Recall Z-1604-2020 ยท FMQ Restraint, Protective
DeRoyal Industries Inc
DeRoyal SECURITY CUFFS, Single Strap, QR Buckle Cuff and Bed, UNIVERSAL, REF M8138 - Product Usage: patient restraint.
| Date | Feb 27, 2020 |
| Status | Terminated |
| Reason | One lot of product was inadvertently manufactured with a buckle which does not meet the mechanical hold force required for this device. |
| Root cause | Nonconforming Material/Component |
| Action | DeRoyal issued their recall on 2/27/2020 to the end user level by emailing its direct accounts and sales representatives. The customers were asked to identify the affected products, quarantine them, return the affected product and the provided notice of return form back to DeRoyal indicating if replacement or credit is requested. Distributors were asked to further notify their customers. They were asked to do this directly or to provide the recalling firm with a customer listing and the recalling firm would notify them. |
| Quantity | 94 pairs |
| Distribution | VA, CA, FL, AZ |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.