FDA Device Recalls in 2002
4 recalls found
December 2002
Drop Hooks for Xact (tm) Lo-Pro with Removeable Drop Seat, Xact Integrated, and Xact Individual with Integrated Drop Seat wheelchairs, model/item numbers 05D, 1D, and 15D. Packaged as set of four in a poly bag.
Wheelchair seat component is defective.
Firm notified customers by certified letter 5/14/02 and advised of potential for serious injury. Letter instructs customers to cease use and distribution of any defective hooks and return for replacement. Firm additonally instructed dealers to notify end-users about the recall.
Gambro ClinicalKit Safety Kit 15G, Catalog Number 0141080405C. Packaged 30 kits per case. Each kit contains 2 Nipro Safetouch Safety Needles.
Gambro's ClinicalKit 15G safety Kits contain the Nipro Safetouch Safety Fistula Needles currently being recalled by Nipro for leakage problems
All consignees were notified by telephone and fax on 11/13/2002.
GEM DR Model 7271 Implantable Cardioverter-Defibrillator (ICD)
Extended charge times prior to defibrillation shock.
An 'Important Patient Management Information' letter, dated November 14, 2002, was sent to physicians following patients who had the defibrillators implanted and this gave recommendations to physicians to prevent the problem.
Spiral Gold Hollow Fiber Oxygenator with Duraflow Treatment, a hollow fiber membrane oxygenator.
Separation between lid and housing unit.
Accounts notified by phone 10/9/02 and letter 11/1/02. Recalling firm is requesting return of the recalled product.