BEUDAMED
    FDA Enforcement Class II Ongoing

    BD Connecta Stopcock with OFF Directed Tap Without Extension Tube (500 eaches/carton) Catalog No. 394910 (US)

    Recall: Z-1431-2022 · Reported July 27, 2022

    Enforcement

    Recall Number
    Z-1431-2022
    Event ID
    90304
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Becton Dickinson & Company
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 27, 2022
    Initiation Date
    May 9, 2022
    Classification Date
    July 21, 2022
    Address
    1 Becton Dr, N/A, Franklin Lakes, NJ, 07417-1815, United States

    Description

    BD Connecta Stopcock with OFF Directed Tap Without Extension Tube (500 eaches/carton) Catalog No. 394910 (US)

    Reason

    May have the potential for leakage at the housing component of the stopcock, may result in delay or interruption in treatment, exposure to infusate and biohazardous material, under dosing/under infusion, contamination and/or air ingress.

    Code Info

    UDI: 382903949106 Lot Number/Exp Date: 1154844 5/31/2024 1098945 3/31/2024 1098944 3/31/2024 1098943 3/31/2024 1061533 2/29/2024 1061535 2/29/2024 1061531 2/29/2024 1061526 2/29/2024 1061527 2/29/2024 1061528 2/29/2024

    Distribution

    Worldwide distribution - US Nationwide distribution in the states of AK, AR, AZ, CA, CO, FL, GA, IL, IN, KS, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NV, NY, OH, OR, PA, SD, TN, TX, UT, VA, WA, WV and the countries of Belgium, China, India, Indonesia, Japan, Korea, Nepal, Philippines, Singapore, Sri Lanka, Thailand, Vietnam.

    Quantity

    485,000 units