Events

Recall of Device Recall UROLOGIX CTC Advance" Standard Microwave Catheter

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Urologix, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    54703
  • Event Risk Class
    Class 2
  • Event Number
    Z-1174-2010
  • Event Initiated Date
    2010-02-18
  • Event Date Posted
    2010-03-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-03-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=89036
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    System, hyperthermia, rf/microwave (benign prostatic hyperplasia), thermotherapy - Product Code MEQ
  • 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.

Device

Device Recall UROLOGIX CTC Advance" Standard Microwave Catheter
  • Model / Serial
    KIT LOT NUMBER:  ACP011610D, ACP011710E, ACP011810F, ACP011910G, AHP01810D, AHP011210A, AHP011310B, AHP012310C, AHP012510C, AHP012710C, ALP012510B, and RH00252  CATHETER LOT NUMBERS:  091226MCA1, 091228MHA1, 091229MCA1, 091229MCA2, 091229MHA1, 09123MCA1, 091230MHA1, 100105MHA1, 100106MHA1, 100106MHA2, 100111MHA1, 100111MHA2, 100111MHA3, 100112MLA2, 100113MHA1, 100113MHA2, and 100114MHA1  RTU PLUS LOT NUMBERS:  Handle =RH00252, Balloon= RB0781 & RB0783
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    AL, AZ, CA, FL, IN, MI, MN, MS, NY, OK PA, TN, TX, and WI.
  • Product 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.
  • Manufacturer
    Urologix, Inc.

Manufacturer

Urologix, Inc.
  • Manufacturer Address
    Urologix, Inc., 14405 21st Ave N, Minneapolis MN 55447-4685
  • Source
    USFDA