Medical device recalls Moderate risk

DeRoyal Industries Inc recalls DeRoyal SECURITY CUFFS, Single Strap, QR Buckle Cuff and Bed, UNIVERSAL, REF M8138 - Product Usage: patient restraint.

Recall date
February 27, 2020
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1604-2020
FDA classification
Class II
Brand / firm
DeRoyal Industries Inc
Sold / distributed
VA, CA, FL, AZ

Why it was recalled

One lot of product was inadvertently manufactured with a buckle which does not meet the mechanical hold force required for this device.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

DeRoyal SECURITY CUFFS, Single Strap, QR Buckle Cuff and Bed, UNIVERSAL, REF M8138 - Product Usage: patient restraint.

Get recall alerts

Free email alert whenever DeRoyal Industries Inc has a new recall — straight from official government data. Unsubscribe anytime.

More recalls from: DeRoyal Industries Inc