BEUDAMED
    FDA Enforcement Class II Terminated

    The 9025TRU Arterial Blood Gas (ABG) Kit is used to obtain arterial blood sampling for pH, Blood Gas, Electrolyte and Metabolite Analysis.

    Recall: Z-2713-2016 · Reported September 7, 2016

    Enforcement

    Recall Number
    Z-2713-2016
    Event ID
    74706
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Cardinal Health
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 7, 2016
    Initiation Date
    June 27, 2016
    Classification Date
    September 1, 2016
    Termination Date
    March 2, 2018
    Address
    1300 Waukegan Rd, N/A, Waukegan, IL, 60085-6724, United States

    Description

    The 9025TRU Arterial Blood Gas (ABG) Kit is used to obtain arterial blood sampling for pH, Blood Gas, Electrolyte and Metabolite Analysis.

    Reason

    Arterial Blood Gas (ABG) Kit- Missing Safety Component. The ABG Kit(s) have been identified as missing the locking clasp component. CareFusion/BD has identified a potential customer/user safety risk associated with the missing locking clasp component.

    Code Info

    Three (3) total lots (lot #884993, lot #903136 & lot #903137).

    Distribution

    Worldwide Distribution - US (nationwide) and Canada.

    Quantity

    Lot #884993 -16,000 units, Lot #903136 -1,900 units and Lot #903137 - 300 units.