Federal health regulators are warning that Baxter Buretrol Solution Sets are being recalled because a defective ball-valve could let air into a patient’s blood, posing a serious risk of an air embolism.
This week the FDA classified a Baxter Buretrol Solution Set market withdrawal as a class 1 medical device recall, which is the most serious category of medical device recalls. This suggest that the FDA believes the problem is likely to result in severe injury or death.
The Buretrol Solution Sets are disposable devices used to control the flow of fluids into a patient’s blood vessels via an intravenous device. They were originally recalled in early September, but this week the FDA determined it constituted the highest threat a medical device could pose to patients. However, there have been no reports of injuries or deaths linked to the defective solution sets.
The problem is a ball-valve feature that the FDA says might not function as expected. Baxter warns that it is allowing air to flow past the valve. From there the air can enter the tubing and be accidentally injected into the patient, resulting in an air embolism, which could lead to death.
The recall affects all lots of the Interlink System Buretrol Solution Set with 150 mL Burette with product code 2C7519, the Interlink System Buretrol Solution Set with 150 mL Burette – Non-DEHP, with product code 2H7519; the Clearlink System Buretrol Solution Set with 150 mL Burette with product code 2C8810, and the Clearlink System Buretrol Solution Set with 150 mL Burette – Non-DEHP. All of the affected medical devices were manufactured from April 30, 2003, through July 26, 2012.
Baxter Healthcare Corporation and the FDA are advising consumers to stop using affected Buretrol Solution Sets and contact Baxter for information on how to return the products by calling (800) 422-9837.