Events

Retiro De Equipo (Recall) de 100cc silicone suction tanks with anti-reflux valv

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 Saint-Gobain Performance Plastics Francel.

¿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
    2010-05-05
  • 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-reservoirs-de-succion-en-silicone-de-100cc-avec-valve-anti-reflux-saint-gobain-performance-plastics-france
  • 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 May 3, 2010, Saint-Gobain Performance Plastics Francel withdrew the lots from the market. 400409100. 40080910. 40060915. 400809202. 400109904. 400100931. 400809007 of the reference 3101-ASS 3101of the medical device called "100cc silicone suction tanks with anti-reflux valve", manufactured by SGPPL France, following a lack of sterility. The company Saint-Gobain Performance Plastics Francel directly notified the recipients of the incriminated lots with the enclosed message validated by Afssaps. (05/05/2010) (878 kb.) This information is intended for the directors and correspondents of materiovigilance for dissemination, where appropriate, to the departments concerned, the relevant European Competent Authorities are informed of this measure by the manufacturer.

Device

100cc silicone suction tanks with anti-reflux valv

Manufacturer

Saint-Gobain Performance Plastics Francel