Recall Z-1785-2014 ยท KNT Tubes, Gastrointestinal (And Accessories)
Convatec Inc.
Convatec Flexi Seal Control Fecal Management System Rx Only REF 411107 Product Usage:For use to manage fecal incontinence through the collection of liquid to semi-liquid stool and to provide access to administer medications as prescribed by a physician.
| Date | Jun 13, 2014 (initiated Apr 29, 2014) |
| Status | Terminated |
| Reason | Convatec Inc. is recalling Flexi-seal FMS Control Kit since it does not have a 510K. In addition, an internal assessment of product performance, including a review of customer feedback, has confirmed that Flexi-Seal Control is not meeting expectations or those of customers. Specifically, the Auto-Valve feature that is unique to the Flexi-Seal Control has not been consistently performing relative |
| Root cause | Device Design |
| Action | Convatec Inc. sent an Urgent Voluntary Medical Device Recall letter dated April 29, 2014 via UPS. The letter identified the affected product, problem and actions to be taken. Customers are asked to immediately stop distributing and quarantine all recalled lots. Affected products must be returned to Distributor. Contact your Distributor for shipping instruction. Customers should completed the attached return response form and return it to the address on the response form. Questions can be directed to Gregory Kowzun at (336) 547-3710. Convatec issued a press release on 7/3/2014. |
| Quantity | 73,021 units US; 24,866 units OUS |
| Distribution | Worldwide Distribution - USA Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.