BEUDAMED
    FDA Enforcement Class II Terminated

    Ethicon Dermabond Advanced Topical Skin Adhesive-topical skin adhesive to hold closed easily approximated skin edges of wounds from surgical incisions, including incisions Product Code: DNX12

    Recall: Z-0953-2021 · Reported February 10, 2021

    Enforcement

    Recall Number
    Z-0953-2021
    Event ID
    87088
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Ethicon, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 10, 2021
    Initiation Date
    January 4, 2021
    Classification Date
    February 4, 2021
    Termination Date
    November 29, 2023
    Address
    Us Highway 22 West, Somerville, NJ, 08876, United States

    Description

    Ethicon Dermabond Advanced Topical Skin Adhesive-topical skin adhesive to hold closed easily approximated skin edges of wounds from surgical incisions, including incisions Product Code: DNX12

    Reason

    Product distributed with a red tape as part of the sterile packaging which could impact the seal and result in a sterility breach

    Code Info

    Lot Number: QEBBTQ Exp. Date: April 30, 2022 GTIN: 10705031203532

    Distribution

    US Nationwide

    Quantity

    23,580 eaches