Events

Recall of Baxter Clearlink System Buretrol Solution Set with 150 mL Burette NonDEHP

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Baxter Healthcare Corp..

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
    63059
  • Event Risk Class
    Class 1
  • Event Number
    Z-0015-2013
  • Event Initiated Date
    2012-09-07
  • Event Date Posted
    2012-10-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-12-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=112404
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Set, administration, intravascular - Product Code FPA
  • Reason
    Baxter has determined that the ball-valve feature of the buretrol solution sets 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 Healthcare Corp. sent an Urgent Product Recall letter dated September 7, 2012, via first class mail to all affected customers, informing them of the problem with the ball-valve, and instructing them to discontinue use of the affected product and to contact Baxter for instructions to return the affected product.. The customers were also requested to complete the attached customer reply form, confirming their receipt of the letter, and fax it to Baxter at the number provided on the form. Any questions regarding the communication were directed to Medical Information Services at Baxter at 1-800-933-0303.

Device

Baxter Clearlink System Buretrol Solution Set with 150 mL Burette NonDEHP
  • Model / Serial
    product code 2H8819, all lots
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Nationwide and Internationally to Canada, Costa Rica, Australia, New Zealand, Hong Kong, and the United Kingdom.
  • Product Description
    Baxter Clearlink System Buretrol Solution Set, 115" (2.9 m) with 150 mL Clearlink Burette (Ball-Valve Drip Chamber) (Non-DEHP); a sterile Rx IV fluid pathway device || Product Usage: The device is used for the administration of fluids from a container into the patient's vascular system through a vascular access device.
  • Manufacturer
    Baxter Healthcare Corp.

Manufacturer

Baxter Healthcare Corp.
  • Manufacturer Address
    Baxter Healthcare Corp., Rt. 120 & Wilson Rd, Round Lake IL 60073
  • Source
    USFDA