Events

Rappel de Potassium 10mmol in 0.225% Sodium Chloride and 10% Glucose (500ml)

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-00421-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2014-04-08
  • 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-00421-1
  • 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 is issuing a recall as a result of a complaint received indicating that the labelling of this product contains an error. underneath the “potassium 10 mmol” type on the main label, there is bracketed text that states “potassium chloride 0.075%”. the figure of 0.075% is incorrect. the correct figure should be 0.15%.
  • Action
    Hospitals are requested to remove all units from affected lots. The affected product should be returned by contacting Baxter Healthcare Customer Service. Baxter is requesting prescribers to monitor patients infused with the affected product for any irregularity in electrolyte levels.

Device

Potassium 10mmol in 0.225% Sodium Chloride and 10% Glucose (500ml)
  • Modèle / numéro de série
    Potassium 10mmol in 0.225% Sodium Chloride and 10% Glucose (500ml)Product Code: AHK6021Batch numbers: S60P3 & S67P2Exempt from registration in the ARTG under Schedule 5A of the Regulations.
  • Manufacturer
    Baxter Healthcare Pty Ltd

Manufacturer

Baxter Healthcare Pty Ltd