BEUDAMED
    FDA Recall Terminated

    MR Coaxial 10g x 140mm (VC10140MR).

    Recall: Z-1881-2009 · Initiated March 26, 2009

    Recall

    Recall Number
    Z-1881-2009
    Event Number
    52455
    Firm
    Bard Peripheral Vas
    FEI Number
    3000131337
    Product Code
    DWF
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    March 26, 2009
    Posted
    August 26, 2009
    Terminated
    April 2, 2012
    Address
    1415 W 3rd St, Ste 109, Tempe, AZ, 85281-7634

    Description

    MR Coaxial 10g x 140mm (VC10140MR).

    Reason

    Some Vacora 10G Plastic Coaxial Cannulas may leave a small metal filament in the breast or the sample obtained post procedure.

    Action

    Bard Peripheral Vascular, Inc. issued an "Urgent Medical Device Recall Notification" dated March 27, 2009 informing Customers of the affected devices. The firm requested that all affected product be removed and returned along with returning a Recall and Effectiveness Check Form via fax. For further information, contact Bard Peripheral Vascular, Inc. at 1-800-321-4254.

    Distribution

    Worldwide Distribution.

    Quantity

    695