Events

Recall of ClearLink System BURETROL Solution Set with 150ml ClearLink Burette (Ball-Valve Drip Chamber) (Administration sets for the infusion of intravenous solutions and blood)

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-2012-RN-00918-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2012-09-07
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-00918-1
  • 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 has received complaints for the buretrol ball-valve products with reports of air travelling below the ball-valve in the drip chamber and into the tubing. the ball-valve component is designed to prohibit the flow of air from the burette into the tubing as the burette is emptied. upon further investigation baxter has determined that the ball-valve feature may not function as expected, allowing air to flow past the valve and into the tubing at the completion of dose within the burette.
  • Action
    Baxter is recalling all affected sets and replacing it with unaffected product codes.

Device

ClearLink System BURETROL Solution Set with 150ml ClearLink Burette (Ball-Valve Drip Chamber) (Ad...

Manufacturer

Baxter Healthcare Pty Ltd