Medical Device Safety and Recalls: ConvaTec, Inc., Flexi-Seal CONTROL Fecal Management System Kit - Not Cleared for Marketing

["U.S. Food & Drug Administration (FDA)" <fda@xxxxxxxxxxxxxxxxxxxxxxx>]

Title: Medical Device Safety and Recalls: ConvaTec, Inc., Flexi-Seal CONTROL Fecal Management System Kit - Not Cleared for Marketing

A recall has been issued for the ConvaTec, Inc., Flexi-Seal CONTROL Fecal Management System Kit as it is not cleared for marketing.  The firm received reports from U.S. healthcare facilities of 13 adverse events including twelve serious injuries and one death for the period February 2013 through March 2014.  A 510(k) application should have been submitted. The Auto-Valve feature that is unique to the Flexi-Seal CONTROL Fecal Management System Kit has not consistently performed relative to the inflation and deflation of the device’s retention balloon.  For more information, please see http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm402137.htm

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