BEUDAMED
    FDA Enforcement Class II Ongoing

    Medtronic DLP Vessel Cannula, Model Number REF 30000

    Recall: Z-1316-2024 · Reported March 27, 2024

    Enforcement

    Recall Number
    Z-1316-2024
    Event ID
    94068
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Medtronic Perfusion Systems
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 27, 2024
    Initiation Date
    February 7, 2024
    Classification Date
    March 19, 2024
    Address
    7611 Northland Dr N, Brooklyn Park, MN, 55428-1088, United States

    Description

    Medtronic DLP Vessel Cannula, Model Number REF 30000

    Reason

    Medtronic is writing to inform you of incorrect labeling for three manufactured lots of the DLP Vessel Cannulae for the model and lot numbers listed above.

    Code Info

    UDI/DI 20613994646211, Lot Numbers: 2023020890, 202305C126, 2023020889

    Distribution

    US and Brazil, Canada, Republic of Georgia, Germany, India, Ireland, Italy, Malaysia, South Africa, UK

    Quantity

    4343 units