BEUDAMED
    FDA Enforcement Class II Ongoing

    Cardinal Health Jackson-Pratt Channel Drain, 10 Fr, REF JP-2187

    Recall: Z-0968-2023 · Reported January 25, 2023

    Enforcement

    Recall Number
    Z-0968-2023
    Event ID
    91322
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Cardinal Health 200, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 25, 2023
    Initiation Date
    December 14, 2022
    Classification Date
    January 18, 2023
    Address
    3651 Birchwood Dr, N/A, Waukegan, IL, 60085-8337, United States

    Description

    Cardinal Health Jackson-Pratt Channel Drain, 10 Fr, REF JP-2187

    Reason

    Cardinal Health recently received multiple complaints regarding various performance issues with Cardinal Health Jackson-Pratt Channel Drains including lack of radiopacity in wound drains, dull trocars impacting product performance, lack of flexibility of wound drains, and broken wound tips.

    Code Info

    UDI/DI 50885380182424(cs), 20885380182423(ea), Lot Numbers: N210278, N210368, N210423, N210460, N210468 , N210469, N210543, N220050, N220099, N220139, N220163

    Distribution

    Worldwide distribution - US Nationwide and the countries of Canada, Saudi Arabia, Singapore, Hong Kong.

    Quantity

    4111 devices