2010 Product Recalls
1,800 recalls issued in 2010.
Showing 1661–1680 of 1,800 recalls
Osteo-Clage Cable System Package Assembly (01-0001-S). Product labeled in part, "2.0mm x 850 mm CoCr Cable / Sleeve... REF 01-0001-S LOT W59192... Acumed 5885 NW Cornelius Pass Road Hilsboro, OR 97124-9432 ".
Cables of incorrect diameter were used in product assembly, resulting in the sleeve not being able to bind to the cable after crimping.
On 3/28/08, the firm sent an Urgent Notification letter to their consignees. The letter explained the issue and requested the customers return the product to Acumend. On 7/16/08, the firm sent a 2nd notification, via mail, to thier customers. The Urgent Notice: Device Recall 2nd Notification, advised customers of the recall, the hazard and requested customers to return existing product to Acumed.
Acu-Loc Distal Radius Plate, Standard, Left. Product labeled in part, " Acu-Loc Distal Radius Plate, Standard, Left... PL-DR50L W48003... Manufactured or Distributed by: Acumed LLC Hillsboro, OR ".
Plates are incorrectly laser marked. The PL-DR50L plates are incorrectly laser marked with PL-DR70L.
The firm issued an Urgent Notification: Product Removal letter on 6-29-2007. The notification was reportedly sent by either FAX or e-mail. The notification informed consignees to remove the plates from their inventory and return them to Acumed. The notification did not include any instructions for a sub-recall. On 6/13/08, the firm sent a second Urgent Notification: Product Removal letter. This letter describes the product as PL-DR50L - Lot Code - W48003, explains the problem and asks customers to return product to Acumed.
Baxter Auto Syringe AS50 Infusion Pump, product code 1M8550; Baxter Healthcare Corporation, Medication Delivery Division, Deerfield, IL 60015 U.S.A. Indicated for infusion via intravenous, intra-arterial, epidural or subcutaneous routes of administration.
Non-conforming Electrostatic Discharge (ESD) grounding squares may cause the pump to be susceptible to shorting-out of circuitry, resulting in a loss of audio, and/or interruption of therapy.
Urgent Product Recall letters dated 9/5/08 were sent on the same date via first class mail to the direct accounts, to the attention of the Director of Biomedical Engineering and Facility Risk Manager. If the account had device(s) that had been serviced by Baxter with a part affected by this action, a serial number list of the affected device(s) was provided with the notification. Customers were instructed to remove the affected device(s)/spare parts from service and contact Baxter to arrange for their return and repair. Alternatively, if removal of the device is not a viable alternative for the customer and they wish to perform self-service, the customers will also be provided with a Service Bulletin to provide instruction on replacement of the rear case assembly.
GE Centricity PACS RA1000 Workstation (for diagnostic image analysis); GE Healthcare Integrated IT Solutions, Barrington, IL 60010. The Centricity PACS (Picture Archiving and Communication System) Workstation is intended for use as a primary diagnostic and analysis tool for diagnostic images by trained healthcare professionals, including radiologists, physicians, technologists, clinicians and nurses. It is also intended for use as a clinical review workstation throughout the healthcare facility.
Unread exams may inadvertently get marked as dictated in PACS workstation when the user signs off the report in Talkstation and opens the next exam.
GE Healthcare Integrated IT Solutions notified their Centricity PACS RA1000 Workstation with Talk Extend software customers via letter (Urgent Medical Device Correction) dated 11/10/08 of the software anomaly resulting in a patient safety issue involving Talk Extend, which could contribute to a delay of care or misdiagnosis due to delay in communicating pertinent exam results or failure to treat due to lack of an attached dictated report by the radiologist for physician review. The letter provided the users with safety instructions to follow until the software is updated. Any questions were directed to the Remote Online Center, Field Engineer or the GE Customer Care Center at 800-437-1171. The accounts were requested to complete the enclosed customer reply form, supplying the workstation software or build number, and fax the completed form to 847-939-1479.
Ambulift, standard basic model manually powered patient lift. The Ambulift is used to move and lift patients from their beds, transport them to the bathroom, and lift them in and out of the bath. Model AB1102 - Standard basic model Ambulift with chair and leg rest. Model AB1552 - Standard basic model Ambulift with chair and leg rest and scales.
The armrests of the lift chair may push up, allowing the patient to slip down and out of the seat. The resultant fall could result in serious or fatal patient injuries.
