Events

Retiro De Equipo (Recall) de PRISMA sets for dialysis

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 GAMBRO.

¿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
    2006-04-12
  • 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-sets-prisma-pour-dialyse-de-la-societe-gambro
  • 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    The company GAMBRO has withdrawn from the market in November 2005, 15 batches of the medical device called "sets PRISMA" distributed by HOSPAL, following several cases of leaks on the intake pressure, after disconnection of the patient (message of 23/11 / 0.) .. As new claims have been reported on batches not listed during this first recall, GAMBRO extends its recall to all batches manufactured before the implementation of the corrective actions (12/04/2006) (25 ko ) (all lots prior to lot 05J2796P, not included). Pending the end of the recall and the implementation of additional preventive actions, instructions for use (12/04/2006) (43 KB) are recalled. The distributor HOSPAL has directly notified the recipients of the incriminated lots with the attached message (12/04/2006) (25 ko). This information is addressed to the directors of health establishments and local correspondents. materiovigilance for dissemination, where appropriate to the services concerned. The relevant European Competent Authorities are informed of this measure by the manufacturer.

Device

PRISMA sets for dialysis
  • Modelo / Serial
  • Descripción del producto
    medical_device
  • Manufacturer
    GAMBRO

Manufacturer

GAMBRO
  • Source
    LAANSM