Retiro De Equipo (Recall) de LogiCal, TranStar, NovaTrans with Trigger flush

Según L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en France que fue producido por Smiths Medical International Ltd.

¿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
  • Fecha
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • Notas / Alertas
    French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and France.
  • Notas adicionales en la data
  • Acción
    On May 30, 2008, Smiths Medical France withdrew from the market batches manufactured between October 2007 and February 2008 medical devices called "LogiCal, TranStar, NovaTrans with Trigger flush", manufactured by Smiths Medical International Ltd, following the malfunction of a number of sets, for which the infusion rate is higher than the specified nominal value of 3 ml / h. This excess flow entails a risk of over-perfusion for the patient but also an error in reading the pressure. The company Smiths Medical France directly notified the recipients of the incriminated lots with the message attached (30/05/2008) (40 KB) validated by Afssaps. This information is addressed to the directors and correspondents of materiovigilance for diffusion if necessary to the services concerned. The relevant European Competent Authorities are informed of this measure by the manufacturer.