2012 Product Recalls
5,173 recalls issued in 2012.
Showing 5081–5100 of 5,173 recalls
KINK IN THE BEAD AREA/TIRE FAILURE
IF A CRACK DEVELOPS AND IS LEFT UNDETECTED, THE TIRE MAY FAIL, POTENTIALLY CAUSING LOSS OF VEHICLE CONTROL AND A CRASH, WHICH COULD RESULT IN INJURY OR DEATH.
TOYO TIRE WILL NOTIFY OWNERS AND REPLACE THE TIRES FREE OF CHARGE. THE SAFETY RECALL BEGAN ON FEBRUARY 3, 2012. OWNERS MAY CONTACT TOYO TIRE AT 1-800-442-8696 (6:30AM TO 5PM PACIFIC TIME) (9:30AM TO 8PM EASTERN TIME).
CERCLAGE WIRE, 0.6 MM DIA. X 175 MM LENGTH, SST, REF 71163006, QTY: (6), STERILE R, CE 008, 2020/07, Smith & Nephew, Inc., Memphis, TN 38116, EC REP: Smith & Nephew Orthopaedics GmbH, Tuttlingen, Germany Usage: Bone fracture fixation
Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, compromising sterility.
All affected Smith & Nephew Sales Representatives were notified of problem and the recall was sent via overnight mail on 01/23/2009. All affected Smith & Nephew International Distributors were notified via email and telephone on 01/23/2009. They were instructed to immediately quarantine the product for return.
Expandable Insulated Lunch Box with Freezer Gel Pack Recalled for Poisoning Hazard
Gel that contains diethylene glycol and ethylene glycol can leak out of damaged freezer gel packs, posing a poisoning hazard if ingested by children or adults.
Consumers should immediately stop using the gel packs and dispose of them according to federal, state and/or local regulations. It is recommended that consumers contact their local waste disposal authority for instructions. Consumers may return the lunch box set to Costco for a full refund or may receive a $5 cash refund for the gel pack only by contacting California Innovations.
Travelin' Chef Expandable Thermal Food Carrier Recalled for Poisoning Hazard
Gel that contains diethylene glycol and ethylene glycol can leak out of damaged freezer gel packs, posing a poisoning hazard if ingested by children or adults.
Consumers should immediately stop using the gel packs and dispose of them according to federal, state and/or local regulations. It is recommended that consumers contact their local waste disposal authority for instructions. Consumers may return the gel pack to Walmart for a refund of $6 or contact California Innovations customer service at (800) 722-2545 for the same refund.
Cook Medical Ciaglia Blue Rhino G2 Advanced Percutaneous Tracheostomy Introducer Set, C-PTIS-100-A-HC-PERC8, G12403.
These set and/or tray products are being recalled because they include a Covidien Shiley 6PERC or Covidien Shiley 8PERC tracheostomy tube component that has been associated with cuff leakage as a result of the pilot balloon inflation assembly.
Cook Medical sent an Urgent Product Recall letter dated April 21, 2010, to hospitals and other user facilities receiving product direct from Cook as well as distribution centers receiving direct shipments from Cook. Consignees were directed to cease distribution of product and notify their customers immediately.
Edwards Lifesciences-Swan-Ganz,Thermodilution Venous Infusion Port (VIP) Catheter with AMC Thromboshield (An Antimicrobial*Heparin Coating), REF:831HF75
Misbranding-One lot of Swan-Ganz Thermodilution VIP Catheters, Model 831HF75, lot 246HC197 was labeled with different model information (831F75) on the edge label . The edge label states the model is 831F75 which incorrectly indicates that product does NOT contain an antimicrobial heparin coating. (The tray lid label correctly states the model is 831HF75, containing the heparin coating)
Edwards initiated the recall in the US by sending a Customer Letter by Federal Express on November 28, 2006, along with a Q&A to their customers Service and Direct Customers to facilitate the uderstanding of the recall and the request for verification and return of all unused product.
Multi-Analyte Urine DAU Control (15 mL); Level 2, For in-vitro diagnostic use only. Lin-Zhi International, Inc. 670 Almanor Ave. Sunnyvale, CA 94085 Multi-Analyte Urine Drug of Drug Abuse (DAU) Controls are for use as controls in the quantitative and semi-quantitative calibration of Amphetamines Enzyme, Opiate Enzyme, Phencyclidine Enzyme, Cocaine Metabolite Enzyme, Benzodiazepine Enzyme, Barbiturate Enzyme, Methadone Enzyme and Propoxyphene Enzyme on a number of automated clinical analyzers.
