BEUDAMED
    FDA Enforcement Class II Ongoing

    Medtronic Vessel Cannulae: a) DLP¿ 2 mm Vessel Cannula Blunt Tip, Model Number 30004; b) DLP¿ 3 mm Vessel Cannula Blunt Tip, Model Number 30003

    Recall: Z-1799-2024 · Reported May 22, 2024

    Enforcement

    Recall Number
    Z-1799-2024
    Event ID
    94274
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Medtronic Perfusion Systems
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 22, 2024
    Initiation Date
    March 19, 2024
    Classification Date
    May 10, 2024
    Address
    7611 Northland Dr N, N/A, Brooklyn Park, MN, 55428-1088, United States

    Description

    Medtronic Vessel Cannulae: a) DLP¿ 2 mm Vessel Cannula Blunt Tip, Model Number 30004; b) DLP¿ 3 mm Vessel Cannula Blunt Tip, Model Number 30003

    Reason

    Potential for unsealed sterile packing.

    Code Info

    a) Model Number 30004, GTIN 00613994646156, Lot Numbers: 2023041305; a) Model Number 30004, GTIN 00673978179841, Lot Numbers: 2023041300; a) Model Number 30004, GTIN 20613994646150, Lot Numbers: 2023041300, 2023041305, 202306C194; b) Model Number 30003, GTIN 20613994646174, Lot Numbers: 2023041298, 202306C221

    Distribution

    Worldwide distribution.

    Quantity

    5719 units