BEUDAMED
    FDA Enforcement Class II Ongoing

    MEDLINE OPEN HEART, REF DYNJ904261B

    Recall: Z-0122-2025 · Reported October 23, 2024

    Enforcement

    Recall Number
    Z-0122-2025
    Event ID
    95393
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    MEDLINE INDUSTRIES, LP - Northfield
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    October 23, 2024
    Initiation Date
    August 28, 2024
    Classification Date
    October 17, 2024
    Address
    3 Lakes Dr, Northfield, IL, 60093-2753, United States

    Description

    MEDLINE OPEN HEART, REF DYNJ904261B

    Reason

    Medline Industries, LP. has identified certain kits containing the recalled Medtronic lots of the DLP Vessel Cannulae. During manufacturing of the three listed lot numbers, product for model 30001 was incorrectly labeled as model 30000.

    Code Info

    UDI/DI 40193489479530 (case), 10193489479539 (each), Lot Numbers: 23LBR364

    Distribution

    US Nationwide distribution.

    Quantity

    30 units