Baxter, a healthcare device manufacturer based in Deerfield, Illinois, launched a voluntary recall of its one-time-use buretrol devices. According to information from the company, faulty valves in the devices can allow air to seep into the liquid solution. This can lead to an extremely dangerous embolism. The United States Food and Drug Administration has put the recall in its Class I designation, its highest recall level.
According to information from the company, the faulty valves are on Baxter's Clearlink and Interlink buretrol-based systems with manufacturing dates from April, 2013 to July, 2012. Baxter first launched the voluntary recall of these product lines in September of this year. The FDA just announced the recall will enter Class I status.
When functioning properly, the Clearlink and Interlink systems are designed to safely infuse solutions directly into a patient's veins, like an IV. However, the ball-valve system found on the device has manufacturing defects. Instead of properly sealing the buretrol tubes, the valves on some devices allow air to enter the tubing system. This can introduce air into a patient's veins. If an air bubble reaches the heart or brain, a patient may experience a heart attack or stroke.
According to a report by the FDA, "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)."