BEUDAMED
    FDA Enforcement Class II Ongoing

    BD Connecta BD Luer-Lok 360, REF 394910 UDI-DI code: 00382903949106 Connecta¿ Plus 1 and Connecta¿ Plus 3 2-way and 3-way Stopcocks are control valves for use in IV. therapy and hemodynamic pressure monitoring.

    Recall: Z-1509-2025 · Reported April 9, 2025

    Enforcement

    Recall Number
    Z-1509-2025
    Event ID
    96399
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    BD SWITZERLAND SARL
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 9, 2025
    Initiation Date
    February 20, 2025
    Classification Date
    April 2, 2025
    Address
    Terre Bonne Park A4, Route De Crassier 17, Eysins, N/A, Switzerland

    Description

    BD Connecta BD Luer-Lok 360, REF 394910 UDI-DI code: 00382903949106 Connecta¿ Plus 1 and Connecta¿ Plus 3 2-way and 3-way Stopcocks are control valves for use in IV. therapy and hemodynamic pressure monitoring.

    Reason

    Due to specific lots of luer-lok devices were shipped to the U.S. market with an Outside US Instruction for Use (IFU)

    Code Info

    Catalog Number: 394910 UDI-DI code: 00382903949106 Lot Numbers: 4277968 4277973 4282451 4282461 4289801 4290582 4292904 4295848 4305108 4306700

    Distribution

    U.S.: AK, AL, AR, AZ, CA, CO, FL, GA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NM, NV, OH, OK, OR, PA, SC, TN. TX, UT, VA, WA, WV O.U.S.: N/A

    Quantity

    500 units