Events

Retiro De Equipo (Recall) de CustomEyes kit

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 BD France SAS.

¿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
    2008-01-31
  • 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-kits-customeyes
  • 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    On 30/01/08, at the request of Afssaps, the company BD France SAS has withdrawn lots 7247645/7304708/7254211/7288250/7310917/7262567/7304613/7318565/7204006/7289434/7254224/7304813 / The medical device known as the CustomEyes kit, manufactured by BD Medical Ophthalmic Systems, as part of the of mismatch observed with the BD Plastipak Luer slip syringes included in these kits .. The company BD France SAS has directly notified the recipients of the incriminated lots with the enclosed message (30/01/2008) (21 KB) validated by the Afssaps. This information is addressed to directors and 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

CustomEyes kit
  • Modelo / Serial
  • Descripción del producto
    medical_device
  • Manufacturer
    BD France SAS

Manufacturer

BD France SAS
  • Source
    LAANSM