has demonstrated poor process control which has raised concerns about the quality of the raw material supplied. As a precaution and due to the potential impact on the mechanical properties of the affected products, Stryker is recalling all products manufactured from material supplied by this supplier.
- Trade Name
- A) S3 Med/Surg Bed Fowler
B) Secure II Med/Surg Bed Fowler - Recall Posting Date
- 2009/07/20
- Manufacturer
- Stryker Medical
- Recall Start Date
- 2009/06/11
- Recall Number
- 49199
- Hazard Classification
- Type II
- Model or Catalog #
- A) 302S3-000-000
B) 3002-000-000 - Lot or Serial #
- A) All lots
B) All lots - Reason for Recall
- There is potential for the Fowlers (backrests) to drift down to the flat position on the beds. The cause of the drifting Fowler is the Fowler clutch wrapspring having the potential to entangle in between the cup and coupler of the Fowler clutch assembly.
- Trade Name
- A) Sabouraud Dextrose Agar
B) Middlebrook 7H11 Agar
C) TSA + 5% Sheep Blood (BA)
D) Nitrient Agar - Recall Posting Date
- 2009/08/03
- Manufacturer
- PML Microbiologicals, Inc.
- Recall Start Date
- 2009/06/30
- Recall Number
- 49558
- Hazard Classification
- Type III
- Model or Catalog #
- A) 303434
B) P2377
C) P2600
D) P3889 - Lot or Serial #
- A) 286801-1, 287425-1
B) 286811-1, 287223-1
C) 287232-1
D) 287173-1 - Reason for Recall
- Specific lots of prepared plated media may be experiencing random fungal contamination.
- 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 - Recall Posting Date
- 2009/09/14
- 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.
- Trade Name
- A) Sheri-I-Bronch Endobronchial Tube Kit
B) Sher-I-SWIV Double Swivel Tracheal Tube - Recall Posting Date
- 2009/08/31
- Manufacturer
- Teleflex Medical
- Recall Start Date
- 2009-07-31
- Recall Number
- 50274
- Hazard Classification
- Type I
- Model or Catalog #
- A) 5-16028, 5-16035, 5-16037, 5-16039, 5-16041, 5-16128, 5-16135, 5-16137, 5-16139, 5-16141
B) 5-15301, 5-15401 - Lot or Serial #
- A) > 10 Numbers, Contact Manufacturer
B) > 10 Numbers, Contact Manufacturer - Reason for Recall
- It has come to the attention of Teleflex that the tether attaching to the double swivel cap may partially or completely break at the attachment points. The broken tether may lodge inside the dual swivel tubing or body during shipment to the end user resulting in the potential for the accidental aspiration of the tether into the patient's lungs.
- Trade Name
- A) Stryker Pain Pump 120cc Catheters
B) Infusion Sets For Stryker Pain Pumps
C) Stryker Pain Pump 270cc Catheters
D) Exfen Catheters
E) Stryker Pain Pump II Infusion Sets
F) Stryker Pain Pump2 Kits - Recall Posting Date
- 2009/08/31
- Manufacturer
- Stryker Instruments
- Recall Start Date
- 2009/06/23
- Recall Number
- 49458
- Hazard Classification
- Type II
- Model or Catalog #
- A) 0500-100-000, 0500-110-000, 0500-120-000, 0500-120-025, 0500-140-000
B) 0500-200-000, 0500-250-000
C) 0501-100-000, 0501-120-000, 0501-140-050, 0501-416-050
D) 0500-050-000, 0525-010-000
E) 525-250-000, 525-500-000
F) 0525-125-000, 540-155-000 - Lot or Serial #
- A) All Lots
B) All Lots
C) All Lots
D) All Lots
E) All Lots
F) All Lots - Reason for Recall
- There is the potential for the catheter to break. Additionally there is the potential for the pain-pump to under-infuse pain medication.
- Trade Name
- A) System 1000 Dialsate Delivery System - Aurora
B) System 1000 Dialsate Delivery System - Tina
C) Arena SPP Hemodialysis Delivery System
D) Arena SPX Hemodialysis Delivery System - Recall Posting Date
- 2009/07/06
- Manufacturer
- Baxter Healthcare Corporation
- Recall Start Date
- 2009/04/09
- Recall Number
- 47924
- Hazard Classification
- Type III
- Model or Catalog #
- A) SYS1000-L3DPHA, SYS1000-L3P, SYS1000-L3PA, SYS1000-L3PHA
B) SYS1000-L3DPHA, SYS1000-L3P, SYS1000-L3PA, SYS1000-L3PH, SYS1000-L3PHA, SYS1000-L3PHDP
C) ARENASPP-DH, ARENASPP-H
D) ARENASPX-BDH, ARENASPX-HR - Lot or Serial #
- A) All Lots
B) All Lots
C) All Lots
D) All Lots - Reason for Recall
- An Arena instrument set to deliver 50 ml/min. may deliver between 40 & 60 ml/min., contrary to operator and service manuals. Sys1000 manuals do not specify blood flow accuracy as required by IEC standard.
- Trade Name
- A) Tube Assembly 142, V2, V12, For DXC 600
B) Tube Assembly 142, V2, V12, For DXC 800
C) Tube Assembly 142,V2,V12, For DXC 600i - Recall Posting Date
- 2009/08/31
- Manufacturer
- Beckman Coulter Inc.
- Recall Start Date
- 2009/07/27
- Recall Number
- 50231
- Hazard Classification
- Type II
- Model or Catalog #
- A) 4764, A10038
B) 4764, A10038
C) 4767, A10038 - Lot or Serial #
- A) All Serial Numbers
B) All Serial Numbers
C) All Serial Numbers - Reason for Recall
- The wash concentrate tube assembly may fail to deliver the appropriate amount of wash concentrate on some Synchron DXC systems due to an accumulation of crystals.
- Trade Name
- A) Unicel DXI800 Thyroglobulin Antibody II
B) Access System Thyroglobulin Antibody II
C) Unicel DXI600 Thyroglobulin Antibady II - Recall Posting Date
- 2009/09/14
- Manufacturer
- Beckman Coulter Inc.
- Recall Start Date
- 2009/08/24
- Recall Number
- 50639
- Hazard Classification
- Type III
- Model or Catalog #
- A) A32898
B) A32898
C) A32898 - Lot or Serial #
- A) >618967
B) >618967
C) >618967 - Reason for Recall
- The Access Thyroglobulin Antibody II (THGAB II) assay demonstrates increased low-end imprecision and false positive rate when run in conjunction (i.e. random access mode) with the Access Accutnl assay.
- Trade Name
- A) Unipolar Intramuscular Leads
B) Enterra Gastric Stimulation Leads
C) Enterra Therapy GastricC Stimulation IPG - Recall Posting Date
- 2009/09/28
- Manufacturer
- Medtronic Inc.
- Recall Start Date
- 2009/09/04
- Recall Number
- 50734
- Hazard Classification
- Type II
- Model or Catalog #
- A) 4300-35, 4300-50
B) 4351
C) 3116, 7425G - Lot or Serial #
- A) >10 Numbers, Contact Manufacturer
B) >10 Numbers, Contact Manufacturer
C) >10 Numbers, Contact Manufacturer - Reason for Recall
- The recall is initiated to provide important new safety information and patient management recommendations related to the potential for bowel obstruction and/or perforation in a small percentage of Medtronic Enterra Therapy System patients. Enterra Therapy leads may wrap around or perforate the bowel.
- Trade Name
- A) Van Sonnenberg
B) Flexima Hydrophilic All Purpose
C) Flexima Hydrophilic Drainage
D) Flexima Hydrophilic Biliary Drainage
E) Flexima Hydrophilic Drainage Kit
F) Flexima Hydrophilic Nephrostomy
G) Flexima Hydrophilic Nephrostomy Catheter
H) VTC Nephrostomy System
I) Nephroureteral Stent System
J) Vansonnenberg Chest Drain Set - Recall Posting Date
- 2009/09/14
- Manufacturer
- Boston Scientific Corporation
- Recall Start Date
- 2009/03/23
- Recall Number
- 47710
- Hazard Classification
- Type III
- Model or Catalog #
- A) 20-307, 21-306, 21-307, 27-303, 27-304, 27-315, 27-316
B) 27-124, 27-131, 27-132, 27-133, 27-134, 27-135
C) 27-196, 27-197, 27-198, 27-199
D) 27-154, 27-155, 27-156, 27-157, 27-158, 27-159, 27-160, 27-161, 27-162, 27-260, 27-261, 27-262, 27-263, 27-264, 27-265, 27-266, 27-267, 28-260, 28-261
E) 27-163, 27-164, 27-165, 27-166
F) 27-177, 27-178, 27-179, 27-180, 27-181, 27-182, 27-183, 27-184, 27-185
G) 27-186, 27-187, 27-188, 27-189, 27-190, 27-191
H) 22-514, 22-524
I) 22-136, 22-137, 22-138, 22-139, 22-140, 22-141, 22-142, 22-143, 23-136, 23-137, 23-138, 23-139, 23-140, 23-141, 23-142, 23-143
J) 24-506, 24-507 - Lot or Serial #
- A) > 10 Numbers, Contact Manufacturer
B) > 10 Numbers, Contact Manufacturer
C) > 10 Numbers, Contact Manufacturer
D) > 10 Numbers, Contact Manufacturer
E) > 10 Numbers, Contact Manufacturer
F) > 10 Numbers, Contact Manufacturer
G) > 10 Numbers, Contact Manufacturer
H) > 10 Numbers, Contact Manufacturer
I) > 10 Numbers, Contact Manufacturer
J) > 10 Numbers, Contact Manufacturer - Reason for Recall
- Boston scientific has decided to revise the DFU for all affected products to include more detailed info about sutures separating from catheter.
- Trade Name
- A) Virtuoso Dual Chamber ICD
B) Concerto CRT-D
C) Virtuoso Single Chamber ICD - Recall Posting Date
- 2009/09/28
- Manufacturer
- Medtronic Inc.
- Recall Start Date
- 2009/09/09
- Recall Number
- 50790
- Hazard Classification
- Type II
- Model or Catalog #
- A) D164AWG
B) C174AWK
C) D164VWC - Lot or Serial #
- A) >10 Numbers, Contact Manufacturer
B) >10 Numbers, Contact Manufacturer
C) >10 Numbers, Contact Manufacturer - Reason for Recall
- Affected devices may not meet expected device longevity due to gradually increasing current drain caused by low voltage capacitor degradation. This issue may present in the affected devices as reaching the recommended replacement time (RRT) earlier than expected.
- Trade Name
- A) Vital-Signs Monitor with Rate and Map
B) Vital-Signs Monitor with Rate/Map Printer
C) Vital-Signs Monitor with Rate/Map/Printer/Temp
D) Vital-Signs Monitor with Temp and Printer
E) Vital-Signs Monitor with Nellcor
F) Vital-Signs Monitor with Nellcor SPO2 and Printer
G) Vital-Signs Monitor with Nellcor SPO2/Temp
H) Vital-Signs Monitor with SPO2/Temp & Printer - Recall Posting Date
- 2009/08/17
- Manufacturer
- Welch Allyn Protocol, Inc.
