FDA Recalls in 2010
716 recalls found
January 2010
VP 2000 Processor; an automated tissue stainer 100 volt - part 30-144100 or list 2J11-60; 117 volt - part 30-144101 or list 2J11-01, and part 30-102832 - processor only; 230 volt - part 30-144102 or list 2J11-04, and part 30-102833 processor only. Designed to automate and standardize slide specimen processing including deparafinization, FISH pretreatment and routine slide staining for the laboratory. The unit is preprogrammed to perform slide pretreatment protocols for FISH assays and can be p
Thermal runaway conditions, in that the target temperature was exceeded and the temperature display could not track the actual temperature within the heated slide basins of the VP 2000 Slide Processor.
Abbott sent Device Recall/Urgent Field Safety Notice letters dated 9/15/08 to the VP2000 customers on 9/12/08, informing them that thermal runaway conditions may occur within the heated slide basins of the VP2000 Slide Processor. The customers were given actions to take to prevent this condition: a) VP2000 should be powered down when not in use and when the controlling computer is not in use; b) Liquid level in all heated basins should be checked periodically to ensure that there is adequate reagent present for slide processing and to keep the sensor probe immersed for accurate temperature sensing; and c) If large, rapid and random fluctuations in indicated basin temperature occurs the unit should be shut down and a Field Service Representative be contacted. Any questions were directed to their local Abbott Technical Service Representative.
Turon Revision Glenoid Poly Liner. The Metal Backed Revision Glenoid is a two piece metal backed polyethylene glenoid component for use in total shoulder arthroplasty. It includes a metal baseplate and polyethylene liner. DJO Surgical shoulder devices are intended for treatment of patients who are candidates for shoulder arthroplasty per the indications for use.
Product devices used for testing are not identical to what was manufactured. Under certain circumstances snap feature could allow poly liner to move on baseplate reducing tightness of fit.
Firm notified consignees by an Urgent: Medical Device Recall letter, dated July 20, 2009. The letter stated the reason for the recall, asked customers to quarantine, and return the affected product. The enclosed response form needed to be completed and returned as soon as possible. Questions were to be directed to David Harris, Manager of Customer Service at 512-834-6330.
VERTIER Surgical Table, Catalog #0788-100-000 (Standard table); distributed by Stryker Communications, Flower Mound, TX. Is an AC powered, general purpose, mobile surgical table with electro-hydraulically controlled movements which are part of a control feedback system.
Hydraulic lines responsible for tilting the surgical table have the potential to be severed when articulating table to its lowest position, possibly resulting in the unexpected and rapid movement of the table.
Urgent: Device Recall letters were sent to consignees on 07/02/08 via FedEx with return receipt. Consignees were asked to discontinue use of the tables until a Stryker representative has come to the facility and updated the table. The firm has identified and validated replacement parts that prevent this occurrence.
Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG087301, .035/150cm, regular/straight/standard, sold as a single hydrophilic guidewire in bulk non-sterile packaging. Argon Medical Devices, Inc. Athens, TX 75751.
Hydrophilic guidewires have the potential to demonstrate degradation of the Pebax cladding.
Argon Medical Devices Inc. issued an "Urgent Field Safety Notice" letter dated February 26, 2009 informing all consignees of the affected product. Consumers were asked to immediately quarantine and return any product remaining followed by completion and return of the provided response form via email or fax (1-903-677-9396). For further questions or additional information call Argon Medical Devices Inc. at 1-903-677-9319.