medical Class II Updated 2020-04-08

DeRoyal Industries Inc recalls DeRoyal SECURITY CUFFS, Single Strap, QR Buckle Cuff and Bed

Recalled Product

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


Hazard / Issue

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

Issued by

FDA

Affected States: VA, CA, FL, AZ
Lot/Code Info: GTIN: 0749756946865 Lot Code: 50192186
View official government recall

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