- Recall Start Date
- 2009/08/04
- Recall Number
- 49917
- Hazard Classification
- Type II
- Model or Catalog #
- A) 53000-E1, 53000-F1
B) 5300P-E1, 5300P-F1
C) 530T0-E1, 530T0-F1
D) 530TP-E1, 530TP-F1
E) 53N00-E1, 53N00-F1, 53S00-E1, 53S00-F1
F) 53N0P-E1, 53N0P-F1,53S0P-E1, 53S0P-F1
G) 53NT0-E1, 53NT0-F1, 53ST0-E1, 53ST0-F1
H) 53NTP-E1, 53NTP-E1R, 53NTP-F1, 53STP-E1, 53STP-F1 - Lot or Serial #
- A) All Serial Numbers
B) All Serial Numbers
C) All Serial Numbers
D) All Serial Numbers
E) All Serial Numbers
F) All Serial Numbers
G) All Serial Numbers
H) All Serial Numbers - Reason for Recall
- Speakers in VSM300 Vital-Signs Monitor failed to produce sound. The failure of the speaker eliminates audio alarm tones for parameter violation, equipment alerts, or error codes, as well as repetitive beeps to indicate pulses when monitoring SP02 (oximetry).
- Trade Name
- A) VNS Demipulse SYS Programming
B) VNS Demipulse SYS Programming Software - Recall Posting Date
- 2009/09/14
- Manufacturer
- Cyberonics Inc.
- Recall Start Date
- 2009/08/11
- Recall Number
- 50356
- Hazard Classification
- Type II
- Model or Catalog #
- A) 250 (Versions 6.1 And Less)
B) 250, 250 V7.1.4 - Lot or Serial #
- A) All Versions And Lot Numbers
B) All Versions And Lot Numbers - Reason for Recall
- In rare instances, a system diagnostic test using model 250 programming software (v 7.1 and earlier) may report "lead impedance: ok" when, in fact, normal wear and trauma has resulted in a short-circuit condition that prevents the lead from delivering therapy to the vagus nerve.
- Trade Name
- A) VNS Model 250 Programming Software
B) VNS Demipulse System Programming Software - Recall Posting Date
- 2009/09/14
- Manufacturer
- Cyberonics Inc.
- Recall Start Date
- 2009/07/31
- Recall Number
- 50356
- Hazard Classification
- Type II
- Model or Catalog #
- A) 250, 250 V7.1.4
B) 250 (Versions 6.1 And Less) - Lot or Serial #
- A) All Versions And Lot Numbers
B) All Versions And Lot Numbers - Reason for Recall
- In rare instances, a system diagnostic test using model 250 programming software (v 7.1 and earlier) may report "lead impedance: ok" when, in fact, normal wear and trauma has resulted in a short-circuit condition that prevents the lead from delivering therapy to the vagus nerve.
- Trade Name
- A) Wiseguide Guide Catheters, bypass
B) Wiseguide Guide Catheters, multipurpose
C) Wiseguide Guide Catheters, q-curve
D) Wiseguide Guide Catheters, radial
E) Wiseguide Guide Catheters, contralateral
F) Wiseguide Guide Catheters, cls
G) Wiseguide Guide Catheters, kimny - Recall Posting Date
- 2009/09/14
- Manufacturer
- Boston Scientific Corporation
- Recall Start Date
- 2009/08/07
- Recall Number
- 50383
- Hazard Classification
- Type II
- Model or Catalog #
- A) 16320-122
B) 16320-131
C) 16320-293
D) 19500-474
E) 16320-573
F) 16320-573
G) 16320-583 - Lot or Serial #
- A) N/A
B) N/A
C) N/A
D) N/A
E) N/A
F) N/A
G) N/A - Reason for Recall
- Sterile barrier in the packaging may be compromised.
- Trade Name
- Accu-Chek Softclix Lancets
- Recall Posting Date
- 2009/08/03
- Manufacturer
- Roche Diagnostics GMBH
- Recall Start Date
- 2009/06/01
- Recall Number
- 48484
- Hazard Classification
- Type III
- Model or Catalog #
- 03146693119, 03146707119, 03583031002
- Lot or Serial #
- > 10 Numbers, Contact Manufacturer
- Reason for Recall
- There is a potential that a single lancet may miss the protective cap in the Accu-Chek Softclix Lancet boxes and in the bags in blood glucose meter kits.
- Trade Name
- Active Cortisol Enzyme Immunoassay Kit
- Recall Posting Date
- 2009/08/31
- Manufacturer
- Diagnostic Systems Laboratories Inc., DSL
- Recall Start Date
- 2009/07/20
- Recall Number
- 50075
- Hazard Classification
- Type II
- Model or Catalog #
- DSL-10-2000
- Lot or Serial #
- > 10 Numbers, Contact Manufacturer
- Reason for Recall
- Active Cortisol Elisa Kits will result in falsely high values for patient samples due to a shift in the calibration of the assigned standard values.
- Trade Name
- Acuson P50 Diagnostic Ultrsound System
- Recall Posting Date
- 2009/08/03
- Manufacturer
- Siemens Medical Solutions USA, Inc.
- Recall Start Date
- 2009/06/19
- Recall Number
- 49589
- Hazard Classification
- Type III
- Model or Catalog #
- 10041762
- Lot or Serial #
- 10120, 10122
- Reason for Recall
- 1) In versions 1.1 and 1.1, the needle guide feature was to be disabled for all transducers but actually activated for 1215 transducer. 2) In non-cardiac application, can be an error in estimation of velocity when using pulsatility index tool which is sensitive to noise in spectral Doppler waveform causing mis-trace, user is unaware of miscalculations.
- Trade Name
- Anti-Cardiolipin IGM Test Kit
- Recall Posting Date
- 2009/08/31
- Manufacturer
- Bio-Rad Laboratories Diagnostics Group
- Recall Start Date
- 2009/07/27
- Recall Number
- 50175
- Hazard Classification
- Type II
- Model or Catalog #
- 425-2020
- Lot or Serial #
- CL-863
- Reason for Recall
- Microbial contamination of Anti-Cardiolipin IGM positive control (lot CPM-591). Calibrator 3, lot CLM3-156, may also be affected. These lots are included in Anti-Cardiolipin IGM Test Kit, lot CL-863 only.
- Trade Name
- Apexpro Telemetry System - Transmitter
- Recall Posting Date
- 2009/08/03
- Manufacturer
- GE Healthcare
- Recall Start Date
- 2009/02/20
- Recall Number
- 45337
- Hazard Classification
- Type II
- Model or Catalog #
- APROCH-XX-XXX-XXX-X
- Lot or Serial #
- S/N RT908139180GA
- Reason for Recall
- Potential for intermittent or unpredictable circuit board failures due to insufficient copper plating resulting in loss of communication and patient data.
- Trade Name
- Aquesure Disposable Filters
- Recall Posting Date
- 2009/09/14
- Manufacturer
- Bomimed Inc.
- Recall Start Date
- 2009/04/30
- Recall Number
- 50420
- Hazard Classification
- Type II
- Model or Catalog #
- N/A
- Lot or Serial #
- 042709, 042309, 042209
- Reason for Recall
- A customer could not get a CO2 tracing while the anesthesia circuit was in use because the CO2 port on the filter was blocked with the plastic mould. Lot numbers listed are the affected anesthesia circuits.
- Trade Name
- Aquillion One
- Recall Posting Date
- 2009/08/31
- Manufacturer
- Toshiba Medical Systems Corporation
- Recall Start Date
- 2009/08/11
- Recall Number
- 50342
- Hazard Classification
- Type II
- Model or Catalog #
- TSX-301A/2
- Lot or Serial #
- > 10 Numbers, Contact Manufacturer
- Reason for Recall
- In Aquilion One System, due to the problem of software and other, a part of the image-related information may be abnormal, or an error may occur at the time of scan setup when sure exposure 3D is used.
- Trade Name
- Architect I System-Total B-HCG Reagent
- Recall Posting Date
- 2009/07/20
- Manufacturer
- Abbott Ireland Diagnostics Division
- Recall Start Date
- 2009/06/30
- Recall Number
- 49556
- Hazard Classification
- Type III
- Model or Catalog #
- 7K78-20, 7K78-25
- Lot or Serial #
- 74908JN00, EXP 17 DEC. 2009, 74908JN01, EXP 17 DEC. 2009
- Reason for Recall
- Abbott has observed an increase in complaints for the following error codes when using ARCHITECT Total ?-hCG Reagent with specified lots:
-1109 "assay (X) number (Y) calibration failure, ratio too small for CAL B/CAL A" and /or
- 1005 "result cannot be calculated, final RLU read is outside the specification of the lowest calibrator".
- Trade Name
- AW Volumeshare2 - CT Perfusion 4
- Recall Posting Date
- 2009/08/03
- Manufacturer
- GE Healthcare
- Recall Start Date
- 2009/06/16
- Recall Number
- 48164
- Hazard Classification
- Type II
- Model or Catalog #
- 5189396
- Lot or Serial #
- > 10 Numbers, Contact Manufacturer
- Reason for Recall
- When using CT Perfusion 4 algorithm on data with longer time sampling intervals, under certain conditions, the noise level in the functional maps may prevent user from clearly seeing a subtle perfusion defect.
- Trade Name
- BD MultiSET Software V.3.0.1
- Recall Posting Date
- 2009/07/20
- Manufacturer
- Becton, Dickinson And Company
- Recall Start Date
- 2009/06/24
- Recall Number
- 49459
- Hazard Classification
- Type III
- Model or Catalog #
- 643347, 643437, 644459
- Lot or Serial #
- N/A
- Reason for Recall
- A multi-sipping issue was found in BD MultiSET Software Version 3.0.1. The software is not adjusting its acquisition criteria for some samples. It only displays the last batch of events acquired.
- Trade Name
- BHR Acetabular Cups
- Recall Posting Date
- 2009/07/20
- Manufacturer
- Smith & Nephew Orthopaedics Ltd.
- Recall Start Date
- 2009/06/30
- Recall Number
- 49557
- Hazard Classification
- Type II
- Model or Catalog #
- 74120152
- Lot or Serial #
- (L)08CW16248
- Reason for Recall
- The engraving on the plastic cap does not match the outer label indications for size. The BHR Acetabular Cup and femoral head packages include labelling and colour coding to prevent mismatch in component size selection. The engraved numbers on the impactor cap do not agree with this information and are erroneous. As such, the numbers engraved on the impactor cap could cause some confusion during surgery and lead to surgical delay.
- Trade Name
- Bond-1 Primer/Adhesive
- Recall Posting Date
- 2009/09/14
- Manufacturer
- Pentron Clinical Technologies, LLC
- Recall Start Date
- 2009/08/25
- Recall Number
- 50640
- Hazard Classification
- Type III
- Model or Catalog #
- N01IAB
- Lot or Serial #
- 186620, 190582, 190985, 183847
- Reason for Recall
- Some of the bottles had already gelled and were unusable.
- Trade Name
- Brightview Gamma Camera Sy. w/ 3/8" Crystal & Detector Caudal Cephalic
- Recall Posting Date
- 2009/08/03
- Manufacturer
- Philips Medical Systems (Cleveland), Inc.
- Recall Start Date
- 2009/07/14
- Recall Number
- 49947
- Hazard Classification
- Type II
- Model or Catalog #
- 2170-3002A
- Lot or Serial #
- N/A
- Reason for Recall
- If the radius drive assembly on the detectors of Brightview Gamma Cameras is severely compromised, the detector may slide, under the influence of gravity, to its hardware limit.
