Events

Rappel de ClearLink System BURETROL Solution Set with 150ml ClearLink Burette (Ball-Valve Drip Chamber) (Administration sets for the infusion of intravenous solutions and blood)

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-2012-RN-00918-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2012-09-07
  • 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-00918-1
  • 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 received complaints for the buretrol ball-valve products with reports of air travelling below the ball-valve in the drip chamber and into the tubing. the ball-valve component is designed to prohibit the flow of air from the burette into the tubing as the burette is emptied. upon further investigation baxter has determined that the ball-valve feature may not function as expected, allowing air to flow past the valve and into the tubing at the completion of dose within the burette.
  • Action
    Baxter is recalling all affected sets and replacing it with unaffected product codes.

Device

ClearLink System BURETROL Solution Set with 150ml ClearLink Burette (Ball-Valve Drip Chamber) (Ad...
  • Modèle / numéro de série
    ClearLink System BURETROL Solution Set with 150ml ClearLink Burette (Ball-Valve Drip Chamber) (Administration sets for the infusion of intravenous solutions and blood)Product Code: 2C8819ARTG Number: 136505
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Manufacturer
    Baxter Healthcare Pty Ltd

Manufacturer

Baxter Healthcare Pty Ltd