Events

Recall of Baxter Irrigation solutions

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Baxter Healthcare Pty Ltd.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2015-RN-00329-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-04-10
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00329-1
  • Notes / Alerts
    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.
  • Extra notes in the data
  • Reason
    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
  • Model / Serial
    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