Baxter Clearlink System Buretrol Solution Set, 115" (2.9 m) with 150 mL Clearlink Burette (Ball-Valve Drip Chamber); 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.
- Company
- Baxter Healthcare Corp. Rt
- Recall Initiated
- September 7, 2012
- Posted
- October 9, 2012
- Terminated
- December 29, 2017
- Recall Number
- Z-0014-2013
- Quantity
- 2,265,453 units
- Firm Location
- Round Lake, IL
Reason for Recall
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.
Distribution
Worldwide Distribution - US Nationwide and Internationally to Canada, Costa Rica, Australia, New Zealand, Hong Kong, and the United Kingdom.
Lot / Code Info
product code 2C8819, all lots
Root Cause
Device Design
Action Taken
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.