BEUDAMED
    FDA Enforcement Class II Ongoing

    Select Series Angled Tip Arterial Cannula, Model Number 72422 (22 Fr)

    Recall: Z-0986-2025 · Reported January 29, 2025

    Enforcement

    Recall Number
    Z-0986-2025
    Event ID
    96015
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Medtronic Perfusion Systems
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 29, 2025
    Initiation Date
    December 12, 2024
    Classification Date
    January 17, 2025
    Address
    7611 Northland Dr N, Brooklyn Park, MN, 55428-1088, United States

    Description

    Select Series Angled Tip Arterial Cannula, Model Number 72422 (22 Fr)

    Reason

    Incorrect labeling for seven manufactured lots of certain models of Arterial Cannulae.

    Code Info

    Model 72422 UDI-DI: 20643169485970, Lot Numbers: 2023071075, 202309C075

    Distribution

    Worldwide - US Nationwide distribution.

    Quantity

    440 units