BEUDAMED
    FDA Enforcement Class II Ongoing

    ENDO KIT, Medline Kit SKU DYKE1577A, Component Number 57469, 10 per case; Medline Convenience Kits containing Single Use Biopsy Valve MAJ-1555

    Recall: Z-0558-2025 · Reported December 4, 2024

    Enforcement

    Recall Number
    Z-0558-2025
    Event ID
    95702
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    MEDLINE INDUSTRIES, LP - Northfield
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    December 4, 2024
    Initiation Date
    October 25, 2024
    Classification Date
    November 26, 2024
    Address
    3 Lakes Dr, Northfield, IL, 60093-2753, United States

    Description

    ENDO KIT, Medline Kit SKU DYKE1577A, Component Number 57469, 10 per case; Medline Convenience Kits containing Single Use Biopsy Valve MAJ-1555

    Reason

    Identified lots of Olympus product may be missing sterile and manufacturing lot numbers and expiration dates on the sterile packaging. The information can be found on the outer box or zipper bag label. Medline is recalling its kits which utilize affected product as a component.

    Code Info

    UDI-DI: 10193489844115 (each), 40193489844116 (case); Lot Number 22EBD372

    Distribution

    US Nationwide distribution in the state of NY.

    Quantity

    100