BEUDAMED
    FDA Enforcement Class II Ongoing

    DuoDERM Control Gel Formula Border Dressings 15x15cm (1x5pk)

    Recall: Z-2614-2021 · Reported October 6, 2021

    Enforcement

    Recall Number
    Z-2614-2021
    Event ID
    88557
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    ConvaTec, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 6, 2021
    Initiation Date
    August 20, 2021
    Classification Date
    September 30, 2021
    Address
    7815 National Service Rd Ste 600, N/A, Greensboro, NC, 27409-9403, United States

    Description

    DuoDERM Control Gel Formula Border Dressings 15x15cm (1x5pk)

    Reason

    Primary packaging labeling may be incorrect.

    Code Info

    Lot Number 8G03458, Expiry Jul 2023

    Distribution

    Distribution in US and Canada US distribution in CA, FL, GA, IL, MD, MN, NC. NM, NJ, OH, PA, TX, VA

    Quantity

    170 packs