- Trade Name
- C0R36 15x100mm Kii Optical Access Sys
- Recall Posting Date
- 2009/09/28
- Manufacturer
- Applied Medical Resources Corporation
- Recall Start Date
- 2009/06/09
- Recall Number
- 50115
- Hazard Classification
- Type II
- Model or Catalog #
- C0R36
- Lot or Serial #
- 1084426, 1085506, 1082348
- Reason for Recall
- A cannula tip had fractured during a gastric bypass procedure. The resulting fragments were recovered and the event did not directly result in patient injury. However, the surgeon converted the laparoscopic procedure to "open" to confirm all fragments were recovered. The identity of other medical devices or accessories used in the event is unknown.
- Trade Name
- Capture-R Ready Screen (4)
- Recall Posting Date
- 2009/09/14
- Manufacturer
- Immucor Inc.
- Recall Start Date
- 2009/08/18
- Recall Number
- 50618
- Hazard Classification
- Type II
- Model or Catalog #
- 0066802, 0066812
- Lot or Serial #
- K226
- Reason for Recall
- Unexpected positive reactivity with this lot of product. Invalid test result due to unexpected negative reactions with the positive control observed with this lot.
- Trade Name
- Carendo Multipurpose Hygiene Chair
- Recall Posting Date
- 2009/07/20
- Manufacturer
- Arjo Hospital Equipment AB
- Recall Start Date
- 2009/06/16
- Recall Number
- 49446
- Hazard Classification
- Type II
- Model or Catalog #
- BIB2003-01
- Lot or Serial #
- > 10 Numbers, Contact Manufacturer
- Reason for Recall
- A limited number of complaints have been received regarding the Carendo related to skin pinching. If the Carendo is not used in compliance with the device instructions for use. Trending has shown a number of events relating to what has been generally described as clip detachments.
- Trade Name
- Centricity PACS Workstation - Hardware
- Recall Posting Date
- 2009/08/03
- Manufacturer
- GE Healthcare Integrated IT Solutions
- Recall Start Date
- 2009/05/26
- Recall Number
- 47838
- Hazard Classification
- Type II
- Model or Catalog #
- K2033LP
- Lot or Serial #
- > 100 Numbers, Contact Manufacturer
- Reason for Recall
- Default configuration may have been modified so that rejected images are included in the retrieved exam, resulting in those images being displayed erroneously on external DICOM device.
- Trade Name
- Chloride Membrane on ABL 700 & 800 Flex
- Recall Posting Date
- 2009/07/06
- Manufacturer
- Radiometer Medical APS
- Recall Start Date
- 2009/06/05
- Recall Number
- 48585
- Hazard Classification
- Type III
- Model or Catalog #
- 942-061
- Lot or Serial #
- 177
- Reason for Recall
- Composition of electrolyte solution in membrane units for the affected lot 177 are incorrect and cause the sensitivity of chloride electrode to be very low and the analyzer rejects calibration.
- Trade Name
- CIC Pro Clinical Information Center
- Recall Posting Date
- 2009/08/03
- Manufacturer
- GE Healthcare
- Recall Start Date
- 2009/06/05
- Recall Number
- 46547
- Hazard Classification
- Type II
- Model or Catalog #
- CIC-XXXX-XXXXX-XXXXX*
- Lot or Serial #
- > 100 Numbers, Contact Manufacturer
- Reason for Recall
- Large number of time change requests between two or more CARESCAPE devices may result in sluggishness of CIC Pro, loss of waveforms, parameters & alarming and inconsistent time values.
- Trade Name
- Clay Adams Dynac III Centrifuge
- Recall Posting Date
- 2009/09/14
- Manufacturer
- Becton Dickinson And Company
- Recall Start Date
- 2009/08/17
- Recall Number
- 50475
- Hazard Classification
- Type III
- Model or Catalog #
- 420104
- Lot or Serial #
- 8192744, 8288054
- Reason for Recall
- Latch bar on centrifuges may have been improperly assembled. May become loose, disabling safety feature which prevents customers from opening centrifuge while it is spinning.
- Trade Name
- Clearview HCG
- Recall Posting Date
- 2009/08/31
- Manufacturer
- Unipath Limited
- Recall Start Date
- 2009/06/29
- Recall Number
- 50405
- Hazard Classification
- Type II
- Model or Catalog #
- 506788
- Lot or Serial #
- All Lot Numbers.
- Reason for Recall
- The manufacturer has updated the instructions for use to state "read the result at 3 minutes. Do not interpret the result after 3 minutes". Previously the instructions allowed tests to be read up to 10 minutes.
- Trade Name
- Clinac IX Radio Therapy Delivery System
- Recall Posting Date
- 2009/08/03
- Manufacturer
- Varian Medical Systems, Inc.
- Recall Start Date
- 2009/05/29
- Recall Number
- 50003
- Hazard Classification
- Type II
- Model or Catalog #
- 2100C, 21EXS, CLINAC IX H14, CLINAC IX H27, CLINAC IX H29
- Lot or Serial #
- > 10 Numbers, Contact Manufacturer
- Reason for Recall
- On Clinacs running C- series version 7.X, the couch can be moved via the float mode when the stereotactic motion disable function is turned on. This may represent a hazard to a stereotactic patient with a head ring mounted on a floor stand or pedestal.
- Trade Name
- Cobra Electrosurgical System
- Recall Posting Date
- 2009/09/14
- Manufacturer
- Boston Scientific EP Technologies
- Recall Start Date
- 2009/08/05
- Recall Number
- 50601
- Hazard Classification
- Type II
- Model or Catalog #
- M00448100, M00448110, M0048400
- Lot or Serial #
- > 10 Numbers, Contact Manufacturer
- Reason for Recall
- Potential to deliver RF energy without depressing the foot switch. If foot switch is not depressed, and the audible sound is heard and/or the indicator light is on, the foot switch is not functioning properly.
- Trade Name
- Compax 40E Table
- Recall Posting Date
- 2009/08/17
- Manufacturer
- GE Medical Systems LLC
- Recall Start Date
- 2009/07/31
- Recall Number
- 49649
- Hazard Classification
- Type II
- Model or Catalog #
- 2208203, 2225864, 2225881
- Lot or Serial #
- 59658ES5, 63221ES6, 69850MA6, 64076ES3
- Reason for Recall
- Table lock safety features are not always being utilized by the users and have resulted in unintended lateral movement that may impact patient safety.
- Trade Name
- Conmed Linvatec Arthro-Knife
- Recall Posting Date
- 2009/08/31
- Manufacturer
- Linvatec Corporation D.B.A. Conmed Linvatec
- Recall Start Date
- 2009/08/05
- Recall Number
- 50381
- Hazard Classification
- Type II
- Model or Catalog #
- 70-0071-103, 70-0071-113, 70-0072-003, 70-0073-003, 70-0074-103, 70-0075-003, 70-0076-003, 70-0077-103, 70-0078-103
- Lot or Serial #
- > 10 Numbers, Contact Manufacturer (Lot #'s With Expiration Dates Of July 2009 to August 2013)
- Reason for Recall
- Manufacturer has determined there is the possibility that the device may not fully retract once it is deployed.
- Trade Name
- Cook Sydney IVF Culture Oil
- Recall Posting Date
- 2009/09/14
- Manufacturer
- William A. Cook Australia, PTY. Ltd.
- Recall Start Date
- 2009/03/31
- Recall Number
- 47702
- Hazard Classification
- Type II
- Model or Catalog #
- K-SICO-200
- Lot or Serial #
- A833541
- Reason for Recall
- Higher than usual viscosity of culture oil may lead to difficulty in culturing. Communication issued to affected facilities but no product return requested.
- Trade Name
- Coonrad/Morrey Total Elbow System
- Recall Posting Date
- 2009/07/20
- Manufacturer
- Zimmer Inc.
- Recall Start Date
- 2009/06/09
- Recall Number
- 49362
- Hazard Classification
- Type II
- Model or Catalog #
- 32-8105-038-00
- Lot or Serial #
- 61249897, 61249899
- Reason for Recall
- Some units in these lots may contain a void in the side seals of the Tyvek/poly pouch.
- Trade Name
- Cyberknife Robotic Radiosurgery System
- Recall Posting Date
- 2009/08/17
- Manufacturer
- Accuray, Inc.
- Recall Start Date
- 2009/06/22
- Recall Number
- 50114
- Hazard Classification
- Type II
- Model or Catalog #
- 27600
- Lot or Serial #
- C185
- Reason for Recall
- A site reported that their End-to-End targeting accuracy was out of specification. The position of one of the robotic manipulator axes differed from the position determined by the robot controller. This discrepancy caused the CyberKnife Treatment Delivery System to post Error 103 (karel e-stop detected). Also, the robot controller detected the inconsistency & reported this error as Error 342: Deviation in absolute position value DSE-RDC". This error is displayed on the computer monitor for the robot controller and on the Teach Pendant display. However, Error 342 did not render the system down.
- Trade Name
- CyberKnife Robotic Radiosurgery System
- Recall Posting Date
- 2009/08/31
- 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
- Dall Miles Trochanter Cable Grip System
- Recall Posting Date
- 2009/07/20
- Manufacturer
- Howmedica Osteonics - Stryker Ireland
- Recall Start Date
- 2009/06/15
- Recall Number
- 49278
- Hazard Classification
- Type II
- Model or Catalog #
- 6704-0-210
- Lot or Serial #
- Serial # 29233201
- Reason for Recall
- During post-sterilization inspection of the outer blister of the affected lots, it was determined that the outer blister did not meet the required minimum seal width. (Note: the inner blister seal was not affected).
- Trade Name
- Damon SS Archwire 227-1043
- Recall Posting Date
- 2009/08/03
- Manufacturer
- Ormco Corporation
- Recall Start Date
- 2009/05/01
- Recall Number
- 49956
- Hazard Classification
- Type III
- Model or Catalog #
- 227-1043
- Lot or Serial #
- 20994915
- Reason for Recall
- Damon SS Archwire 227-1029, 26 mm, mislabeled as 227-1043, 40 mm.
- Trade Name
- Datex Ohmeda Carestations Interface
- Recall Posting Date
- 2009/09/14
- Manufacturer
- GE Healthcare Finland OY
- Recall Start Date
- 2009/04/14
- Recall Number
- 47422
- Hazard Classification
- Type II
- Model or Catalog #
- M1079844
- Lot or Serial #
- > 10 Numbers, Contact Manufacturer
- Reason for Recall
- The N-DISVENT-02 acts as an interface between the anesthesia machine or ventilator and the patient monitor. Because of incorrect patient weight and/or height synchronization between anesthesia machine/ventilator and the patient monitor through the N-DISVENT-02 interface, there is the possibility of incorrect patient weight and/or height recorded in the patient monitor.
- Trade Name
- Definium 5000 Digital Radiographic System
- Recall Posting Date
- 2009/07/06
- Manufacturer
- GE Healthcare
- Recall Start Date
- 2009/06/11
- Recall Number
- 47773
- Hazard Classification
- Type II
- Model or Catalog #
- 5220493-2
- Lot or Serial #
- GEHC00070 & GEHC00096
- Reason for Recall
- When configured for AEC, after first exposure terminates, subsequent exposures fail to terminate because functionality of ion chamber ramp comparator with low reference voltage is not reliable.
- Trade Name
- Delfia Xpress PAPP-A Kit
- Recall Posting Date
- 2009/07/06
- Manufacturer
- Wallac OY
- Recall Start Date
- 2009/05/21
- Recall Number
- 48607
- Hazard Classification
- Type II
- Model or Catalog #
- 6003-0020
- Lot or Serial #
- 490042, 490656, 503140, 506860, 507311, 516518
- Reason for Recall
- There is a decrease in the measurement of PAPP-A levels compared to previous lots, leading to the possibility of an increased false positive rate in screening programs.
