Events

Retiro De Equipo (Recall) de UV-Flash system transfer line

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
    2004-11-09
  • 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/retrait-de-lot-de-ligne-de-transfert-systeme-uv-flash-dialyse-peritoneale-societe-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 November 8, 2004, the BAXTER company withdrew the H03L12057 batch of the reference R5C4325 medical device called UV-Flash system transfer line used for peritoneal dialysis following the occurrence in France of twelve cases of disconnection between the tubing and the clamp. No serious medical consequences have been reported following these events thanks to the rapid implementation of prophylactic antibiotherapy. BAXTER has directly informed the recipients of the offending lot with the attached message (08 / 11/2004) (14 kb) validated by Afssaps. This information is addressed to the directors, pharmacists and local correspondents of materiovigilance for diffusion if necessary, to the services concerned. The relevant European Competent Authorities are informed of this measure by the manufacturer. Message Baxter (08/11/2004) (14 KB)

Device

UV-Flash system transfer line
  • Modelo / Serial
  • Descripción del producto
    medical_device
  • Manufacturer
    BAXTER

Manufacturer

BAXTER