BEUDAMED
    FDA Recall Terminated

    Portex Anaerobic Pulsator Arterial Blood Sampling Kit, with Liquid Sodium Heparin for Gases and Electrolytes. Reorder Number: G1392 Product Usage: The Arterial Blood Sampling Kit is intended for sampling arterial blood for the measurement of blood gasses, Cooximetry, electrolytes, total magnesium, and metabolites, (Glucose and Lactate).

    Recall: Z-1028-2015 · Initiated December 17, 2014

    Recall

    Recall Number
    Z-1028-2015
    Event Number
    70034
    Firm
    Smiths Medical ASD, Inc.
    FEI Number
    1217052
    Product Code
    JKA
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    December 17, 2014
    Posted
    January 29, 2015
    Terminated
    June 25, 2015
    Address
    10 Bowman Dr, Keene, NH, 03431-5043

    Description

    Portex Anaerobic Pulsator Arterial Blood Sampling Kit, with Liquid Sodium Heparin for Gases and Electrolytes. Reorder Number: G1392 Product Usage: The Arterial Blood Sampling Kit is intended for sampling arterial blood for the measurement of blood gasses, Cooximetry, electrolytes, total magnesium, and metabolites, (Glucose and Lactate).

    Reason

    The outer box label is marked with the correct expiration date of 08/2016. The inner Tyvek Unit Label is marked with 08-2017 which exceeds the actual expiration date by one year.

    Action

    Smiths Medical notified American Medical Depot via telephone on 12 December 2014. Smiths Medical instructed them to put product at their location on hold. American Medical Depots customer will be instructed to return their unused product for replacement.

    Distribution

    US in the state of FL.

    Quantity

    900 units