Events

Recall of Softpac C299 (used in preparing dialysate for haemodialysis therapies)

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-2016-RN-00815-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-06-17
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00815-1
  • 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
    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)
  • Model / Serial
    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