BEUDAMED
    FDA Recall Open, Classified

    ICU Medical 60" (152 cm) Appx 1.2 ml, Ext Set, Smallbore w/ChemoLock Port, Clamp, Spiros w/Red Cap REF: CL4173

    Recall: Z-0339-2026 · Initiated September 8, 2025

    Recall

    Recall Number
    Z-0339-2026
    Event Number
    97583
    Firm
    ICU Medical, Inc.
    FEI Number
    2025816
    Product Code
    ONB
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    September 8, 2025
    Posted
    October 27, 2025
    Address
    951 Calle, Amanecer San Clemente, CA, 92673-6212

    Description

    ICU Medical 60" (152 cm) Appx 1.2 ml, Ext Set, Smallbore w/ChemoLock Port, Clamp, Spiros w/Red Cap REF: CL4173

    Reason

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

    Action

    On September 8, 2025, ICU Medical issued an "Urgent Medical Device" Recall notification via E-Mail. ICU Medical ask consignees to take the following actions: 1. Check all inventory locations within your institution for the affected products listed in recall notification and discontinue use. Destroy all affected products following your institution's process for destruction. If destroying is not immediately possible at your facility, then the product should be quarantined until disposal. 2. Share this notification with all potential users of the device, to ensure they are aware of this notification. If the devices are used at another location, please ensure this communication is delivered there. 3. Complete and return the attached Customer Response Form to [email protected] within 10 days of receipt to acknowledge your understanding of this notification. 4. If you have distributed affected products to your customers, please immediately forward this notice to them. Request that they complete the response form and return it to [email protected] For further inquiries, please contact ICU Medical Customer Service via email: [email protected] or call: 1-(800)-258-5361 for additional information or technical assistance. Or contact Field Service Processing via email: [email protected] for Assistance with Customer Notifications and Response Forms.

    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

    200 units