- Trade Name
- Delta Ceramic Ball Heads
- Recall Posting Date
- 2009/08/17
- Manufacturer
- Howmedica Osteonics - Stryker Ireland
- Recall Start Date
- 2009/07/27
- Recall Number
- 50100
- Hazard Classification
- Type II
- Model or Catalog #
- 18-3200
- Lot or Serial #
- 28635501, 28575801
- Reason for Recall
- The third party who supplies Delta Ceramic Ball Heads did not comply with its specifications. The spherical diameter feature was measuring out of specification (oversized).
- Trade Name
- Digital Radiography Imaging System
- Recall Posting Date
- 2009/07/20
- Manufacturer
- Toshiba Medical Systems Corporation
- Recall Start Date
- 2009/06/12
- Recall Number
- 49202
- Hazard Classification
- Type II
- Model or Catalog #
- TFD-3000A1/WV
- Lot or Serial #
- N/A
- Reason for Recall
- In rare cases, the target image cannot be displayed or output to an external device after the system is simultaneously operated from the control room and the examination room in the Radrex-i system.
- Trade Name
- Dimension Vista System-Urea Nitrogen Assay
- Recall Posting Date
- 2009/07/06
- Manufacturer
- Siemens Healthcare Diagnostics Inc.
- Recall Start Date
- 2009/06/19
- Recall Number
- 49361
- Hazard Classification
- Type III
- Model or Catalog #
- K1021
- Lot or Serial #
- 09061AA
- Reason for Recall
- Customer complaints received regarding inaccurate results with Dimension Vista Bun Flex Reagent Cartridge in that test results may be falsely elevated or depressed, with a variable error magnitude.
- Trade Name
- Dual Offset Broach Handle Left and Right
- Recall Posting Date
- 2009/07/06
- Manufacturer
- Biomet, Inc.
- Recall Start Date
- 2009/03/31
- Recall Number
- 48593
- Hazard Classification
- Type II
- Model or Catalog #
- N/A
- Lot or Serial #
- All Lots
- Reason for Recall
- Handle body may crack or fracture, which could puncture or rupture the skin of the patient, surgeon or attending nurse and lead to increased risk of infection.
- Trade Name
- Easylink Informatics System
- Recall Posting Date
- 2009/08/17
- Manufacturer
- Siemens Healthcare Diagnostics Inc.
- Recall Start Date
- 2009/07/20
- Recall Number
- 49974
- Hazard Classification
- Type II
- Model or Catalog #
- 100034941
- Lot or Serial #
- All Versions
- Reason for Recall
- Inaccurate results reported to the system when a sample is diluted and placed back into the system without assigning the sample a unique, different, sample ID. As a result, patient sample results may be reported with an incorrect result value resulting in inaccuracy, imprecision, or error comment reports together with the result.
- Trade Name
- E-Cylinder Canister Holder
- Recall Posting Date
- 2009/07/20
- Manufacturer
- Stryker Communications
- Recall Start Date
- 2009/06/08
- Recall Number
- 49172
- Hazard Classification
- Type II
- Model or Catalog #
- 0682-000-449, 0682-001-111
- Lot or Serial #
- All Lots
- Reason for Recall
- The older version of the device has a design defect which allows for a fatigue related failure. There are two screws that attach the cage to the bracket which may fatigue over time and fail causing the cage to become detached from the mount and fall.
- Trade Name
- Elecsys Anti-CCP reagent Kit
- Recall Posting Date
- 2009/08/31
- Manufacturer
- Roche Diagnostics GMBH
- Recall Start Date
- 2009/07/31
- Recall Number
- 50171
- Hazard Classification
- Type III
- Model or Catalog #
- 5031656190
- Lot or Serial #
- Lots #153989 And Above
- Reason for Recall
- Reduction on the measuring range from 7-100 u/ml to 7-500 u/ml for the product Anti-CCP Reagent Kit.
- Trade Name
- Emax 2 Plus System - Foot Pedal
- Recall Posting Date
- 2009/09/14
- Manufacturer
- The Anspach Effort Inc.
- Recall Start Date
- 2009/08/17
- Recall Number
- 50456
- Hazard Classification
- Type II
- Model or Catalog #
- EPLUS-FP
- Lot or Serial #
- SN C08301701901
- Reason for Recall
- The foot control cable lacks the shield connection from the cable to the connector body. The lack of shielding may result in radiated emissions exceeding CISPR11.
- Trade Name
- Exogen Bone Healing System
- Recall Posting Date
- 2009/07/20
- Manufacturer
- Smith & Nephew, Inc.
- Recall Start Date
- 2009/06/10
- Recall Number
- 49177
- Hazard Classification
- Type II
- Model or Catalog #
- 71034101
- Lot or Serial #
- > 10 Numbers, Contact Manufacturer
- Reason for Recall
- A small percentage of the devices (approximately 1%) may deliver less than the intended amount of ultrasound. This reduction in ultrasound output is the result of partial loosening of internal glued components within the small black cylindrical head, called a transducer. Reduced ultrasound output may affect the progress of patient fracture healing.
- Trade Name
- Factor V Leiden Kit on LightCycler 2.0
- Recall Posting Date
- 2009/08/17
- Manufacturer
- Roche Molecular Systems, Inc
- Recall Start Date
- 2009/07/24
- Recall Number
- 49994
- Hazard Classification
- Type III
- Model or Catalog #
- 36101790001
- Lot or Serial #
- 14674120
- Reason for Recall
- Possible failure of the factor V Leiden control template (positive control) included in the factor V Leiden Kit for use with the LightCycler 2.0 instrument. The factor V Leiden control template may fail to meet the validity criteria set by the macro component of the LightCycler 2.0 instrument.
- Trade Name
- Fetal Bleed Screening Test
- Recall Posting Date
- 2009/08/03
- Manufacturer
- Immucor Inc.
- Recall Start Date
- 2009/07/01
- Recall Number
- 49726
- Hazard Classification
- Type II
- Model or Catalog #
- 7892
- Lot or Serial #
- 17411
- Reason for Recall
- Complaints of particulate matter in the indicator cells, positive and negative control components of the test kit. An investigation has confirmed microbial contamination in one vial of indicator cell.
- Trade Name
- Flexicair
- Recall Posting Date
- 2009/07/06
- Manufacturer
- Hill-Rom Manufacturing, Inc.
- Recall Start Date
- 2009/05/18
- Recall Number
- 49146
- Hazard Classification
- Type II
- Model or Catalog #
- I3000, M4000
- Lot or Serial #
- N/A
- Reason for Recall
- It is possible for the identified devices to emit smoke from the blower box assembly. Hazard of smoke inhalation and presence of smoke which can trigger smoke detection alarms.
- Trade Name
- Fogarty Occlusion Catheter
- Recall Posting Date
- 2009/08/03
- Manufacturer
- Baxter Healthcare Corporation,
Edwards Critical-Care Division - Recall Start Date
- 2009/06/29
- Recall Number
- 49905
- Hazard Classification
- Type II
- Model or Catalog #
- 62080822F
- Lot or Serial #
- > 100 Numbers, Contact Manufacturer
- Reason for Recall
- Two parts of the tubular packaging could become loose under the shrink wrap that holds the directions for use insert on the packaging tube and could render the product non-sterile.
- Trade Name
- G40, X150, X300 Ultrasound System
- Recall Posting Date
- 2009/09/14
- Manufacturer
- Siemens Medical Solutions USA, Inc.
- Recall Start Date
- 2009/08/12
- Recall Number
- 50581
- Hazard Classification
- Type III
- Model or Catalog #
- 8648375
- Lot or Serial #
- 302351, 303316, 300477
- Reason for Recall
- Letter to inform all customers on how volume flow calculations are calculated on the affected ultrasound systems and that the formulas determining flow volume are described in the included manual addendum.
- Trade Name
- Galileo 1000 Microliter Syringe
- Recall Posting Date
- 2009/09/28
- Manufacturer
- Immucor Inc.
- Recall Start Date
- 2009/08/24
- Recall Number
- 50713
- Hazard Classification
- Type III
- Model or Catalog #
- 65051
- Lot or Serial #
- >10 Numbers, Contact Manufacturer
- Reason for Recall
- The glue joint between the glass and the metal can be insufficient on some syringes, which, over the time, can lead to leaking and possibly to breakage of the glass barrel.
- Trade Name
- Galileo 500ul Syringes
- Recall Posting Date
- 2009/09/14
- Manufacturer
- Immucor Inc.
- Recall Start Date
- 2009/08/11
- Recall Number
- 50526
- Hazard Classification
- Type II
- Model or Catalog #
- 64999, 65050 (Syringe)
- Lot or Serial #
- N/A
- Reason for Recall
- The glue joint between the glass and the metal can be insufficient on some syringes, which can lead to leaking and possibly to breakage of the glass barrel.
- Trade Name
- Galileo Echo Blood Bank Analyzer
- Recall Posting Date
- 2009/09/28
- Manufacturer
- Immucor Inc.
- Recall Start Date
- 2009/08/28
- Recall Number
- 50717
- Hazard Classification
- Type II
- Model or Catalog #
- 87000
- Lot or Serial #
- N/A
- Reason for Recall
- QC may not be reset after reported QC failure. This occurs because QC passed but was repeated and failed prior to the 24-hour expiration period established for the first QC.
- Trade Name
- Genesis II Femorals
- Recall Posting Date
- 2009/07/20
- Manufacturer
- Smith & Nephew, Inc.
- Recall Start Date
- 2009/06/10
- Recall Number
- 49201
- Hazard Classification
- Type II
- Model or Catalog #
- 71420026
- Lot or Serial #
- 08HM17084
- Reason for Recall
- Smith & Nephew has received complaints of lugs missing from the femorals. The missing lugs are apparent to the user upon opening of the inner sterile tray.
- Trade Name
- Heartstart MRX Defibrillator/Monitor
- Recall Posting Date
- 2009/08/31
- Manufacturer
- Philips Medical Systems
- Recall Start Date
- 2009/07/02
- Recall Number
- 50290
- Hazard Classification
- Type II
- Model or Catalog #
- M3536A
- Lot or Serial #
- > 100 Numbers, Contact Manufacturer
- Reason for Recall
- In certain external transport use environments, the mechanical/electrical connection between the pads therapy cable (including pads/CPR cable) and the Heartstart MRX Defibrillator/Monitor may wear at an increased rate. Without routine operational checks, wear of the connection could ultimately prevent the device from sensing that the pads therapy cable is connected, or, cause the device to inappropriately identify external paddles or internal paddles when the pads therapy cable is connected.
- Trade Name
- HeartStart MRx Defibrillator/Monitor
- Recall Posting Date
- 2009/09/14
- Manufacturer
- Philips Medical Systems
- Recall Start Date
- 2009/08/18
- Recall Number
- 50623
- Hazard Classification
- Type II
- Model or Catalog #
- M3535A, M3536A
- Lot or Serial #
- Serial numbers US00533518 - US00535118
- Reason for Recall
- The devices were shipped with an incorrect configuration file, disarming the 'flashing red x' and audible alarms when they are powered by AC or DC power and have no battery or low battery capacity. This also causes a weekly self diagnostic test to run hourly depleting batteries faster than normal when stored without an external power source.
