BEUDAMED
    FDA Enforcement Class II Ongoing

    ChemoLock Close Vial Spike REF CL-80 The Chemolock Closed System Transfer Device prevents the transfer of environmental contaminants. The Chemolock is needle free and cannot be deactivated, which will passively aid in preventing needlestick injuries and the exposure to cytotoxic medications for healthcare personnel.

    Recall: Z-0652-2025 · Reported December 18, 2024

    Enforcement

    Recall Number
    Z-0652-2025
    Event ID
    95649
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    ICU Medical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 18, 2024
    Initiation Date
    November 6, 2024
    Classification Date
    December 9, 2024
    Address
    951 Calle Amanecer, San Clemente, CA, 92673-6212, United States

    Description

    ChemoLock Close Vial Spike REF CL-80 The Chemolock Closed System Transfer Device prevents the transfer of environmental contaminants. The Chemolock is needle free and cannot be deactivated, which will passively aid in preventing needlestick injuries and the exposure to cytotoxic medications for healthcare personnel.

    Reason

    Due to finished goods incorrectly packaged and labeled.

    Code Info

    Model/Catalog Number: CL-80 UDI code: (01)10887709057125(17)290401(30)50(10)13959938 Lot Number: 13959938

    Distribution

    Worldwide - U.S. Nationwide distribution in the state of IL and the country of Canada.

    Quantity

    6000 units