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U.S. Department of Health and Human Services

Class 2 Device Recall DeRoyal

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  Class 2 Device Recall DeRoyal see related information
Date Initiated by Firm July 15, 2022
Create Date August 22, 2022
Recall Status1 Completed
Recall Number Z-1562-2022
Recall Event ID 90629
Product Classification Restraint, protective - Product Code FMQ
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.
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.
Recalling Firm/
Manufacturer		 DeRoyal Industries Inc
200 Debusk Ln
Powell TN 37849-4703
For Additional Information Contact Theresa Marsee
865-362-6465
Manufacturer 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.
FDA Determined
Cause 2		 Under Investigation by firm
Action The recalling firm issued recall letters dated 7/15/2022 via email to the distributors and sale representative, and via overnight mail to the institution on 7/15/2022. The letter with an attached Affected Products Listing explained the reason for recall, the health risk, and provided actions for the customer to take, which included the following: Using the attached Affected Products Listing, identify the affected part numbers and lot numbers in inventory and place them in quarantine pending return. Complete the Notice of Return Form and return it to the recalling firm via FAX or email no later than 8/26/2022. If the product has been further distributed, the customer is requested to contact their customers by either forwarding the recall notification or requesting the recalling firm notify them.
Quantity in Commerce 36 eaches and 7 pairs
Distribution US Nationwide distribution in the states of FL, IN, NV, RI, TN, TX, and WV.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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