Recall Z-1991-2013 ยท KNT Tubes, Gastrointestinal (And Accessories)
Convatec Inc.
ConvaTec Flexi-Seal SIGNAL +, Rx Only Product Usage: For use to manage fecal incontinence through the collection of liquid to semi-liquid stool and to provide access to administer medication.
| Date | Aug 20, 2013 (initiated Jun 25, 2013) |
| Status | Terminated |
| Reason | ConvaTec notified their customers on 6/25/2013 regarding the manufacturing irregularity that occurred related to the packaging of certain lots of Flexi-Seal Signal FMS. In certain lots, the lot number convention was duplicated on the packaging. |
| Root cause | Under Investigation by firm |
| Action | ConvaTec issued a notification letters to their customers dated June 25, 2013 via UPS. The letter informed the customer of the issue with the related product and the action to be taken. If the customer has any question regarding the notification they can contact customer service at 1-800-422-8811. |
| Quantity | 22,896 units |
| Distribution | US Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K032734 | CONVATEC FECAL MANAGEMENT SYSTEM Convatec, A Bristol-Myers Squibb Co., Apr 8, 2004 |