Z-1604-2020 Class II Terminated
FDA device recall Z-1604-2020 was initiated by DeRoyal Industries Inc on February 27, 2020 and is designated Class II. 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. The recall status is terminated (terminated May 10, 2022). Affected quantity: 94 pairs.
Recall Details
- Product Type
- Devices
- Report Date
- April 8, 2020
- Initiation Date
- February 27, 2020
- Termination Date
- May 10, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 94 pairs
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.
Distribution Pattern
VA, CA, FL, AZ
Code Information
GTIN: 0749756946865 Lot Code: 50192186