BEUDAMED
    FDA Enforcement Class II Ongoing

    CLEARLINK SYSTEM Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves, 10 drops/mL, 100-inch (2.5 meters), Product Code 2C8425

    Recall: Z-0191-2026 · Reported October 22, 2025

    Enforcement

    Recall Number
    Z-0191-2026
    Event ID
    97604
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Baxter Healthcare Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Report Date
    October 22, 2025
    Initiation Date
    August 29, 2025
    Classification Date
    October 16, 2025
    Address
    1 Baxter Pkwy, Deerfield, IL, 60015-4625, United States

    Description

    CLEARLINK SYSTEM Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves, 10 drops/mL, 100-inch (2.5 meters), Product Code 2C8425

    Reason

    IV sets may leak.

    Code Info

    UDI/DI 00085412071190, Lot numbers: R25C27086

    Distribution

    US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV.

    Quantity

    1440