Events

Retiro De Equipo (Recall) de Device Ranger Single Use

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 ARIZANT.

¿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
    2007-07-18
  • 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/rappel-de-lots-dispositif-ranger-usage-unique-arizant
  • 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    The company ARIZANT has withdrawn from the market on 17/07/07 the batches B4798 to B4803 (included) of the reference 24200 of the medical device called Device Ranger Single Use (set with normal flow) and the batch E5111 of the reference 24250 of the medical device referred to as Single Use Ranger Device (Normal Flow Package with Single Use Extension Line). The company has directly notified the recipients of the incriminated lots with the message attached (17/07/2007) (252 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

Device Ranger Single Use
  • Modelo / Serial
  • Descripción del producto
    medical_device
  • Manufacturer
    ARIZANT

Manufacturer

ARIZANT
  • Source
    LAANSM