2010 Product Recalls
1,800 recalls issued in 2010.
Showing 1641–1660 of 1,800 recalls
ABS ECU PROGRAMMING
VEHICLE STOPPING DISTANCES MAY INCREASE RELATIVE TO A CUSTOMER'S EXPECTATION INCREASING THE RISK OF A CRASH.
DEALERS WILL REWRITE THE PROGRAMMING OF THE ABS CONTROL UNIT FREE OF CHARGE. THE SAFETY RECALL BEGAN ON MARCH 3, 2010, AND IS EXPECTED TO BE COMPLETED IN LATE MARCH 2010. OWNERS MAY CONTACT TOYOTA AT 1-800-331-4331 AND LEXUS AT 1-800-255-3987.
Discovery Kids™ Animated Marine and Safari Lamps Recalled for Fire Hazard
A defect in the lamp's printed circuit board can cause an electrical short, posing a fire and burn hazard to consumers.
Consumers should immediately stop using the lamps, and contact Innovage for information on returning the product for a full refund.
Generation 2 Worldwide and "ChildESIGNS" Drop Side Crib Recalled for Entrapment Hazard
The crib's plastic hardware can break, which can cause the drop side of the crib to detach from a corner of the crib. When detached, the drop side creates a space, into which a child can roll and become entrapped. Entrapment between the drop side and the crib mattress creates a risk of suffocation or strangulation. In addition, the crib's mattress support can detach from the crib frame, creating a hazardous space in which a child could become entrapped and suffocate or strangle.
CPSC staff urges parents and caregivers to stop using these cribs immediately and find an alternative, safe sleeping environment for their baby. Do not attempt to fix these cribs.
Prelude Short Sheath Introducer, Carolina Kidney and Endocrine - Declot tray, K12T-02693, Merit Medical Systems, Inc., South Jordan, Utah 84095. To provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries while maintaining hemostasis for a variety of diagnostic and therapeutic procedures. This device can also provide access to a native or synthetic graft used for hemodialysis. The side port of the sheath allows adequate flow to perform temporar
External tubing may separate during use, allowing blood loss.
All of Merit's US sales representatives and distributors were notified by Prelude Short Sheath Introducer - Product Recall letter on 4/14/2009. They were instructed to promptly contact their customers. Customers were instructed to isolate, remove from inventory, and return all affected inventory. A Product Retrieval Form was to be returned to Merit. Further information is available at 801-316-4998 or 801-208-4344.
ON-Q PainBuster Infusion Pump (270 ml, 5 ml/hr), REF PS6504, Part No. 5001260. The pump is indicated for continuous and/or intermittent delivery of medication (such as local anesthetics or narcotics) to or around surgical wound sites and/or close proximity to nerves for preoperative, perioperative and postoperative regional anesthesia and pain management. Routes of administration may be intraoperative, perineural, percutaneous and epidural. The ON-Q Pump is also intended to significantly decrea
The ON-Q PainBuster, REF PS6504 (lot number 772166), box may contain the wrong product, ON-Q PainBuster, REF PS6502. If the wrong product is used, patients would receive a 2 ml/hr infusion rather than a 5 ml/hr infusion, which could result in inadequate pain relief.
Firm sent letters on 2/12/2008 to affected customers advising of the possibility of an ON-Q PainBuster PS6502 (100 ml x 2 ml/hr) packed inside the ON-Q PainBuster PS6504 outer box. The intent of the letter is as follows: a) Inform customers of the potential for the wrong product inside the box. b) Require customers to inspect lot 772166 to ensure product inside is correct. c) If the product inside the box is correct, then no further action is required. d) If the product inside the box is incorrect, then the customer is advised to contact I-Flow Customer Service in order to exchange their product. Customers are also advised to send the letter to end users if they sold lot 772166 to other customers. Fax back forms will be provided to document customer compliance with the proposed field correction. If you have questions about this recall contact I-Flow Customer Service at 949-206-2700 from 8:00 am - 5:00 pm U.S. Pacific time.
