Events

Rappel de Vented Spike with Clearlink (fluid transfer set)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Baxter Healthcare 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-2014-RN-00033-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2014-01-23
  • 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-2014-RN-00033-1
  • 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
    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.
  • Action
    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)
  • Modèle / numéro de série
    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