Events

Recall of Potassium 10mmol in 0.225% Sodium Chloride and 10% Glucose (500ml)

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-2014-RN-00421-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2014-04-08
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00421-1
  • 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
    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)
  • Model / Serial
    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