BEUDAMED
    FDA Enforcement Class II Terminated

    Convatec Esteem(TM) Synergy Stomahesive(R), 7/8 in. / 22mm, REF 405475 Product Usage: Esteem Synergy Stomahesive with Flexible Collar 22mm Precut Skin Barrier is used together with Esteem Synergy pouches as an ostomy system intended for the management of stomal output.

    Recall: Z-1890-2018 · Reported May 23, 2018

    Enforcement

    Recall Number
    Z-1890-2018
    Event ID
    79953
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    ConvaTec, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 23, 2018
    Initiation Date
    April 25, 2018
    Classification Date
    May 16, 2018
    Termination Date
    February 27, 2023
    Address
    7900 Triad Center Dr Ste 400, Greensboro, NC, 27409-9076, United States

    Description

    Convatec Esteem(TM) Synergy Stomahesive(R), 7/8 in. / 22mm, REF 405475 Product Usage: Esteem Synergy Stomahesive with Flexible Collar 22mm Precut Skin Barrier is used together with Esteem Synergy pouches as an ostomy system intended for the management of stomal output.

    Reason

    It was discovered that the stoma hole of one lots of the Esteem synergy Stomahesive Skin Barrier wafers is larger that the 7/8 inch / 22mm specified on the box label.

    Code Info

    Lot Number 7F00987

    Distribution

    US Nationwide Distribution

    Quantity

    200 boxes of 10