Convatec Flexi Seal Control Fecal Management System Rx Only REF… — Class I medical device recall Z-1785-2014
Terminated recall by Convatec Inc., reported 2014-06-25, distributed nationwide. Convatec Inc. is recalling Flexi-seal FMS Control Kit since it does not have a 510K. In addition, an internal
| Recall number | Z-1785-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Convatec Inc., Skillman, NJ, United States |
| Recall initiated | 2014-04-29 |
| Classified | 2014-06-13 |
| Reported by FDA | 2014-06-25 |
| Terminated | 2015-08-28 |
| Distributed | Nationwide (US) |
| Reason classes | packaging |
| Model numbers | 411107 |
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.
Reason for recall
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1785-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.