Events

Retiro De Equipo (Recall) de Urologix Targis System, Coolant Bag

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
    Recall
  • ID del evento
    58695
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2710-2011
  • Fecha de inicio del evento
    2011-04-28
  • Fecha de publicación del evento
    2011-06-30
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-04-26
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=99976
  • 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
    Sustem, hypertheria, rf/microwave (benign prostatic hyperplasia), thermotherapy - Product Code MEQ
  • Causa
    Urologix is recalling certain lots of targis¿ system coolant bag devices distributed over a two week period. the devices are packaged into disposable procedure kits containing a microwave catheter, a coolant bag and a rtu plus¿ balloon. the reason for this recall involves three lots of coolant bags that contain an increased risk of leakage of water at the sensor module. this leak is detectabl.
  • Acción
    Urologix, Inc. sent an "IMPORTANT RECALL INFORMATION" letter dated April 28, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. The letter instructs the customers to identify the affected kit lots, remove the Coolant Bag pouch(s) and to complete and return a Return Material Authorization form with the product(s). Additionally, an enclosed Customer Acknowledgement Form should be completed and faxed to 763-475-1443. Customers with questions should contact the Director of Regulatory and Quality at 763-475-1400.

Device

Urologix Targis System, Coolant Bag
  • Modelo / Serial
    Catalog # / Lot No.  PT1034 / AHP0333111A, AHP040411A, AHP040411B, AHP040611A, AHP040711A, AHP040811A, AHP041211A  PT1036 / ACP033011B, ACP040111A, ACP040111B, ACP040611A, ACP040711A, ACP040711B, ACP040811A, ACP041211A  PT1038 / ALP033111A, ALP040411A  PT1013 / KP040711A  CA1111B / C900284, C900285 and C900286  C900284, C900285 and C900286  C900284 and C900285  C900285
  • Clasificación del producto
    Gastroenterology-Urology Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution--including the states of AL, CA, CO, FL, GA, MA, MI, MN, NJ, NY, OR, PA, TN, WV, and including Puerto Rico.
  • Descripción del producto
    The following kits contain the UROLOGIX, Coolant Bag, CA1111B, Sterile EO, Manufactured for: UROLOGIX, Inc., 14405 Twenty-first Avenue North, Minneapolis, MN 55447. || UROLOGIX, CTC Advance Short, (2.5-3.5 cm), PT1034, Sterile EO,Manufactured by: UROLOGIX, Inc., 14405 Twenty-first Avenue North, Minneapolis, MN 55447. || CTC Advance Standard , (3.0-5.0 cm), PT1036, Sterile EO,, Manufactured by: UROLOGIX, Inc., 14405 Twenty-first Avenue North, Minneapolis, MN 55447. || CTC Advance Long, (4.5+ cm), PT1038, Sterile EO,Manufactured by: UROLOGIX, Inc., 14405 Twenty-first Avenue North, Minneapolis, MN 55447. || Targis Standard, (3.0-5.0 cm), PT1013, Sterile EO,Manufactured by: UROLOGIX, Inc., 14405 Twenty-first Avenue North, Minneapolis, MN 55447. || The Urologix Targis system is a non-surgical device intended to relieve symptoms and obstruction associated with Benign Prostatic Hyperplasia (BPH) and is indicated for men with prostatic urethral lengths greater than 2.5 cm.
  • Manufacturer
    Urologix, Inc.

Manufacturer

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