Customer complaint investigation found that the Multi-Analyte Urine DAU Level 2 control was incorrectly labeled and actually contained Multi-Analyte DAU Low Level Calibrators.
Lin Zhi International, Inc. sent a Recall notification letter dated August 5, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were asked to determine whether they wanted credit or a replacement product. The incorrectly labeled product should be disposed of properly. For questions regarding this recall call 408-732-3856.
AxSYM total B-hCG Reagent is composed of one bottle of Coated Microparticles, one bottle of Alkaline Phosphatase Conjugate and one bottle of Specimen Diluent.
Abbott Diagnostics is investigation a recent increase in customer complaints for AxSYM calibration error code 1048 and controls out of range when using AxSYM Total B-hCG reagent lots. Testing has shown that protein aggregates are present in the specimen diluents of both IMx and the AxSYM Total B-hCG reagent kits. This is responsible for the calibration errors and shift in control values.
Abbot Health Products, Inc. informed and instructed their customers via Device Recall Letter to Identify if they have used or have inventory of the affected product. Discontinue use of and destroy any remaining inventory of reagent lots listed in the Device Recall letter according to their laboratory procedures. Record the quantity of the recalled reagents currently in inventory in their facility that will be destroyed on the attached reply form and fax the form back to Abbott 1-800-777-0051. (US only) Follow their laboratory''s procedure for communicating this issue to the health care providers they serve.
FMVSS 121-ANTI-LOCK MALFUNCTION SIGNAL
WITHOUT THE CHECK LAMP FEATURE, THE DRIVER MAY NOT BE AWARE THAT THE INDICATOR LAMP IS NOT WORKING PROPERLY, AND IF THERE WERE AN ABS PROBLEM, THE DRIVER WOULD NOT RECEIVE A WARNING. A MALFUNCTIONING ANTI-LOCK BRAKE SYSTEM MAY INCREASE THE RISK OF A CRASH.
TEMSA WILL NOTIFY OWNERS, AND DEALERS WILL REPAIR THE BUSES FREE OF CHARGE. THE SAFETY RECALL BEGAN ON MARCH 15, 2012. OWNERS MAY CONTACT TEMSA AT 1-407-601-7801.
AXLE BEAM FAILURE
IF COMPLETE FRACTURE OCCURS, THE DRIVER MAY LOSE CONTROL OF THE VEHICLE, INCREASING THE RISK OF A CRASH.
THIS RECALL RELATES TO PREVIOUS RECALLS 09V-240 AND 10V-069. ANALYSIS OF THESE RECALLS HAS SHOWN THAT AFTER THE RECEIVING THE REMEDIES, THE AXLES MAY STILL CRACK. AS SUCH, MACK TRUCKS WILL REPLACE THE AFFECTED AXLES ON ANY MR AND LE MODELS CONFIGURED AS FRONT-LOADER OR SIDE-LOADER REFUSE TRUCKS. AXLES ON ALL OTHER MR AND LE MODELS WILL RECEIVE A MAG-PARTICLE INSPECTION AND MACK WILL REPLACE ANY AFFECTED AXLE BEAMS FREE OF CHARGE. THE SAFETY RECALL BEGAN iIN JULY 2012. OWNERS MAY CONTACT MACK TRUCKS AT 1-800-866-1177.
ANTILOCK BRAKE SYSTEM ELECTRICAL CONNECTORS
CORROSION MAY DEVELOP IN THE ELECTRICAL CONNECTOR LEADING MELTING, SMOKING OR POSSIBLE FIRE.
MAZDA WILL NOTIFY OWNERS, AND DEALERS WILL REPLACE THE VEHICLE'S BRAKE MASTER CYLINDER RESERVOIR CAP AND MODIFY THE ABS ELECTRICAL SYSTEM, FREE OF CHARGE. UNTIL THE REPAIR HAS BEEN PERFORMED, VEHICLE OWNERS SHOULD PARK THEIR VEHICLES OUTSIDE. THE SAFETY RECALL BEGAN ON JUNE 22, 2012. OWNERS MAY CONTACT MAZDA AT 1-800-222-5500, OPTION 6.
Baxter Colleague CX Infusion Pump, Single Channel Volumetric Infusion Pumps. Baxter Healthcare Corporation, Medication Delivery Division. Product Code: 2M8161. Product Usage: Intended for use in a wide variety of patient environments for adult, pediatric and neonatal patients. Electronic infusion pumps indicated for continuous or intermittent delivery of solution through clinically acceptable routes of administration, such as intravenous (IV), intra-arterial (IA), subcutaneous, epidural or ir
While replacing a defective pump head mechanism and performing calibration, Baxter's Service center may have failed to apply GLYPTOL (a red insulating varnish) on a potentiometer that helps maintain pump accuracy for detecting an air bolus.
