BEUDAMED
    FDA Enforcement Class I Ongoing

    Cardinal Health Monoject, 3 mL Syringe Luer-Lock Tip Soft Pack, REF 1180300777

    Recall: Z-0852-2024 · Reported February 14, 2024

    Enforcement

    Recall Number
    Z-0852-2024
    Event ID
    93676
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Cardinal Health 200, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 14, 2024
    Initiation Date
    December 28, 2023
    Classification Date
    February 2, 2024
    Address
    3651 Birchwood Dr, Waukegan, IL, 60085-8337, United States

    Description

    Cardinal Health Monoject, 3 mL Syringe Luer-Lock Tip Soft Pack, REF 1180300777

    Reason

    Cardinal Health is expanding their previous product correction actions to a product removal of all sizes of Cardinal Health brand Monoject sterile Syringe Luer-Lock (1, 3, 6, 12, 20, 35, and 60 mL) and Cardinal Health brand Monoject sterile Enteral Syringes with the ENFit connection (1, 3, 6, 12, 35, and 60 mL) due to a change in manufacturing and rebranding efforts.

    Code Info

    UDI/DI 50192253033517 (Case), 20192253033516 (Box), 10192253033519 (Each), Lot Numbers: 230201, 230202, 221201, 221202, 230203, 230204, 230205, 230206, 230208, 230209, 230210, 230211, 230212, 230213, 230214, 230215, 230216, 230217, 230218, 230219, 230207, 230602, 230601, 230602, 230603, 230701, 230702, 230703, 230704, 230705, 230706, 230707

    Distribution

    Distribution US nationwide and Canada. Foreign distribution updated 9/6/2024 to only include Canada.