- Trade Name
- Hi-Art System
- Recall Posting Date
- 2009/09/14
- Manufacturer
- Tomotherapy Incorporated
- Recall Start Date
- 2009/08/13
- Recall Number
- 50472
- Hazard Classification
- Type II
- Model or Catalog #
- 101264
- Lot or Serial #
- 10037, 10169, 10014, 10072, 10130, 101212, 110009, 110129
- Reason for Recall
- During radiation treatment the usual data were not visible on the operator station display, even though the rad on indicators were active. The treatment was then stopped at around the 4min mark, but the system did not mark the treatment as interrupted. When the treatment was re-run, the entire treatment was delivered instead of starting at the 4min mark.
- Trade Name
- Hispeed FXi, LXi System
- Recall Posting Date
- 2009/08/03
- Manufacturer
- GE Healthcare
- Recall Start Date
- 2009/01/13
- Recall Number
- 45604
- Hazard Classification
- Type III
- Model or Catalog #
- B7520AZ, B7530AZ
- Lot or Serial #
- > 10 Numbers, Contact Manufacturer
- Reason for Recall
- X-ray leakage from diagnostic source (tube + collimator) exceeded 21CFR regulatory requirement and IEC standard. Concerns of increased patient exposure due to leakage of radiation.
- Trade Name
- HTA System
- Recall Posting Date
- 2009/09/14
- Manufacturer
- Boston Scientific Microvasive
- Recall Start Date
- 2009/08/05
- Recall Number
- 50466
- Hazard Classification
- Type II
- Model or Catalog #
- M006550160, M006550161, M006560200, M006560201
- Lot or Serial #
- > 10 Numbers, Contact Manufacturer
- Reason for Recall
- Possibility of thermal injury to patient resulting from fluid leakage at the cervix around the sheath.
- Trade Name
- Hydrodissector Cannulas
- Recall Posting Date
- 2009/09/14
- Manufacturer
- Hurricane Medical
- Recall Start Date
- 2009/05/14
- Recall Number
- 50440
- Hazard Classification
- Type II
- Model or Catalog #
- 4027
- Lot or Serial #
- 90402
- Reason for Recall
- It was discovered during final review of the product 4027, lot 090402 that the wrong product was issued for packaging. A similar ophthalmic cannula, product 2027 was inadvertently retrieved and packed as a product 4027.
- Trade Name
- Icelock expulsion valve 551
- Recall Posting Date
- 2009/08/03
- Manufacturer
- OSSUR HF
- Recall Start Date
- 2009/06/25
- Recall Number
- 49594
- Hazard Classification
- Type II
- Model or Catalog #
- N/A
- Lot or Serial #
- CO081010
- Reason for Recall
- The plastic cap on valve may detach from valve body breaking the vacuum and allowing the prosthesis to loosen or completely detach.
- Trade Name
- Immulite 2000 System-Androstenedione AS
- Recall Posting Date
- 2009/09/28
- Manufacturer
- Siemens Healthcare Diagnostics Products Limited
- Recall Start Date
- 2009/09/04
- Recall Number
- 50731
- Hazard Classification
- Type III
- Model or Catalog #
- L2KAO2
- Lot or Serial #
- 217
- Reason for Recall
- Lot numbers exhibit a positive bias with quality controls and patient results (average about +20%).
- Trade Name
- Immulite System-Total T4 Assay
- Recall Posting Date
- 2009/09/28
- Manufacturer
- Siemens Healthcare Diagnostics Products Ltd.
- Recall Start Date
- 2009/09/14
- Recall Number
- 50818
- Hazard Classification
- Type III
- Model or Catalog #
- LKT41, LKT45
- Lot or Serial #
- 351
- Reason for Recall
- Siemens Healthcare Diagnostics received customer complaints regarding Immulite / Immulite 1000 total T4 kit assay where the barcode did not correspond to the kit barcode lot number.
- Trade Name
- Impression Coping Closed Tray Regular Platform 05x9mm
- Recall Posting Date
- 2009/07/06
- Manufacturer
- Nobel Biocare AB
- Recall Start Date
- 2009/05/21
- Recall Number
- 48621
- Hazard Classification
- Type II
- Model or Catalog #
- N/A
- Lot or Serial #
- 687218
- Reason for Recall
- Impression Coping Closed Tray NobelActive Internal Regular Platform (RP) 05x9mm (article no. 34235, lot no. 687218) was incorrectly packaged with the larger size 06x9mm.
- Trade Name
- Instatrak 3500 System
- Recall Posting Date
- 2009/08/17
- Manufacturer
- GE OEC Medical Systems Inc.
- Recall Start Date
- 2009/07/23
- Recall Number
- 49926
- Hazard Classification
- Type II
- Model or Catalog #
- 1006236-001
- Lot or Serial #
- S/N'S IT35079, IT35214P, IT35226P
- Reason for Recall
- Proper validation was not performed on using the headset in an inverted (upside down) manner as described in the noted system's operators manual.
- Trade Name
- Instrument Manager
- Recall Posting Date
- 2009/07/06
- Manufacturer
- Data Innovations
- Recall Start Date
- 2009/06/18
- Recall Number
- 49308
- Hazard Classification
- Type III
- Model or Catalog #
- IM-B02 VX.XX
- Lot or Serial #
- N/A
- Reason for Recall
- Previous results retrieved from the specimen management database, which may be used by rules, may not be the most recent previous result.
- Trade Name
- InterDry Ag
- Recall Posting Date
- 2009/09/14
- Manufacturer
- Coloplast A/S
- Recall Start Date
- 2009/07/28
- Recall Number
- 50228
- Hazard Classification
- Type II
- Model or Catalog #
- 7910
- Lot or Serial #
- 1789435
- Reason for Recall
- Coloplast became aware of an InterDry AG stability test failure in that a sample submitted for testing contained no silver. Only a portion of 1 lot did not meet product specifications for silver content.
- Trade Name
- Kodiak Power Supply
- Recall Posting Date
- 2009/08/03
- Manufacturer
- Breg, Inc.
- Recall Start Date
- 2009/06/18
- Recall Number
- 49511
- Hazard Classification
- Type II
- Model or Catalog #
- N/A
- Lot or Serial #
- 3508, 3908, 4308, 4808
- Reason for Recall
- The power supply have short circuited at the electrical outlet upon initial use of the power supply, causing the circuit breaker for the specific electrical outlet to trip.
- Trade Name
- Kuschall K-Junior Manual Wheelchair
- Recall Posting Date
- 2009/08/03
- Manufacturer
- Kuschall AG
- Recall Start Date
- 2009/06/15
- Recall Number
- 49293
- Hazard Classification
- Type II
- Model or Catalog #
- K-Junior
- Lot or Serial #
- 806135534
- Reason for Recall
- A breakage of the pushbuggy handle has been occurring at a calculated weight of 65 kg.
- Trade Name
- Laparo-Thoraco Telescopes, Cable Unit
- Recall Posting Date
- 2009/07/20
- Manufacturer
- Olympus Winter & IBE GMBH
- Recall Start Date
- 2009/06/25
- Recall Number
- 49518
- Hazard Classification
- Type III
- Model or Catalog #
- A50001A, A50003A, A50021A, A50023A, WA50003L
- Lot or Serial #
- > 10 Numbers, Contact Manufacturer
- Reason for Recall
- Due to a geometrical incompatibility between the light guide cable and light source the "high intensity mode" cannot be switched on. Due to a production failure of the manufacturing partner, the distance between the coverglass of the light guide cable and the ledge does not meet specifications. Production between January 2009 and May 28, 2009 was affected.
- Trade Name
- Lasertek 5000
- Recall Posting Date
- 2009/08/31
- Manufacturer
- Scalp Laser
- Recall Start Date
- 2009/07/10
- Recall Number
- 50348
- Hazard Classification
- Type III
- Model or Catalog #
- N/A
- Lot or Serial #
- N/A
- Reason for Recall
- The Lasertek 5000 has been classified as a class II device in Canada. This device is not currently licenced for use in Canada.
- Trade Name
- LCT-1000 Therapy Laser
- Recall Posting Date
- 2009/07/06
- Manufacturer
- Litecure, LLC
- Recall Start Date
- 2009/05/15
- Recall Number
- 49192
- Hazard Classification
- Type II
- Model or Catalog #
- N/A
- Lot or Serial #
- N/A
- Reason for Recall
- The LCT-1000 Deep Tissue Laser Therapy is an unlicenced medical device.
- Trade Name
- Lightwave Ablator IA-2000-S
- Recall Posting Date
- 2009/08/31
- Manufacturer
- Linvatec Corporation D.B.A. Conmed Linvatec
- Recall Start Date
- 2009/08/05
- Recall Number
- 50376
- Hazard Classification
- Type II
- Model or Catalog #
- IA-2000-S
- Lot or Serial #
- > 10 Numbers, Contact Manufacturer (Numbers With Expiration Dates From July 2009 to Sept. 2013)
- Reason for Recall
- The manufacturer has determined there is a possibility that the device may not shut off if the ablate button is released.
- Trade Name
- M Series Remstar Heated Humidifier System
- Recall Posting Date
- 2009/08/17
- Manufacturer
- Respironics Inc.
- Recall Start Date
- 2009/07/31
- Recall Number
- 50202
- Hazard Classification
- Type II
- Model or Catalog #
- 1049109, 1049110, 1049124, 1051157, 1051158, R1049109, R1049110, U1049109, U1049110
- Lot or Serial #
- N/A
- Reason for Recall
- Some humidifiers may fail to operate due to a potential malfunction of the internal connection between the heater plate and the circuit board which results in a blinking blue light on the control knob.
- Trade Name
- M3 Micro-MLC For Varian With MLC
- Recall Posting Date
- 2009/07/06
- Manufacturer
- Brainlab AG
- Recall Start Date
- 2009/03/19
- Recall Number
- 47235
- Hazard Classification
- Type II
- Model or Catalog #
- 41600-3, 41600-5, 41600-6
- Lot or Serial #
- 01-006-41600, 01-044-41600, 41600-052-99, E41600-3/30793
- Reason for Recall
- Potential risk of interference when using BrainLAB M3 on a Varian Linear Accelerator with the Internal Varian Multileaf Collimator not in Park mode during treatment. The Internal Varian F-Collimator could interfere with the intended conformal fields of the BrainLAB M3 during patient treatment. This may cause a critical under-dosage of the target region.
- Trade Name
- Magna-FX Cannulated Screw Fixation
- Recall Posting Date
- 2009/09/14
- Manufacturer
- Zimmer Inc.
- Recall Start Date
- 2009/08/14
- Recall Number
- 50432
- Hazard Classification
- Type III
- Model or Catalog #
- 114607000
- Lot or Serial #
- 60471710
- Reason for Recall
- Some units in the affected lot of Magna-FX Cannulated Screw Fixation System cannulated bone screws may not have the hex broached into the head of the screw, making driver engagement impossible.
- Trade Name
- MC5057 Universal Cable
- Recall Posting Date
- 2009/09/14
- Manufacturer
- Linvatec Corporation D.B.A. Conmed Linvatec
- Recall Start Date
- 2009/08/14
- Recall Number
- 50401
- Hazard Classification
- Type II
- Model or Catalog #
- MC5057
- Lot or Serial #
- N/A
- Reason for Recall
- The possibility that a sufficiently worn/damaged Universal Cable MC5057, when used with various Conmed Linvatec electric handpieces may cause the handpiece to self activate.
