BEUDAMED
    FDA Recall Terminated

    Pneumothorax Kit

    Recall: Z-1299-2018 · Initiated October 24, 2017

    Recall

    Recall Number
    Z-1299-2018
    Event Number
    79294
    Firm
    Arrow International Inc
    FEI Number
    3015859709
    Product Code
    KDD
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    October 24, 2017
    Terminated
    April 17, 2020
    Address
    2400 Bernville Rd, Reading, PA, 19605-9607

    Description

    Pneumothorax Kit

    Reason

    Product packaging may not be completely sealed.

    Action

    On October 24, 2017 and Urgent Medical Device Recall letter was issued to customers to review inventory and if there's any affected stock, to immediately discontinue use, quarantine and prepare to return to recalling firm. Questions or concerns can be directed to 1-855-419-8507 or 1-866-246-6990

    Distribution

    Nationally