Events

Retiro De Equipo (Recall) de Cordis S.M.A.R.T. Flex Vascular Stent System

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Cardinal Health Australia 503 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-2017-RN-01446-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-11-29
  • 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-2017-RN-01446-1
  • 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
    Cordis has determined that certain lots of the s.M.A.R.T. flex vascular stent system have a potential for cracked luer hubs, due to a manufacturing error.The luer hub is used to inject contrast/saline during procedure preparation, prior to insertion of the stent system into the patient. a cracked hub could result in leakage of saline, or in the worst case, inability to flush the outer sheath of the catheter. the potential medical consequence would be a delay in device preparation, resulting in the need to prepare a replacement device for use. cordis does not anticipate any other patient impact.
  • Acción
    Cordis is advising users to inspect stock and quarantine any remaining units of the affected product for return.

Device

Cordis S.M.A.R.T. Flex Vascular Stent System

Manufacturer

Cardinal Health Australia 503 Pty Ltd