BEUDAMED
    FDA Enforcement Class II Ongoing

    BD Connecta Stopcock Without Extension Tube Catalog No. 394602 (OUS)

    Recall: Z-1434-2022 · Reported July 27, 2022

    Enforcement

    Recall Number
    Z-1434-2022
    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 Without Extension Tube Catalog No. 394602 (OUS)

    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

    GTIN: 382903946020 Lot Numbers/Exp.Date: 1152283 5/31/2024 1113643 3/31/2024 1120601 3/31/2024 1113657 3/31/2024 1098327 3/31/2024 1124487 4/30/2024 1098376 3/31/2024 1098372 3/31/2024 1097651 3/31/2024 1098181 3/31/2024 1098379 3/31/2024 1085636 2/29/2024 1085897 2/29/2024 1097647 3/31/2024 1061613 2/29/2024 1063398 2/29/2024 1090040 2/29/2024 1097641 3/31/2024 1097637 3/31/2024 1098371 3/31/2024 1090039 2/29/2024 1085895 2/29/2024 1063392 2/29/2024 1090052 2/29/2024 1061609 2/29/2024 1084430 2/29/2024 1061606 2/29/2024 1063402 2/29/2024 1063369 2/29/2024 1063367 2/29/2024 1063370 2/29/2024 1063390 2/29/2024 1063368 2/29/2024 1063389 2/29/2024 1063366 2/29/2024 1033529 1/31/2024 1040952 1/31/2024 1040913 1/31/2024

    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

    2,100,210