BEUDAMED
    FDA Enforcement Class II Ongoing

    Medline Convenience kits used for various procedures: 1) CW PERI GYN, Model Number: DYNJ80807B

    Recall: Z-1612-2025 · Reported April 23, 2025

    Enforcement

    Recall Number
    Z-1612-2025
    Event ID
    96510
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    MEDLINE INDUSTRIES, LP - Northfield
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 23, 2025
    Initiation Date
    March 3, 2025
    Classification Date
    April 17, 2025
    Address
    3 Lakes Dr, Northfield, IL, 60093-2753, United States

    Description

    Medline Convenience kits used for various procedures: 1) CW PERI GYN, Model Number: DYNJ80807B

    Reason

    There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.

    Code Info

    1) DYNJ80807B, UDI-DI: 10195327415624(each), 40195327415625(case), Lot Number: 24IBH993

    Distribution

    Worldwide distribution - US Nationwide and the countries of Canada, Mexico, Panama, Virgin Islands.

    Quantity

    48 units