Z-1991-2013Class III

ConvaTec Flexi-Seal SIGNAL +, Rx Only

Name: Z-1991-2013 ConvaTec Flexi-Seal SIGNAL +, Rx Only
Creator: Convatec Inc.
Published: 2013-06-25
License: https://open.fda.gov/license/

ConvaTec Limited / initiated 2013-06-25 / Terminated / root cause: packaging

FDA source

Convatec Inc. began a recall of ConvaTec Flexi-Seal SIGNAL +, Rx Only Product Usage: For use to manage fecal incontinence through the collection of liquid to semi-liquid stool and to provide... on 2013-06-25. FDA classified it as Class III and gives the reason as "ConvaTec notified their customers on 6/25/2013 regarding the manufacturing irregularity that occurred related to the packaging of certain lots of Flexi-Seal Signal FMS. In certain lots, the lot number convention was...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1991-2013
Classification: Class III
Status: Terminated
Initiated: 2013-06-25
Posted: 2013-08-20
Terminated: 2014-01-08
Recalling firm: ConvaTec Limited
Product: ConvaTec Flexi-Seal SIGNAL +, Rx Only Product Usage: For use to manage fecal incontinence through the collection of liquid to semi-liquid stool and to provide access to administer medication.
Product code: KNT Tubes, Gastrointestinal (And Accessories)
Reason for recall: ConvaTec notified their customers on 6/25/2013 regarding the manufacturing irregularity that occurred related to the packaging of certain lots of Flexi-Seal Signal FMS. In certain lots, the lot number convention was duplicated on the packaging.
Root cause tag: packaging
FDA root cause: Under Investigation by firm
Action: ConvaTec issued a notification letters to their customers dated June 25, 2013 via UPS. The letter informed the customer of the issue with the related product and the action to be taken. If the customer has any question regarding the notification they can contact customer service at 1-800-422-8811.
Quantity in commerce: 22,896 units
Distribution: US Nationwide Distribution
Product codes and lots: Flexi-Seal Signal + ICC Code 418000; SAP Code# 1705108, Lots 12-FM-01 and 12-FM-02.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1991-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1990-2013	Class III	Terminated	Voluntary: Firm initiated	2013-08-28	2013-08-20
Z-1991-2013	Class III	Terminated	Voluntary: Firm initiated	2013-08-28	2013-08-20

Product code KNT

K032734Class IIConvatec Fecal Management SystemConvatec, A Bristol-Myers Squibb Co. / cleared 2004-04-08

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)