2011 Product Recalls
2,055 recalls issued in 2011.
Showing 1–20 of 2,055 recalls
Medtronic DBS" 3387S-40 Lead Kit for Deep Brain Stimulation , length: 40 cm. Contents of the inner packages are Sterile and Non-Pyrogenic. Method of Sterilization: Ethylene Ox ide, Rx Only, Activa Therapy, Model 3387 Lead Kit Manufactured at : Medtronic, Inc., Villalba, Puerto Rico, STIMLOC Burr Hole Kit: Manufacturer: Medtronic Image-Guided Neurologics, Melbourne, FL 32935-3145 Implant manual: DBS Leads: Proximal 40 mm, Distal 12.0 mm, Medtronic, Inc. Medtronic Active Therapy includes Activ
Medtronic has received reports of DBS" leads being damaged at the proximal connector end of the lead when the lead cap is used in the implant procedure. The lead damage is the result of excessive torsion and / or tensile lading of the proximal connector end of the lead. Data also suggest that excessive torque while tightening or loosening the setscrews may twist the setscrew connector block and d
Consignees were sent a "Medtronic Urgent: Medical Device Correction" letter 8/2008. The letter addressed to Healthcare Professionals, described the product involved, explanation of the issue, recommendations for Implant and included an attachment "Updated Instructions for Using the Lead Cap". Contact Medtronic Neuromodulation at 1-800-707-0933 for assistance.
iDXA, GE Lunar DEXA bone densitometers operating with enCORE software versions 12.0, 12.1, 12.2,13.0, & 13.1. The systems provide an estimate of BMD
Failure to properly pre-indicate the technique factors to be used during a patient scan.
An Important Electronic Product Radiation Warning letter will be sent to customers. The letter will discuss the defect description and related hazards, the affected product details, safety instructions, and product correction. Customers are to contact their local GE Healthcare service representative with questions.
Medtronic HMS PLUS, Hemostasis Management System. Medtronic, Inc., Cardiovascular Division, Moundsview, MN 55112. A microprocessor based, multichannel clot timing instrument with automated syringe handling for pipetting blood into single use cartridges. It performs in vitro heparin sensitivity evaluations, heparin assays, activated clotting times and platelet function evaluations.
The heparin assay controls may run longer than normal and in some cases, fail to give an acceptable result.
Medtronic issued an "Urgent Medical Device Notification" letter dated March 8, 2010 addressed to "Dear Valued Customer" and was sent to three locations at each customer site: Risk Management, Cardiovascular Surgery and Clinical Laboratory-Point of Care. The letter described the product and the issue, provided instructions for control and patient testing. The customer was requested to return an enclosed certificate as proof of notification. For further information, contact your Medtronic Sales Representative or call 1-763-391-9915.
INSTRUMENT CLUSTER SOFTWARE
WITHOUT WARNING MESSAGES, THE DRIVER MAY CONTINUE TO OPERATE THE VEHICLE UNTIL IT GOES INTO A SAFE MODE, WHICH COULD RESULT IN A REDUCTION OF POWER OR POSSIBLY A STALL. EITHER CONDITION INCREASES THE RISK OF A CRASH.
PARKER HANNIFIN IS WORKING WITH NEW FLYER TO CONTACT THEIR OWNERS, AND NEW FLYER DEALERS WILL UPLOAD A CORRECTED SOFTWARE VERSION. PARKER HANNIFIN CAN BE CONTACTED AT 1-204-452-6776.
EMERGENCY VEHICLE ENGINE SHUTDOWN
IF THE VEHICLE OPERATOR RECEIVES AND IGNORES MULTIPLE WARNINGS INDICATING THE NEED FOR OPERATOR INTERVENTION, THE ENGINE MAY SHUT DOWN UNEXPECTEDLY. UNEXPECTED EMERGENCY VEHICLE ENGINE SHUTDOWN UNDER CERTAIN CONDITIONS COULD HAMPER RESCUE OPERATIONS AND PLACE THE PUBLIC AT RISK.
