Events

Retiro De Equipo (Recall) de GUIDELINER Intravascular Guiding Catheter

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Pyramed Pty Ltd.

¿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
  • ID del evento
    RC-2012-RN-00779-3
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2012-08-22
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-00779-3
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notas adicionales en la data
  • Causa
    Guideliner catheter is being recalled due to a regulatory compliance issue. guideliner catheter has now been cancelled from the australian register of therapeutic goods (artg) because it should have been classified as a class iii medical device, not a class iia medical device in accordance with the therapeutic goods (medical devices) regulations 2002. the guideliner catheter has not undergone the more rigorous pre-market conformity assessment procedure relevant to a class iii device to provide assurance of its quality, safety and performance. in particular, the tga has not been provided with appropriate data on the design verification and validation of the device necessary for a class iii classification.
  • Acción
    Pyramed is asking customers to identify and quarantine the Guideliner Catheter stock and advising that it cannot be used other than in accordance with the specific conditions attached to the Special Access Scheme (SAS).

Device

GUIDELINER Intravascular Guiding Catheter
  • Modelo / Serial
    GUIDELINER Intravascular Guiding Catheter Previous ARTG: 180817All remaining stock in the market
  • Manufacturer
    Pyramed Pty Ltd

Manufacturer

Pyramed Pty Ltd