Low risk — use of or exposure to this product is not likely to cause adverse health consequences.
ConvaTec Flexi-Seal SIGNAL Fecal Management System Recalled by Convatec Inc. Due to ConvaTec notified their customers on 6/25/2013 regarding the...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Convatec Inc. directly.
Affected Products
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.
Quantity: 22,896 units
Why Was This 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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Convatec Inc.
Convatec Inc. has 9 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report