SHELL/BASE ATTACHING OR DETACHING DIFFICULTY
IF THE SHELL IS IMPROPERLY MOUNTED TO THE BASE, THE CHILD COULD BE INJURED IN THE EVENT OF A CRASH.
DJG WILL NOTIFY ALL REGISTERED OWNERS AND WILL SEND A REMEDY KIT CONSISTING OF TWO BASE SPRINGS, A HEX WRENCH, AND INSTRUCTIONS FOR THE BASE SPRING REPLACEMENT. THE REPAIR KIT IS FREE OF CHARGE. THE SAFETY CAMPAIGN BEGAN ON MARCH 5, 2010. OWNERS MAY CONTACT DJG AT 1-877-657-9546.
I-Flow Corporation Easy Pump LT 60-24 (60 ml x 2 ml/hr), REF: 04434366, assembled in Mexico. The Easypump LT is indicated for continuous and/or intermittent infusion of medication for general infusion use, including antibiotic delivery, chemotherapy and pain management.
I-Flow Corporation received two complaints involving Easypump LT 60-24 (Lot 612996) containing a 100 ml x 2 ml/hr pump in the sterile package instead of a 60 ml x 2 ml/hr pump (Illustration was included to show consignee what both the correct and incorrect part looks like). Lot 612996 was manufactured on January 6, 2006. As of February 7, 2008, there have been no further complaints received on t
I-Flow Corp. issued an "Important Recall Information" letter dated February 7, 2008 informing Consignees to quarantine and return any remaining inventory and notify any end users of the affected lot. For further information, contact I-Flow Corp. at 1-949-206-2653.
Battery Caps used with insulin pumps and glucose monitoring systems. The pump is used to help maintain blood glucose targets.
Unintentional rebooting: Pump products exhibit an intermittent loss of power due intermittent loss of contact between battery cap and battery canister resulting in the device resetting. The failure of the battery cap may result in failure of the device to administer insulin therapy which may result in hyperglycemia.
The recalling firm issued a notification letter to the patients with insulin pumps on 8/5/08 to inform them of the problem and that they needed to replace the battery. The recalling firm contacted OneTouch Ping users by telephone on 8/5/08 for this issue and another issue. The recalling firm issued letters to distributors informing them of the problem and notified customers to replace the batteries. In addition, a letter was issued to physicians to alert them of the situation with regard to current patients. Consumers can contact 1-800-423-4087 for additional information or questions.
LED MARKERS
IN THE EVENT OF A FIRE, THERE IS A POTENTIAL FOR PROPERTY DAMAGE, PERSONAL INJURY OR DEATH.
DEALERS WILL REPLACE THE LED MARKER FREE OF CHARGE. THE SAFETY RECALL IS EXPECTED TO BEGIN DURING MARCH 2010. OWNERS MAY CONTACT ELDORADO NATIONAL AT 1-800-955-9086.
AIR TANK
LESS THAN OPTIMAL RSC CONTROL OF THE TRAILER BRAKES DURING A ROLL STABILITY EVENT MAY INCREASE THE RISK OF A CRASH WHICH CAN RESULT IN PROPERTY DAMAGE, PERSONAL INJURY, OR DEATH.
DEALERS WILL INSPECT AND RELOCATE THE AIR LINE THAT SUPPLIES THE RSC TRACTION SOLENOID VALVE TO THE CORRECT PORT ON THE AIR TANK. THIS SERVICE WILL BE PERFORMED FREE OF CHARGE. THE SAFETY RECALL BEGAN ON FEBRUARY 19, 2010. OWNERS MAY CONTACT NAVISTAR AT 1-800-448-7825.
LOAD CARRYING CAPACITY MODIFICATION LABELS
A DRIVER MAY OVERLOAD A VEHICLE WHICH MAY INCREASE THE RISK OF A CRASH.
DEALERS WILL MAIL TO CONSUMERS THE CORRECTED LABEL OR THE CUSTOMER WILL HAVE THE OPTION FOR DEALERS TO INSTALL THE LABEL FREE OF CHARGE. THE SAFETY RECALL BEGAN ON MAY 27, 2010. OWNERS MAY CONTACT SOUTHEAST TOYOTA AT 1-800-301-6859.
