CLASS III Device recall · Reported 28 Aug 2013 · FDA Enforcement Report
Flexi-Seal Signal Fecal Management System recalled by Convatec
Convatec is recalling ConvaTec Flexi-Seal Signal Fecal Management System, distributed nationwide in the US. The recall was initiated on 25 Jun 2013 and the FDA has classified it as Class III.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1990-2013
- FDA event ID
- 65879
- Recalling firm
- Convatec, Skillman, NJ
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 25 Jun 2013
- FDA classified
- 20 Aug 2013
- Reported
- 28 Aug 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Other Medical Devices
Timeline
| 25 Jun 2013 | Recall initiated by company | |
| 20 Aug 2013 | Classified by FDA | +56 days |
| 28 Aug 2013 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
ConvaTec Flexi-Seal SIGNAL Fecal Management System, 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.
Where it was distributed
US Nationwide Distribution
Questions about this recall
Is Flexi-Seal Signal Fecal Management System recalled?
Yes. Convatec recalled Flexi-Seal Signal Fecal Management System on 25 Jun 2013. The recall is Class III and its status is Terminated. Recall number Z-1990-2013.
Why was it recalled?
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.
Which lots are affected?
Flexi-Seal Signal FMS Kit - ICC Code: 418000 SAP Code #1262167 Lot# 12-FM-01 and Lot# 12-FM-02.
Where was it sold?
US Nationwide Distribution
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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