FDA Recalls in 2008
610 recalls found
January 2008
JariTrak Table Clamp, 1 inch diameter, vertical post, Catalog Number 206-160. The JariTrak Table Clamp with vertical post (206-160) is part of the Table Mounted Hardware that is used with the JariTrak Retractor System. The JariTrak self-retaining retractor system consists of the Table Clamp with Vertical Post, Flexible or Horizontal Bar with Universal Joint, Oval or Segment Rings, Tilting Blade Clamps and various blades. The product is supplied non-sterile and may be packaged individually or
The JariTrak Table Clamp may not securely fasten to the bed rail of the OR table during set up of the retractor system. In the event that the clamp is not securely fastened to the bed rail, the system may move during surgery. The firm received several complaints from hospitals.
On 11/14/06, an "URGENT-PRODUCT NOTIFICATION" letter (dated 11/14/06) and accompanying Fax Back Form were sent via Certified Mail Return Receipt Requested, to each customer that purchased or was supplied with the 206-160 Table Clamp. The letter instructs each surgical instrument coordinator (user) to review the inventory of 206-160 JariTrak" Table Clamps at the facility. The letter also provides instructions for the proper installation of the clamp to the bed rail. The customer is also asked to complete the Fax Back Form and fax it to back to Customer Service. J. Jamner Surgical Instruments, Inc. (J. Jamner) will replace any Table Clamps at the request of the customer. J. Jamner will account for all Fax Back replies and product returns. A second notification letter will be sent to any non-responding customers. Table Clamps returned from customers and from J. Jamner's inventory will be returned to the manufacturer, Koros USA Inc. or be destroyed by J. Jamner.
Dyonics Electroblade, 4.5 Full Radius, Valleylab Generator-Compatible Part Number: 7205961
Sterility seal of the package tray may have gaps/voids compromising the sterility of the device.
Smith & Nephew notified consignees by Certified letter dated 6/19/06. Accounts are requested to return product. Smith & Nephew expanded the recall on 8/2/5/06 by letter to include addtional lot numbers.
Foundation Hip System Bipolar Modular, Size 40mm OD; Cat. #412-01-040; Sterile; assembly required by physician prior to implant; manufactured by Encore Medical, L.P., Austin, TX 78758.
Device mislabeled. Hip prosthesis components validated for 5 years were labeled as having a 6 year expiration date.
Firm notified consignees of recall via phone, e-mail and overnight letters beginning on 08/02/07. Consignees asked to return devices for a properly labeled replacement.
Contact lens solution. The product is distributed under the following trade names: Bausch & Lomb ReNu Multi-Plus Multi-Purpose Solution, Equate Multi-Purpose Solution and Target Brand Multi-Purpose Solution. The product is distributed in up to three sizes: 4 fl.oz., 12 fl. oz. and 16 fl. oz
A higher than expected amount of trace iron in some bottles of finished product that over time affects the product's stability and color.
The firm issued a press release on 03/05/2006. Consignees were notified on 03/06/2007 via a customized Recall Notification Package via overnight courier with tracking and delivery confirmation capability. Bausch & Lomb Sales Representatives will visit the home offices of the major wholesale and distributors concurrent with the mailing of the notification packages.
TM-300 Traction System; an Rx software driven device used for patient traction; Manufactured for Sammons Preston Roylan, An Ability One Company, Bolingbrook, IL 60440, Manufactured by: ITO Co., Ltd., 3-3-3 Toyotama-Minami, Nerima-ku, Tokyo, 176-8605, Japan
The traction device may malfunction, producing oscillation and a jerking motion.
Sammons Preston Roylan, the U.S. agent for Ito Co., Ltd. issued recall letters dated 7/13/05 to all of their customers who purchased the Performa TM-300 traction unit, informing them that the manufacturer, Ito Co., Ltd., is recalling the units because the units may exhibit oscillation during some traction modes. The accounts were requested to contact Tina Kreisher at 1-800-323-5547, ext. 1383 if their TM-300 unit has a serial number that falls in the range listed in the recall letter. Tina will arrange for the unit to be shipped to the manufacturer's authorized repair center for upgrading of the software to version 2.8, and for the shipment of a loaner unit while their unit is being upgraded.
ARCHITECT Estradiol Reagent, each kit contains bottles of coated Microparticles and bottles of Conjugate; 400 Test Kit-list number 2K25-20 (4 x 100 tests) and 100 Test Kit-list number 2K25-25 (1 x 100 tests); Abbott Laboratories, Abbott Park, IL 60064-3500
A small number of reagent kits were incorrectly configured. The affected kits contain either two bottles of conjugate or two bottles of assay diluent instead of one bottle of each.
Abbott initiated a field correction recall by letter dated 2/19/07 to all customers receiving the affected reagent. The accounts were informed of the incorrectly configured reagent kits. The accounts were requested to assess the inventory for the affected lots of reagents, inspect each kit and destroy any kits incorrectly configured, recording the number of kits inspected and the number of kits discarded on the customer reply form and faxing it to Abbott by 3/2/07, indicating that the letter was received and understood. Replacement kits will be issued for the number of kits destroyed, as indicated on the reply sheet. Customers requiring additional information were directed to contact Abbott Customer Service at 1-877-422-2688.
One Touch Ultra Blood Glucose Test Strips-Lot # 2691191, LifeScan
Counterfeit Test Strips (manufacturer unknown)
Matrix Distributors contacted by telephone those pharmacies to which they had shipped the affected lots. These call were conducted from 10/9 to 10/13/2006. A follow-up letter was issued to the pharmacies extending the recall to the user level.
CryoValve, Pulmonary Valve & Conduit
This recall was initiated as part of the firm's retrospection review of tissues associated with complaints of alleged recipient infection.
Consignees were notified by telephone and letter on 04/19/2004.
Altaire, Magnetic Resonance Imaging Device.
The absorber unit in the helium compressor which is located in equipment rooms, and is not accessed by patients or system operators, may fail under pressure, causing an explosion that damages the compressor.
The firm implemented site inspections of customers beginning on 11/19/04 which have been completed. Customers that had the suspect component had it replaced.
Pronto Series Power Wheelchair, model M50.
If the arm of the wheelchair is overloaded, the joystick mounting brackett and/or arm pivot may fail due to variability in the plastic used by the supplier to make the components. This failure may cause the user or a caregiver to fall if they are leaning on the arm, and result in injury.
The recalling firm contacted all consignees by phone between May 9 and May 25, 2005 and sent an urgent field correction needed letter, dated April, 2005 to all consignees.