BEUDAMED
    FDA Recall Terminated

    ARROW Bipolar Electrode Catheter with shrouded pins , 6 Fr, 110 cm Product Code: AI-06210-S Product Usage: Arrow electrophysiology catheters are intended for temporary use in electrophysiology studies for intracardiac stimulation and/or ECG recording

    Recall: Z-3197-2018 · Initiated July 30, 2018

    Recall

    Recall Number
    Z-3197-2018
    Event Number
    80872
    Firm
    Arrow International Inc
    FEI Number
    3015859709
    Product Code
    DRF
    Status
    Terminated
    Root Cause
    Error in labeling
    Initiated
    July 30, 2018
    Terminated
    July 11, 2019
    Address
    2400 Bernville Rd, Reading, PA, 19605-9607

    Description

    ARROW Bipolar Electrode Catheter with shrouded pins , 6 Fr, 110 cm Product Code: AI-06210-S Product Usage: Arrow electrophysiology catheters are intended for temporary use in electrophysiology studies for intracardiac stimulation and/or ECG recording

    Reason

    Products are labeled with an incorrect expiration date

    Action

    Arrow International notified US consignee notification by letter on 30 JUL 2018 via FedEx 2-day mail. Account action: immediately discontinue use and quarantine any products with the product codes and lot numbers listed above, so that the affected products can be returned to Arrow. To return product, complete the enclosed Recall Acknowledgement Form and fax it to 1-855-419-8507, Attn: Customer Service or email to [email protected].

    Distribution

    US in the state of PA

    Quantity

    7 eaches