BEUDAMED
    FDA Enforcement Class II Ongoing

    BD Connecta White 360 Shelf 100Ea Catalog No. 395000 (OUS)

    Recall: Z-1438-2022 · Reported July 27, 2022

    Enforcement

    Recall Number
    Z-1438-2022
    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 White 360 Shelf 100Ea Catalog No. 395000 (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: 382903950003 Lot Numbers/Exp.Date: 1120604 3/31/2024 1098929 3/31/2024 1123643 4/30/2024 1063423 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

    448,040