Events

Retiro De Equipo (Recall) de Diego Elite Tubesets

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Olympus Australia 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-2015-RN-00397-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-05-12
  • 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-2015-RN-00397-1
  • 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 reason for the recall is due to a possible breach of the package’s sterile barrier, therefore compromising the sterility of the product. the breach may not be easily seen. it is important to note that there are no concerns regarding the diego elite product performance. however, as a result there has been a temporary disruption in the supply of diego elite tube sets.
  • Acción
    End users are requested to cease use of any affected product and quarantine it until it is shipped back to Olympus Australia Pty Ltd. This action has been closed-out on 08/08/2016.

Device

Diego Elite Tubesets
  • Modelo / Serial
    Diego Elite TubesetsItem Codes:TS100S – Diego Elite Tubeset, StandardTS101DC – Diego Elite Tubeset, DeclogARTG Number: 143268
  • Manufacturer
    Olympus Australia Pty Ltd

Manufacturer

Olympus Australia Pty Ltd