- Trade Name
- MCS+Mobile Collection System, LN 9000
- Recall Posting Date
- 2009/09/28
- Manufacturer
- Haemonetics Corporation
- Recall Start Date
- 2009/08/31
- Recall Number
- 50666
- Hazard Classification
- Type II
- Model or Catalog #
- 09000-100-E, 09000-110-EWC
- Lot or Serial #
- >10 Numbers, Contact Manufacturer
- Reason for Recall
- The rare possibility exists for a pump encoder failure to go undetected and cause a pump to spin rapidly and possibly infuse anticoagulant to a donor. This has occurred just one time in over fifteen million procedures in the past 10 years.
- Trade Name
- MIS Diamond Burs
- Recall Posting Date
- 2009/08/17
- Manufacturer
- Stryker Instruments
- Recall Start Date
- 2009/07/13
- Recall Number
- 49950
- Hazard Classification
- Type II
- Model or Catalog #
- 8420-107-120, 8420-107-125, 8420-107-130, 8420-107-135
- Lot or Serial #
- > 10 Numbers, Contact Manufacturer
- Reason for Recall
- MIS Diamond Burs have the potential to deform and fracture at speeds above 50,000 rpm.
- Trade Name
- NX 8000 With V. NX2008 Or NX.x.8000
- Recall Posting Date
- 2009/08/03
- Manufacturer
- AGFA Healthcare N.V.
- Recall Start Date
- 2009/06/22
- Recall Number
- 49490
- Hazard Classification
- Type II
- Model or Catalog #
- NX SOFTWARE 2.0.7000, NX SOFTWARE 2.0.8000, NX SOFTWARE 3.0.7000, NX SOFTWARE 3.0.8000
- Lot or Serial #
- N/A
- Reason for Recall
- Under certain circumstances, after opening and closing a study on a CMS system while a study is still open on an in-room NX system, a problem of image mis-up can occur on the in-room NX system.
- Trade Name
- Olympus Mobile Workstation, Transformer
- Recall Posting Date
- 2009/07/20
- Manufacturer
- Keymed (Medical & Industrial Equipment) Ltd.
- Recall Start Date
- 2009/06/16
- Recall Number
- 49339
- Hazard Classification
- Type III
- Model or Catalog #
- MAJ-174, MH-787
- Lot or Serial #
- Serial Numbers Less Than 2810808
- Reason for Recall
- The fuse holder on the transformers assembled on the bottom of a number of Olympus WM Series Mobile Workstations (WM-NP1, WM-WP1, WM-DP1, WM-SC) can overheat and arc if the fuse carrier is not sufficiently tightened.
- Trade Name
- Operon D850/750/752/B810 Surgical Table
- Recall Posting Date
- 2009/08/17
- Manufacturer
- Berchtold Medizen-Elektronik GMBH
- Recall Start Date
- 2009/02/03
- Recall Number
- 50000
- Hazard Classification
- Type III
- Model or Catalog #
- B 810, D 750, D 752, D 850
- Lot or Serial #
- 3272-O10001, 3270-O10002, 3261-O10036
- Reason for Recall
- Upgrades initiated to avoid potential problems: pinch points and binding of release mechanism on headrest adaptors, floorlock retracting to unlock position, CPU errors involving involuntary table movements.
- Trade Name
- Oxidase Touch Sticks
- Recall Posting Date
- 2009/08/31
- Manufacturer
- Oxoid Limited
- Recall Start Date
- 2009/04/20
- Recall Number
- 50095
- Hazard Classification
- Type II
- Model or Catalog #
- N/A
- Lot or Serial #
- 657819, 660081, 669024, 680190, 682455
- Reason for Recall
- May produce weak positive or false negative results.
- Trade Name
- Paradigm Quick-Set Infusion Sets
- Recall Posting Date
- 2009/08/03
- Manufacturer
- Unomedical A/S
- Recall Start Date
- 2009/07/07
- Recall Number
- 49737
- Hazard Classification
- Type I
- Model or Catalog #
- MMT-396, MMT-397, MMT-398, MMT-399
- Lot or Serial #
- > 10 Numbers, Contact Manufacturer
- Reason for Recall
- Approximately 2% of infusion sets in the affected lots (lots starting with 8) may not allow the insulin pump to vent properly. Venting is necessary to equalize the pressure in the reservoir compartment with the surrounding atmosphere. If the vent does not work properly, this could result in too much or too little insulin being delivered. / Environ 2 % des dispositifs de perfusion des lots concernés (lots commençant par 8) ne permettent probablement pas à la pompe à insuline de s’aérer convenablement. L’aération est nécessaire pour pressuriser le compartiment de la seringue, où est inséré le réservoir, par rapport à l’air ambiant. Si la bouche d’aération fait défaut, il peut en résulter une administration excessive ou insuffisante d’insuline.
- Trade Name
- PCR AC-500/PCR AC-5000 Basic System
- Recall Posting Date
- 2009/08/03
- Manufacturer
- Philips Medical Systems DMC GMBH
- Recall Start Date
- 2009/02/23
- Recall Number
- 46769
- Hazard Classification
- Type II
- Model or Catalog #
- MCR1511
- Lot or Serial #
- N/A
- Reason for Recall
- Possibility that choice of patient will be changed when using filtered work lists. Normally problem detected because the "active" name of patient is displayed. This affects PCR Eleva system connected to a RIS.
- Trade Name
- Pedicap / Pedicap 6
- Recall Posting Date
- 2009/09/14
- Manufacturer
- Covidien LP - Respiratory & Monitoring Solutions GBU
- Recall Start Date
- 2009/08/18
- Recall Number
- 50527
- Hazard Classification
- Type I
- Model or Catalog #
- Pedicap, Pedicap 6
- Lot or Serial #
- > 10 Numbers, Contact Manufacturer
- Reason for Recall
- A recent modification to Pedicap end-tidal co2 detector may result in increased resistance to airflow through Pedicap and may cause ineffective ventilation of patient and inadequate detection of co2 levels, so that the indicator paper will not change colour.
- Trade Name
- Phenobarbital And Drug Calibrator 1
- Recall Posting Date
- 2009/09/14
- Manufacturer
- Beckman Coulter Inc.
- Recall Start Date
- 2009/08/28
- Recall Number
- 50663
- Hazard Classification
- Type II
- Model or Catalog #
- 469600, 469785
- Lot or Serial #
- Reagent part # 469785 lots M810083 and earlier, Drug Calibrator part # 469600 lots M810440 and earlier.
- Reason for Recall
- There is variability in results of Phenobarbital (PHE) Reagent and Drug Calibrator 1. Results may vary from -3% to +17% with different reagent and calibrator lot combinations when measured against the established gas chromatography flame ionization detection (GC-FID) method traceable to certified phenobarbital standards.
- Trade Name
- Powersail Coronary Dilation Catheter
- Recall Posting Date
- 2009/07/06
- Manufacturer
- Abbott Vascular
- Recall Start Date
- 2009/06/18
- Recall Number
- 49279
- Hazard Classification
- Type II
- Model or Catalog #
- 1005726-08
- Lot or Serial #
- 7112051
- Reason for Recall
- Received a report of damage to the distal shaft of the catheter. While the issue should be detected during the preparation of the product, it has the potential to cause a leak of contrast material. A leak has the potential to lead to a variety of catheter functional failures and clinical consequences as described in the instructions for use. Patients who have already been treated are not affected by this action and this action does not affect any other part number or lot number of the Powersail product line.
- Trade Name
- Quinton QStress TM55 Stress Treadmill
- Recall Posting Date
- 2009/07/20
- Manufacturer
- Cardiac Science Corporation
- Recall Start Date
- 2009/03/30
- Recall Number
- 49032
- Hazard Classification
- Type II
- Model or Catalog #
- N/A
- Lot or Serial #
- Serial # 11040079567, 11040079568
- Reason for Recall
- Review of test records indicated that the two impacted TM55 Stress Treadmills may not have received adequate testing prior to being shipped from the factory.
- Trade Name
- R Series Defibrillator/Pacemaker/Monitor
- Recall Posting Date
- 2009/09/28
- Manufacturer
- Zoll Medical Corporation
- Recall Start Date
- 2009/09/02
- Recall Number
- 50795
- Hazard Classification
- Type II
- Model or Catalog #
- Zoll R Series
- Lot or Serial #
- S/N AF07F001253, S/N AF08G005269, S/N AF08J005776, S/N AF08L006574, S/N AF09B006789, S/N AF09B006791
- Reason for Recall
- R series may display an ECG fault 7 message and fail to display the ECG baseline. Failure to display the patient's ECG could delay delivery of defibrillation or pacing therapy.
- Trade Name
- Removable Magnet Hires 90K
- Recall Posting Date
- 2009/07/20
- Manufacturer
- Advanced Bionics, LLC
- Recall Start Date
- 2009/06/12
- Recall Number
- 49409
- Hazard Classification
- Type II
- Model or Catalog #
- CI 1400-01, CI-1400-01, CI-1400-02H
- Lot or Serial #
- N/A
- Reason for Recall
- Advanced Bionics (AB) is notifying implant surgeons about the removable magnet component of the HiRes 90K Cochlear Implant (model no. CI-1400-01 and CI-1400-02h). The magnet is designed to be surgically removable if the Cochlear Implant patient needs to undergo an MRI. AB reports that devices manufactured between May 27 and June 30 of 2005 may have a magnet laser welding defect. The magnets were made such that the metal case surrounding the magnet is not properly welded. A patient implanted with an unwelded magnet could experience a decrease in the strength of the magnet over time, leading to headpiece retention issues. AB is aware of 14 defective magnets. In 7 cases the unwelded magnet resulted in surgery and replacement of the magnet. 2 of the replacements were for devices sold in Canada. An additional 5 potential cases outside of Canada and the USA are under investigation. Based on random sampling AB has determined the weld failure occurred at a rate of 1 in 126 devices. Devices manufactured outside the above time frame were not affected.
- Trade Name
- Reusable Metal Needle Guides & Bushings
- Recall Posting Date
- 2009/08/17
- Manufacturer
- GE Healthcare
- Recall Start Date
- 2009/04/30
- Recall Number
- 48986
- Hazard Classification
- Type I
- Model or Catalog #
- N/A
- Lot or Serial #
- > 10 Numbers, Contact Manufacturer
- Reason for Recall
- Operator manual does not contain description of a re-sterilization process for reusable biopsy metal needle guides for the stereotactic positioner.
- Trade Name
- Search-Cyte Duo Reagent Red Blood Cells
- Recall Posting Date
- 2009/09/28
- Manufacturer
- Biotest Medical Diagnostics GMBH
- Recall Start Date
- 2009/08/24
- Recall Number
- 50727
- Hazard Classification
- Type III
- Model or Catalog #
- 70226
- Lot or Serial #
- 169053
- Reason for Recall
- Cell II of this product tests positive with the direct coombs test which interferes with antibody screening procedures causing false positive results.
- Trade Name
- Sequencer
- Recall Posting Date
- 2009/09/28
- Manufacturer
- Impac Medical Systems Inc.
- Recall Start Date
- 2009/08/27
- Recall Number
- 50644
- Hazard Classification
- Type III
- Model or Catalog #
- 10-0020
- Lot or Serial #
- Sequencer for MOSAIQ 1.30, Sequencer for MOSAIQ 1.40, Sequencer for MOSAIQ 1.41, Sequencer for MOSAIQ 1.50, Sequencer for MOSAIQ 1.60, Sequencer for MOSAIQ 2.00
- Reason for Recall
- The problem is a defect in the RTP Import functionality (SEQUENCER) during the import of an RTP plan, which converts the Field between coordinate systems that swap the X and Y axes (e.g., from IEC1217 to IEC601). The subject defect did not impair the accuracy of or the ability to use QA mode.
