BEUDAMED
    FDA Recall 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 · Initiated April 25, 2018

    Recall

    Recall Number
    Z-1890-2018
    Event Number
    79953
    Firm
    ConvaTec, Inc
    FEI Number
    3011987967
    Product Code
    MMH
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    April 25, 2018
    Terminated
    February 27, 2023
    Address
    7900 Triad Center Dr, Ste 400, Greensboro, NC, 27409-9076

    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.

    Action

    ConvaTec sent an Urgent Voluntary Medical Device Recall dated April 20, 2018. Customers were directed to inspect their inventory, perform a count of affected product, and respond even if none of the recalled product was found. Once the response is received, return instructions will be provided. Distributors were directed to perform a sub-account recall, forwarding the letter to their customers. The firm will be providing replacement product.

    Distribution

    US Nationwide Distribution

    Quantity

    200 boxes of 10