BEUDAMED
    FDA Recall Terminated

    VNUS ClosureFAST catheters, Model Number: CL7-7-100, VNUS Medical Technologies, Inc., San Jose, CA 95138

    Recall: Z-0132-2008 · Initiated March 6, 2007

    Recall

    Recall Number
    Z-0132-2008
    Event Number
    38381
    Firm
    VNUS Medical Technologies Inc
    FEI Number
    3001236355
    Product Code
    GEI
    Status
    Terminated
    Root Cause
    Package design/selection
    Initiated
    March 6, 2007
    Posted
    December 15, 2007
    Terminated
    December 17, 2007
    Address
    5799 Fontanoso Way, San Jose, CA, 95138

    Description

    VNUS ClosureFAST catheters, Model Number: CL7-7-100, VNUS Medical Technologies, Inc., San Jose, CA 95138

    Reason

    Sterility (package integrity) Compromised: Product sterility may be compromised due to a pinhole under the pouch foldover.

    Action

    The recalling firm has issued customer notification letters by mail on 03/06/2007. The firm is requesting that consignees discontinue their use of the device and return recalled product . The firm will provide replacements.

    Distribution

    Nationwide: Product was distributed to 18 health care providers and medical centers throughout the US in the following states: TX, UT, CA, CT, MI, NY, MI, OR, WA, VA, PA, and NJ.

    Quantity

    92 units