Events

Rappel de Softpac C299 (used in preparing dialysate for haemodialysis therapies)

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-2016-RN-00815-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-06-17
  • 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-2016-RN-00815-1
  • 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
    Two complaints were received from customers that bags labelled as containing softpac c295 were found in boxes labelled as containing softpac c299. after investigation, baxter determined that the bags labelled as containing softpac c295 actually contained softpac c299 solution. the softpac c295 and c299 formulations have the same composition except for the calcium (ca+) and chloride (cl-) content. the labelling error may lead to electrolyte imbalances, under circumstances of repetitive use of mislabelled product. no reports of related adverse events have been received by baxter.
  • Action
    Baxter is advising users to remove the affected product from use. Affected product will be replaced with unaffected stock. This action has been closed-out on 15/02/2017.

Device

Softpac C299 (used in preparing dialysate for haemodialysis therapies)
  • Modèle / numéro de série
    Softpac C299 (used in preparing dialysate for haemodialysis therapies)Product Code: 114667Lot Number: 755756Expiry Date: 30 April 2017ARTG Number: 146875
  • Manufacturer
    Baxter Healthcare Pty Ltd

Manufacturer

Baxter Healthcare Pty Ltd