FDA-Device2014-06-25Class I
Convatec Flexi Seal Control Fecal Management System Rx Only REF 411107 Product Usage:For use to manage fecal incontinence through the collection of liquid to semi-liquid stool and to provide access to administer medications as prescribed by a physician.
Convatec Inc.
Hazard
Convatec Inc. is recalling Flexi-seal FMS Control Kit since it does not have a 510K. In addition, an internal assessment of product performance, including a review of customer feedback, has confirmed that Flexi-Seal Control is not meeting expectations or those of customers. Specifically, the Auto-Valve feature that is unique to the Flexi-Seal Control has not been consistently performing relative
Sold states
Worldwide Distribution - USA Nationwide
Affected count
73,021 units US; 24,866 units OUS
Manufactured in
200 Headquarters Park Dr, N/A, Skillman, NJ, United States
Products
Convatec Flexi Seal Control Fecal Management System Rx Only REF 411107 Product Usage:For use to manage fecal incontinence through the collection of liquid to semi-liquid stool and to provide access to administer medications as prescribed by a physician.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1785-2014Don't want to check this manually?
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