Recall Z-1771-2008 ยท IOR Wheelchair, Mechanical
Medline Industries Inc
Bariatric Wheelchair, 26" Wide and 20" Deep Seat, 700 lb. Weight Capacity; Manufactured in Taiwan for Medline Industries, Inc., Mundelein, IL 60060 USA; Item #MDS809700 comes with Removable Full-Length Arms, Swing-Away Detachable Footrests, Hemi-Height Adjustable. item #MDS809750 comes with Removable Full-Length Arms, Swing-Away Detachable Elevating Legrests, Hemi-Height Adjustable.
| Date | Aug 19, 2008 (initiated Mar 31, 2008) |
| Status | Terminated |
| Reason | 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 | 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 instructi |
| Quantity | 507 wheelchairs |
| Distribution | Class II Recall - Worldwide Distribution --- including USA and Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K051302 | EXCEL BARIATRIC OR EXCEL SHUTTLE WHEELCHAIR Medline Industries, Inc., Aug 15, 2005 |