Arjo sent Customer Field Correction Notification letters dated 5/2/08 on the Arjo letterhead to the end user accounts who received the affected Ambulift Patient Lifts, to the attention of the Administrator/Risk Manager, via UPS 2nd day delivery on 5/5/08. The letters informed the consignees of the incident with the patient slipping from the seat of the lift and sustaining fatal injuries and advised them to always ensure that a clinical assessment to verify that the resident has sufficient upper body strength to maintain a steady position on the chair, and that the resident has sufficient mental capacity to adhere to the caregiver's instructions, is carried out by a qualified nurse or therapist before lifting residents with the Ambulift. To further enhance safety, a seat belt is being made available, which must be fitted to the chair, enabling it to be used when required by clinical assessment. Instructions on how to apply, use, and maintain the seat belt will be provided with the belts. The belts will be provided at no cost. The accounts were requested to review, complete and return the enclosed customer response form, indicating the number seat belts needed. Any questions were directed to Arjo's Quality Department at 1-800-323-1245, ext. 6140 or 6165.
Special Forces and Police SWAT Toy Gun Sets Recalled for Choking Hazard
The orange tips located at the end of the toy guns' barrels, which are designed to distinguish them from real guns, can easily be removed from the barrels, posing a choking hazard to children.
Consumers should immediately take the recalled toy guns away from children and return them to any Dollar General for a full refund or a replacement product.
POWER WINDOW SWITCH
AN OVERHEATED SWITCH CAN CAUSE SMOKE, MELTING AND FIRE.
DEALERS WILL INSPECT THE SWITCH AND INSTALL A COVER AROUND THE SWITCH HOUSING TO PREVENT WATER FROM ENTERING THE SWITCH. IF THE SWITCH IS DAMAGED, THE SWITCH WILL BE REPLACED AND A COVER WILL BE INSTALLED. THIS SERVICE WILL BE PERFORMED FREE OF CHARGE. THE SAFETY RECALL BEGAN ON DURING MARCH 19, 2010. OWNERS MAY CONTACT HONDA AT 1-800-999-1009.
Tiny Tink and Friends Children's Toy Jewelry Sets Recalled for Poisoning Hazard
A cylindrical metal connector on a charm can contain levels of total lead in excess of 300 ppm, which is prohibited under federal law.
Consumers should immediately take the charm and cord away from children, discard the items, and contact Playmates Toys for a replacement charm accessory.
21 Pro USA Children's Pullovers and Hoodies Recalled for Strangulation Hazard
The children's sweatshirts have a drawstring through the hood, which can pose a strangulation hazard to children.
Consumers should immediately remove the drawstrings from the sweatshirts to eliminate the hazard or return the garments to the place of purchase or to New Mode Sportswear for a full refund.
Orthofix Spinal Implants; Pillar SA PEEK Spacer System Instrument Case. Case contents: Implant Insertion Instrument, Straight Tamp, Bone Awl Drill Guide, Straight Drill, U-Joint Driver with and without retention, Flex Shaft Driver, Trial Insertion Instrument, Drill Tips, Cover Plate Inserter, Cover Plate Driver, Cover Plate Holder, Ratcheting Handle, Torque Limiting Handle, Hex Driver, Distractors/Sizers, Sizers REF: 49-0021: Orthoflex Spinal Implants, 1211 Hamburg Tnpk, Suite 300, Wayne, NJ 0
The Pillar SA Implant Insertion Instrument 49-1100 may experience resistance in turning the activation knob while releasing an implant after intra-operative positioning.
A notification letter dated November 19, 2009 was sent to customers via Federal Express. The letter described the recalled product (PILLAR SA Implant Insertion Instrument, 49-1100) and problem and actions for customers to take. The affected product, PILLAR SA lmplant lnsertion lnstrument, 49-1100 is in the PILLAR SA set (set part number 49-0021) which was shipped to customers. An enclosed attachment provide instructions on product removal and return. Customers were instructed to complete the enclosed Tracking and Verification Form and fax to Orthofix Spinal Implants at 1-973-406-2912. A replacement instrument will be provided as available. In the interim, the Implant Inserter (Part Number 49-1000) included in the PILLAR SA UPE set (set number 49-0020) that was provided earlier this year may be used as an alternative to the affected product. For questions regarding the removal and return of the recalled product to Orthofix Spinal Implants, please contact your Account Services Representative. Direct other questions to the Regulatory Affairs Department at 1-973-406-2812. Direct product questions to Marketing at 1-862-221-1335 or Product Development at 1-973-406-2824.
Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup 46 mm cup Ref.: 74120146. Hip implant component.
The carton label may not reflect the correct size of the acetabular cup.
The consignees were notified of the problem and the recall by initially by telephone on 07/12/2007 and followed by a letter dated 07/24/2007.
