Sterile surgical kits containing the Umbilicup device: DeRoyal (R) VAGINAL DELIVERY PACK, REF 89-5260.04, Rx Only, STERI

FDA device recall Z-1397-2012 · posted 2012-04-12 · Terminated

Recall details

Recalling firm

DeRoyal Industries Inc

Reason for recall

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

Action taken

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.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

LRP

Quantity affected

1562 units

Distribution

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

Date initiated

2012-01-20

Date posted

2012-04-12

Date terminated

2013-07-11

Location

Powell, TN