BEUDAMED
    FDA Enforcement Class II Terminated

    BD Vacutainer PST Gel and Lithium HeparinN (LH) 126 Units Blood Collection Tubes, Catalog Number 367964

    Recall: Z-2305-2019 · Reported August 28, 2019

    Enforcement

    Recall Number
    Z-2305-2019
    Event ID
    82963
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Becton Dickinson & Company
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 28, 2019
    Initiation Date
    June 12, 2019
    Classification Date
    August 21, 2019
    Termination Date
    June 29, 2020
    Address
    1 Becton Dr, N/A, Franklin Lakes, NJ, 07417-1815, United States

    Description

    BD Vacutainer PST Gel and Lithium HeparinN (LH) 126 Units Blood Collection Tubes, Catalog Number 367964

    Reason

    False elevation of carboxyhemoglobin (COHb) results have been reported when using venous blood gas samples collected with tubes analyzed with the IL GEM 4000 instrument.

    Code Info

    UDI: (01)30382903679646

    Distribution

    Worldwide Distribution, including US Nationwide

    Quantity

    1,436,228,004 total