Class I — Convatec Inc.
| Recalling firm | Convatec |
|---|---|
| Registered facility | CONVATEC TRIAD LIFE SCIENCES, LLC (the firm's only registered facility) |
| Classification | Class I |
| 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 |
| Product | 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. |
| Quantity | 73,021 units US; 24,866 units OUS |
| Distribution | Worldwide Distribution - USA Nationwide |
| Initiated | 2014-04-29 |
| Classified | 2014-06-13 |
| Terminated | 2015-08-28 |
| Recall number | Z-1785-2014 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class I recall — Convatec Inc. (Z-1785-2014).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/68292/
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