BEUDAMED
    FDA Recall Terminated

    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.

    Recall: Z-1990-2013 · Initiated June 25, 2013

    Recall

    Recall Number
    Z-1990-2013
    Event Number
    65879
    Firm
    Convatec Inc.
    FEI Number
    3011987967
    Product Code
    KNT
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    June 25, 2013
    Posted
    August 20, 2013
    Terminated
    January 8, 2014
    Address
    200 Headquarters Park Dr, Skillman, NJ, 08558-2600

    Description

    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.

    Reason

    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.

    Action

    ConvaTec issued a notification letters to their customers dated June 25, 2013 via UPS. The letter informed the customer of the issue with the related product and the action to be taken. If the customer has any question regarding the notification they can contact customer service at 1-800-422-8811.

    Distribution

    US Nationwide Distribution

    Quantity

    22,896 units