Events

Retiro De Equipo (Recall) de Debriflo Ultrasonic Wound Irrigation Hand-piece

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Debriflo 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-2016-RN-01165-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2016-09-14
  • 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-2016-RN-01165-1
  • 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
    It has been found that the current ifu includes an incorrect cleaning and sterilisation procedure. the ifu (version 14) has been updated to include the new validated cleaning and sterilisation instructions, including the use of a new cleaning solution and wipes, specific dilution directions and contact times, specific lumen flushing instructions and changes to the sterilisation temperature and time.
  • Acción
    Debriflo is providing users with a copy of the revised IFU (Version 14) with the new cleaning and sterilisation instructions.

Device

Debriflo Ultrasonic Wound Irrigation Hand-piece
  • Modelo / Serial
    Debriflo Ultrasonic Wound Irrigation Hand-pieceAll lot numbers affectedARTG Number: 265127
  • Manufacturer
    Debriflo Pty Ltd

Manufacturer

Debriflo Pty Ltd
  • Source
    DHTGA