BEUDAMED
    FDA Recall Open, Classified

    TourniKwik Tourniquet Set (CFN 79012)

    Recall: Z-2423-2024 · Initiated May 16, 2024

    Recall

    Recall Number
    Z-2423-2024
    Event Number
    94856
    Firm
    Medtronic Perfusion Systems
    FEI Number
    1000116158
    Product Code
    GDJ
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    May 16, 2024
    Posted
    July 23, 2024
    Address
    7611 Northland Dr N, Brooklyn Park, MN, 55428-1088

    Description

    TourniKwik Tourniquet Set (CFN 79012)

    Reason

    Incorrect component placed in four manufactured lots of the TourniKwik" Tourniquet Set.

    Action

    Consignees were notified of the recall via mail beginning on 05/16/2024. Consignees were instructed to review inventory for listed product, immediately identify and quarantine all unused, listed product in inventory, return unused, listed product in the inventory to Medtronic, complete the customer confirmation form, and share the notification with orders in the organization.

    Distribution

    Worldwide - US Nationwide distribution in the states of MN, MA, UT, CA, and FL. The countries of Japan and Slovenia.

    Quantity

    636 units