BEUDAMED
    FDA Enforcement Class II Ongoing

    ICU Medical ChemoLock Closed Vial Spike w/Skirt, 5 Units REF: CL-80S-5

    Recall: Z-0348-2026 · Reported November 5, 2025

    Enforcement

    Recall Number
    Z-0348-2026
    Event ID
    97583
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    ICU Medical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 5, 2025
    Initiation Date
    September 8, 2025
    Classification Date
    October 27, 2025
    Address
    951 Calle Amanecer, N/A, San Clemente, CA, 92673-6212, United States

    Description

    ICU Medical ChemoLock Closed Vial Spike w/Skirt, 5 Units REF: CL-80S-5

    Reason

    Port weld of drug transfer device may separate or break during use and potentially result in a leak.

    Code Info

    UDI:10887709077116/Lot:14395313, 14393195, 14396054

    Distribution

    Worldwide distribution: US (Nationwide) including states of: AK AL AR AZ CA CO CT DE FL GA IA ID IL KS KY LA MA MD MI MN MS MT NC NE NJ NM NV NY OH OK OR PA SD TN TX VA WA WY and OUS (foreign) to countries of: Canada, France, and Japan.

    Quantity

    8475 units