Events

Retiro De Equipo (Recall) de Dialyzer Xenium LF 190

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 BAXTER.

¿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
  • Fecha
    2009-09-02
  • País del evento
    France
  • Fuente del evento
    ANSM
  • URL de la fuente del evento
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/rappel-de-dialyseur-xenium-lf-190-baxter
  • 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 31/08/09, BAXTER withdrew from the market lot 09A22SX of the reference R5M6410LF of the medical device called Dialyzer Xenium LF 190. Indeed, this reference is likely to present the same problem as another reference (not distributed in France) for which have been received complaints about blood leaks observed at the beginning of treatment on the upper part of the dialyzer. The company BAXTER has directly notified the recipients of the offending lot with the message attached (02/09/2009) (45 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.

Device

Dialyzer Xenium LF 190
  • Modelo / Serial
  • Descripción del producto
    medical_device
  • Manufacturer
    BAXTER

Manufacturer

BAXTER