Baxter Healthcare Corp. Buretrol Solution Sets: Class 1 Recall - May Not Function as Expected

AUDIENCE: Risk Managers

ISSUE: Baxter Healthcare Corp. (Baxter) has initiated a voluntary recall of its Buretrol Solution Sets because the ball-valve feature may not function as expected. Baxter has determined that the ball-valve component is allowing air to flow past the valve and enter the tubing once the pre-measured amount of fluids is completely administered to the patient. If the air is not removed, the air present in the tubing may enter the patient’s vascular system potentially causing air in the bloodstream (an air embolism). This product may cause serious adverse health consequences, including death.

BACKGROUND: Baxter Healthcare Corp. Buretrol Solution Sets are non-reusable, disposable devices used for the administration of fluids from a container into the patient’s blood vessels (vascular system) through a device that allows frequent access to patients’ veins (a vascular access device). Products were manufactured from April 30, 2003 through July 26, 2012 and were distributed from May 1, 2003 through August 16, 2012. For products affected see Recall Notice.

RECOMMENDATION: On September 7, 2012, Baxter Healthcare sent an Urgent Product Recall letter to affected customers informing them of the problem with the ball-valve feature. Customers were asked to do the following:

• STOP using affected Buretrol Solution Sets
• Contact Baxter for instructions on how to return the affected product.

Any questions regarding the communication were directed to Medical Information Services at Baxter at 1-800-933-0303. Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

Complete and submit the report Online: www.fda.gov/MedWatch/report.htm.  Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

Read the MedWatch safety alert, including a link to the Recall Notice, at http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm327543.htm