FDA-Device2022-08-31Class II
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.
DeRoyal Industries Inc
Hazard
The webbing strap was laced improperly through the teeth of the buckle allowing the webbing strap to slide and was, therefore, not secure.
Sold states
US Nationwide distribution in the states of FL, IN, NV, RI, TN, TX, and WV.
Affected count
36 eaches and 7 pairs
Manufactured in
200 Debusk Ln, Powell, TN, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1562-2022Don't want to check this manually?
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