BEUDAMED
    FDA Enforcement Class II Ongoing

    ConvaTec Esteem+ Durahesive Plus, Drainable Pouch, 3/4-2 1/2 in., 19-64mm, REF 416976. For the management of stoma output following a colostomy or ileostomy procedure.

    Recall: Z-0127-2023 · Reported November 2, 2022

    Enforcement

    Recall Number
    Z-0127-2023
    Event ID
    90856
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    ConvaTec, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 2, 2022
    Initiation Date
    August 16, 2022
    Classification Date
    October 24, 2022
    Address
    7815 National Service Rd Ste 600, N/A, Greensboro, NC, 27409-9403, United States

    Description

    ConvaTec Esteem+ Durahesive Plus, Drainable Pouch, 3/4-2 1/2 in., 19-64mm, REF 416976. For the management of stoma output following a colostomy or ileostomy procedure.

    Reason

    impaired functionality of the release liner

    Code Info

    UDI/DI: 768455115358, Batch Numbers: 2A00585, 2A00586, 2A04528, 2A04529, 2A04530m

    Distribution

    US Nationwide distribution.

    Quantity

    5284 units