DeRoyal limb holders: (1) DeRoyal Limb Holder, Wrist, Fixed, Quick Release, REF M8124; (2) DeRoyal Limb Holder, Ankle, Fixed, Quick Release, REF M8125; (3) DeRoyal Security Cuffs, Wrist and Ankle, Universal, REF M8136; and (4) DeRoyal Security Cuffs, Heavy Duty Vertical Psychiatric, University, REF
Check against the official notice below — it lists the full affected range.
DeRoyal Industries Inc is recalling DeRoyal limb holders, including wrist and ankle models (REF M8124, M8125, M8136, and M8137), distributed nationwide in Florida, Indiana, Nevada, Rhode Island, Tennessee, Texas, and West Virginia. The webbing straps on these devices were laced improperly through the buckle teeth, which allows the straps to slide and become unsecured.
The recall affects 36 individual units and 7 pairs across multiple lot numbers with expiration dates ranging from May 2032 to June 2032. The source document does not specify what action affected consumers should take.
Written by software from the official notice below. Not reviewed by a lawyer.
The webbing strap was laced improperly through the teeth of the buckle allowing the webbing strap to slide and was, therefore, not secure.
Reason for recall: The webbing strap was laced improperly through the teeth of the buckle allowing the webbing strap to slide and was, therefore, not secure. Distribution: US Nationwide distribution in the states of FL, IN, NV, RI, TN, TX, and WV. Quantity: 36 eaches and 7 pairs Lot/code info: (1) M8124 - Lot 57372551 / exp 06/06/2032; Lot 57285721 / exp 05/22/2032; Lot 57369651 / exp 06/06/2032; Lot 57497652 / exp 6/27/2032; GTIN: 00749756780728; (2) M8125 - Lot 5746744 / exp 6/20/2032; Lot 57419195 / exp 6/13/2032; Lot 57420031 / exp 6/14/2032; GTIN: 00749756780735; (3) M8136 - Lot 57501121 / exp 6/27/2032; GTIN: 00749756837828; (4) M8137 - Lot 57462151 / exp 6/20/2032; GTIN: 00749756849234.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.