Events

Retiro De Equipo (Recall) de Device Recall Sirtex SIRyttrium 90 microspheres (Radionuclide)

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 Sirtex Medical Limited.

¿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
    64508
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-1162-2013
  • Fecha de inicio del evento
    2013-02-27
  • Fecha de publicación del evento
    2013-04-23
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-03-30
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=116369
  • 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
    Microspheres radionuclide - Product Code NAW
  • Causa
    Incorrect expiration date.
  • Acción
    Sirtex notified medical end users on 2/27/13 via email correspondence with a copy of the recall letter attached. This was done to ensure advice was received at the same time that the goods were arriving. Hard copies of the recall letter, which were stamped "copy", were also sent to the individual facilities via UPS, processed for delivery Thursday, 28 February, 2013. Medical end users were advised in the recall letter to contact the US Customer Service staff at (888) 474-7839 x 702 to arrange for the pick-up if they decide to return the unused product.

Device

Device Recall Sirtex SIRyttrium 90 microspheres (Radionuclide)
  • Modelo / Serial
    Batch HB024V02 to HB024V14; Batch HB025V02 to HB024V10
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    Nationwide Distribution-USA (nationwide) including DC and the states of AZ, CA, CT, GA, ID, IL,KY, LA, MD, ME, MO, MT, NJ, NV, WA, and WV.
  • Descripción del producto
    Sirtex SIR-yttrium 90 microspheres (Radionuclide); SIR-Y001. || Indicated for the treatment of unresectable metastatic liver tumors.
  • Manufacturer
    Sirtex Medical Limited

Manufacturer

Sirtex Medical Limited
  • Dirección del fabricante
    Sirtex Medical Limited, Centrecourt Business Park,, Unit D4, 25-27, Paul Street North, North Ryde, New South Wales Australia
  • Empresa matriz del fabricante (2017)
    Sirtex Medical Limited
  • Source
    USFDA