Device Recall Umbilicup 의 리콜

Recall

61434

Class 2

Z-1398-2012

2012-01-20

2012-04-12

Terminated

United States

2013-07-11

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=108068

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

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.