BEUDAMED
    FDA Recall Terminated

    Walrus Arterial Embolectomy Catheter The arterial embolectomy catheter is intended for use in removing arterial emboli.

    Recall: Z-2911-2016 · Initiated July 7, 2016

    Recall

    Recall Number
    Z-2911-2016
    Event Number
    75014
    Firm
    Arrow International Inc
    FEI Number
    3015859709
    Product Code
    DXE
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    July 7, 2016
    Terminated
    October 25, 2017
    Address
    2400 Bernville Rd, Reading, PA, 19605-9607

    Description

    Walrus Arterial Embolectomy Catheter The arterial embolectomy catheter is intended for use in removing arterial emboli.

    Reason

    Arrow is recalling due to incorrect labeling of products.

    Action

    The firm, Arrow International, Inc., sent an "Urgent Medical Device Recall Notification" letter dated July 07, 2016 via FedEx to its customers. The letter described the product, problems and actions to be taken. The customers were instructed to immediately discontinue use and quarantine any products they may have on hand; return product, and complete the enclosed Recall Acknowledgement Form and fax it to 1-855-419-8507, Attn: Customer Service or email to [email protected], even if you have no affected stock. If you have any other questions, feel free to contact your local sales representative or Customer Service at 1-866-246-6990.

    Distribution

    US Nationwide Distribution

    Quantity

    2,425 catheters