Events

Recall of BURETROL IV SOLUTION ADM. SETS W/CLEARLINK BURETTE & CLEARLINK VALVES

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by BAXTER CORPORATION.

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
    46671
  • Event Risk Class
    I
  • Event Initiated Date
    2012-09-12
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • 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. 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.

Device

BURETROL IV SOLUTION ADM. SETS W/CLEARLINK BURETTE & CLEARLINK VALVES
  • Model / Serial
    Model Catalog: 2H8819 (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: 2H7519 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: 2C8819 (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: 2C7519 (Lot serial: >10 NUMBERS CONTACT MFR)
  • Product Classification
    General Hospital and Personal Use Devices
  • Product Description
    CLEARLINK BURETROL SOLN. SET BURETTE
  • Manufacturer
    BAXTER CORPORATION

Manufacturer

BAXTER CORPORATION