BEUDAMED
    FDA Enforcement Class II Ongoing

    Baster Continu-Flo Solution Set, Non-Vented, 2 Clearlink Luer Activated Valves, Backcheck Valve. 10 drops/mL. 112" (2.8 m), Product Code REF 2C8519; intravascular administration set

    Recall: Z-2594-2025 · Reported October 1, 2025

    Enforcement

    Recall Number
    Z-2594-2025
    Event ID
    97447
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Baxter Healthcare Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 1, 2025
    Initiation Date
    August 8, 2025
    Classification Date
    September 19, 2025
    Address
    1 Baxter Pkwy, N/A, Deerfield, IL, 60015-4625, United States

    Description

    Baster Continu-Flo Solution Set, Non-Vented, 2 Clearlink Luer Activated Valves, Backcheck Valve. 10 drops/mL. 112" (2.8 m), Product Code REF 2C8519; intravascular administration set

    Reason

    Baxter Healthcare Corporation is issuing an Urgent Medical Device Recall for one lot of Continu-Flo solution sets listed below due to customer reports of tubing separation.

    Code Info

    UDI/DI 00085412048994, Lot Number R24I20079, Exp. 9/21/2026

    Distribution

    US Nationwide distribution.

    Quantity

    14400 units