FDA recall Z-1604-2020

DeRoyal Industries Inc · Class II · device

Product

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

VA, CA, FL, AZ

Key facts

Status
Terminated
Initiation date
2020-02-27
Report date
2020-04-08
Termination date
2022-05-10
Voluntary/Mandated
Voluntary: Firm initiated
Location
Powell, TN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1604-2020