BEUDAMED
    FDA Recall Terminated

    Arrow Embolectomy Catheters: 4 French, 2 Lumen x 40cm, Product Number: W01798, Single use, Latex Free, Rx only, Arrow International, 2400 Bernville Road, Reading, PA 19605. The arterial embolectomy catheter is intended for use in removing arterial emboli.

    Recall: Z-1473-2009 · Initiated March 25, 2009

    Recall

    Recall Number
    Z-1473-2009
    Event Number
    51960
    Firm
    Arrow International Inc
    FEI Number
    3015859709
    Product Code
    DXE
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    March 25, 2009
    Posted
    June 25, 2009
    Terminated
    February 1, 2010
    Address
    2400 Bernville Road, Reading, PA, 19605

    Description

    Arrow Embolectomy Catheters: 4 French, 2 Lumen x 40cm, Product Number: W01798, Single use, Latex Free, Rx only, Arrow International, 2400 Bernville Road, Reading, PA 19605. The arterial embolectomy catheter is intended for use in removing arterial emboli.

    Reason

    The inflation arm tubing may separate from the stopcock adapter.

    Action

    Arrow International issued an "Urgent Medical Device Recall" letter dated March 25, 2009 describing proper handling of the affected device. Consignees were also instructed to complete a Recall Acknowledgement and Stock Status Form and fax to Arrow International at 1-800-343-2935. Further questions should be directed to Arrow International, Customer Service Department at 1-800-523-8446.

    Distribution

    Worldwide Distribution - USA and Panama.

    Quantity

    6910 units (total all three products)