Events

Retiro De Equipo (Recall) de Fenwal Transfer Pack 150ml with spike coupler (Blood collection/cell-culture container)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Aurora BioScience 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-01290-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-02-01
  • 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-01290-1
  • 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
    Instruction for use (ifu) manual for fenwal transfer packs 150ml with spike coupler is updated to instruct the users of the proper technique to insert/remove the coupler in order to access the bag. additionally a statement advising users that a suitable filter (170-200 microns) should be used when administering/transfusing blood products from this bag will also be added to the ifu.
  • Acción
    Aurora Bio Science is arranging for recovery of affected stock, which is to be rectified with correct Instructions for Use (IFU). Replacement stock or a credit note is to be issued for the recovered stock.

Device

Fenwal Transfer Pack 150ml with spike coupler (Blood collection/cell-culture container)
  • Modelo / Serial
    Fenwal Transfer Pack 150ml with spike coupler (Blood collection/cell-culture container)Catalogue / Order number: R4R2001All batch numbersARTG Number: 169160
  • Manufacturer
    Aurora BioScience Pty Ltd

Manufacturer

Aurora BioScience Pty Ltd