FDA Device recall Z-1785-2014
Convatec Flexi Seal Control Fecal Management System Rx Only REF 411107 Product Usage:For use to manage fecal incontinence through the colle…
- FDA Device
- Class I
- terminated
- Published 2014-06-25
On 2014-06-25 the FDA classified a Class I recall of Convatec Flexi Seal Control Fecal Management System Rx Only REF 411107 Product Usage:For use to manage fecal incontinence through the colle… by Convatec, citing 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 fee….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1785-2014 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2014-04-29 |
| Published | 2014-06-25 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Convatec |
| Distribution | US |
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
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
Identifiers
| code_info | 13-FM-0301 13-FM-0302 13FM0303 13-FM-0303 13FM0309 13VM509948 13VM509949 13VM510046 13VM512473 13VM51…13-FM-0301 13-FM-0302 13FM0303 13-FM-0303 13FM0309 13VM509948 13VM509949 13VM510046 13VM512473 13VM513636 13VM513642 13VM516733 13VM520039 13VM521731 13VM521733 13VM524363 13VM524364 13VM527149 13VM527150 13VM528992 13VM528994 13VM531214 14FM0301 14VM531935 14VM532098 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1785-2014%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.