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Convatec Inc. recalls ConvaTec Flexi-Seal SIGNAL Fecal Management System, Rx Only Product Usage: For use to manage fecal incontinence thro
Recalled August 28, 2013 · FDA recall Z-1990-2013 · Convatec
Hazard
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. · FDA Class III
Units
22,896 units
Sold at
US Nationwide Distribution
Description
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.
Product
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.
Manufacturer(s)
Convatec Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →