Bariatric Wheelchair, 26" Wide and 20" Deep Seat, 700 lb. Weight Capacity; Manufactured in Taiwan for Medline Industries

FDA device recall Z-1771-2008 · posted 2008-08-19 · Terminated

Recall details

Recalling firm

Medline Industries Inc

Reason for recall

Injuries to fingers. There is a potential for users to pinch their fingers between the seat bars when opening the wheelchairs. The injuries can be severe from fracture to severing.

Action taken

A Voluntary Field Correction letter dated 3/31/08 was issued to customers. The letter informed them of reports of users catching their fingers under the seat bars, which are identified on the chair with warning stickers. The customers were requested to change the backrest with the enclosed replacement upholstery kit, properly dispose of the old back rest, and place the enclosed cautionary tags on both sides of the chair seat. Instructions for installation of the upholstery and cautionary tags were included, as was a sheet entitled "How to Open a Wheelchair" which gives step by step instructions with illustrations for opening the wheelchair, as well as the warning "CAUTION KEEP YOUR FINGERS ON TOP OF THE UPHOLSTERY AT ALL TIMES. DO NOT PLACE YOUR FINGERS ON THE SIDES OR BOTTOM OF THE CHAIR SEAT." The accounts were requested to complete the enclosed response sheet and fax it back to Medline at 847-643-4482, indicating the serial numbers of chairs corrected. Any questions were directed to 800-633-5463, extension 5349, between 8:00 AM and 5:00 PM CST. Distributors were requested to notify their accounts of the recall.

Root cause

Component design/selection

Status

Terminated

Product code

IOR

Quantity affected

507 wheelchairs

Distribution

Class II Recall - Worldwide Distribution --- including USA and Canada.

Date initiated

2008-03-31

Date posted

2008-08-19

Date terminated

2010-05-11

Location

Mundelein, IL

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