Agency classClass IIOur severity:High FDA (Devices)·Z-1562-2022·Announced 2022-08-31

DeRoyal Limb Holders and Security Cuffs Buckle Webbing Strap Failure

DeRoyal is recalling specific limb holders and security cuffs due to improperly laced webbing straps that may slide loose, potentially compromising device security.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II device with a documented manufacturing defect that could cause restraint failure. No injuries or illnesses have been reported. Because the device is designed to secure patient limbs during medical procedures, failure could pose risk of harm, meeting the rubric criterion for High severity.

Plain-English summary

DeRoyal Industries Inc is recalling four models of limb holders and security cuffs used in medical and psychiatric care settings. The recalled devices are: Limb Holder Wrist (REF M8124), Limb Holder Ankle (REF M8125), Security Cuffs Wrist and Ankle Universal (REF M8136), and Security Cuffs Heavy Duty Vertical Psychiatric (REF M8137).

The webbing strap on these devices was laced improperly through the buckle teeth. This improper lacing allows the webbing strap to slide and prevents the device from securing properly. Because these devices are designed to maintain secure restraint of a patient's limb, improper function could result in loss of limb control during medical procedures.

The affected devices were distributed nationwide to healthcare facilities in Florida, Indiana, Nevada, Rhode Island, Tennessee, Texas, and West Virginia. The recall includes 36 individual units and 7 pairs. Specific lot numbers and expiration dates are available through FDA records.

The recalled product

Product: 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…
Manufacturer: DeRoyal Industries Inc
Category: Medical Device — Restraints / Limb Holders
Hazard: restraint-failure
strap-separation

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (13)

(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.

Distribution

Distributed nationwide across the United States.

The notice also names 7 states specifically:

Same manufacturer · DeRoyal Industries Inc

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