Events

Rappel de Fenwal Transfer Pack 150ml with spike coupler (Blood collection/cell-culture container)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Aurora BioScience Pty Ltd.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    RC-2012-RN-01290-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2013-02-01
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-01290-1
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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.
  • Action
    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)
  • Modèle / numéro de série
    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