Retiro De Equipo (Recall) de Algerbrush II and Algerbrush II Accessories Algerbrush – II Rust Ring 0.5mm instrument and Rust Ring 1.0mm instrument Algerbrush – II Accessories0.5mm Burr/Chuck and 1.0mm Burr/Chuck

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por iNova Pharmaceuticals 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-2016-RN-01586-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2016-12-12
  • País del evento
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
  • 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 operating instructions for sterilisation (version 2) were either missing or obsolete. the new operating instructions (version 3) contain specific time and temperature for sterilisation. failure to follow the new operating instructions may result in potential adverse events, including eye infections.
  • Acción
    iNova Pharmaceuticals is advising health practitioners to replace their Algerbrush-II Operating Instructions (v2) with the new instructions provided (v3) and to ensure that all relevant staff is informed of this change to the operating instructions. This action has been closed-out on 27/06/2017.

Device

  • Modelo / Serial
    Algerbrush II and Algerbrush II AccessoriesAlgerbrush – II Rust Ring 0.5mm instrument and Rust Ring 1.0mm instrument Algerbrush – II Accessories0.5mm Burr/Chuck and 1.0mm Burr/Chuck ARTG Number: 93755
  • Clasificación del producto
  • Manufacturer

Manufacturer