Events

Retiro De Equipo (Recall) de Arterial and venous line batches for hemodialysis generator

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 B.Braun.

¿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
    2006-10-10
  • 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-lots-de-lignes-arterielles-et-veineuses-pour-generateur-d-hemodialyse-b-braun
  • 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
    The company B.BRAUN has withdrawn from the market on October 4, 2006 lots 06D21934, 06E02934, 06E06934, 06E08934, 06E25934, 06F07934, 06F19934, 06G20934 of the medical device called arterial and venous lines reference 7210684 for hemodialysis generators B.Braun DIALOG more a few cases of visible pinching of the tube resulting in cracks resulting in leakage of rinsing liquid or blood. The company has directly notified the recipients of the incriminated lots with the attached message (10/10/2006) (13 KB) validated by Afssaps. This information is addressed to the directors of health establishments and the local correspondents of materiovigilance for diffusion, if necessary to the services concerned. The relevant European competent authorities are informed of this defect by the manufacturer.

Device

Arterial and venous line batches for hemodialysis generator
  • Modelo / Serial
  • Descripción del producto
    medical_device
  • Manufacturer
    B.Braun

Manufacturer

B.Braun