BEUDAMED
    FDA Enforcement Class I Terminated

    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.

    Recall: Z-1785-2014 · Reported June 25, 2014

    Enforcement

    Recall Number
    Z-1785-2014
    Event ID
    68292
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Convatec Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 25, 2014
    Initiation Date
    April 29, 2014
    Classification Date
    June 13, 2014
    Termination Date
    August 28, 2015
    Address
    200 Headquarters Park Dr, N/A, Skillman, NJ, 08558-2600, United States

    Description

    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.

    Reason

    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

    Code Info

    13-FM-0301 13-FM-0302 13FM0303 13-FM-0303 13FM0309 13VM509948 13VM509949 13VM510046 13VM512473 13VM513636 13VM513642 13VM516733 13VM520039 13VM521731 13VM521733 13VM524363 13VM524364 13VM527149 13VM527150 13VM528992 13VM528994 13VM531214 14FM0301 14VM531935 14VM532098

    Distribution

    Worldwide Distribution - USA Nationwide

    Quantity

    73,021 units US; 24,866 units OUS