2011 Product Recalls
2,055 recalls issued in 2011.
Showing 2041–2055 of 2,055 recalls
Autoimmune EIA ANA Screening Test Kit, 96 Tests, Model/Catalog Number: 96AN manufactured by Bio-Rad, Hercules, CA
The ANA Screening kit generates a high percentage of false positive results, associated with a low check control reading.
Bio-Rad issued an Urgent Medical Device Recall Notification letter dated March 1, 2010 to customers describing the issue and actions to be taken. Responses will be tracked via response forms. The letter instructed customers that affected products should be identified, quarantined, and discarded, or reworked with shorter expiration dates until newer lots are available. Bio-Rad can be contacted at 510-724-7000 concerning this recall.
Quest EIA ANA Screen Bulk Kit, model number 96AN-BPU-QUEST. Manufactured by Bio-Rad Laboratories, Inc., Hercules, CA. For labeling and distribution by Quest International Inc. Medical device is used as a qualitative enzyme immunoassay (EIA) intended to screen for the presence of antinuclear antibodies (ANAs) in human serum as an aid in the diagnosis of certain rheumatic diseases. This assay collectively detects, in one well, total ANAs against double stranded DNA (dsDNA, nDNA), histones, SS-A/
The value for the ANA Cutoff and ANA Positive Controls will decrease overtime resulting in an unusually elevated positivity rate for patient samples tested.
Bio-Rad Laboratories, Inc. sent an URGENT MEDICAL DEVICE RECALL NOTIFICATION letter dated February 24, 2010, to their customer. The letter identified the product, the problem, and the action to be taken. The customer was instructed to: Examine inventory and quarantine affected product. Identify all customers that have received the affected product and immediately notify them. Instruct them to discontinue use of the affected product. Complete and return the enclosed MEDICAL DEVICE RECALL RESPONSE FORM. For questions regarding this recall call (510) 724-7000.
Transseptal Sheath Introducer Kits (under trade names: HeartSpan, Channel FX, Torflex, Braided Guiding Introducer Kit). The product is shipped 5 per carton. Intended to allow left heart catheterization procedure to occur through the right atrium.
Radiopaque tip may fracture
Thomas Medical Products, A GE Healthcare Company, issued an "Urgent Medical Device Correction" letter dated February 1, 2010. Consignees were informed of the affected product then asked to cease distribution, return any product to firm and contact all sub-accounts. For further information, contact Thomas Medical Products Customer Service at 1-866-446-3003.
Vail 500 Enclosed Bed System.
Risk of patient entrapment, may result in serious injury or death.
The recalling firm sent consignees an urgent notification letter, dated 5/6/05.
Acacia Catalog # 385150 IV Extension Set 15cm Small Bore, Spin Nut w/BD Q-Syte
Some lots of IV Extension Sets with BD Q-Syte Luer Access Split Septum have a manufacturing deviation which could cause the product to not function properly, possibly resulting in an air embolism.
A letter dated December 18, 2009 was sent to Acacia customers with the following instructions. 1. Immediately review your inventory of Acacia IV Extension Sets with BD Q-Syte for REF numbers and lot numbers listed and remove them from all inventory printed on the unit packaging , shelf box and shelf shipper containers. 2. Complete the Distributor Recall response Card (Attachment 1) and return by fax immediately to the number on the Distributor Recall Response Card for product in your facility at the time of receipt of this letter. This form must be completed and f axed to Acacia, Inc even if there is no product in inventory. 3. Acacia, Inc is currently working to ensure that replacement products are readily available. Once you have identified how much product you will be returning, please call your Customer Representative at 1-800-453-4538, opt. 2, ext. 2534, to arrange for product replacement. Questions are to be directed to the Customer Representative at 1-800-453-4538, opt. 2, ext. 2534, between 8:00AM and 5:00PM MST, Monday-Friday.
Roche ACCU-CHEK Softclix Lancing Device, Distributed by Roche Diagnostics, Indianapolis, IN. Models 3144844001 (10 lancets) and 3583031002 (17 lancets). The device is used to prick the finger and to obtain a drop of blood in preparation for diabetes/insulin level testing.
The lancet cap may be missing, which could result in an unintended lancet stick to the user.
An "Urgent Medical Device Correction" letter dated May 13, 2009 was sent to all affected customers, distributors and consumer consignees who have either registered their blood glucose meter, contacted the firm about the lancets since 10/1/08, or have been shipped lancets by Roche since 10/1/08 were notified of the problem. Distributors were requested to notify each patient self-tester to whom a meter kit was distributed since October 1, 2008. The firm issued a press release on May 18, 2009. Diabetes Care customers: If you have questions regarding the recall, please contact the ACCU-CHEK Softclix Lancet Hotline at 1-800-778-7057. CoaguChek meter customers: If you have questions regarding the recall, please contact the ACCU-CHEK Softclix Lancet Hotline at 1-800-778-7505.
