Events

Recall of Clearlink System Solution Set (Infusion administration set)

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-2013-RN-00741-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2013-07-19
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00741-1
  • 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 anz received feedback from a customer that an iv tube could not be loaded into an infusion pump because the slide clamp was not correctly assembled. baxter facility received the complaint sample and confirmed the slide clamp had been assembled in the reverse direction. the incorrect assembly would lead to incorrect direction of infusion such that blood may be withdrawn from a patient and result in acute blood loss and/or delay in treatment of life sustaining medication as a worse case scenario.
  • Action
    Baxter Healthcare are advising customers to remove affected product from use and return to Baxter for credit.

Device

Clearlink System Solution Set (Infusion administration set)
  • Model / Serial
    Clearlink System Solution Set (Infusion administration set)Product Code: FNC3110Lot Numbers: SR13A04021, SR13A02041, SR13A07032 (Expiration date: Jan 2018), SR13B14077 (Expiration date: Feb 2018)
  • Manufacturer
    Baxter Healthcare Pty Ltd

Manufacturer

Baxter Healthcare Pty Ltd