Baxter Healthcare Corporation telephoned its customers on July 1, 2011 and sent a follow up "URGENT PRODUCT RECALL" letter dated July 6, 2011, informing them that the Glyptol (a red insulating varnish) may not have been applied on the Air-In-Line (AIL) circuit board. The letter described the product, problem and actions to be taken. The customers were instructed to locate the affected pumps, remove from service and return to Baxter for inspection as soon as possible. If GLYPTOL is found to be missing, recalibration will be performed and GLYPTOL will be applied per requirement before returning the pumps back to the customer at no cost. The customer was instructed to complete and sign the attached customer reply form. The letter states that if the COLLEAGUE Pumps were distributed to other facilities, please forward communication to the pump owner as appropriate. For any questions contact The Center for One Baxter at 1-800-422-9837 during the hours of 8:00 am to 5:00 pm Central Time, Monday through Friday.
Rapid Strand Rx; the RAPID Strand Rx kit consists of custom loaded absorbable seeding spacers and I-125 radionuclide brachytherapy sources (seeds) spaced at prescribed distance and configuration within a sleeve (tube) made of absorbable suture material, stiffened, loaded into prostate seeding needles, packaged and then sterilized by Gamma sterilization method, accompanied by a calibration strand, a sealed source calibration certificate (100% assay report), a radiograph of the loaded needles in t
There is a potential brachytherapy over or under dose with the RAPID Strand Rx kit that may impact patient therapy.
GE Healthcare/Oncura sent a "Urgent Medical Device Correction" letter dated September 20, 2011, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The customers were advised to assess the pre and post plan dosimetry for their patient, taking into account the possible variation of the seed strength. GE Healthcare/Oncura will contact the customers in the near future to confirm their receipt of the letter and to discuss any questions they may have. Please call if you have any further questions (847) 398-8400 and 011-44-1494-737251 (Amersham, United Kingdom, GMT)
Spacelabs Medical Ultraview SL Command Module, Model 91496. The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use. Physiological parameters that may be monitored include ECG with arrhythmia detection, respiration, invasive and noninvasive blood pressure, temperature, oxygen saturation (S
One Spacelabs Medical Ultraview SL Command Module, Model 91496, was removed from customer due to software error.
Spacelabs removed one affected unit of Medical Ultraview SL Command Module from a hospital in Troy, MI. during a site visit on July 13, 2011. This recall pertains to one single unit at one location. Contact Spacelabs at 425-657-7200 for questions regarding this recall.
Baxter Colleague CX and CXE Infusion Pumps, Single Channel Volumetric Infusion Pumps. Baxter Healthcare Corporation, Medication Delivery Division. Product Codes: 2M8161 and 2M9161. Intended for use in a wide variety of patient environments for adult, pediatric and neonatal patients.
The Air In Line (AIL) test was not properly performed by the service technician at the Service Center.
Baxter telephoned the two customers on December 1, 2010, informing them that that a post repair test was not performed correctly on their Colleague pumps (serial numbers 12070599CC and 17086323CP) during the last service. As a result, the device Air Sensor may not function as designed and could lead to undetected air in the IV line. Baxter wants to ensure that the devices are properly tested, safe and effective. Baxter requested that they locate the pumps and remove them from use as soon as possible. Baxter will then send a shipping container for retrieval, reinspection and return of the device back to the customer at no cost. *** Baxter expanded the recall to include twelve additional pumps on June 22, 2011 by telephone calls to the affected accounts. The recall strategy remains the same as the December 1, 2010 instructions. ****
Anchor Tissue Retrieval System; ETO sterilized, single use disposable device; port size 10 mm, 225 mL capacity; 3 units per box; Manufacturer: Anchor Products Co., 52 Official Rd, Addison, IL 60101 U.S.A.; Ref TRS100SB The device is a single use, sterile disposable pouch used with a dedicated introducer for the capture and removal of tissue or organ from the body cavity during laparoscopic surgery.
The metal component within the unit can break and cause a malfunction. Use of the device may represent a potential health hazard if the metal component is not removed after breakage.
The firm, Anchor, sent an "URGENT: MEDICAL DEVICE RECALL" letter dated December 8, 2010 to all customers. The letter described the product, problem and actions to be taken. The customers were instructed to examine their inventory and return any remaining units to their distributor for replacement; and complete and return the attached ANCHOR RECALL RETURN RESPONSE FORM via fax to (314) 961-4535 or mail to: Progressive Medical, Inc., Attn: Marketing Manager, 11085 Gravois Industrial Court, St. Louis, MO 63128, even if they have no inventory. A representative of Anchor Products then visited each of the direct accounts to help them implement their subrecall of the devices from their customers. For additional information please contact: Vice President, Anchor Products Company at 1-800-543-9124 or 1-630-543-9124; and the distributor at 1-800-969-6331 or 1-314-961-4535.
