Retiro De Equipo (Recall) de Device Recall UROLOGIX CTC Advance" Standard Microwave Catheter

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Urologix, Inc..

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
  • ID del evento
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
  • Fecha de inicio del evento
  • Fecha de publicación del evento
  • Estado del evento
  • País del evento
  • Fecha de finalización del evento
  • Fuente del evento
  • URL de la fuente del evento
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    System, hyperthermia, rf/microwave (benign prostatic hyperplasia), thermotherapy - Product Code MEQ
  • Causa
    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.
  • Acción
    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.


  • Modelo / 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
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    AL, AZ, CA, FL, IN, MI, MN, MS, NY, OK PA, TN, TX, and WI.
  • Descripción del producto
    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


  • Dirección del fabricante
    Urologix, Inc., 14405 21st Ave N, Minneapolis MN 55447-4685
  • Source