Events

Retiro De Equipo (Recall) de Medi-Vac Range Sterile Tubing

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 Care Fusion.

¿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
    2010-09-08
  • 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/tubulures-steriles-gamme-medivac-cardinal-health-care-fusion-retrait-de-lots
  • 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    On 06/09/10, the company Care Fusion has withdrawn from the market all the batches not included pa. in the list in Appendix 1, references NEX510, NEX56A, NEX66A, NEX710, NEX712, NEX76A of the medical device called Medi-Vac Range Sterile Tubing, manufactured by Cardinal Health, following the identification of a potential defect in sold on the packaging of the subject references, delivered in the period from 2 January 2007 to 23 August 2010. Care Fusion directly notified the recipients concerned with the enclosed message (08/09/2010) (60 ko) validated by the Afssaps. This information is addressed to the directors and correspondents of materiovigilance for diffusion if necessary to the services concerned. The competent European authorities concerned shall be informed of this measure by the European representative. Read auss. Expansion of Initial Removal - Sterile Tubing Medivac Range, Cardinal Health - Care Fusio. (21/09/2010)

Device

Medi-Vac Range Sterile Tubing
  • Modelo / Serial
  • Descripción del producto
    medical_device
  • Manufacturer
    Care Fusion

Manufacturer

Care Fusion