Reported Apr 8, 2020 · Terminated
DeRoyal SECURITY CUFFS, Single Strap, QR Buckle Cuff and Bed, UNIVERSAL, REF M8138 - Product Usage: patient restraint.
DeRoyal Industries Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: DeRoyal Industries Inc · 200 Debusk Ln · Powell, TN · 37849-4703
Is this the product you have?
- DeRoyal SECURITY CUFFS, Single Strap, QR Buckle Cuff and Bed, UNIVERSAL
- REF M8138 - Product Usagepatient restraint
- Lot codes and dates
- GTIN0749756946865
- Lot Code50192186
- Amount recalled
- 94 pairs
Where it was sold
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.
This product could cause temporary or reversible health problems — stop using it.
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