Events

Retiro De Equipo (Recall) de STF Load Check Indicators (ultrasonic bath efficacy indicator)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Device Technologies 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-2013-RN-00416-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-05-09
  • 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-00416-1
  • 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
    Lot 022473 was manufactured in june 2012 and is incorrectly labelled an expiry date of june 2013; the correct expiry date is may 2013, indicating that the product can be used through 31 may 2013.
  • Acción
    Customers are requested to inspect their stock and isolate any product from lot 022473. All affected stock is required to be destroyed prior to 31 May 2013. Replacement units will be provided by Device Technologies.

Device

STF Load Check Indicators (ultrasonic bath efficacy indicator)

Manufacturer

Device Technologies Australia Pty Ltd