BEUDAMED
    FDA Recall Terminated

    Portex Pulsator Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes, REF 4080P-2, Sterile, RX. The firm name on the label is Smiths Medical ASD, Inc., Keene, NH.

    Recall: Z-3196-2018 · Initiated July 13, 2018

    Recall

    Recall Number
    Z-3196-2018
    Event Number
    80632
    Firm
    Smiths Medical ASD Inc.
    FEI Number
    3012307300
    Product Code
    JKA
    Status
    Terminated
    Root Cause
    Labeling Change Control
    Initiated
    July 13, 2018
    Terminated
    October 19, 2018
    Address
    6000 Nathan Ln N, Minneapolis, MN, 55442-1690

    Description

    Portex Pulsator Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes, REF 4080P-2, Sterile, RX. The firm name on the label is Smiths Medical ASD, Inc., Keene, NH.

    Reason

    The product was mislabeled with the incorrect label.

    Action

    Recall notifications dated 7/13/2018 were issued via FedEx overnight mail on 7/13/2018 explaining the reason for recall, risk to health, and instructing the customer to check their inventory for the affected lot numbers.

    Distribution

    US Nationwide Distribution in the states of CT, MA, MI, NC, NJ, NY, RI, TX, UT, and WA.

    Quantity

    29,600 kits