BEUDAMED
    FDA Recall Open, Classified

    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 · Initiated February 20, 2025

    Recall

    Recall Number
    Z-1509-2025
    Event Number
    96399
    FEI Number
    3012798826
    Product Code
    FMG
    Status
    Open, Classified
    Root Cause
    Labeling Change Control
    Initiated
    February 20, 2025
    Posted
    April 2, 2025
    Address
    BD SWITZERLAND SARL Terre Bonne Park A4 Route De Crassier 17 Eysins 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)

    Action

    On 02/20/2025, the firm sent via FedEx and/or email an "URGENT: Medical Device Product Recall MDS-25-5241" letter informing customers that BD confirmed that specific lots of BD Connecta BD Luer-Lok 360 were shipped to the U.S. market with Instruction for Use (IFU) labeling meant for Outside U.S. market. Customers are instructed to: 1. Locate any unused affected BD Connecta" BD Luer-Lok" 360, as listed in Table 1. 2. Remove the IFU from each shelf-box and destroy it. (OUS IFU version, Document number 500037734). 3. Insert a copy of Attachment 1 BD Connecta IFU Document Number: 500081278 (US IFU version). 4. Circulate this notice to all those who need to be aware within their organization or to any organization where the potentially affected products have been transferred. 5. Complete the attached Customer Response Form and return to the BD contact noted on the form whether or not customers have any of the impacted material so that BD may acknowledge their receipt of this notification. Report any questions or complaints experienced with the use of this product to BD via the North American Regional Complaint Center: Phone: 1-844-8BD-LIFE (1-844-823-5433) Say Product Complaints when prompted Mon Fri 8:00am and 5:00pm CT Email: [email protected] or [email protected]

    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