- Trade Name
- Sireskop SX/SD
Updated recall # 47071 previously posted on 2009-06-22. - Recall Posting Date
- 2009/09/14
- Manufacturer
- Siemens AG
- Recall Start Date
- 2009/02/11
- Recall Number
- 47071
- Hazard Classification
- Type III
- Model or Catalog #
- 10093754, 31 11 676, 3111668
- Lot or Serial #
- 21005, 21040, 21087, 21107, 21110, 31036, 34170, 36103, 41021
- Reason for Recall
- Penetrating liquids or sprays entering the system may lead to malfunction of the system, resulting in unintentional movement, unintentional radiation, extended radiation or useless image, endangering the patient or operator.
- Trade Name
- Smartmonitor 2 With PCMCIA
- Recall Posting Date
- 2009/08/17
- Manufacturer
- Respironics Inc.
- Recall Start Date
- 2009/05/11
- Recall Number
- 48114
- Hazard Classification
- Type I
- Model or Catalog #
- 4002, 4003
- Lot or Serial #
- S/N: 3000033364 to 3000038740
- Reason for Recall
- There is a variation in the SmartMonitor 2 manufacturing process that could allow the wire harness attached to the alarm to be pinched between the upper and lower case of the SmartMonitor 2 units. If the wire harness is pinched such that the conductive wires are exposed, they can short to the electrically conductive coating on the inside of the case. This can result in a situation where the alarm will not sound. However, even if the audible alarm fails, the unit will still trigger a visual alert (red lights will come on).
.
- Trade Name
- Sonara Transcranial Doppler System
- Recall Posting Date
- 2009/08/17
- Manufacturer
- Cardinal Health 209, Inc. DBA Viasys Healthcare Inc, Viasys Neurocare
- Recall Start Date
- 2009/02/11
- Recall Number
- 49919
- Hazard Classification
- Type II
- Model or Catalog #
- 982A0470
- Lot or Serial #
- PWH0201
- Reason for Recall
- Various forms of system lockup or display screen "freezes" can occur. Surgical monitoring has a remote probability that a lockup could cause any permanent impairment of the body function or permanent damage to a body structure.
- Trade Name
- Spinnaker Elite Flow Directed Catheter
- Recall Posting Date
- 2009/09/28
- Manufacturer
- Boston Scientific Cork Ltd.
- Recall Start Date
- 2009/08/05
- Recall Number
- 50289
- Hazard Classification
- Type II
- Model or Catalog #
- 549015-2, 549020-2, 549030-2, 559010-2, 559020-2, 559030-2
- Lot or Serial #
- N/A
- Reason for Recall
- Boston is sending safety alert to customers to re-emphasize the device's approved indications and remind that this product is not intended or indicated for use with glue or glue mixtures.
- Trade Name
- Staph Xtra Latex Kit
- Recall Posting Date
- 2009/09/28
- Manufacturer
- Pro-Lab Diagnostics
- Recall Start Date
- 2009/06/30
- Recall Number
- 49925
- Hazard Classification
- Type II
- Model or Catalog #
- PL.1080, PL.1081
- Lot or Serial #
- PL1080 Lot 6066, PL1080 LOT 6087, PL1080 LOT 6240, PL1081 LOT 5927, PL1081 LOT 6067, PL1081 LOT 6088, PL1081 LOT 6127, PL1081 LOT 6237, PL1081 LOT C6340, PL1081 LOT C6375
- Reason for Recall
- The affected lot numbers of the reagent, may display graininess that could be mis-interpreted as a false positive result.
- Trade Name
- Staphaurex Plus 150/450 Test Kits
- Recall Posting Date
- 2009/08/31
- Manufacturer
- Remel Europe Ltd.
- Recall Start Date
- 2009/03/27
- Recall Number
- 50094
- Hazard Classification
- Type II
- Model or Catalog #
- N/A
- Lot or Serial #
- J477610, J359510
- Reason for Recall
- A potential for false positive reactions with some strains of staphylococcus epidermidis which may result in misidentification as taphylococcus aureus.
- Trade Name
- Stat G3+ Cartridges
- Recall Posting Date
- 2009/07/06
- Manufacturer
- Abbott Point Of Care Inc.
- Recall Start Date
- 2009/05/12
- Recall Number
- 48497
- Hazard Classification
- Type II
- Model or Catalog #
- 06F03-01, 06F03-02
- Lot or Serial #
- P08321C
- Reason for Recall
- Box numbers 1491 and 1534 of this device from lot # P083221C have suboptimal pouch seals. If a cartridge or suboptimal pouch seal is run, there is a possibility that the performance of the cartridge assays may be impacted.
- Trade Name
- Stellant CT Dual Injector Systems P3T
- Recall Posting Date
- 2009/08/03
- Manufacturer
- Medrad Inc.
- Recall Start Date
- 2009/06/19
- Recall Number
- 49618
- Hazard Classification
- Type II
- Model or Catalog #
- 3007301, 3010432, 3014849
- Lot or Serial #
- N/A
- Reason for Recall
- 1. When P3T cardiac protocols are programmed with saline test inject and used in conjunction with ISI 700 or ISI 800 products and the Stellant CT Injection system, the pre-diagnostic protocol must include a transit bolus.
2. A defect in SW version 103.0 and 104.0 of the Stellant CT injection systems may cause ISI 700 accessory to incorrectly trigger bolus tracking on a Philips CT system for P3T cardiac protocol.
- Trade Name
- Stratus OCT Tomographer Vers. 6.0 Software
- Recall Posting Date
- 2009/09/14
- Manufacturer
- Carl Zeiss Meditec Inc.
- Recall Start Date
- 2009/08/14
- Recall Number
- 50625
- Hazard Classification
- Type II
- Model or Catalog #
- Stratus OCT
- Lot or Serial #
- Software Version 6.0.0
- Reason for Recall
- A defect in Version 6.0.0 of Stratus OCT instrument and review software, in certain situations reports generated will have incorrectly labelled OD (right eye) or OS (left eye).
- Trade Name
- Stromatolyser-IM
- Recall Posting Date
- 2009/08/03
- Manufacturer
- Sysmex Reagents America
- Recall Start Date
- 2009/06/26
- Recall Number
- 49463
- Hazard Classification
- Type III
- Model or Catalog #
- SIM-220A
- Lot or Serial #
- c0910, c9011, c9013, c9014, c9015, c9016, c9017
- Reason for Recall
- Seven lots of Stromatolyser-IM (SIM-220A) manufactured between March 3,2009 and March 26th,2009 have tested positive for a pseudomonas type species of bacteria.
- Trade Name
- Sur-Catch No Tip Nitinol Stone Basket
- Recall Posting Date
- 2009/07/06
- Manufacturer
- Gyrus Acmi, Inc.
- Recall Start Date
- 2009/06/04
- Recall Number
- 49030
- Hazard Classification
- Type II
- Model or Catalog #
- 5711222
- Lot or Serial #
- 89261CB, 89262CB, 91665DB, 91666DB
- Reason for Recall
- Due to an error, some product was shipped out with a new polyamide sleeve material before the qualifying process was completed. Because of this, Gyrus ACMI cannot ensure that the product's shelf life will meet the expiration date on the label.
- Trade Name
- Sutureless Connector Intrathecal Catheters and Revision Kits
- Recall Posting Date
- 2009/09/28
- Manufacturer
- Medtronic Inc.
- Recall Start Date
- 2009/08/27
- Recall Number
- 50614
- Hazard Classification
- Type I
- Model or Catalog #
- 8578, 8709SC, 8731SC, 8596SC
- Lot or Serial #
- >10 Numbers, Contact Manufacturer
- Reason for Recall
- Medtronic has determined that Sutureless Connector (SC) Intrathecal Catheters and Revision Kits are not compatible with Isomed Infusion Pumps. A physical interference between the SC Catheter Connector and the Isomed Pump prevents the SC Catheter from completely connecting to the Isomed Pump even though it may appear to be connected and feel secure.
- Trade Name
- Synchromed II Implantable Infusion Pump
- Recall Posting Date
- 2009/08/03
- Manufacturer
- Medtronic Inc.
- Recall Start Date
- 2009/07/14
- Recall Number
- 49972
- Hazard Classification
- Type II
- Model or Catalog #
- 8637
- Lot or Serial #
- > 100 Numbers, Contact Manufacturer
- Reason for Recall
- Reduced battery performance (estimated at 2.1% of affected population) has resulted in 8 occurrences of low battery reset between 47 and 56 months, and 1 occurrence of premature elective replacement indicator (ERI) at 54 months post-implant. For affected pumps, the minimum time frame of 90 days between ERI and end of service (EOS) may also be reduced.
- Trade Name
- Synchron CX Immuno-Protein Calibrator
- Recall Posting Date
- 2009/09/14
- Manufacturer
- Beckman Coulter Inc.
- Recall Start Date
- 2009/08/24
- Recall Number
- 50657
- Hazard Classification
- Type II
- Model or Catalog #
- 442840
- Lot or Serial #
- M901330 And Higher
- Reason for Recall
- The recovery of the standard has shifted. Standardizaton of the Immuno Protein Calibrator Set has been re-established to IFCC reference preparation for plasma proteins, BCD-470. This has caused a shift in quality control results and patient results for IgG, IgA, TRF and IgM.
- Trade Name
- Synchron Rheumatoid Factor (RF) Reagent
- Recall Posting Date
- 2009/08/03
- Manufacturer
- Beckman Coulter Inc.
- Recall Start Date
- 2009/07/08
- Recall Number
- 49912
- Hazard Classification
- Type II
- Model or Catalog #
- 475136
- Lot or Serial #
- M802452, M804502, M807345, M808329
- Reason for Recall
- As the Synchron RF Rreagent ages, it may fail calibration with the condition of "math error" on the calibration report. Real time testing in manufacturing indicates the stability claim of 24 months will not be met for lot numbers: M802452, M804502, M807345 and M808329. Calibration failures occur at 12 months.
- Trade Name
- TDWorkstation Working With Sebia Hyris
- Recall Posting Date
- 2009/08/31
- Manufacturer
- Technidata S.A.S.
- Recall Start Date
- 2009/07/26
- Recall Number
- 50203
- Hazard Classification
- Type II
- Model or Catalog #
- TD-WST-01
- Lot or Serial #
- V.11.11.A, V.12.51.A, V.12.61.A
- Reason for Recall
- In a specific case, the TDWorkstation sends the total protein result to the instrument for a wrong patient. Software defect 24578.
- Trade Name
- TDX SR Power Wheelchair
- Recall Posting Date
- 2009/09/28
- Manufacturer
- Invacare Corporation
- Recall Start Date
- 2009/09/02
- Recall Number
- 50704
- Hazard Classification
- Type II
- Model or Catalog #
- TDXSR, TDXSR-CG, TDXSR-CG-HD, TDXSR-HD, TDXSR-MCG, TDXSR-MCG-HD, TDXSRV-HD
- Lot or Serial #
- N/A
- Reason for Recall
- On some chairs the stability lock feature may not be engaging properly or consistently. If the stability lock feature does not engage properly, the wheelchair may exhibit a tendency to do one or more of the following: 1) veer to one side, 2) rock forward onto its front riggings, 3) drive in an unintended circular motion, and/or 4)fall forward or to one side and injure the user.
