BEUDAMED
    FDA Enforcement Class I Ongoing

    Microbore Extension Set with 0.2 Micron Filter. Catalog Number: V6215. for use with IV tubing.

    Recall: Z-2176-2025 · Reported August 13, 2025

    Enforcement

    Recall Number
    Z-2176-2025
    Event ID
    97167
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    B BRAUN MEDICAL INC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 13, 2025
    Initiation Date
    July 9, 2025
    Classification Date
    August 6, 2025
    Address
    861 Marcon Blvd, N/A, Allentown, PA, 18109-9577, United States

    Description

    Microbore Extension Set with 0.2 Micron Filter. Catalog Number: V6215. for use with IV tubing.

    Reason

    Label is incorrect. The product label indicates that the device contains an air eliminating filter. However, the filter utilized on this extension set is not indicated for removal of air and does not feature an air vent, which is common to air eliminating filters.

    Code Info

    Catalog Number: V6215. Primary UDI-DI 04046964189173, Unit of Use UDI-DI: 04046964189166. Lot Number (Expiration Date): 0061742452 (30JUN2025), 0061747379 (31AUG2025 0, 0061767411 (31JAN2026), 0061780914 (30APR2026), 0061803499 (30SEP2026), 0061806173 (30NOV2026), 0061822333 (30APR2027), 0061836578 (30APR2027), 0061849109 (31JUL2027), 0061850836 (31AUG2027), 0061899902 (30SEP2028), 0061936368 (31MAR2029), 0061936119 (31MAR2029), 0061936369 (31MAR2029), 0061940584 (30APR2029).

    Distribution

    US distribution to AZ, CA, CO, CT, FL, GA, HI, IL, IN, KS, MA, MD, ME, MI, MN, MO, MS, NC, NJ, NV, NY, OH, OR, PA, SC, SD, TN, TX, UT, VA, WA, WY. International distribution to Canada.

    Quantity

    34,825 units US