2012 Product Recalls
5,173 recalls issued in 2012.
Showing 4941–4960 of 5,173 recalls
CAPIOX Flexible Venous Reservoirs, 1500 mL, product codes: CXFVR1500X and CXFVRI500XC, used singly or packaged as components in cardiovascular procedure trays labeled in part ***Terumo Caerdiovascular Systems Corporation, Elkton, MD 21921*** Product Usage: The reservoir bag is intended for use as a blood collection and storage device during cardiopulmonary bypass procedures. The device is intended for use in conjunction with blood-gas oxygenators in the extra-corporeal circuit. The device may
Reservoir blood bag used in cardiovascular procedures may leak.
Terumo Cardiovascular Systems Corporation sent an "URGENT MEDICAL DEVICE REMOVAL" letter dated July 20, 2011, to all affected consignee. The letter described the problem, the potential hazard, and the actions to be taken. The letter instructed customers to identify affected inventory and segregate from non-affected product. The recalling firm advises users to not use affected product and return for replacement. The customers are instructed to call the recalling firm Customer Service for a Returned Goods Authorization (RGA) number. Customers were asked to complete the attached Response Form and return as per the instructions. Consignees with questions should call 1-800-521-2818 Monday through Friday 8AM to 6PM EST.
ARCHITECT C-Peptide Reagent Kit; a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of C-Peptide in human serum, plasma and urine on the ARCHITECT i System; Produced by Biokit S.A., 08186 Barcelona, Spain for Abbott Diagnostics Division, Distributed by Abbott Laboratories, Abbott Park, IL 60064 USA and Abbott, 65205 Wiesbaden, Germany; list 3L53-25 The ARCHITECT C-Peptide assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative deter
C-Peptide lots 03610K000 and 01711A000 have the potential to generate falsely elevated results with certain patient samples and with non-Abbott Controls.
Abbott Laboratories sent a "PRODUCT RECALL" letter dated July 11, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. The letter instructs customers to discontinue use of the lots and destroy any remaining inventory of the lots according to laboratory procedures. A Customer Reply form was provided to customers to complete and return via fax at 1-800-777-0051. Customers can contact Abbott Customer Service at 1-877-4ABBOTT for questions regarding this notice.
Pathfinder End Screw Extender Sleeve, REF 1165-10, Rx, non-sterile, sold under label Abbott Spine, Inc. Austin TX (prior to 2008) and Zimmer Spine Austin TX (7/2009 to present)
The tip of the PathFinder End Screw Extender Sleeve has fractured during use. In some cases, this instrument fracture led to surgical delay or additional surgical steps necessary to remove the fragments of the broken tip.
Zimmer Spine issued an "Urgent Medical Device Correction" letter through the Zimmer Spine sales force to be provided to PathFinder system users in February 2010. the letter identified the affected product, safety issue, and actions to be taken by customers. Customers will receive replacement devices with a design change for the recalled devices, as they are available from the manufacturer.
Photo DR, Model V-230HV Implantable Cardioverter Defibrillator
Vendor-supplied memory chip in a limited number of St. Jude Medical ICDs can trigger a temporary loss of pacing function and permanent los of defibrillation support.
Notification material sent to physicians by FedEx. Acknowledgement of receipt of the notification material will be monitored with this information being fed back to St. Jude Medical CRMD in Sylmar, California. In addition, St Jude Medical issued a press release on October 7, 2005.
X-Ray High Voltage Generator, Model KXO-80G used on Image Intensified Fluoroscopoc X-Ray System DUA-450D
Non-compliance with Radiation Standards. Incorrect display of the radiographic time, due to software anomaly.
Firm sent recall letters to customers and will be following up with field corrections which will be made on-site by the firm's own employees.
Alaris Medical Systems IV Administration Set, Low Sorbing Extension Set, Model C20014, Rx Only, Alaris Medical Systems, Lot Number 07036013
The sterility of the product may be compromised as the packaging used for the sterility barrier was not designed for the sterility process used by the firm.
Recall Notification consists of a phone call and Recall Notification letters to consignees (distributors) as well as direct customers. On June 5, 2007, Cardinal Health began calling customers and distributors to inform them of a recall affecting IV Administration Set, Model C20014, Lot Number 07036013 (Low Sorbing Extension Set). A follow-up Recall Notification Letter was sent on June 11, 2007. The customers and distributors were notified by registered return receipt mail. For direct customers, letters were sent directly to the point of contact at the hospital. For distributors, they were sent multiple copies of the Recall Notification; along with a cover letter outlining their responsibilities to complete the Recall plan and notify their customers as requested.
PARKING BRAKE
IF THE PARKING BRAKE CABLE RUBS, IT MAY FAIL TO RELEASE, OR OVER TIME IT MAY ABRADE UNTIL IT TO FAILS, RESULTING IN THE VEHICLE ROLLING AWAY WITHOUT PRIOR WARNING POSSIBLY CAUSING PERSONAL INJURY OR DEATH.
