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Convatec Inc. recalls Convatec Flexi Seal Control Fecal Management System Rx Only REF 411107 Product Usage:For use to manage fecal inco
Recalled June 25, 2014 · FDA recall Z-1785-2014 · Convatec
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 · FDA Class I
Units
73,021 units US; 24,866 units OUS
Sold at
Worldwide Distribution - USA Nationwide
Description
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
Product
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.
Manufacturer(s)
Convatec Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →