Recall Z-1604-2020— DeRoyal Industries Inc

Name: FDA recall Z-1604-2020
Creator: U.S. Food and Drug Administration
Published: 2020-02-27

Class II · Terminated

Class II FDA medical device recall by DeRoyal Industries Inc, initiated 2020-02-27, terminated 2022-05-10. FDA's recall record names no specific 510(k) clearance for this event. Product: DeRoyal SECURITY CUFFS, Single Strap, QR Buckle Cuff and Bed, UNIVERSAL, REF M8138 - Product Usage: patient restraint.. Reason: One lot of product was inadvertently manufactured with a buckle which does not meet the mechanical hold force required for this device..

Recalling firm: DeRoyal Industries Inc
Classification: Class II
Status: Terminated
Initiated: 2020-02-27
Terminated: 2022-05-10
Firm location: Powell, TN, United States

Product description

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

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.