BEUDAMED
    FDA Enforcement Class II Ongoing

    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 · Reported May 27, 2026

    Enforcement

    Recall Number
    Z-2210-2026
    Event ID
    98622
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    ICU Medical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Report Date
    May 27, 2026
    Initiation Date
    March 24, 2026
    Classification Date
    May 18, 2026
    Address
    951 Calle Amanecer, San Clemente, CA, 92673-6212, United States

    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.

    Code Info

    UDI-DI: 10887709083278. Lots: 13919794, 14134777, 14196319

    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