Events

Retiro De Equipo (Recall) de Sangofix set with hand pump (Blood/Solution Transfusion 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 B Braun 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-2016-RN-00185-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-02-19
  • 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-2016-RN-00185-1
  • 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
    This recall is initiated due to incorrect information provided on the labelling. in the course of routine quality tests, it was discovered that sangofix sets with hand pump contain dehp (approx. 1.6% per set). the sangofix sets, however, are labelled dehp-free.The mislabelling is limited to the affected article numbers as the dehp containing hand-pumps are only used in the specified products.
  • Acción
    B. Braun is advising users to inspect stock and quarantine all units with the affected article codes. Affected stock can be returned to B. Braun and users will be issued a credit note. This action has been closed-out on 15/05/2017.

Device

Sangofix set with hand pump (Blood/Solution Transfusion Set)
  • Modelo / Serial
    Sangofix set with hand pump (Blood/Solution Transfusion Set)Article Codes: 4050192, 4050192H and 4050193All Batch Numbers affectedARTG Number: 137615
  • Manufacturer
    B Braun Australia Pty Ltd

Manufacturer

B Braun Australia Pty Ltd