BEUDAMED
    FDA Recall Terminated

    UROLOGIX CTC Advance" Standard Microwave Catheter (3.0-5.0 cm), CTC Advance" Long Microwave Catheter (4.5+ cm), CTC Advance" Short Microwave Catheter (2.5 -3.5 cm), RTU Plus Balloon, and RTU Plus Handle, Sterile EO, Manufactured by UROLOGIX, INC, 14405 Twenty-First Avenue North, Minneapolis, MN 55447. The CTC Advance" catheters and RTU Plus are used as part of the Targis System. Each disposable device is packaged on a card inside a heat sealed pouch. Each Kit Box then hold 3 product pouches: 1 catheter, 1 coolant bag and 1 RTU Plus balloon. The RTU Plus Kit contains 3 RTU Plus Handles packaged in separate sterile pouches.

    Recall: Z-1174-2010 · Initiated February 18, 2010

    Recall

    Recall Number
    Z-1174-2010
    Event Number
    54703
    Firm
    Urologix, Inc.
    FEI Number
    3000718675
    Product Code
    MEQ
    Status
    Terminated
    Root Cause
    Incorrect or no expiration date
    Initiated
    February 18, 2010
    Posted
    March 19, 2010
    Terminated
    March 8, 2012
    Address
    14405 21st Ave N, Minneapolis, MN, 55447-4685

    Description

    UROLOGIX CTC Advance" Standard Microwave Catheter (3.0-5.0 cm), CTC Advance" Long Microwave Catheter (4.5+ cm), CTC Advance" Short Microwave Catheter (2.5 -3.5 cm), RTU Plus Balloon, and RTU Plus Handle, Sterile EO, Manufactured by UROLOGIX, INC, 14405 Twenty-First Avenue North, Minneapolis, MN 55447. The CTC Advance" catheters and RTU Plus are used as part of the Targis System. Each disposable device is packaged on a card inside a heat sealed pouch. Each Kit Box then hold 3 product pouches: 1 catheter, 1 coolant bag and 1 RTU Plus balloon. The RTU Plus Kit contains 3 RTU Plus Handles packaged in separate sterile pouches.

    Reason

    Urolgix is recalling certain lots of CTC Advance" catheters and RTU Plus devices which are integral components of the Targis System. The reason for this Recall is a labeling error only; the issue involves a discrepancy in the"Use Before" date printed on the product label. In the affected lots, the "Use Before" date , commonly known as the expiration date, is printed as 2012-12 when it should r

    Action

    Consignees were sent a UROLOGIX " Important Recall Information" letter dated February 18, 2010. The letter was addressed to the client's name. The letter described the problem and product involved. It provided Instructions for "Returning and Replacing Affected Product" and requested the return of the "Customer Acknowledgement Form". If you have questions, please call (763)-475-1400.

    Distribution

    AL, AZ, CA, FL, IN, MI, MN, MS, NY, OK PA, TN, TX, and WI.

    Quantity

    154