DTNA WILL NOTIFY OWNERS, AND DEALERS WILL DISABLE THE ENGINE SHUTDOWN SOFTWARE FREE OF CHARGE. THE SAFETY RECALL BEGAN ON MARCH 13, 2012. OWNERS MAY CONTACT DTNA AT 1-800-547-0712.
EMERGENCY VEHICLE ENGINE SHUTDOWN
IF THE VEHICLE OPERATOR RECEIVES AND IGNORES MULTIPLE WARNINGS INDICATING THE NEED FOR OPERATOR INTERVENTION, THE ENGINE MAY SHUT DOWN UNEXPECTEDLY. UNEXPECTED EMERGENCY VEHICLE ENGINE SHUTDOWN UNDER CERTAIN CONDITIONS COULD HAMPER RESCUE OPERATIONS AND PLACE THE PUBLIC AT RISK.
DTNA WILL NOTIFY OWNERS, DEALERS WILL DISABLE THE ENGINE SHUTDOWN SOFTWARE FREE OF CHARGE. THE SAFETY RECALL IS EXPECTED TO BEGIN ON OR ABOUT FEBRUARY 22, 2012. OWNERS MAY CONTACT DTNA AT 1-800-547-0712.
Dover Dining Table Recalled for Fall Hazard
The wooden base of the table can collapse, causing the glass table top to fall. This poses an injury hazard to consumers.
Consumers should contact West Elm for a full store credit. West Elm will schedule a free return pickup of the table.
REPLACEMENT OF THE CERTIFICATION LABEL/PART 567
CUSTOMERS MAY UNKNOWINGLY EXCEED THE GVWR. EXCEEDING THE GVWR OF THE VEHICLE, CAN LEAD TO LOSS OF VEHICLE STABILITY, INCREASING THE RISK OF A CRASH.
JAGUAR WILL NOTIFY OWNERS, AND DEALERS WILL REPLACE THE LABEL. THIS SERVICE WILL BE PERFORMED FREE OF CHARGE. THE SAFETY RECALL IS EXPECTED TO BEGIN ON OR BEFORE JANUARY 23, 2012. OWNERS MAY CONTACT JAGUAR AT 1-800-452-4827.
IGNITION CONTROL UNIT REPLACEMENT
IMPROPER IGNITION TIMING MAY CAUSE AN ENGINE BACKFIRE INTO THE AIRBOX, INCREASING THE RISK OF A FIRE.
PIAGGIO WILL NOTIFY OWNERS, AND DEALERS WILL REPLACE THE IGNITION CONTROL UNIT FREE OF CHARGE. THE SAFETY RECALL IS EXPECTED TO BEGIN ON OR BEFORE JANUARY 17, 2012. OWNERS MAY CONTACT PIAGGIO CUSTOMER CARE HELPLINE AT 212-380-4433.
COOLANT LEAK/POSSIBLE FIRE
IF COOLANT ENTERS THE BATTERY COMPARTMENT, AN ELECTRICAL SHORT COULD OCCUR POSSIBLY RESULTING IN A FIRE.
FISKER WILL NOTIFY OWNERS, AND DEALERS WILL REPLACE THE HIGH-VOLTAGE BATTERY WITH A NEW PART AT NO COST TO THE OWNER. THE SAFETY RECALL BEGAN ON JANUARY 5, 2012. OWNERS MAY CONTACT FISKER CONSUMER AFFAIRS AT 1-855-575-7577, OPTION 2, 6AM - 7PM (PST) MONDAY THROUGH FRIDAY.
FRONT SUSPENSION DAMPER BOLT
IF THE NUT LOOSENS, THE FRONT HUB ASSEMBLY WOULD ONLY BE ATTACHED BY ONE BOLT, ALLOWING THE WHEEL ASSEMBLY TO SHIFT TO AN EXTREME INWARD ANGLE, RESULTING IN A LOSS OF STEERING, INCREASING THE RISK OF A CRASH.
