DeRoyal (R) Umbilicup, REF 72-8000NS, Rx Only, Manufactured by DeRoyal, Powell, TN 37849 Product Usage: Collection of cord blood
FDA Recall Z-1398-2012 · Posted 2012-04-12
Recalling FirmDeRoyal Industries Inc
Recall StatusTerminated
Product CodeKSR
Date Initiated2012-01-20
Date Terminated2013-07-11
Product Quantity5400 units
Reason for Recall
Device's needle may become dislodged from the cup during shipment or during use.
Firm 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 ([email protected]) 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.
Root Cause
Nonconforming Material/Component
Distribution Pattern
Worldwide Distribution - USA Nationwide and the countries of: Canada, Dominican Republic, South Africa, and the United Arab Emirates.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.