Events

Retiro De Equipo (Recall) de Neuro Flap Fix Kit (used for fixation of cranial bone flaps and fractures)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Life Healthcare 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-01497-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-11-16
  • 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-01497-1
  • 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
    The manufacturer has received a report from a user advising that the secondary peel bag of the sterile packaged article was not completely sealed. an incorrect welding process has resulted in the secondary peel bag not being sealed. a non-welded secondary peel bag results in the primary bag becoming no longer sterile and thus a “non-sterile article” can reach the sterile area of the operating room. this presents a potential safety risk for the patient. the manufacturer is not aware of any other incidents, however the affected batch is being recalled as a precaution.
  • Acción
    LifeHealthcare is advising customers to quarantine affected stock and to contact LifeHealthcare to arrange for collection and replacement. This action has been closed-out on 18/05/2017.

Device

Neuro Flap Fix Kit (used for fixation of cranial bone flaps and fractures)
  • Modelo / Serial
    Neuro Flap Fix Kit (used for fixation of cranial bone flaps and fractures)Product Code: 25-302-10-71Lot Number: 33173390ARTG Number: 202843
  • Manufacturer
    Life Healthcare Pty Ltd

Manufacturer

Life Healthcare Pty Ltd