Events

Retiro De Equipo (Recall) de STRYKEFLOW 2

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 STRYKER.

¿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
    2006-01-19
  • 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-boites-d-aspirateurs-irrigateurs-strykeflow-2-de-la-societe-stryker
  • 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    The STRYKER company has withdrawn from the market on November 28, 2005 the defective units of lots 05258FG2 to 05299FG2 of the medical device called "vacuum cleaners / irrigators STRYKEFLOW 2 - box of 6" reference 250-070-500 following the risk of damage to the packaging may lead to loss of sterility of the product. The analysis of cause led STRYKER to extend the recall to batches 05151FG2 to 05257FG2 .. The company directly notified the recipients of the incriminated lots with the message attached (19/01/2006) (37 KB) validated by Afssaps .. This information is addressed to the directors of health establishments and local 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

STRYKEFLOW 2
  • Modelo / Serial
  • Descripción del producto
    medical_device
  • Manufacturer
    STRYKER

Manufacturer

STRYKER
  • Empresa matriz del fabricante (2017)
    Stryker
  • Source
    LAANSM