Device product
DeRoyal SECURITY CUFFS, Single Strap, QR Buckle Cuff and Bed, UNIVERSAL, REF M8138 - Product Usage: patient restraint.
Z-1604-2020
Product summary
- Event
- Event 85102
- Status
- Terminated
- Classification
- Class II
- Quantity
- 94 pairs
- Official record key
device-enforcement:Z-1604-2020
Official wording
Reason: One lot of product was inadvertently manufactured with a buckle which does not meet the mechanical hold force required for this device.
Code information: GTIN: 0749756946865 Lot Code: 50192186
Distribution pattern: VA, CA, FL, AZ
Derived failure modes
-
Unknown
One lot of product was inadvertently manufactured with a buckle which does not meet the mechanical hold force required for this device.