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U.S. Department of Health and Human Services

Class 2 Device Recall DeRoyal(R) LIMB HOLDERS, COTTON ADJUSTABLE, UNIVERSAL, REF M2017,

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 Class 2 Device Recall DeRoyal(R) LIMB HOLDERS, COTTON ADJUSTABLE, UNIVERSAL, REF M2017,see related information
Date Initiated by FirmFebruary 21, 2014
Date PostedMarch 14, 2014
Recall Status1 Terminated 3 on May 08, 2015
Recall NumberZ-1210-2014
Recall Event ID 67686
510(K)NumberK963476 
Product Classification Restraint, protective - Product Code FMQ
ProductDeRoyal(R) LIMB HOLDERS, COTTON ADJUSTABLE, UNIVERSAL, REF M2017 Product Usage: Limb holders are intended for mildly to moderate agitated or disoriented patients who disrupt medical treatment and/or cause harm to themselves and/or others
Code Information lot numbers 1143442 and 1161762
FEI Number 1043214
Recalling Firm/
Manufacturer		 DeRoyal Industries Inc
200 Debusk Ln
Powell TN 37849-4703
For Additional Information ContactMr. Tracy Edmundson
865-362-2334
Manufacturer Reason
for Recall		Moldy smell in product
FDA Determined
Cause 2		Packaging
ActionDeRoyal initiated an Urgent Voluntary Recall dated February 21, 2014 to all affected customers. The letter identified the affected product, problem and actions to be taken. DeRoyal has asked that products be destroyed, and that notice of destruction be sent back. For questions contact your DeRoyal Sales Representative or DeRoyal Customer Service at 1-800-251-9864.
Quantity in Commerce8,962 pairs
DistributionWorldwide Distribution - USA Nationwide in the states of FL, NC, IA, AL, IL, TX and the countries of Argentina.
Total Product Life CycleTPLC 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.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = FMQ
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