—#180091

Product

DeRoyal SECURITY CUFFS, Single Strap, QR Buckle Cuff and Bed, UNIVERSAL, REF M8138 - Product Usage: patient restraint.

FDA product code: FMQ — Restraint, Protective
Device class: Class 1
Medical specialty: General Hospital
Affected lot / code info: GTIN: 0749756946865 Lot Code: 50192186

Why it was recalled

One lot of product was inadvertently manufactured with a buckle which does not meet the mechanical hold force required for this device.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

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.

Recalling firm

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

Distribution

Distribution pattern: VA, CA, FL, AZ

Timeline

Recall initiated: 2020-02-27
Terminated: 2022-05-10
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #180091. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.