CyberKnife Treatment Delivery System, a subsystem of the CyberKnife Robotic Radiosurgery System, manufactured by Accuray Inc., Sunnyvale, CA. Indicated for treatment for planning and image-guided stereotactic radiosurgery and precision radiotherapy of lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.
Targeting accuracy out of specification, Error alert does not render the system down, which may result in mistreatment in the wrong area.
Accuray, Inc. issued an "Urgent Device Correction" notice dated June 22, 2009. The consignees were informed of the defect including methods for detecting the error. The firm is in the process of developing a software patch to address the issue. For further information, contact Accuray, Inc. Customer Support at +1-877-668-8667 (US) or +1-408-716-4700 (outside US) or customersupport@accuray.com.
Avalung backpacks Recalled for Suffocation Hazard
The air intake tubing can crack under cold temperatures, causing the unit not to function as intended, posing a suffocation hazard.
Consumers should immediately stop using these recalled backpacks and contact Black Diamond Equipment to receive a free replacement product or a full refund.
ROOF BODY PANEL JOINTS/OMITTED ADHESIVE
IN THE EVENT OF A VEHICLE CRASH THE ROOF PANELS AND JOINTS MAY NOT ABSORB THE IMPACT AND COULD OPEN UP, INCREASING THE RISK OF DEATH OR SERIOUS PERSONAL INJURY TO OCCUPANTS IN THE EVENT OF A CRASH.
TCI IS CURRENTLY DEVELOPING THE REMEDY FOR THIS NONCOMPLIANCE. OWNERS WILL BE SUPPLIED WITH THE PARTS AND INSTRUCTIONS ON HOW TO REPAIR ANY AFFECTED VEHICLE(S). TCI WILL ASSIST ALL OWNERS WITH SCHEDULING REPAIRS AND LOCATING AUTHORIZED REPAIR FACILITIES. ANY REPAIRS WILL BE PERFORMED FREE OF CHARGE. OWNERS MAY CONTACT TCI AT 1-845-988-2333.
Salsa Handlebar Stems Recalled for Fall Hazard
The handlebar stems can crack or break, posing a fall hazard to the rider.
Consumers should stop riding bicycles containing these handlebar stems immediately and contact an authorized Salsa Bicycles dealer for a free inspection and a handlebar stem replacement or a full refund.
Manual Wheelchairs with Transit System Option, Model: Quickie LXI (EILXI), Product is manufactured and distributed by Sunrise Medical, Inc. Fresno, CA Intended to provide mobility to persons restricted to a sitting position and are unable to transfer from their wheelchairs when traveling in motor vehicles, the wheelchair must serve as a vehicle seat.
The stabilizer bar was inadvertently omitted during the manufacturing process.
An Urgent: Medical Device Correction letter, dated February 2009, with certified return receipt was sent to customers in the United States; Canadian consignees were notified via e-mail. The letter identified the affected product and the reason for the recall. The letters asked customers to contact their Quickie dealer to make arrangements to have their device wheelchair corrected at no charge and to also verify their wheelchair serial number on the form. Questions should be directed towards their dealer or Sunrise Medical at 800-456-8168.
Stryker brand End Cutter Shaver Blade F-Series, 4.0 mm; Model Number -375-747-000, manufactured by Stryker Puerto Rico
Potential breakage of the internal shaft of the End Cutter Shaver Blade; F-Series, 4.0mm. if breakage occurs, the device becomes non-functional and the defect could be observed through the camera/console system.
Stryker issued Urgent Product Recall letters dated November 12, 2009 to all its direct consignees, informing them of the affected products and providing instructions on the recall. Customers were requested to return the product to Stryker. Stryker can be contacted concerning this recall at 408 754-2124.
Stryker Infravision Esophageal Kit, Model Numbers 220180548, 220180540, 220180560, manufactured by Stryker Endoscopy San Jose.
The silicone sheath component of the product detaches from the catheter during removal of the e-kit from the body.
Stryker issued Urgent Product Recall letters dated August 20, 2009 to all its direct consignees, informing them of the affected products and providing instructions on the recall. Customers were requested to return the affected product to Styrker.
GreenLight MoXy Fiber Optic, part number 0010-2400, for use with the GreenLight XPS Laser System, manufactured by American Medical Systems Inc., San Jose, CA The XPS Laser system is indicated for surgical incision and excision, vaporization, ablation, hemostasis and coagulation of soft tissue.
Product not intended for release was distributed, which may result in old components, not built to specifications, or undergo final testing
American Medical Systems sent oral notifications that the product used for patient case evaluations was from the 2 year shelf life study. Products have been returned, as the product was with AMS field personnel. For questions regarding this recall call 847-855-6270.
LumiWave 1X4 Infrared Therapy Device, Catalog # LW1X4, BioCare Systems, Inc.
Electrical Safety Hazard-when pulling on the cord of the AC adapter, to remove it from an outlet, the prongs on the AC adapter, may detach from the unit, damaging it and exposing the user to an electrical safety hazard
Consignees were notified by telephone beginning 06/08/2006, followed by a letter on 06/23/2006.