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U.S. Department of Health and Human Services

Class 2 Device Recall Umbilicup

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  Class 2 Device Recall Umbilicup see related information
Date Initiated by Firm January 20, 2012
Date Posted April 12, 2012
Recall Status1 Terminated 3 on July 11, 2013
Recall Number Z-1398-2012
Recall Event ID 61434
510(K)Number K020753  
Product Classification Container, empty, for collection & processing of blood & blood components - Product Code KSR
Product DeRoyal (R) Umbilicup, REF 72-8000NS, Rx Only, Manufactured by DeRoyal, Powell, TN 37849

Product Usage: Collection of cord blood
Code Information Lot Numbers: 17486924, 17920399, 18040342, 18316290, 18551118, 19341884, 19396771, 19464008, 19504031,  19546960, 19743023, 20687057, 21157488, 21413621, 21699341, 22142544, 22373051, 22688811,  23111424, 23161430, 23434063, 23794510, 24095551, 24163955, 24296281, 24451957, 24508634,  24793826, 25043550, 25313548, 25439757, 25747451, 26023059, 26199281, 26544541, 26611133, 26706327, 26943568, 27105291, 27304418, 27571604  
Recalling Firm/
Manufacturer		 DeRoyal Industries Inc
200 Debusk Ln
Powell TN 37849-4703
For Additional Information Contact Tracy Edmundson
865-362-2334
Manufacturer Reason
for Recall		 Device's needle may become dislodged from the cup during shipment or during use.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action DeRoyal Industries sent Recall communication by letter to all affected consignees of the Non-Sterile Bulk and Single Sterile Units on January 20, 2012 and of the Kits and Trays on Febraury 6, 2012. The letters identified the affected products, problem and actions to be followed. Customers were instrructed to complete the enclosed Notice of Destruction form and return this form by fax (865-362-3716) or email (recalls@deroyal.com) within two weeks of the date of this letter. DeRoyal will use your response on the Notice of Destruction form to send replacements as soon as they become available. Distributors were instructed to forward this recall to any of their end users that may have affected product. If you have questions or need assistance with the recall, please call 865.362.1020 or Robby Lockett at 865.362.1034.
Quantity in Commerce 5400 units
Distribution Worldwide Distribution - USA Nationwide and the countries of: Canada, Dominican Republic, South Africa, and the United Arab Emirates.
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.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = KSR and Original Applicant = DEROYAL
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