Z-1785-2014Class I

Convatec Flexi Seal Control Fecal Management System Rx Only REF 411107

Name: Z-1785-2014 Convatec Flexi Seal Control Fecal Management System Rx Only REF 411107
Creator: Convatec Inc.
Published: 2014-04-29
License: https://open.fda.gov/license/

ConvaTec Limited / initiated 2014-04-29 / Terminated / root cause: design

FDA source

Convatec Inc. began a recall of 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... on 2014-04-29. FDA classified it as Class I and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1785-2014
Classification: Class I
Status: Terminated
Initiated: 2014-04-29
Posted: 2014-06-13
Terminated: 2015-08-28
Recalling firm: ConvaTec Limited
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.
Product code: KNT Tubes, Gastrointestinal (And Accessories)
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
Root cause tag: design
FDA 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 in commerce: 73,021 units US; 24,866 units OUS
Distribution: Worldwide Distribution - USA Nationwide
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1785-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1785-2014	Class I	Terminated	Voluntary: Firm initiated	2014-06-25	2014-06-13

Product code KNT

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)