Events

Retiro De Equipo (Recall) de CORODYN TD balloon catheter 7F and 7 F PVC

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
    2005-06-28
  • 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-corodyn-td-catheters-a-ballonnet-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 B. Braun Medical company withdrew from the market on June 24, 2005, the batches (see appendix (24/06/2005) (11 ko)) of the medical device called CORODYN TD balloon catheter 7F and 7 F PVC (references 5041953 and 5041252) following reports of end of cracked caheter, leakage at the 3-way valve and cracked tip .. No report has been reported in France to date. The company has directly notified the recipients of the offending lot with the message attached (24/06/2005) (9 KB) validated by Afssaps. This information is addressed to the directors of health establishments and the 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

CORODYN TD balloon catheter 7F and 7 F PVC
  • Modelo / Serial
  • Descripción del producto
    medical_device
  • Manufacturer
    B. Braun

Manufacturer

B. Braun