Events

Retiro De Equipo (Recall) de Chlorhexidine 0.5% in Alcohol 70%

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Advanced Pharmaceuticals 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-00187-1
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2013-02-28
  • 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-00187-1
  • 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
    A precipitate was located in the chlorhexidine 0.5% in alcohol 70% solution. testing of other bottles in the same batch found the precipitate present in all bottles tested. in addition a colour variation in darkness of the pink solution was observed between these tested bottles. this colour variation corresponded with the amount and size of the particulate matter in the solution (ie darker colour solution particles were less and smaller, and in lighter colour solutions the particles were larger).This recall action was carried out prior to approval of the recall strategy by the tga.
  • Acción
    Advanced Pharmaceuticals has recalled affected batches from distributors and hospitals.

Device

Chlorhexidine 0.5% in Alcohol 70%

Manufacturer

Advanced Pharmaceuticals Pty Ltd
  • Source
    DHTGA