BEUDAMED
    FDA Enforcement Class II Ongoing

    Medtronic DLP Single Stage Venous Cannulae with right angle metal tip, REF 67312

    Recall: Z-3128-2024 · Reported September 18, 2024

    Enforcement

    Recall Number
    Z-3128-2024
    Event ID
    95152
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Medtronic Perfusion Systems
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 18, 2024
    Initiation Date
    July 9, 2024
    Classification Date
    September 12, 2024
    Address
    7611 Northland Dr N, Brooklyn Park, MN, 55428-1088, United States

    Description

    Medtronic DLP Single Stage Venous Cannulae with right angle metal tip, REF 67312

    Reason

    During manufacturing, DLP Single Stage Venous Cannulae - straight tip (Model 66118) was incorrectly placed into a product labeled as DLP Single Stage Venous Cannulae - right angle metal tip (Model 67312).

    Code Info

    GTIN 20613994879329, Lot Numbers: 2023090954, 202312C065

    Distribution

    Worldwide distribution - US Nationwide and the countries of Cambodia, Greece, Ireland, Italy, Saudi Arabia, Switzerland, United Kingdom, Viet Nam.

    Quantity

    290 units