—#195196

Product

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.

FDA product code: FMQ — Restraint, Protective
Device class: Class 1
Medical specialty: General Hospital
Affected lot / 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.

Why it was recalled

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 (FDA determination)

Under Investigation by firm

Action the firm took

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 later than 8/26/2022. If the product has been further distributed, the customer is requested to contact their customers by either forwarding the recall notification or requesting the recalling firm notify them.

Recalling firm

Firm: DeRoyal Industries Inc
Address: 200 Debusk Ln, Powell, Tennessee 37849-4703

Distribution

Distribution pattern: US Nationwide distribution in the states of FL, IN, NV, RI, TN, TX, and WV.

Timeline

Recall initiated: 2022-07-15
Terminated: 2024-08-06
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #195196. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.