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DeRoyal Industries Inc recalls DeRoyal SECURITY CUFFS, Single Strap, QR Buckle Cuff and Bed, UNIVERSAL, REF M8138 - Product Usage: patient restraint.
Recalled April 8, 2020 · FDA recall Z-1604-2020 · DeRoyal Industries
Hazard
One lot of product was inadvertently manufactured with a buckle which does not meet the mechanical hold force required for this device. · FDA Class II
Units
94 pairs
Sold at
VA, CA, FL, AZ
Description
One lot of product was inadvertently manufactured with a buckle which does not meet the mechanical hold force required for this device.
Product
DeRoyal SECURITY CUFFS, Single Strap, QR Buckle Cuff and Bed, UNIVERSAL, REF M8138 - Product Usage: patient restraint.
Manufacturer(s)
DeRoyal Industries Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →