Events

Retiro De Equipo (Recall) de Disposable Myringotomy blade with handle (used during surgery on the ear drum to relieve pressure)

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-01002-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-10-13
  • 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-01002-1
  • 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
    Olympus australia is issuing a product recall of the affected lot of the disposable myringotomy blade with handle, due to missing or compromised seals in the sterile packaging, therefore compromising the sterility of the product.
  • Acción
    Olympus is requesting users inspect stock and quarantine any affected units. Affected stock will be replaced or a credit issues. This action has been closed-out on 29/08/2016.

Device

Disposable Myringotomy blade with handle (used during surgery on the ear drum to relieve pressure)
  • Modelo / Serial
    Disposable Myringotomy blade with handle (used during surgery on the ear drum to relieve pressure)Item Code: 70130791Lot Number: SD954316 ARTG Number: 142726
  • Manufacturer
    Olympus Australia Pty Ltd

Manufacturer

Olympus Australia Pty Ltd