LOAD CARRYING CAPACITY MODIFICATION LABELS
THIS DOES NOT MEET THE STANDARD REQUIREMENTS.
DEALERS WILL MAIL TO CONSUMERS THE CORRECTED LABEL OR THE CUSTOMER WILL HAVE THE OPTION FOR DEALERS TO INSTALL THE LABEL FREE OF CHARGE. DEALERS WILL ALSO CORRECT THE OWNER'S MANUAL. THE SAFETY RECALL BEGAN ON MAY 27, 2010. OWNERS MAY CONTACT GULF STATES TOYOTA AT 713-580-3300.
AIR VOLUME CALCULATION ERROR
THIS SITUATION MAY IMPACT THE OPERATOR'S ABILITY TO STOP THE VEHICLE WHICH MAY CAUSE AN ACCIDENT INVOLVING DEATH OR PERSONAL INJURY.
DEALERS WILL INSTALL AN ADDITIONAL AIR RESERVOIR TO THE AIR SYSTEM FREE OF CHARGE. THE RECALL BEGAN ON FEBRUARY 10, 2010. OWNERS MAY CONTACT PETERBILT AT 940-591-4196.
Screwdriver for 3.5mm Screws, DARCO system, instrument for use in orthopaedic implant surgery. REF: DC4261, Non-sterile, Rx only, 1 each, Wright Medical Technology, Inc., 5677 Airline, Road, Arlington, TN 38002
The package insert lists 3 sterilization procedures, 2 of which are not validated. Pre-vacuum steam sterilization is validated.
Wright Medical notified their distributors of the recall on 03/11/2009 by letter explaining the problem and requesting return of the product from their inventory and from their consignees. The letter included a "fax back" response page to ensure the receipt of the notice. The hospitals and surgeons were notified of the recall also on 03/11/2009. All letters were delivered by Fed Ex.
GE Centricity PACS RA1000 Workstation; for diagnostic image analysis. GE Healthcare Integrated IT Solutions, Barrington, IL 60010
A software anomaly results in incorrect study date and time information being displayed in the report screen and title, which may result in a potential patient misdiagnosis.
GE Healthcare IITS sent Product Safety Notification letters dated 5/5/08 to all customers who have the GE Centricity PACS Software Versions 3.0.0.X, 3.0.1.X, 3.0.2.X and 3.0.3.X informing them of the incorrect study date and time information being displayed in the report screen and title, which may lead to a potential patient misdiagnosis. The users were instructed to refer to the image overlay for the correct date and time until the new software version can be installed. A software patch to permanently resolve the issue will be installed at no charge. Any questions were directed to the GE Customer Care Center at 800-437-1171.
Smooth or threaded metallic bone fixation fastener. 3.5mm x 14.0 mm Locking Cortical Screw. Product labeled in 3.5mm x 14.0 mm Locking Cortical Screw. Product labeled in part, "Congruent Plate System... Size: 3.5mm x 14.0 mm Locking Cortical Screw... REF COL-3140-S LOT W46772... Acumed 5885 NW Cornelius Pass Road Hilsboro, OR ". Product is used as an orthopedic implant.
Product mislabeled. The inner sticky labels for the patient identified the product incorrectly as a Cortical screw (non-locking). The product package was labeled correctly.
The firm issued a Product Removal notification on 8-9-2007. The notification was reportedly sent by either FAX or e-mail. The firm notified consignees of the issue and gave the consignees the choice of returning the screws. The notification did not include any instructions for a sub-recall. If you have any questions contact Jason Gozdecki at 1-888-627-9957.
3.5mm X 32.5mm Cortical Screw used with the Polarus Humeral Fixation System,. Product labeled in part, "Polarus Humeral Fixation System& SIZE: 3.5mm X 32.5mm Cortical Screw... REF HCO3325-S... Acumed 5885 NW Cornelius Pass Road Hillsboro, OR 97124-9432 ". Polarus Humeral Fixation System, 3.5mm X 32.5mm Cortical Screw are packaged in a sterile inner package which are placed into an outer box. The cortical screws are used with the Polarus Locking Humeral Rod (Polarus Huemral Fixation System)
Package of 3.5mm X 32.5mm cortical screw may contain 3.5mm X 22.5mm cortical screw.
