BEUDAMED
    FDA Recall Terminated

    LuMend brand percutaneous catheter .35'' R in plastic sealed bag, sterilized with ethylene oxide gas.

    Recall: Z-0995-04 · Initiated May 18, 2004

    Recall

    Recall Number
    Z-0995-04
    Event Number
    29212
    Firm
    Lumend Inc
    FEI Number
    3002912012
    Product Code
    DQY
    Status
    Terminated
    Root Cause
    Other
    Initiated
    May 18, 2004
    Posted
    July 20, 2004
    Terminated
    July 26, 2004
    Address
    400 Chesapeake Dr, Redwood City, CA, 94063-4739

    Description

    LuMend brand percutaneous catheter .35'' R in plastic sealed bag, sterilized with ethylene oxide gas.

    Reason

    Recall initiated after Lumend received a report of a malfunction of an Outback Catheter in Ohio.

    Action

    Area Sales managers were contacted via phone conference on 05/18/04 and instructed to quarantine all outback catheters in their possession and notify all customers with any outback inventory to quarantine the product and make arrangements to retrieve the product from them.

    Distribution

    Sent mainly to Area sales representatives.

    Quantity

    Quantity distributed = 122 catheters.