Recall Z-1397-2012 ยท LRP Tray, Surgical
DeRoyal Industries Inc
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
| Date | Apr 12, 2012 (initiated Jan 20, 2012) |
| Status | Terminated |
| Reason | Device's needle may become dislodged from the cup during shipment or during use. |
| Root 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. |
| Quantity | 1562 units |
| Distribution | Worldwide Distribution - USA Nationwide and the countries of: Canada, Dominican Republic, South Africa, and the United Arab Emirates. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.