The FDA issued an early alert after Baxter (NYSE:BAX) recommended the removal of certain Duo-Vent intravascular administration sets.
Baxter sent all affected customers a letter on June 30, telling them to immediately identify, quarantine and return affected lots. The communication affects lots DR26C27062, DR26D14031 and DR26E13055 of the Duo-Vent solution set and male luer lock adapter. Duo-Vent offers the administration of fluids from a container into the patient’s vascular system through a vascular access device.
According to the FDA, certain lots of Duo-Vent solution sets may have air bubbles in the drip chamber and tubing when a pressure cuff is in use or when the tubing is flushed at the fully open position. The issue may result in air entering the administration set when pressure is applied to the bag (e.g., via a pressure cuff) or when the tubing is flushed while fully open.
If an infusion pump with an air-in-line detector is not in use, there is a potential for air to be delivered through the IV line to the patient. The FDA says this instance may occur during pressure infusions.
In most cases, the FDA says the lungs absorb small amounts of air without harm. However, patients with certain cardiac or vascular conditions may face significant risks. Such conditions include a patent foramen ovale or other right-to-left shunts, the FDA said. In these patients, the presence of air in the circulation may lead to serious adverse events. Those may include stroke, myocardial ischemia or death.
As of July 15, 2026, Baxter reports no serious injuries or deaths associated with the issue.