HONDA CONTACTED ALL NINE OWNERS BY PHONE ON DECEMBER 19, 2011, AND REPAIRED THE VEHICLES AS NECESSARY FREE OF CHARGE. OWNERS MAY CONTACT HONDA AT 1-800-999-1009.
AUTOMATIC SLACK ADJUSTER
IF THE SLACK ADJUSTER HOUSING WERE TO BREAK, THE WHEEL BRAKE TO WHICH THE SLACK ADJUSTER IS ATTACHED WOULD NO LONGER FUNCTION, CAUSING THE VEHICLE TO HAVE REDUCED BRAKING CAPACITY AND, IF MOUNTED ON THE STEER AXLE, THE VEHICLE COULD PULL TO ONE SIDE, POSSIBLY RESULTING IN A CRASH.
ROSA TRAILER WILL NOTIFY OWNERS, AND DEALERS WILL REPLACE THE SLACK ADJUSTERS FREE OF CHARGE. THE SAFETY RECALL BEGAN IN MID-FEBRUARY 2012. OWNERS MAY CONTACT ROSA TRAILERS AT 1-715-478-3435.
BATTERY SEPARATOR
OVERHEATING OF THE BATTERY SEPARATOR CAN RESULT IN SMOKE AND POSSIBLE FIRE.
ALTEC WILL NOTIFY OWNERS AND REPLACE THE BATTER SEPARATORS FREE OF CHARGE. THE SAFETY RECALL BEGAN ON JANUARY 11, 2012. OWNERS MAY CONTACT ALTEC AT 1-877-462-5832.
MISSING BRAKE PAD
A MISSING PAD COULD RESULT IN REDUCED BRAKE SYSTEM PERFORMANCE, INCREASING THE RISK OF A CRASH.
GM WILL NOTIFY OWNERS, AND DEALERS WILL INSPECT THE FRONT BRAKES FOR A MISSING INNER OR OUTER PAD. IF A BRAKE PAD IS MISSING, DEALERS WILL INSTALL NEW INNER AND OUTER PADS, A NEW BRAKE CALIPER, AND A NEW ROTOR. THIS SERVICE WILL BE PERFORMED FREE OF CHARGE. THE SAFETY RECALL IS EXPECTED TO BEGIN ON OR BEFORE JANUARY 14, 2012
Bed Canopy Recalled for Fall Hazard
The connections of the posts to the top rails of the canopy can come apart, allowing components of the canopy to fall and posing an impact hazard to consumers.
Consumers should immediately remove the canopy from the bed and contact Pottery Barn Kids to schedule a free repair.
Sterrad 50 Sterilizer, Product Code 10050. Low-temperature general-purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.
The capacitor in the vacuum pump component within the Sterrad 50 System could overheat and potentially create a hazardous condition inside the system, resulting in smoke and/or fire.
Advanced Sterilization Products (ASP) sent an "Urgent: Product Correction" letter dated January 12, 2009 to each consignee informing them of the issue and instructed them to report smoke or a burning odors in or around their STERRAD 50 System. ASP strongly recommended for consignees to follow their facility's safety protocols and if possible, immediately disconnect the STERRAD 50 System from its electrical source. Customers were instructed to contact ASP to schedule an onsite visit to investigate the issue. If the issue is caused by a malfunctioning capacitor in the vacuum pump, the firm will replace the malfunctioning component right away. To correct this situation, an ASP Field Service Engineer (FSE) will visit all customers facilities within the next sixty days to replace the capacitor in the vacuum pump on the affected STERRAD 50 System.
FemSoft Insert, Female Urethral Insert, Size 1 Standard, 3.5 cm Length, REF 71201 or 71201DT, Sterile (R), Rx Only. Rochester Medical Corporation, One Rochester Medical drive, Stewartville, MN 55976 USA.
