Events

Rappel de Baxter Irrigation solutions

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-2015-RN-00329-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-04-10
  • 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-2015-RN-00329-1
  • 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
    An investigation into an adverse event report concerning a 6l renal dialysis solution that affected a single patient revealed the solution had been diluted. baxter healthcare is recalling the irrigation solutions listed above as further investigations revealed that these products were also potentially diluted with water for injection.
  • Action
    Customers are advised to locate and remove affected product from potential use. The TGA has published a web statement regarding this recall which is available at https://www.tga.gov.au/alert/dianeal-peritoneal-dialysis-solution-and-various-irrigation-solutions

Device

Baxter Irrigation solutions
  • Modèle / numéro de série
    Baxter Irrigation solutions1.5% Glycine IrrigationCode: AHB7316Batch: S63S1Expiry: 30/09/20150.9% Sodium Chloride for Irrigation Code: AHB7616Batch: S66P2Expiry: 30/11/2015 0.9% Sodium Chloride for IrrigationCode: AHB7616Batch: S71N8Expiry: 31/03/20161.5% Glycine Irrigation SolutionCode: AHB7317Batch: S74P6Expiry: 31/05/20160.9% Sodium Chloride for Irrigation Code: AHB7127Batch: S82F6Expiry: 31/10/2016ARTG number: 155928
  • Manufacturer
    Baxter Healthcare Pty Ltd

Manufacturer

Baxter Healthcare Pty Ltd