BEUDAMED
    FDA Enforcement Class II Ongoing

    Medline Convenience kits used for various procedures: 1) ARTHROSCOPIE DU GENOU-LF, Model Number: DYNJ40229A; 2) ARTHROSCOPY PACK-LF, Model Number: OPK382N; 3) ARTHROSCOPY NEW TEGH-LF, Model Number: DYNJ46723B

    Recall: Z-1619-2025 · Reported April 23, 2025

    Enforcement

    Recall Number
    Z-1619-2025
    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) ARTHROSCOPIE DU GENOU-LF, Model Number: DYNJ40229A; 2) ARTHROSCOPY PACK-LF, Model Number: OPK382N; 3) ARTHROSCOPY NEW TEGH-LF, Model Number: DYNJ46723B

    Reason

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

    Code Info

    1) DYNJ40229A, UDI-DI: 10889942670482(each), 40889942670483(case), Lot Number: 24JBM438; 2) OPK382N, UDI-DI: 10889942686704(each), 40889942686705(case), Lot Number: 24JBN001; 3) DYNJ46723B, UDI-DI: 10889942747405(each), 40889942747406(case), Lot Number: 24JBQ891

    Distribution

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

    Quantity

    222 units