Class 2 Device Recall Umbilicup

• Date Initiated by Firm: January 20, 2012
• Date Posted: April 12, 2012
• Recall Status: Terminated on July 11, 2013
• Recall Number: Z-1397-2012
• Recall Event ID: 61434
• Product Classification: Tray, surgical - Product Code LRP
• Product: Sterile surgical kits containing the Umbilicup device: DeRoyal (R) VAGINAL DELIVERY PACK, REF 89-5260.04, Rx Only, STERILE EO, Manufacturer: DeRoyal, Powell, TN 37849 DeRoyal (R) VAGINAL DELIVERY TRAY, REF 89-3928.10, Rx Only, STERILE EO, Manufacturer: DeRoyal, Powell, TN 37849 DeRoyal (R) C-SECTION TRAY, REF 89-2960.20, Rx Only, STERILE EO, Manufacturer: DeRoyal, Powell, TN 37849 Product Usage: Collection of cord blood
• Code Information: REF 89-5260.04, Lot Numbers: 17636582, 18080838, 18146577, 18178608, 18298693, 18952510, 19419055, 19480569, 19518336, 19592131, 19901141, 20128925, 20176492, 20678329, 20724372, 20822626, 21815858, 21923306, 22732536, 24157900, 24291754, 24630752, 24747336, 24823319, 25460353, 25721453, 25784489, 26018591, 26037952, 26149090, 26280549, 27163133, 27206527; REF 89-3928.10, Lot Numbers: 17826968, 17857924, 18177242, 18407790, 19021830, 19140417, 19676836, 20009408, 20127383, 20495653, 20676711, 20887981, 21023367, 21184339, 21531020, 21717131, 21839219, 22016935, 22057411, 22204397, 22379218, 22585169, 22731293, 23094151, 23420711, 23874561, 24230804, 24429928, 24519157, 24774801, 26098270, 26316468, 26663347, 26728235, 26956844, 27180961, 27343071, 27826304, 27911550, 27931729; REF 89-2960.20, Lot Numbers: 17903599, 17935806, 18183757, 19140610, 19325542, 19480673, 19881274, 20208693, 20679330, 20822829, 21056863, 21067909, 21318966, 21422472, 21649319, 21816375, 22123933, 22587164, 22782189, 23422927, 23696522, 23949622, 24007645, 24073423, 24232105, 24432131, 24468732, 24576258, 24823474, 26019527, 26281120, 26368444, 26785141, 26923452, 27227192, 27473916, 27931868
• 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: 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: 1562 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.