Recall Z-1562-2022 ยท FMQ Restraint, Protective
DeRoyal Industries Inc
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.
| Date | Jul 15, 2022 |
| Status | Terminated |
| Reason | The webbing strap was laced improperly through the teeth of the buckle allowing the webbing strap to slide and was, therefore, not secure. |
| Root cause | Under Investigation by firm |
| Action | The recalling firm issued recall letters dated 7/15/2022 via email to the distributors and sale representative, and via overnight mail to the institution on 7/15/2022. The letter with an attached Affected Products Listing explained the reason for recall, the health risk, and provided actions for the customer to take, which included the following: Using the attached Affected Products Listing, identify the affected part numbers and lot numbers in inventory and place them in quarantine pending return. Complete the Notice of Return Form and return it to the recalling firm via FAX or email no la |
| Quantity | 36 eaches and 7 pairs |
| Distribution | US Nationwide distribution in the states of FL, IN, NV, RI, TN, TX, and WV. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.