Events

Retiro De Equipo (Recall) de Combicath

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 PRODIMED - Division PLASTIMED.

¿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
    2005-05-09
  • 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-d-un-lot-du-dm-combicath-prodimed-division-plastimed
  • 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 PRODIMED - Division PLASTIMED withdrew from the market on 06.05.2005 the batch S2004G27 of the medical device called Combicath reference 58228 19 following difficulties of sampling related to the cutting length, too short, of the internal catheter .. This defect is visualized during sampling because the outer catheter remains obstructed by a plug that should normally be ejected from the outlet of the internal catheter. This device is used for protected bronchial distal sampling. The company has directly notified the recipients of the incriminated lot with the enclosed message validated by Afssaps (06/05/2005) (45 KB). This information is addressed to the directors of health establishments and local correspondents of materiovigilance for dissemination, where appropriate to the services concerned. The relevant European competent authorities are informed of this measure by the manufacturer.

Device

Combicath

Manufacturer

PRODIMED - Division PLASTIMED
  • Source
    LAANSM