Events

Retiro De Equipo (Recall) de Vented Spike with Clearlink (fluid transfer set)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Baxter 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-2014-RN-00033-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2014-01-23
  • 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-2014-RN-00033-1
  • 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
    Baxter has determined that the vented spike with clearlink, product code emc3481 does not have sufficient stability data to support its labelling claims. as such, the sterile barrier cannot be assured for the duration of the claimed shelf life. deterioration in the integrity of the device packaging has the potential to result in a breach of the sterile barrier which could lead to complications due to infection.
  • Acción
    Baxter is requesting users to locate and quarantine affected product. Affected product can be returned to Baxter for credit. Baxter has no alternative products to propose at this stage.

Device

Vented Spike with Clearlink (fluid transfer set)
  • Modelo / Serial
    Vented Spike with Clearlink (fluid transfer set)Product Code: EMC3481All lot numbers affectedARTG Number: 149588
  • Manufacturer
    Baxter Healthcare Pty Ltd

Manufacturer

Baxter Healthcare Pty Ltd