WINNEBAGO WILL NOTIFY OWNERS, AND DEALERS WILL SHORTEN THE METAL TUBE TO PROVIDE CLEARANCE FOR THE PARKING BRAKE CABLE, FREE OF CHARGE. THE SAFETY RECALL BEGAN ON FEBRUARY 17, 2012. OWNERS MAY CONTACT WINNEBAGO INDUSTRIES OWNER RELATIONS AT 1-641-585-6939.
V-BAND CLAMP ASSEMBLY
IF THE INLET OR OUTLET SECTIONS DISCONNECT, HOT EXHAUST GASES CAN VENT PRIOR TO EXITING THE TAILPIPE, CREATING THE RISK OF COMBUSTION AND A FIRE. IF BOTH CLAMPS FAIL, THERE IS A RISK IN SOME APPLICATIONS THAT THE DOC/DPF HOUSING MAY DETACH COMPLETELY, CREATING A ROAD HAZARD.
TIFFINS IS WORKING WITH CUMMINS TO IDENTIFY AND NOTIFY OWNERS OF THE RECALL CAMPAIGN. REPAIRS WILL BE PERFORMED BY AUTHORIZED CUMMINS DEALERS FREE OF CHARGE. OWNERS MAY CONTACT CUMMINS AT 1-812-377-5000 OR TIFFINS AT 256-356-8661.
SIDE CURTAIN AIR BAG INFLATOR
THE SIDE CURTAIN AIR BAGS MAY NOT DEPLOY, INCREASING THE RISK OF INJURY.
SUBARU WILL NOTIFY OWNERS, AND DEALERS WILL REPLACE ONE OR BOTH SIDE CURTAIN AIR BAG MODULES, FREE OF FEBRUARY 21, 2012. OWNERS MAY CONTACT SUBARU AT 1-800-782-2783.
SERVICE BRAKES/TRACTION RELAY VALVE
UNEXPECTED CONTINUOUS BRAKE APPLICATION CAN CAUSE THE BRAKES TO OVERHEAT AND LEAD TO A FIRE. UNEXPECTED CONTINUOUS BRAKE APPLICATION CAN CAUSE THE DRIVER TO LOSE CONTROL OF THE VEHICLE, INCREASING THE RISK OF A CRASH. ALSO, THE BRAKES MAY BE APPLIED WITHOUT ILLUMINATING THE BRAKE LIGHTS, FAILING TO GIVE PROPER WARNING TO OTHER DRIVERS.
AUTOCAR WILL NOTIFY OWNERS, AND DEALERS WILL PROVIDE A TEMPORARY REPAIR UNTIL BENDIX DEVELOPS A PERMANENT REMEDY. THIS SERVICE WILL BE PERFORMED FREE OF CHARGE. THE SAFETY RECALL BEGAN ON AUGUST 8, 2012. OWNERS MAY CONTACT AUTOCAR AT 1-765-489-5499.
DOOR CLOSURE WARNING SYSTEM/FMVSS 206
A DOOR LATCH SYSTEM THAT DOES NOT COMPLY WITH STRENGTH REQUIREMENTS MAY NOT REMAIN FULLY LATCHED KEEPING THE DOOR CLOSED, ESPECIALLY IN THE EVENT OF A CRASH, AND MAY INCREASE THE POSSIBILITY OF OCCUPANT PARTIAL OR FULL EJECTION.
MORGAN OLSON WILL NOTIFY OWNERS, AND THE VEHICLES WILL BE REPAIRED FREE OF CHARGE. THE SAFETY RECALL BEGAN ON APRIL 25, 2012. OWNERS MAY CONTACT MORGAN OLSON AT 1-269-659-0200.
Tassimo espresso T Discs Recalled for Burn Hazard
The recalled espresso T Discs can become clogged and spray hot liquid and coffee grounds onto consumers and bystanders during or after brewing, posing a burn hazard.
Consumers should stop using the recalled espresso T Discs immediately and contact the firm for a full refund.
Tassimo Single-Cup Brewers Recalled for Burn Hazard
The plastic disc, or T Disc, that holds the coffee or tea can burst and spray hot liquid and coffee grounds or tea leaves onto consumers using the brewer and onto bystanders, posing a burn hazard.
Consumers should immediately stop using the recalled Tassimo brewers and contact the firm to order a free replacement T Disc holder for the brewing mechanism.
EVAPORATOR ASSEMBLIES/POSSIBLE FIRE
IF SUFFICIENT ARCING OCCURS, THE FUSE HOLDER MAY MELT AND POTENTIALLY CAUSE A FIRE.
TURTLE TOP WILL NOTIFY OWNERS AND PROVIDE INFORMATION ON HOW TO OBTAIN THE RETROFIT KIT FROM CARRIER ALONG WITH REPAIR INSTRUCTIONS. THIS SERVICE WILL BE PERFORMED FREE OF CHARGE. THE SAFETY RECALL BEGAN ON MARCH 21, 2012. (SEE CARRIER'S RECALL CAMPAIGN 11E-003.) OWNERS MAY CONTACT CARRIER AT 1-800-348-7440.