REAR BRAKE HOSE RESTRICTION
BRAKES THAT DRAG COULD OVERHEAT AND MAY LEAD TO A FIRE, WHICH MAY CAUSE PROPERTY DAMAGE, PERSONAL INJURY, OR DEATH.
NAVISTAR WILL NOTIFY OWNERS, AND DEALERS WILL INSTALL A CLIP TO ENSURE THAT THE BRAKE LINE CANNOT BE PINCHED. THIS SERVICE WILL BE PERFORMED FREE OF CHARGE. THE SAFETY RECALL BEGAN ON APRIL 27, 2012. OWNERS MAY CONTACT NAVISTAR AT 1-800-448-7825.
Depuy Mitek Ratchet Handle with Quick Connect Product code: 219970. Instrument used with anchor inserters for insertion of DePuy Mitek Interference Screws (orthopedic).
Quick Disconnect Ratchet Handle may slip up the driver shaft or disengage leaving the shaft in the screw head.
Depuy Mitek issued Original Customer Notification Letter on 6/27/11 and an Updated letter to clarify the lot number information sent 6/29/11. Hospitals requested to immediately check all inventories for affected product and return for repalcement product. Also notify surgeons aware of this potential issue and potential risk of a delay in surgery. questions or concerns with regard to this program, please contact your local DePuy Mitek Representative or DePuy Mitek Customer Service directly at 1-800-382-4682, PROMPT 3.
Sechrist Hyperbaric Chamber Gurney. The Sechrist Hyperbaric Chamber Gurney is an accessory device to the Sechrist Monoplace Hyperbaric Chambers. It is intended solely for the loading and unloading of patients into Sechrist Monoplace Hyperbaric Chambers. It is not intended for general hospital patient transport and is sold only to be used in conjunction with Sechrist Monoplace Hyperbaric Chambers.
Stryker Medical has received complaints from customers that indicate a bushing in the braking system may fracture, which could result in the brake/steer pedal seizing. If the pedal seizes, the braking system may become inoperable or steering around corners may come more difficult. While no injuries have been associated with these reported events nor has there been reported failure events resulting
Sechrist Industries sent a Urgent Medical Device Correction letter dated September 9, 2009, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. 1. Locate the gurneys with the serial numbers listed in this advisory. 2. If any of the affected gurneys cannot be located, determine if they have been sold, transferred, or donated to another facility and notify us regarding their new location. 3.Verify the braking system is working properly. If the brake system is inoperable, or if the brake and /or steer require a greater than normal force to engage, remove the stretcher from service and contact Stryker Medical at 800-Stryker, option 3. Reference RA-2009-135. Do not put the stretcher back into service until is repaired by the Stryker field representative. 4. Contact Stryker Medical to schedule a service call for replacement of the bushing and mating parts of the stretcher. 5.Complete retrofit of the Gurney. 6.Verify correct function of the brake assembly following retrofit. 7.Complete and send the Correction Verification Form contained with this notice to Sechrist. For further questions please call (714) 579-8400. .
Software versions Eos software versions: 1.2.4, 1.2.5, 1.2.6,1.2.7,1.2.8, 1.2.9,1.2.10, .2.11,1.2.12, 1.2.13, 1.3.2,1.3.3, 1.3.4, 1.4.0, 1.4.1, 1.4.2. sterEOS software versions: 1.2.3.3788, 1.2.4.4286, 1.3.2.3373, 1.3.3.3671, 1.3.4.3740, 1.3.5.3915, 1.3.6.4272,1.4.1.4813,1.4.2.4850. EOS system is a digital radiography system used in general radiographic examinations. sterEOS workstation is a medical image review station for acceptance, transfer, display, storage, and digital processing of 2D X
Print true size, print requests from the EOS acquisition station or the sterEOS image review station may, in certain cases, be affected by a different enlargement factor during printing. T
EOS imaging sent a "FIELD SAFETY NOTICE" letter dated April 13, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. The letter instructs customers to wait for the printing queue to empty before sending a second "print true queue" request with different print settings. Customers should then click the button shown on the instruction sheet to view the print queue. EOS imaging will provide a software update to correct all affected systems at no cost to the customers. An EOS representative will contact customers to schedule a time to upgrade the software. Questions can be answered by calling 33 1 55 25 63 90.