BEUDAMED
    FDA Enforcement Class II Ongoing

    Arrow Bipolar Balloon Electrode Catheter 5 Fr. 105 cm, Product Code: AI-07154 - Product Usage: intended for temporary use in electrophysiology studies for intracardiac stimulation and/or ECG recording.

    Recall: Z-2070-2021 · Reported July 21, 2021

    Enforcement

    Recall Number
    Z-2070-2021
    Event ID
    88120
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Arrow International Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 21, 2021
    Initiation Date
    May 19, 2021
    Classification Date
    July 13, 2021
    Address
    2400 Bernville Rd, Reading, PA, 19605-9607, United States

    Description

    Arrow Bipolar Balloon Electrode Catheter 5 Fr. 105 cm, Product Code: AI-07154 - Product Usage: intended for temporary use in electrophysiology studies for intracardiac stimulation and/or ECG recording.

    Reason

    Marketed without a 510K

    Code Info

    Lot Numbers: 16F19J0109

    Distribution

    US Nationwide distribution in the states of FL, ID, IL, NY, OH, TX.

    Quantity

    4 units