BEUDAMED
    FDA Enforcement Class III 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 · Reported February 4, 2015

    Enforcement

    Recall Number
    Z-1028-2015
    Event ID
    70034
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Smiths Medical ASD, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 4, 2015
    Initiation Date
    December 17, 2014
    Classification Date
    January 28, 2015
    Termination Date
    June 25, 2015
    Address
    10 Bowman Dr, N/A, Keene, NH, 03431-5043, United States

    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.

    Code Info

    Lot Number: 2782094

    Distribution

    US in the state of FL.

    Quantity

    900 units