Events

Retiro De Equipo (Recall) de Divercleanse 750ml

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Diversey 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-00262-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-03-19
  • 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-00262-1
  • 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 come to the attention of diversey australia that some bottles packed during this batch run may contain foreign particles. the contamination can accelerate the deterioration of chlorine levels and could result in ineffective disinfection.
  • Acción
    Diversey Care is requesting their customers to quarantine all stock from the affected batch. Return of the product can be arranged by contacting Diversey customer service. This action has been closed-out on 1/06/2016.

Device

Divercleanse 750ml
  • Modelo / Serial
    Divercleanse 750ml Batch Number: 35475424ARTG Number: 106816(Hospital grade disinfectant)
  • Manufacturer
    Diversey Australia Pty Ltd

Manufacturer

Diversey Australia Pty Ltd