—#108068

Product

DeRoyal (R) Umbilicup, REF 72-8000NS, Rx Only, Manufactured by DeRoyal, Powell, TN 37849 Product Usage: Collection of cord blood

FDA product code: KSR — Container, Empty, For Collection & Processing Of Blood & Blood Components
Device class: Class 2
Medical specialty: Hematology
510(k) numbers: K020753
Affected lot / code info: 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

Why it was recalled

Device's needle may become dislodged from the cup during shipment or during use.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

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.

Recalling firm

Firm: DeRoyal Industries Inc
Address: 200 Debusk Ln, Powell, Tennessee 37849-4703

Distribution

Distribution pattern: Worldwide Distribution - USA Nationwide and the countries of: Canada, Dominican Republic, South Africa, and the United Arab Emirates.

Timeline

Recall initiated: 2012-01-20
Posted by FDA: 2012-04-12
Terminated: 2013-07-11
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #108068. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.