FDA-Device2013-08-28Class III
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.
Convatec Inc.
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.
Sold states
US Nationwide Distribution
Affected count
22,896 units
Manufactured in
200 Headquarters Park Dr, N/A, Skillman, NJ, United States
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1990-2013Don't want to check this manually?
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