BEUDAMED
    FDA Enforcement Class II Ongoing

    Medtronic Bio-Medicus Insertion Kits, Model number 96553, Pediatric Insertion Kit, Sterile; and Model number 96551, Venous Insertion Kit, Sterile.

    Recall: Z-0003-2022 · Reported October 13, 2021

    Enforcement

    Recall Number
    Z-0003-2022
    Event ID
    88685
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Medtronic Perfusion Systems
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 13, 2021
    Initiation Date
    September 13, 2021
    Classification Date
    October 1, 2021
    Address
    7611 Northland Dr N, Brooklyn Park, MN, 55428-1088, United States

    Description

    Medtronic Bio-Medicus Insertion Kits, Model number 96553, Pediatric Insertion Kit, Sterile; and Model number 96551, Venous Insertion Kit, Sterile.

    Reason

    There was a label mix-up between two model numbers resulting in the incorrect guidewire being contained in the kits for both model numbers.

    Code Info

    Model 96553 - Serial number 220719040, GTIN 20763000116006; Model 96551 - Serial number 220641720, GTIN 20763000115986.

    Distribution

    Worldwide distribution - US Nationwide distribution in the state of Massachusetts and the countries of Belgium, France, Germany Japan, Korea, Saudi Arabia, Spain, and Turkey.

    Quantity

    168 kits