FDA-Device2020-04-08Class II
DeRoyal SECURITY CUFFS, Single Strap, QR Buckle Cuff and Bed, UNIVERSAL, REF M8138 - Product Usage: patient restraint.
DeRoyal Industries Inc
Hazard
One lot of product was inadvertently manufactured with a buckle which does not meet the mechanical hold force required for this device.
Sold states
VA, CA, FL, AZ
Affected count
94 pairs
Manufactured in
200 Debusk Ln, N/A, Powell, TN, United States
Products
DeRoyal SECURITY CUFFS, Single Strap, QR Buckle Cuff and Bed, UNIVERSAL, REF M8138 - Product Usage: patient restraint.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1604-2020Don't want to check this manually?
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