Events

Retiro De Equipo (Recall) de STERRAD 100NX and STERRAD 200 Sterilisation Systems

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Johnson & Johnson Medical 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-2013-RN-00298-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-04-04
  • 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-2013-RN-00298-1
  • 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
    The manufacturer (asp) has determined that these systems may emit an odour or smell into the surrounding environment that is not typical to normal operating conditions. although odours/ smells occur environmentally throughout the healthcare environment, odours/smells may also be related to normal breakdown of the oil used in the steriliser vacuum pump on the sterrad 100nx and/or sterrad 200.
  • Acción
    The manufacturer is providing users with work around instructions while it continues to investigate the root cause of the problem.

Device

STERRAD 100NX and STERRAD 200 Sterilisation Systems
  • Modelo / Serial
    STERRAD 100NX and STERRAD 200 Sterilisation SystemsProduct Code: 10104 & 10200 All units shipped to dateARTG Number: 123603
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd

Manufacturer

Johnson & Johnson Medical Pty Ltd