Class 2 Device Recall Universal security cuffs

• Date Initiated by Firm: February 27, 2020
• Create Date: March 30, 2020
• Recall Status: Terminated on May 10, 2022
• Recall Number: Z-1604-2020
• Recall Event ID: 85102
• Product Classification: Restraint, protective - Product Code FMQ
• Product: DeRoyal SECURITY CUFFS, Single Strap, QR Buckle Cuff and Bed, UNIVERSAL, REF M8138 - Product Usage: patient restraint.
• Code Information: GTIN: 0749756946865 Lot Code: 50192186
• FEI Number: 1043214
• Recalling Firm/ Manufacturer: DeRoyal Industries Inc; 200 Debusk Ln; Powell TN 37849-4703
• For Additional Information Contact: 865-938-7828
• Manufacturer Reason for Recall: One lot of product was inadvertently manufactured with a buckle which does not meet the mechanical hold force required for this device.
• FDA Determined 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 in Commerce: 94 pairs
• Distribution: VA, CA, FL, AZ
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.