BEUDAMED
    FDA Recall Terminated

    VNUS 7F ClosureFAST Catheter, Order # ClF7-7-100 (100 cm working length), Manufactured by VNUS Medical Technologies, Inc., 5799 Fontanoso Way, San Jose, CA 95138

    Recall: Z-0543-2008 · Initiated August 8, 2007

    Recall

    Recall Number
    Z-0543-2008
    Event Number
    45510
    Firm
    VNUS Medical Technologies Inc
    FEI Number
    3001236355
    Product Code
    GEI
    Status
    Terminated
    Root Cause
    Labeling design
    Initiated
    August 8, 2007
    Posted
    January 24, 2008
    Terminated
    May 22, 2008
    Address
    5799 Fontanoso Way, San Jose, CA, 95138-1015

    Description

    VNUS 7F ClosureFAST Catheter, Order # ClF7-7-100 (100 cm working length), Manufactured by VNUS Medical Technologies, Inc., 5799 Fontanoso Way, San Jose, CA 95138

    Reason

    Instructions for Use change: Instructions for Use have been changed to include a modified placement recommendation.

    Action

    The Recalling firm is updating the Instructions For Use, training materials, and procedural guides to incorporate the treatment recommendations. The recalling firm sent an Update to customers who received the product, Important Update Regarding the Use of the VNUS ClosureFAST Catheter, dated August 6, 2007 with supplemental device instructions. Future product distribution will include the updated labeling.

    Distribution

    Worldwide

    Quantity

    6,221 units