BEUDAMED
    FDA Enforcement Class II Ongoing

    ICU Medical 31" (79 cm) Appx 3.4 ml, Admin Set w/20 Drop Integrated ChemoLock Drip Chamber, Spiros", Purple Cap, Hanger REF: CL3951

    Recall: Z-0359-2026 · Reported November 5, 2025

    Enforcement

    Recall Number
    Z-0359-2026
    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 31" (79 cm) Appx 3.4 ml, Admin Set w/20 Drop Integrated ChemoLock Drip Chamber, Spiros", Purple Cap, Hanger REF: CL3951

    Reason

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

    Code Info

    Lot:14397353, 14418912; Distributed in Canada

    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

    11000 units