BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-2305-2019 · Initiated June 12, 2019

    Recall

    Recall Number
    Z-2305-2019
    Event Number
    82963
    Firm
    Becton Dickinson & Company
    FEI Number
    2243072
    Product Code
    JKA
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    June 12, 2019
    Terminated
    June 29, 2020
    Address
    1 Becton Dr, Franklin Lakes, NJ, 07417-1815

    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.

    Action

    Urgent Medical Device Correction notification letters dated 6/12/19 were sent to customers.

    Distribution

    Worldwide Distribution, including US Nationwide

    Quantity

    1,436,228,004 total