BEUDAMED
    FDA Enforcement Class II Ongoing

    BD TEXIUM CLOSED MALE LUER WITH FEMALE CAP, REF: 10012241-0500

    Recall: Z-1973-2025 · Reported June 18, 2025

    Enforcement

    Recall Number
    Z-1973-2025
    Event ID
    96737
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    BD SWITZERLAND SARL
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 18, 2025
    Initiation Date
    May 12, 2025
    Classification Date
    June 12, 2025
    Address
    Terre Bonne Park A4, Route De Crassier 17, Eysins, N/A, Switzerland

    Description

    BD TEXIUM CLOSED MALE LUER WITH FEMALE CAP, REF: 10012241-0500

    Reason

    Sterile, single use closed system drug transfer devices, standalone or on infusion sets or bonded syringes, may leak at the interface between the closed male luer component and the needle-free connector, which may cause procedure delay, treatment interruptions, exposure to hazardous drugs, and/or underdosing of medication.

    Code Info

    REF/UDI-DI/Lot(Expiration): 10012241-0500/10885403221705/23045145(April 3, 2026), 23045146(April 3, 2026), 23055091(May 4, 2026), 23065090(June 3, 2026), 23075107(July 5, 2026), 23095124(September 8, 2026), 23105027(October 3, 2026), 23115047(November 2, 2026), 23125146(December 5, 2026), 24015245(January 11, 2027), 24025887(February 7, 2027), 24026421(February 27, 2027), 24036126(March 25, 2027), 24045690(April 24, 2027), 24066893(June 25, 2027), 24075111(July 26, 2027), 24095556(September 24, 2027), 24125014(December 2, 2027), 23035049(March 1, 2026)

    Distribution

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

    Quantity

    1,655,300