Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1770-2008

Bariatric Wheelchair, 24" Wide and 19" Deep Seat, 600 lb. Weight Capacity; Manufactured in Taiwan for Medline...

MEDLINE INDUSTRIES, LP - Northfield / initiated 2008-03-31 / Terminated / root cause: design

Medline Industries Inc began a recall of Bariatric Wheelchair, 24" Wide and 19" Deep Seat, 600 lb. Weight Capacity; Manufactured in Taiwan for Medline Industries, Inc., Mundelein, IL 60060 USA; Item... on . The reason FDA records is "Fingers can get injured. There is a potential for users to pinch their fingers between the seat bars when opening the wheelchairs. Injuries can be severe from fractures to severing". As of , the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number
Z-1770-2008
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
MEDLINE INDUSTRIES, LP - Northfield
Product
Bariatric Wheelchair, 24" Wide and 19" Deep Seat, 600 lb. Weight Capacity; Manufactured in Taiwan for Medline Industries, Inc., Mundelein, IL 60060 USA; Item #MDS809600 comes with Removable Desk-Length Arms, Swing-Away Detachable Footrests, Fixed Height. item #MDS809650 comes with Removable Desk-Length Arms, Swing-Away Detachable Elevating Legrests, Fixed Height.
Product code
IOR Wheelchair, Mechanical
Reason for recall
Fingers can get injured. There is a potential for users to pinch their fingers between the seat bars when opening the wheelchairs. Injuries can be severe from fractures to severing.
Root cause tag
design
FDA root cause
Component design/selection
Action
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.
Quantity in commerce
430 wheelchairs
Distribution
Class II Recall - Worldwide Distribution --- including USA and Canada.
Product codes and lots
Item numbers MDS809600 and MDS809650; all wheelchairs purchased between 12/01/2005 and 08/31/2007