BEUDAMED
    FDA Enforcement Class II Ongoing

    Brand Name: B. Braun Product Name: BBraun Medical 21G X4.4CM Winged INF Model/Catalog Number: 7B3050 Software Version: N/A Product Description: A device designed for subcutaneous implantation and intended to be used temporarily to expand an implanted tissue expander by percutaneous injection of air or fluids. Component: N/A

    Recall: Z-1481-2026 · Reported March 11, 2026

    Enforcement

    Recall Number
    Z-1481-2026
    Event ID
    98380
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    B Braun Medical Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 11, 2026
    Initiation Date
    February 2, 2026
    Classification Date
    March 2, 2026
    Address
    824 12th Ave, N/A, Bethlehem, PA, 18018-3524, United States

    Description

    Brand Name: B. Braun Product Name: BBraun Medical 21G X4.4CM Winged INF Model/Catalog Number: 7B3050 Software Version: N/A Product Description: A device designed for subcutaneous implantation and intended to be used temporarily to expand an implanted tissue expander by percutaneous injection of air or fluids. Component: N/A

    Reason

    The potential for the needle tip to be dull/blunt, difficult to advance, and/or break.

    Code Info

    Model/Catalog Number: 7B3050; Primary-DI 4046964341298, Unit of Use- DI 4046964341274; Lot 0062006430, Exp 30APR2032; Lot 0062006470, Exp 30JUN2032; Lot 0062006471, Exp 31MAY2032; Lot 0062014964, Exp 31JUL2032; Lot 0062014965, Exp 31JUL2032; Lot 0062014966, Exp 30SEP2032; Lot 0062027579, Exp 31AUG2032.

    Distribution

    Worldwide - US Nationwide distribution in the state of TX and the country of Costa Rica.

    Quantity

    105550 units