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# FDA Issues Early Alert on Baxter IV Administration Sets
- URL: https://www.fdaweb.com/fda-issues-early-alert-on-baxter-iv-administration-sets/
- Published: 2026-07-20T12:00:00.000Z
- Updated: 2026-09-14T13:43:10.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5161481

FDA has issued an Early Alert warning healthcare providers about a potentially high-risk issue involving certain Baxter Duo-Vent solution sets that could allow air to enter a patient's intravenous line under specific conditions. The [agency said ](https://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/early-alert-intravascular-administration-set-issue-baxter?utm%5Fmedium=email&utm%5Fsource=govdelivery)Baxter has notified affected customers and is recommending that certain lots of the Duo-Vent Solution Set with Male Luer Lock Adapter (product code 1C8507) be immediately removed from use and returned.

According to Baxter, certain lots of the administration sets may develop air bubbles in the drip chamber and tubing when a pressure cuff is used to pressurize an IV fluid bag or when the tubing is flushed while fully open. The company warned that, under these conditions, air may enter the administration set and be delivered to the patient if an infusion pump equipped with an air-in-line detector is not being used, such as during pressure infusions.

While small amounts of air are generally absorbed by the lungs without causing harm, FDA said patients with certain cardiac or vascular abnormalities — including a patent foramen ovale or other right-to-left shunts — may face a risk of serious complications, including stroke, myocardial ischemia, or death if air enters the bloodstream.

Baxter reported that, as of 7/15, it had received no reports of serious injuries or deaths associated with the issue.

The Duo-Vent solution set is used to administer intravenous fluids from a container into a patient's vascular system through a vascular access device.