BEUDAMED
    FDA Enforcement Class II Terminated

    BD 3ml Syringer Luer-Lok Tip Catalog #309604 The BD Single Use, Hypodermic Syringe is intended for use by health care professionals for general purpose fluid aspiration/injection

    Recall: Z-2753-2017 · Reported July 26, 2017

    Enforcement

    Recall Number
    Z-2753-2017
    Event ID
    77513
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Becton Dickinson & Company
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 26, 2017
    Initiation Date
    September 16, 2016
    Classification Date
    July 19, 2017
    Termination Date
    March 20, 2018
    Address
    1 Becton Dr, N/A, Franklin Lakes, NJ, 07417-1815, United States

    Description

    BD 3ml Syringer Luer-Lok Tip Catalog #309604 The BD Single Use, Hypodermic Syringe is intended for use by health care professionals for general purpose fluid aspiration/injection

    Reason

    BD identified that several lots did not receive the specified dose of irradiation necessary to meet the Sterility Assurance Level (SAL) required.

    Code Info

    6061746 2021-02 6082982 2021-02 6089821 2021-03 6117858 2021-04 6117863 2021-04 6117889 2021-04 6117891 2021-04 6146962 2021-04 6173697 2021-05 6173767 2021-06 6173779 2021-06 6208614 2021-07

    Distribution

    Nationwide Distribution

    Quantity

    1,528,000 units