Deroyal Security Cuffs recall
DeRoyal SECURITY CUFFS, Single Strap, QR Buckle Cuff and Bed, UNIVERSAL, REF M8138 - Product Usage: patient restraint.
Why was Deroyal Security Cuffs recalled?
One lot of product was inadvertently manufactured with a buckle which does not meet the mechanical hold force required for this device.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
GTIN: 0749756946865 Lot Code: 50192186
- Product
- DeRoyal SECURITY CUFFS, Single Strap, QR Buckle Cuff and Bed, UNIVERSAL, REF M8138 - Product Usage: patient restraint.
- Recalling firm
- DeRoyal Industries Inc
- Quantity
- 94 pairs
- Distribution
- VA, CA, FL, AZ
- Recall date
- April 8, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)