—#70165

Product

Bariatric Wheelchair, 28" Wide and 20" Deep Seat, 700 lb. Weight Capacity; Manufactured in Taiwan for Medline Industries, Inc., Mundelein, IL 60060 USA; Item #MDS809800 comes with Removable Desk-Length Arms, Swing-Away Detachable Footrests, Hemi-Height Adjustable. item #MDS809850 comes with Removable Desk-Length Arms, Swing-Away Detachable Elevating Legrests, Hemi-Height Adjustable.

FDA product code: IOR — Wheelchair, Mechanical
Device class: Class 1
Medical specialty: Physical Medicine
510(k) numbers: K051302
Affected lot / code info: Item numbers MDS809800 and MDS809850, all wheelchairs purchased between 12/01/2005 and 08/31/2007

Why it was recalled

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.

Root cause (FDA determination)

Component design/selection

Action the firm took

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.

Recalling firm

Firm: Medline Industries Inc
Address: 1 Medline Pl, Mundelein, Illinois 60060-4486

Distribution

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

Timeline

Recall initiated: 2008-03-31
Posted by FDA: 2008-08-19
Terminated: 2010-05-11
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #70165. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.