BEUDAMED
    FDA Enforcement Class II Terminated

    Henry Schein Single Use Syringe Luer-Lock, 10 mL, Intended for use by health care professionals for general purpose fluid aspiration/injection

    Recall: Z-1936-2016 · Reported June 15, 2016

    Enforcement

    Recall Number
    Z-1936-2016
    Event ID
    73828
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Becton Dickinson & Company
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 15, 2016
    Initiation Date
    March 25, 2016
    Classification Date
    June 9, 2016
    Termination Date
    April 3, 2017
    Address
    1 Becton Dr, N/A, Franklin Lakes, NJ, 07417-1815, United States

    Description

    Henry Schein Single Use Syringe Luer-Lock, 10 mL, Intended for use by health care professionals for general purpose fluid aspiration/injection

    Reason

    BD 10 mL Syringe Luer-Lok Tip with BD PrecisionGlide Needle 21G x 1 (0.8 mm x 25 mm) and Henry Schein 10 mL Single Use Syringe Luer-Lock are being recalled due to possible adulteration and non-conforming manufacturing practices.

    Code Info

    Catalog (REF #) 9004476, Lot #4163707

    Distribution

    Nationwide Distribution to NY only

    Quantity

    176,000 units