BEUDAMED
    FDA Enforcement Class II Terminated

    BD Vacutainer¿ Push Button Blood Collection Set 0.8 x 19 mm x 305 mm 21G x ¿ x 12 Catalog 367344

    Recall: Z-1532-2018 · Reported May 2, 2018

    Enforcement

    Recall Number
    Z-1532-2018
    Event ID
    79687
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Becton Dickinson & Company
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 2, 2018
    Initiation Date
    March 20, 2018
    Classification Date
    April 26, 2018
    Termination Date
    April 20, 2020
    Address
    1 Becton Dr, N/A, Franklin Lakes, NJ, 07417-1815, United States

    Description

    BD Vacutainer¿ Push Button Blood Collection Set 0.8 x 19 mm x 305 mm 21G x ¿ x 12 Catalog 367344

    Reason

    Products do not meet the labeled sterility claim of a Sterility Assurance Level (SAL) 10-6.

    Code Info

    7346627 7348974 7348975 7354740 7354743 7354745 7354764 8005556 8005557 8005814 8010735 8012910 8015923 8015925

    Distribution

    US (Nationwide) Canada, Kuwait, Guyana, Guatemala, Taiwan, UK, Belgium, Sweden, Ireland, Israel, Spain, Switzerland and Lithuania

    Quantity

    N/A