The firm issued a Product Removal notification on 12-27-2005 to their customers. The notification was sent by either FAX or by e-mail. The Product Removal Notification informed their customers of the issue, asked them to remove the screws from inventory and return the screws to Acumed. A reminder notification, dated 1/20/08 was issued to customers identifying the product and the problem and requesting the product be returned.
GE Centricity PACS RA1000 Workstation; for diagnostic image analysis. GE Healthcare Integrated IT Solutions, Barrington, IL 60010
The Centricity PACS RA1000 Workstation Software may manifest certain mammography image display problems only if the images were acquired through GE Senographe versions 2000D, DS or Essential.
GE Healthcare IITS sent recall letters dated 1/12/07 to all customers who have the combination of GE Centricity PACS RA1000 Workstation software versions 2.1.X.X, or 3.0.X.X combined with the GE Senographe 2000D, the Senographe DS, or Senographe Essential mammography scanners, informing them that the entire breast image or a portion of the breast image may not be displayed in the monitor regions and may not be evident to the end-user. To mitigate this problem, the users were provided a Quick Reference Guide detailing how to use the Pan tool to move the image left, right, up and down in order to display any portion of the image that may not be displayed on the screen. The customers were requested to make sure that all necessary physicians and personnel at their location are made aware of the issues and understand the risk mitigation provided. A software patch to permanently resolve the issue will be installed at no charge when it becomes available. Any questions were directed to the GE Customer Care Center at 800-437-1171.
Baxter RenalSoft v.2.0 Patient Management Software Suite - HD Module; clinical data management software; Baxter Healthcare Corporation, McGaw Park, Illinois 60085
Pre-Treatment/Post-Treatment Report errors: 1) The Heparin Bolus Value is displayed on Pre and Post Treatment Reports for patients with "No Heparin" orders (RenalSoft v2.0, Renal Software Suite v.3.0 and v.3.1), and 2) Withheld Medications are incorrectly displayed as Administered on the Pre-Treatment report (RenalSoft v.2.0 only).
Baxter Healthcare Corporation sent an Urgent Device Correction letter, dated 11/14/07, to all of the affected customers, informing them of the Heparin Bolus and the Withheld Medication issues and provided them with interim mitigation instructions that they should implement while waiting for a software correction. A Baxter representative will contact the customer to schedule the software update when the upgraded software is released. Customers were requested to complete and return the enclosed Customer Reply Form, indicating that they have disseminated the information to their staff, and indicating if they still have RenalSoft software and require an upgrade. Any questions were directed to Baxter Global Technical Services at 1-800-553-6898, option 4. A follow-up letter dated 3/6/08 was sent to the consignees on the same date, informing them that the upgraded RenalSoft Software v.2.0.1 was now available for installation. The consignees were requested to complete and fax back the customer reply form indicating that they received the letter, and were informed that they would be contacted by a Baxter representative to schedule an installation of the software upgrade at no charge.
5 Hole Locking 1st Tarsometatarsal Plate. Product labeled in part, "ACUMED 5885 NW Cornelius pass Road Hillsboro, OR. 97124-9432... Size: 5 Hole Locking 1st Tarsometatarsal Plate... REF 70-0007-S... LOT W58115".
Product sterility may be compromised.
The firm issued four separate Urgent Notification: Product Removal were issued by the firm on 2-14-2008, 2-20-2008, 2-26-2008, and 3-25-2008 for the issue of poorly sealed sterile pouches. The notifications were reportedly sent by either FAX or e-mail. The firm explained the issue and requested customers to return the specified products. On 7/16/08, the firm issued a second recall notification to their customers. This letter informed the customer of the recall, listed the products affected, stated the reason for the recall, tells customers, "return existing inventories of the recalled products to Acumed... If you further distributed this product, please notify those customers/consignees of this recall. This recall is to be extended to the user level." The letter includes an effectiveness form to be filled out by the customer and returned to Acumed.