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.
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