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# Baxter Recalls Duo-Vent Solution Sets Over Air Embolism Risk
- URL: https://www.fdaweb.com/baxter-recalls-duo-vent-solution-sets-over-air-embolism-risk/
- Published: 2026-08-14T12:00:00.000Z
- Updated: 2026-09-14T13:45:10.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5161628

Baxter is recalling (Class 1) certain lots of its Duo-Vent solution sets because the devices may allow air bubbles to enter the administration set during pressure infusion or flushing, potentially exposing patients to serious injury or death. The issue involves the potential formation of air bubbles in the drip chamber and tubing when a pressure cuff is being used or when the tubing is flushed with the line in the fully open position, according to a [recall notice](https://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/intravascular-administration-set-recall-baxter-removes-duo-vent-solution-sets?ref=fdaweb.com).

The action involves Duo-Vent Solution Set and Male Luer Lock Adapter. The Duo-Vent solution set is used to administer fluids from a container into a patient's vascular system through a vascular access device. As of 7/15, Baxter had reported no serious injuries or deaths associated with the issue.

According to Baxter, the problem can allow air to enter the administration set when pressure is applied to the IV bag or when the tubing is flushed while fully open. If an infusion pump equipped with an air-in-line detector is not being used, as may occur during pressure infusions, air could potentially be delivered through the IV line to the patient.

“In most cases, small amounts of air are absorbed in the lungs without causing harm,” the receall notice says. “However, in patients with certain cardiac or vascular conditions (such as a patent foramen ovale or other right-to-left shunts), the presence of air in the circulation may lead to serious adverse events, including stroke, myocardial ischemia, or death.”