DeRoyal Industries Inc Recall 90629
Description: DeRoyal limb holders: (1) DeRoyal Limb Holder, Wrist, Fixed, Quick Release, REF M8124; (2) DeRoyal Limb Holder, Ankle, Fixed, Quick Release, REF M8125; (3) DeRoyal Security Cuffs, Wrist and Ankle, Universal, REF M8136; and (4) DeRoyal Security Cuffs, Heavy Duty Vertical Psychiatric, University, REF M8137.
DeRoyal Industries Inc Recall 90629 Information
| Status | Completed |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1562-2022 |
| Event ID | 90629 |
| Event Description | DeRoyal limb holders: (1) DeRoyal Limb Holder, Wrist, Fixed, Quick Release, REF M8124; (2) DeRoyal Limb Holder, Ankle, Fixed, Quick Release, REF M8125; (3) DeRoyal Security Cuffs, Wrist and Ankle, Universal, REF M8136; and (4) DeRoyal Security Cuffs, Heavy Duty Vertical Psychiatric, University, REF M8137. |
| Product Type | Devices |
| Distribution | US Nationwide distribution in the states of FL, IN, NV, RI, TN, TX, and WV. |
| Quantity | 36 eaches and 7 pairs |
| Recall Reason | The webbing strap was laced improperly through the teeth of the buckle allowing the webbing strap to slide and was, therefore, not secure. |
| Device Classification | 20220831 |
| Device Code Info | (1) M8124 - Lot 57372551 / exp 06/06/2032; Lot 57285721 / exp 05/22/2032; Lot 57369651 / exp 06/06/2032; Lot 57497652 / exp 6/27/2032; GTIN: 00749756780728; (2) M8125 - Lot 5746744 / exp 6/20/2032; Lot 57419195 / exp 6/13/2032; Lot 57420031 / exp 6/14/2032; GTIN: 00749756780735; (3) M8136 - Lot 57501121 / exp 6/27/2032; GTIN: 00749756837828; (4) M8137 - Lot 57462151 / exp 6/20/2032; GTIN: 00749756849234. |
| Center Classification Date | 20220822 |
| Recall Initiation Date | 20220715 |
| Recalling Firm | DeRoyal Industries Inc |
| Initial Notification | Letter |
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