BEUDAMED
    FDA Enforcement Class III 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 · Reported August 28, 2013

    Enforcement

    Recall Number
    Z-1990-2013
    Event ID
    65879
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Convatec Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 28, 2013
    Initiation Date
    June 25, 2013
    Classification Date
    August 20, 2013
    Termination Date
    January 8, 2014
    Address
    200 Headquarters Park Dr, N/A, Skillman, NJ, 08558-2600, United States

    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.

    Code Info

    Flexi-Seal Signal FMS Kit - ICC Code: 418000 SAP Code #1262167 Lot# 12-FM-01 and Lot# 12-FM-02.

    Distribution

    US Nationwide Distribution

    Quantity

    22,896 units