- Trade Name
- Teleflex Medical Surgical Scissors
- Recall Posting Date
- 2009/08/31
- Manufacturer
- Teleflex Medical
- Recall Start Date
- 2009/07/06
- Recall Number
- 49787
- Hazard Classification
- Type II
- Model or Catalog #
- 352164, 352165, 352166, 352167, 352168, 352169, 352178
- Lot or Serial #
- RR8, SS8, TT8, UU8, VV8, WW8, XX8, MM9, WW7, XX7, MM8, NN8, OO8, PP8, QQ8
- Reason for Recall
- Manufacturer has identified a defect, a rough square finish to the scissor tips rather than a smooth tip, could cause damage to the inner wall of the blood vessel rendering it unsuitable for bypass graft.
- Trade Name
- TempBond Clear with Triclosan
- Recall Posting Date
- 2009/09/28
- Manufacturer
- Kerr Corporation
- Recall Start Date
- 2009/09/09
- Recall Number
- 50813
- Hazard Classification
- Type III
- Model or Catalog #
- 33351
- Lot or Serial #
- 3257280, 3229807, 3268505, 3277455, 3258772, 3269811
- Reason for Recall
- Manufacturer received 21 complaints that catalyst portion of TempBond Clear with Triclosan syringes was polymerized and therefore unusable. An investigation confirmed the complaints.
- Trade Name
- TestOxidase Reagent
- Recall Posting Date
- 2009/09/28
- Manufacturer
- Pro-Lab Diagnostics
- Recall Start Date
- 2009/06/30
- Recall Number
- 49922
- Hazard Classification
- Type III
- Model or Catalog #
- PL.390
- Lot or Serial #
- 5824, 5884, 5971, 6038, 6136
- Reason for Recall
- The affected lot numbers of the reagent, normally clear or tan in colour, have shown a purple discolouration. Product performance is not affected.
- Trade Name
- Tina-quant a Apolipoprotein A1
- Recall Posting Date
- 2009/08/03
- Manufacturer
- Roche Diagnostics GMBH
- Recall Start Date
- 2009/07/17
- Recall Number
- 49761
- Hazard Classification
- Type III
- Model or Catalog #
- 3032612122
- Lot or Serial #
- All Lot Numbers
- Reason for Recall
- The manufacturer identified a reduction of the on board stability from 42 days to 14 days for the Hitachi Tina-quant Apolipoprotein A1 reagent when used on the Roche Hitachi 912 and 917 and MODULAR P systems.
- Trade Name
- Triage Tox Drug Screen PN 94400
- Recall Posting Date
- 2009/08/03
- Manufacturer
- Biosite Incorporated
- Recall Start Date
- 2009/05/29
- Recall Number
- 50030
- Hazard Classification
- Type III
- Model or Catalog #
- 94400
- Lot or Serial #
- > 10 Numbers, Contact Manufacturer
- Reason for Recall
- Biosite, Inc. initiates notice of correction for Triage TOX Drug Screen Kit, PN 94400. Boxes shipped after August 6, 2008 are misprinted on the right side of the box flap. The misprint incorrectly states "use EDTA whole blood or plasma sample only". The kit is intended for use with urine samples not blood or plasma.
- Trade Name
- Trident Acetabular Surgical Protocol
- Recall Posting Date
- 2009/07/20
- Manufacturer
- Howmedica Osteonics Corporation
- Recall Start Date
- 2009/06/15
- Recall Number
- 49269
- Hazard Classification
- Type II
- Model or Catalog #
- N/A
- Lot or Serial #
- N/A
- Reason for Recall
- The Trident Acetabular System surgical protocol (LSP55) needs to be modified to create separate and distinct surgical protocols, one for the Trident PSL Shell (LSP68) and one for the Trident Hemispherical Shell (LSP69) in order to clarify and highlight the differences in reaming technique.
- Trade Name
- Trinclot APTT HS, Product Code T1204
- Recall Posting Date
- 2009/08/03
- Manufacturer
- Trinity Biotech PLC
- Recall Start Date
- 2009/05/25
- Recall Number
- 49896
- Hazard Classification
- Type II
- Model or Catalog #
- T1204
- Lot or Serial #
- R324001
- Reason for Recall
- Precision issues with this lot may result in increased aPTT times across the range of the assay.
- Trade Name
- Trinical Reference Plasma T5102
- Recall Posting Date
- 2009/08/03
- Manufacturer
- Trinity Biotech PLC
- Recall Start Date
- 2009/05/21
- Recall Number
- 49894
- Hazard Classification
- Type II
- Model or Catalog #
- T5102
- Lot or Serial #
- R332037, R332037R, S287001
- Reason for Recall
- Trinity Biotech initiates a corrective field action for TriniCAL Reference Plasma, product code T5102 (lots R332037, R332037R and S287001). The protein C chromogenic value is misassigned in these lots and can result in an erroneous protein C chromogenic activity result.
- Trade Name
- Triniclot APPT S, Cat. No. T1202
- Recall Posting Date
- 2009/08/03
- Manufacturer
- Trinity Biotech PLC
- Recall Start Date
- 2009/04/23
- Recall Number
- 49895
- Hazard Classification
- Type II
- Model or Catalog #
- T1202
- Lot or Serial #
- S067009
- Reason for Recall
- Precision and open vial stability issues with this lot may result in increased or decreased aPTT times across the range of the assay. The lot is not stable for the full 30 day period when opened and stored at 2-8 c as recommended.
- Trade Name
- Twin-Pass Dual Access Catheter
- Recall Posting Date
- 2009/08/17
- Manufacturer
- Vascular Solutions, Inc.
- Recall Start Date
- 2009/07/02
- Recall Number
- 49872
- Hazard Classification
- Type I
- Model or Catalog #
- 5200
- Lot or Serial #
- > 10 Numbers, Contact Manufacturer
- Reason for Recall
- 3 occurrences of catheters containing a piece of PTFE beading material in the OTW lumen have been reported. The PTFE beading material is a processing aide used during hydrophilic coating. The beading is to be removed followed by a visual inspection prior to packaging. The problem may cause partial or complete blockage of a vessel due to embolization, and/or vessel injury.
- Trade Name
- Ultrapower Diamond Wheel Bur
- Recall Posting Date
- 2009/09/14
- Manufacturer
- Linvatec Corporation D.B.A. Conmed Linvatec
- Recall Start Date
- 2009/08/04
- Recall Number
- 50380
- Hazard Classification
- Type II
- Model or Catalog #
- 7021-092, 7021-292, 7021-393
- Lot or Serial #
- > 10 Numbers, Contact Manufacturer
- Reason for Recall
- This device ID was included because of the error on device ID #23037. The catalogue # 7021-392 was wrongly listed under device ID 406636 instead of 406639. Company already have send corrective fax-back to MDB.
- Trade Name
- Uniglide Femoral Component, Non-Cemented
- Recall Posting Date
- 2009/08/17
- Manufacturer
- Corin Limited
- Recall Start Date
- 2009/07/20
- Recall Number
- 49985
- Hazard Classification
- Type II
- Model or Catalog #
- 514.0300, 514.0400
- Lot or Serial #
- KNRU, KNTK
- Reason for Recall
- The nonconforming devices were comingled during the manufacturing process. For lot KNRU, there are devices in unit boxes with labels marked size 4 and devices marked '514.0400, size 4', that are actually size 3. For lot KNTK, there are devices in unit boxes with labels marked size 3 and devices marked '514.0300, size 3', that are actually size 4.
- Trade Name
- Uniglide Tibia, Cementless Size 7
- Recall Posting Date
- 2009/09/28
- Manufacturer
- Corin Limited
- Recall Start Date
- 2009/08/06
- Recall Number
- 50619
- Hazard Classification
- Type III
- Model or Catalog #
- 525.07
- Lot or Serial #
- NACN
- Reason for Recall
- Insufficient process control of the sterile barrier (blister lid) sealing process. The devices have been sealed in blister packs. Pack test results from one day's production met minimum requirements of the testing regime but there was a step change in the test results indicating a change to the validated process.
- Trade Name
- Varelisa MPO ANCA
- Recall Posting Date
- 2009/08/03
- Manufacturer
- Phadia GMBH
- Recall Start Date
- 2009/04/09
- Recall Number
- 49897
- Hazard Classification
- Type III
- Model or Catalog #
- 17696
- Lot or Serial #
- 32
- Reason for Recall
- The negative control shows an elevated signal. It can exceed the upper quality control limit of 0.200 OD given in the directions for use.
- Trade Name
- Versys Hip System Femoral Head
- Recall Posting Date
- 2009/08/31
- Manufacturer
- Zimmer Inc.
- Recall Start Date
- 2009/08/06
- Recall Number
- 50277
- Hazard Classification
- Type II
- Model or Catalog #
- 801802802
- Lot or Serial #
- 60378581
- Reason for Recall
- This action is being conducted because the potential exists for residual buffing compound to be present on the surfaces of the femoral head.
- Trade Name
- VGM 19" Monitor
Updated recall # 48079 previously posted on 2009-05-25. - Recall Posting Date
- 2009/08/31
- Manufacturer
- Welch Allyn Protocol, Inc.
- Recall Start Date
- 2009/04/21
- Recall Number
- 48079
- Hazard Classification
- Type II
- Model or Catalog #
- VG930M
- Lot or Serial #
- S/NS > QC2082880001
- Reason for Recall
- 48 complaints reporting that the monitors lost power unexpectedly or when they attempted to power up which resulted in loss of both visual and secondary alarm enunciation from the LCD flat panel.
- Trade Name
- Warmer, Infant Radiant
- Recall Posting Date
- 2009/09/14
- Manufacturer
- Draeger Medical Systems, Inc.
- Recall Start Date
- 2009/07/20
- Recall Number
- 50549
- Hazard Classification
- Type I
- Model or Catalog #
- 1250, 1500, 200, 2000, 2000/3000, 2200/3200, 300, 3000, 3200, 79 FMT
- Lot or Serial #
- All Serial Numbers
- Reason for Recall
- After a brief intense fire in a neonatal unit in the United States, an ECRI investigations concluded the stabilet was the ignition source for the fire.
- Trade Name
- Welch Allyn AED10 Defib, MRL Jumpstart
- Recall Posting Date
- 2009/08/17
- Manufacturer
- Welch Allyn Protocol, Inc.
- Recall Start Date
- 2009/07/30
- Recall Number
- 50054
- Hazard Classification
- Type II
- Model or Catalog #
- 970300E, 970302E, 970302F, 970308E,
970311-E - Lot or Serial #
- > 10 Numbers, Contact Manufacturer
- Reason for Recall
- If a user experiences a flashing low battery status indicator and does not understand that the device can continue to be used, the user might choose not to continue operating the device, causing therapy to be delayed or
- Trade Name
- Wellcolex Colour Salmonella
- Recall Posting Date
- 2009/08/31
- Manufacturer
- Remel Europe Ltd.
- Recall Start Date
- 2009/04/03
- Recall Number
- 50093
- Hazard Classification
- Type II
- Model or Catalog #
- RE30858301, RE30858302
- Lot or Serial #
- J438110, J438910
- Reason for Recall
- Potential of false positive reactions (blue agglutination) for salmonella E or G serogroups with reagent # 2 included in the kits.
