Events

Retiro De Equipo (Recall) de 12 Instrument Sterilisation Tray (used for the Conquest Manual Instrument line)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Stryker 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-2014-RN-00480-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-04-29
  • 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-2014-RN-00480-1
  • 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
    Stryker has become aware that gravity sterilisation parameters provided in the 12 instrument sterilisation reprocessing guide (1000400920 rev d) did not fully consider all worst-case scenarios during validation testing. although, to date there have been no reported events to stryker of infection as a result of the use of the sterilization parameters previously provided with these trays, there is a remote possibility for infection.
  • Acción
    End users are advised to discard any old Instructions for Use (IFU) for 12 Instrument Sterilization Tray(s) that make reference to the gravity steam sterilization method (121oC for 30 minutes). New IFU can be downloaded from www.stryker.com/12instrumenttray

Device

12 Instrument Sterilisation Tray (used for the Conquest Manual Instrument line)
  • Modelo / Serial
    12 Instrument Sterilisation Tray (used for the Conquest Manual Instrument line)Catalogue Number: 0242000012All lots shipped from manufacturer between January 10, 2008 and January 10, 2014 ARTG Number: 140639
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

Stryker Australia Pty Ltd
  • Empresa matriz del fabricante (2017)
    Stryker
  • Source
    DHTGA