ELECTRIC DRIVE MOTOR
THE UNINTENDED MOVEMENT OF THE VEHICLE MAY CAUSE A COLLISION WITH A PERSON OR OBJECT, LEADING TO PROPERTY DAMAGE, PERSONAL INJURY OR DEATH.
CRANE CARRIER NOTIFIED THE OWNER OF THE THREE UNITS ON JANUARY 26, 2012. CRANE CARRIER WILL CONDUCT THE REMEDY FOR THIS CAMPAIGN, FREE OF CHARGE.
R3 TM CERAMIC ACETABULAR LINER, BIOLOX FORTE, 32 MM I.D. 48 MM O.D., REF 71338948, STERILE R, QTY (1), Smith & Nephew, Inc., Memphis, TN 38116, 2017/06 Usage: Primary total hip arthroplasty due to non-inflammatory arthritis (degenerative joint disease) such as osteoarthritis, avascular necrosis or traumatic arthritis
During the manufacturing process for several batches of R3 Ceramic Liners, the titanium rings were pressed onto the ceramic component with a higher force than allowed by manufacturing specifications. This has the potential to result in lower than expected strength for the liners.
All affected Smith & Nephew Distributors were notified via email and the hospitals were notified by letter delivered by Fed-Ex on 3/11/2011. They were instructed to immediately cease distribution, quarantine affected product for return, if product further distributed, identify customers and immediately notify them of recall. Please contact Mr. David Archer, Group Director, at 701.396.2121, ext. 5373, if you have questions.
Crystal chandeliers Recalled for Fall Hazard
The recalled chandeliers contain a mounting loop that can fail during use causing the chandeliers to fall from the ceiling and injure bystanders under the chandelier.
Consumers should prevent people from going into immediate area under the chandeliers. Contact Spectrum Home Furnishings to receive a free replacement part, $150 to cover costs with replacement of the defective part, and a $25 incentive credit. Spectrum Home Furnishings is contacted all known purchasers.
Vigilance II Monitor Model: VIG2/VIG2E Software: versions 00.51, 00.60, 00.61, 00.62, 00.63, 00.64, 00.67, 00.69, 00.71, 00.73. Product Usage: The Vigilance II CCO/SvO2/CEDV Monitor is indicated for use in patients requiring monitoring of hemodynamic parameters, including cardiac output, oximetry and right ventricular, ejection, fraction, and end diastolic volume.
Edwards Lifesciences has made the decision to initiate a field corrective action for the Edwards Vigilance II Model: Software: versions 00.51, 00.60, 00.61, 00.62, 00.63, 00.64, 00.67, 00.69, 00.71, 00.73 due to the potential of inaccurate Injectate Cardiac Output (ICO) measurements.
Edwards initiated two Urgent Product Notification - Action Required letters to all affected customers. The letters identified the affected product, problem, and actions to be taken. The letters instructed users to immediately discontinue use of in-line temperature probes for Intermittent Cardiac Output (ICO) measurements on the Vigilance II instrument and recommends use of the bath probe only (model 9850A) to measure the temperature of the injectate solution for ICO calculations, until software update have been completed. Customers were instructed to complete and return a software upgrade form to Edwards as record of completion. For questions call Edwards Technical Support department at 800-822-9837.
EZ Steer ThermoCool Nav Part Number D-1292-01-S Diagnostic/Ablation Catheter instructions for use. The Biosense EZ STEER~ THERMOCOOL~ NAV Diagnostic/Ablation Deflectable Tip Catheter is a multi-electrode luminal catheter with a deflectable tip designed to facilitate electrophysiological mapping of the heart and to transmit radiofrequency (RF) current to the catheter tip electrode for ablation purposes. The catheter shaft measures 7.5 F with 8 F ring electrodes. For ablation, the catheter is u
Biosense Webster, Inc. has recently become aware of the omission of the following two Warning and Precaution statements on the Instructions For Use (IFU) for the above catheter: 1. If phrenic nerve location is a concern, precautionary measures are recommended to evaluate the proximity of the nerve to the ablation electrode, such as pacing maneuvers. 2. To minimize risk of atrio-esophageal fist
Biosense Webster, Inc. sent an Urgent Field Safety Notice letter dated Novembe 22, 2010, to all affected customers. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees were advised to continue use of the affected product and that no further action is required on their part. Consignees were advised that the updated IFU can be found at www.jnjgatewayifu.com. Consignees were instructed to contact their local Biosense Webster representative if they have any questions or require additional information. For questions regarding this recall call 909-839-8604.
ABS/ESC FUSE AND HEADLAMP JUMPER WIRE HARNESS
THIS COULD LEAD TO LOSS OF VISIBILITY AND/OR BRAKING ABILITY, INCREASING THE RISK OF A CRASH.
CHRYSLER WILL NOTIFY OWNERS AND DEALERS WILL REPLACE THE HEADLAMP JUMPER HARNESSES AND RELOCATE THE ABS/ESC SYSTEM FUSE WITHIN THE POWER DISTRIBUTION CENTER, FREE OF CHARGE. THE SAFETY RECALL BEGAN ON APRIL 2, 2012. OWNERS MAY CONTACT CHRYSLER AT 1-800-853-1403.