Greeting Cards with Bracelets Recalled for Poisoning Hazard
The surface paint coating on the bracelets sold with greeting cards contain excessive levels of lead violating the federal lead paint standard.
Consumers should immediately stop using the bracelet and contact Schurman Fine Papers for instructions on how to receive a refund.
Children's Jackets with Drawstrings Recalled for Strangulation Hazard
The children's jackets have drawstrings through the hood, which can pose a strangulation hazard to children.
Consumers should immediately remove the drawstrings from the jackets to eliminate the hazard or return the jackets to their place of purchase or to GTM Sportswear for a full refund.
AIRV CEILING ASSEMBLIES/HEATER ELEMENT
THIS DEFECT COULD RESULT IN A FIRE.
TRAILMANOR WILL NOTIFY OWNERS AND THE VEHICLES WILL BE REPAIRED FREE OF CHARGE. THE REPAIRS WILL BE PERFORMED BY CARRIER. PLEASE SEE CARRIER'S DEFECT REPORT 09E-053. THE SAFETY RECALL IS EXPECTED TO BEGIN DURING JANUARY 2010. OWNERS MAY CONTACT CARRIER AT 1-877-584-7059.
ELECTRICAL POWER CABLE/POSSIBLE FIRE
IF THIS OCCURS AN ELECTRICAL FIRE MAY OCCUR.
OSHKOSH WILL NOTIFY OWNERS AND REPAIR THE VEHICLES FREE OF CHARGE. THE SAFETY RECALL BEGAN ON MARCH 1, 2010. OWNERS MAY CONTACT OSHKOSH CUSTOMER SERVICE TOLL FREE AT 1-800-222-6635.
Arrow Embolectomy Catheters: 5 French, 2 Lumen x 40cm, Product Number: W01800, Single use, Latex Free, Rx only, Arrow International, 2400 Bernville Road, Reading, PA 19605. The arterial embolectomy catheter is intended for use in removing arterial emboli.
The inflation arm tubing may separate from the stopcock adapter.
Arrow International issued an "Urgent Medical Device Recall" letter dated March 25, 2009 describing proper handling of the affected device. Consignees were also instructed to complete a Recall Acknowledgement and Stock Status Form and fax to Arrow International at 1-800-343-2935. Further questions should be directed to Arrow International, Customer Service Department at 1-800-523-8446.
TIRE AND LOADING INFORMATION
INFLATING TIRES TO A PRESSURE OTHER THAN SPECIFIED ON THE ORIGINAL LABELS MAY HAVE AN ADVERSE EFFECT ON VEHICLE BRAKING, AND HANDLING, AND STABILITY IN AN EMERGENCY MANEUVER INCREASING THE RISK OF A CRASH.
FORD WILL MAIL OWNERS THE CORRECT TIRE LABEL ALONG WITH INSTRUCTIONS OF WHERE AND HOW TO AFFIX THE LABEL. THE SAFETY CAMPAIGN BEGAN ON FEBRUARY 11, 2010. OWNERS MAY CONTACT FORD MOTOR COMPANY CUSTOMER RELATIONSHIP CENTER AT 1-866-436-7332.
ENGINE FAILURE
CONNECTING RODS IN THE AFFECTED VEHICLES COULD FAIL AND CAUSE ENGINE FAILURE THAT COULD LEAD TO A LOSS OF VEHICLE CONTROL, RESULTING IN A CRASH, PERSONAL INJURY, OR DEATH.
PIAGGIO WILL NOTIFY OWNERS AND REPLACE THE ENGINES FREE OF CHARGE. THE SAFETY RECALL BEGAN ON JANUARY 25, 2010. OWNERS MAY CONTACT PIAGGIO AT 1-212-380-4431.
CRACKS IN THE PLATE WELDS OF THE LOWER BOOM PIVOT
FAILURE OF THE PLATES WILL CAUSE UNEXPECTED MOTION OF THE BOOM AND COULD CAUSE THE PLATFORM TO FALL, RESULTING IN SERIOUS INJURY OR DEATH TO A PERSON STANDING ON THE PLATFORM.
TEREX WILL NOTIFY OWNERS AND WILL REPAIR THE VEHICLES FREE OF CHARGE. THE SAFETY RECALL BEGAN ON FEBRUARY 5, 2010. OWNERS MAY CONTACT TEREX UTILITIES WARRANTY DEPARTMENT AT 1-605-884-3892.
Children's Metal Necklaces Recalled for Poisoning Hazard
The recalled necklaces contain high levels of cadmium. Cadmium is toxic if ingested by young children and can cause adverse health effects.
Consumers should immediately take this recalled jewelry away from children. Consumers should return the recalled jewelry to any Walmart store for a full refund or a free replacement product.