Events

Rappel de In-Line Blood Set with Filter

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-2018-RN-00783-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2018-06-18
  • 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-2018-RN-00783-1
  • 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 healthcare have identified the potential for a leak to occur at the tube to cap junction of the in-line blood set with filter (mmc2433). preliminary investigation has shown that this issue is due to the combination of cap dimension variability, especially on lower limit, and insertion depth of the cap into the tube on the lower side.To date, no complaints have been received as a result of this issue.
  • Action
    Baxter is advising customers to identify and quarantine affected product from their facility. Baxter will arrange return of product from impacted users.

Device

In-Line Blood Set with Filter
  • Modèle / numéro de série
    In-Line Blood Set with FilterProduct Code: MMC2433Multiple Lot NumbersARTG Number: 108533(Baxter Healthcare - Blood transfusion set)
  • Manufacturer
    Baxter Healthcare Pty Ltd

Manufacturer

Baxter Healthcare Pty Ltd