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Class 2 Device Recall DeRoyal(R) LIMB HOLDERS, COTTON ADJUSTABLE, UNIVERSAL, REF M2017, |
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Date Initiated by Firm |
February 21, 2014 |
Date Posted |
March 14, 2014 |
Recall Status1 |
Terminated 3 on May 08, 2015 |
Recall Number |
Z-1210-2014 |
Recall Event ID |
67686 |
510(K)Number |
K963476
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Product Classification |
Restraint, protective - Product Code FMQ
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Product |
DeRoyal(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 |
Recalling Firm/ Manufacturer |
DeRoyal Industries Inc 200 Debusk Ln Powell TN 37849-4703
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For Additional Information Contact |
Mr. Tracy Edmundson 865-362-2334
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Manufacturer Reason for Recall |
Moldy smell in product
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FDA Determined Cause 2 |
Packaging |
Action |
DeRoyal 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 Commerce |
8,962 pairs |
Distribution |
Worldwide Distribution - USA Nationwide in the states of FL, NC, IA, AL, IL, TX and the countries of Argentina. |
Total Product Life Cycle |
TPLC Device Report
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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.
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510(K) Database |
510(K)s with Product Code = FMQ and Original Applicant = DEROYAL INDUSTRIES, INC.
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