Recall Z-1613-2015 ยท IKX Aid, Transfer
Handicare USA, Inc.
ReTurn belt, wipeable, sizes Small through Extra Large, Plastic pouch, 1 item per pouch. Patient transfer aid.
| Date | May 14, 2015 (initiated Mar 26, 2015) |
| Status | Terminated |
| Reason | Complaints were received that the heat-welded seam on the wipeable belt's strap tore when force was applied. |
| Root cause | Device Design |
| Action | Handicare sent an Voluntary Product Recall Notification letter dated April 2, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were requested to quarantine any remaining stock and to contact customers if product was further distributed and to return the affected product for a replacement and/or full refund. Also, enclosed is a response form. Please complete and return the form even if you do not have any product to return. Your Sales representative can assist you in completing this form. This informati |
| Quantity | 64 |
| Distribution | US Distribution to the states of : FL, CA, NJ, NC and MD. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.