BEUDAMED
    FDA Enforcement Class II Terminated

    BD Vacutainer¿ Push Button Blood Collection Set with Pre-Attached Holder Catalog number 368356 - Product Usage: This product is designed to provide customers an increased level of safety during IV blood collection, convenience and to improve OSHA single-use holder compliance. Figure 1 shows a BD Vacutainer¿ Push Button Blood Collection Set with the needle protector removed prior to needle retraction.

    Recall: Z-0193-2020 · Reported October 30, 2019

    Enforcement

    Recall Number
    Z-0193-2020
    Event ID
    83507
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Becton Dickinson & Company
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 30, 2019
    Initiation Date
    July 31, 2019
    Classification Date
    October 24, 2019
    Termination Date
    July 27, 2020
    Address
    1 Becton Dr, Franklin Lakes, NJ, 07417-1815, United States

    Description

    BD Vacutainer¿ Push Button Blood Collection Set with Pre-Attached Holder Catalog number 368356 - Product Usage: This product is designed to provide customers an increased level of safety during IV blood collection, convenience and to improve OSHA single-use holder compliance. Figure 1 shows a BD Vacutainer¿ Push Button Blood Collection Set with the needle protector removed prior to needle retraction.

    Reason

    Separation of front and rear barrels upon activation of the safety feature that retracts the needle

    Code Info

    Lot / Serial Number. 9079767 9079770 9081829 9086811 9086812 9091607 9091626 9094659 9094661 9098547 9100711 9100712 9115965 9115913

    Distribution

    Worldwide distribution - US Nationwide distribution including the states of CT, FL, MO, TN, OH, TX, GA, NC, SC, IN, IL, PA, CO and countries of Trinidad and Tobago, Hong Kong.

    Quantity

    1735600 units