Rochester Medical is voluntarily recalling specific lots of FemSoft urethral inserts manufactured and distributed in 2009 and 2010. Testing has revealed a small number of packages which contain a small void in the package seal, and it has been determined that product sterility cannot be guaranteed. If product sterility has been compromised, there is a potential for increased risk of urinary trac
Consignees were contacted by telephone on 5/3/10 and if not reached, were sent a Rochester Medical "Urgent Medical Device Recall" letter on 5/6/10 dated April 26, 2010. The letter was addressed to Rochester Medical Corporation Customers. The letter described the problem and product involved; recommended consignees to record the quantity and lot numbers (s) on the enclosed postcard and return it to them; and to immediately destroy the product with the lots affected. In the case of distributors, the telephone call was followed by a letter sent/dated April 27, 2010 to each distributor. It advised distributors to isolate any remaining inventory with the specified lot numbers and to complete the disposition report. Letters included a customer letter for dissemination to their retail level customers. Retail customers were asked to segregate and destroy the affected products and record the action. The company will replace the destroyed product. The distributors started their contact to consignees on 4/28/10. Please contact Rochester Medical at 1-800-243-3315, or the firm's Customer Service Department at 1-507-533-9309 for additional information or for product return & replacement instructions.
dideco Preassembled Surgical Wash Set, Compact , Cobe part numbers WS55C, WS125C, WS225C, Cobe Cardiovascular, Inc.
Foreign particles-manufacturing error may lead to abrasion of bowl seal in blood recovery sets, possibly causing particles in the blood.
Consignees were notified by telephone and e-mail on 08/04/2006.
Ikaria INOMAX DS Drug Delivery System, model 10003. Ikaria 6 Route 173, Clinton, NJ 08809 USA. The INOMAX DS Delivery System delivers INOMAX (nitric oxide for inhalation) therapy gas into the inspiratory limb of the patient breathing circuit in a way that provides a constant concentration of nitric oxide (NO), as set by the user, to the patient throughout the inspired breath. It uses a specially designed injector module, which enables tracking of the ventilator waveforms and the delivery of a
The pressure switch in the INOMAX DS drug-delivery system may fail, which may interrupt or delay the administration of INOMAX (nitric oxide) for inhalation to patients. Delay in administration of INOMAX therapy may cause: -worsening of systemic oxygenation indices (i.e., hypoxemia, especially manifested as decreased arterial oxygenation saturation). -hypotension, and/or -increase in pulm
Ikaria sent an Urgent Medical Device Recall letter to customers dated July 21, 2010. This letter is also posted on the Inomax webpage. The letter described the issue, how to recognize it, what to do in the event of a suspected leak, and recommended maintaining back-up cylinders and depressurization of the regulator when not in use. The replacement plan for all INOMAX DS drug-delivery systems was described. Customers can contact Ikaria Customer Care at 1-877-566-9466.
St. Jude Medical, Engage TR Introducer, 6 F - ACT (2.25 mm), 7 cm length, .025" Max Guidewire O.D., Rx, Sterile EO, REF C408524, 100028093.
Potential for a partial or complete separation of the Shaft (sheath) from the hub or a material break in the hub assembly just distal to the hemostasis seal. If either of these were to occur during use, it is likely that fluids would leak around the Introducer hub and strain relief.
Consignees were sent "Urgent Medical Device Recall Notice" dated June 24, 2010 from St. Jude Medical . The letter was addressed to Cath Lab Manger/ Risk Manager. The letter described the problem and the product involved. Advised consignees to discontinue use of the product and remove from inventory. Sales Representatives were also sent a St. Jude Medical Memorandum "Field Action Notice" dated June 24, 2010 and a reconciliation form. The memorandum described the problem and product. Advised Sales Rep to visit the affected accounts and to performed the assigned tasks. A St. Jude Medical sales representative will be contacting for removal and replacement of the affected product. For additional information, please contact St. Jude Medical at 651-491-4470.