Events

Retiro De Equipo (Recall) de TRACHEOSOFT PERC Percutaneous

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 Tyco Healthcare.

¿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
    2006-04-07
  • 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-canules-de-tracheotomie-de-la-societe-tyco-healthcare
  • 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 TYCO HEALTHCARE withdrew from the market on April 5, 2006, the lots whose expiry date is between 2008 and 2010 inclusive (N of lot starting with 2003, 2004 or 2005) of the medical device called "tracheostomy tubes" 8.0 mm TRACHEOSOFT PERC Percutaneous "reference 137-80, following incidents reporting detachment of the locking system of the collar that can allow the cannula to migrate into the trachea .. The company has directly notified the recipients of the incriminated lots using of the message attached (05/04/2006) (188 ko) 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 competent European authorities concerned shall be informed of this measure by the manufacturer.

Device

TRACHEOSOFT PERC Percutaneous
  • Modelo / Serial
  • Descripción del producto
    medical_device
  • Manufacturer
    Tyco Healthcare

Manufacturer

Tyco Healthcare
  • Source
    LAANSM