BEUDAMED
    FDA Recall Terminated

    Urologix Microwave Delivery System 3.0 - 5.0. For use with prostatic urethra lengths of 3.0-5.0 cm only. Model TA1121D.

    Recall: Z-0720-2007 · Initiated March 16, 2007

    Recall

    Recall Number
    Z-0720-2007
    Event Number
    37638
    Firm
    Urologix, Inc.
    FEI Number
    3000718675
    Product Code
    MEQ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 16, 2007
    Posted
    April 5, 2007
    Terminated
    May 25, 2007
    Address
    14405 21st Ave N, Minneapolis, MN, 55447-4685

    Description

    Urologix Microwave Delivery System 3.0 - 5.0. For use with prostatic urethra lengths of 3.0-5.0 cm only. Model TA1121D.

    Reason

    The catheter in the kit matches the description on the kit and pouch label; however, an incorrect label was placed onto the catheter during manufacturing.

    Action

    A letter dated 3/16/07 was FedEx overnight to consignees. The letter described the product, problem and gave instructions for returning and replacing the affected product.

    Distribution

    Nationwide and the Netherlands.

    Quantity

    96