BEUDAMED
    FDA Enforcement Class II Ongoing

    Cardinal Health Monoject Tuberculin Syringe, 1 mL Luer Lock, Catalog Number 1180100777

    Recall: Z-1768-2026 · Reported April 8, 2026

    Enforcement

    Recall Number
    Z-1768-2026
    Event ID
    98534
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Cardinal Health 200, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 8, 2026
    Initiation Date
    February 27, 2026
    Classification Date
    April 2, 2026
    Address
    3651 Birchwood Dr, Waukegan, IL, 60085-8337, United States

    Description

    Cardinal Health Monoject Tuberculin Syringe, 1 mL Luer Lock, Catalog Number 1180100777

    Reason

    The outer packaging and blister pack labeling identify the product as 1mL Luer Lock Tuberculin Syringe (Product Code 1180100777), however the syringes contained within the packages are U-100 Insulin syringes.

    Code Info

    UDI/DI 10884521013414 (each), 20884521013411 (box), 30884521013418 (case), Lot Numbers: 531164X, 531162X

    Distribution

    Worldwide distribution - US Nationwide and the country of Canada.

    Quantity

    198,900 units