Z-1562-2022 Class II Terminated
FDA device recall Z-1562-2022 was initiated by DeRoyal Industries Inc on Jul 15, 2022 and is designated Class II. 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. The recall status is terminated (terminated Aug 6, 2024). Affected quantity: 36 eaches and 7 pairs.
Recall Details
- Product Type
- Devices
- Report Date
- Aug 31, 2022
- Initiation Date
- Jul 15, 2022
- Termination Date
- Aug 6, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 36 eaches and 7 pairs
Product Description
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.
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 Pattern
US Nationwide distribution in the states of FL, IN, NV, RI, TN, TX, and WV.
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.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1562-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026