BEUDAMED
    FDA Recall Open, Classified

    Oncology Kit w/60" (152 cm) Appx 2.2 ml, Smallbore Ext Set w/ChemoLock Port, Clamp, Anti-Siphon Valve, Spiros; ChemoLock; Syringe Transfer Set w/MicroClave, ChemoLock Port, REF: CL3960

    Recall: Z-2210-2026 · Initiated March 24, 2026

    Recall

    Recall Number
    Z-2210-2026
    Event Number
    98622
    Firm
    ICU Medical, Inc.
    FEI Number
    2025816
    Product Code
    ONB
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    March 24, 2026
    Posted
    May 18, 2026
    Address
    951 Calle, Amanecer San Clemente, CA, 92673-6212

    Description

    Oncology Kit w/60" (152 cm) Appx 2.2 ml, Smallbore Ext Set w/ChemoLock Port, Clamp, Anti-Siphon Valve, Spiros; ChemoLock; Syringe Transfer Set w/MicroClave, ChemoLock Port, REF: CL3960

    Reason

    Oncology sets/closed system transfer devices with extension sets may leak resulting in therapy delayed if noticed and corrected during setup, but if the leak occurs during therapy this may result in therapy interruption with the potential for the patient to receive less infusion solution than intended. Exposure of hazardous substances to the patient, caregiver, or pharmacy technician is possible.

    Action

    On 3/24/2026, correction notices were emailed to customers who were asked to do the following: 1) 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] For further inquiries, please contact firm: Global Complaint Management, [email protected], 1-866-216-8806. Customer Service, [email protected], 1-800-258-5361. Field Service Processing, [email protected]

    Distribution

    US Nationwide distribution in the states of GA, MA, OH, NC, CA, ND, MI, TX, FL, AR, CT, PA, WA, WI, CO, VT, NY, NH, KY, IA, KS, AL, NM, IL, MO, NJ.

    Quantity

    20,506