BEUDAMED
    FDA Enforcement Class II Ongoing

    Esteem Synergy Stomahesive Skin Barrier, part of Esteem synergy, which is a two-piece ostomy system consisting of an adhesive skin barrier and an adhesive pouch: ESTEEM SYN FLX WHT16/35MM PRECUT(1X10), REF: 405473; ESTEEM SYN FLX WHT35/35MM PRECUT(1X10), REF: 405479

    Recall: Z-0903-2025 · Reported January 22, 2025

    Enforcement

    Recall Number
    Z-0903-2025
    Event ID
    95955
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    ConvaTec, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 22, 2025
    Initiation Date
    November 29, 2024
    Classification Date
    January 10, 2025
    Address
    7815 National Service Rd Ste 600, Greensboro, NC, 27409-9403, United States

    Description

    Esteem Synergy Stomahesive Skin Barrier, part of Esteem synergy, which is a two-piece ostomy system consisting of an adhesive skin barrier and an adhesive pouch: ESTEEM SYN FLX WHT16/35MM PRECUT(1X10), REF: 405473; ESTEEM SYN FLX WHT35/35MM PRECUT(1X10), REF: 405479

    Reason

    Ostomy skin barrier package contains a pre-cut wafer of 28mm instead of 16mm and/or 35mm pre-cut wafers, as stated package labeling. If pre-cut wafers are too big the device cannot be used and if the pre-cut wafer is too small and the device user tries to apply, this could cause abrasion, stomal cut, and bleeding

    Code Info

    REF/UDI-DI/Lot: 405473/00768455185399/3J03813, 405479/00768455185450/3J03814

    Distribution

    US distribution to states of: OH, NY, IL

    Quantity

    240