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Recall Observatory FDA recall evidence

Device 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 Psychiatric, University, REF M8137.

Z-1562-2022

July 15, 2022

Class II

Product summary

Firm
DeRoyal Industries Inc
Event
Event 90629
Status
Terminated
Classification
Class II
Quantity
36 eaches and 7 pairs
Official record key
device-enforcement:Z-1562-2022

Official wording

Reason: The webbing strap was laced improperly through the teeth of the buckle allowing the webbing strap to slide and was, therefore, not secure.

Code information: (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 pattern: US Nationwide distribution in the states of FL, IN, NV, RI, TN, TX, and WV.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The webbing strap was laced improperly through the teeth of the buckle allowing the webbing strap to slide and was, therefore, not secure.

Field note

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