FDA Recall Terminated

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

Recall: Z-1397-2012 · Initiated January 20, 2012

Recall

Recall Number: Z-1397-2012
Event Number: 61434
Firm: DeRoyal Industries Inc
FEI Number: 1043214
Product Code: LRP
Status: Terminated
Root Cause: Nonconforming Material/Component
Initiated: January 20, 2012
Posted: April 12, 2012
Terminated: July 11, 2013
Address: 200 Debusk Ln, Powell, TN, 37849-4703

Description

Reason

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

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.

Distribution

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

Quantity

1562 units