Events

Retiro De Equipo (Recall) de Surecan Angled Needle (Non-coring needle for access ports)

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-2012-RN-01018-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2012-10-04
  • 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-2012-RN-01018-1
  • 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 action is being taken as a result of a potential defect detected in the packaging of the batches produced in june 2012. this packaging defect could compromise the sealing integrity of the single unit packaging and therefore the product sterility.
  • Acción
    Quarantine and return affected stock to B. Braun.

Device

Surecan Angled Needle (Non-coring needle for access ports)
  • Modelo / Serial
    Surecan Angled Needle (Non-coring needle for access ports)Article code: 4439830Batch number: 2F2425A681ARTG Number: 133684
  • Manufacturer
    B Braun Australia Pty Ltd

Manufacturer

B Braun Australia Pty Ltd