BEUDAMED
    FDA Enforcement Class I Ongoing

    B Braun Hemodialysis Bloodlines, LOW VOL, NO CHAMBER 4.8MM PUMP SEGMENT. Model Number: B3-4630M4705.

    Recall: Z-1803-2026 · Reported April 22, 2026

    Enforcement

    Recall Number
    Z-1803-2026
    Event ID
    98552
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    B Braun Medical Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 22, 2026
    Initiation Date
    March 19, 2026
    Classification Date
    April 15, 2026
    Address
    824 12th Ave, N/A, Bethlehem, PA, 18018-3524, United States

    Description

    B Braun Hemodialysis Bloodlines, LOW VOL, NO CHAMBER 4.8MM PUMP SEGMENT. Model Number: B3-4630M4705.

    Reason

    Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.

    Code Info

    Model Number: B3-4630M4705; UDI-DI Primary: 04046955348848; UDI-DI Unit: 04046955348831; All lots manufactured since 05AUG2025.

    Distribution

    Worldwide distribution - US Nationwide and the country of Canada.

    Quantity

    4,884 units