The Food and Drug Administration (FDA) Dec. 31 released an alert highlighting a Baxter letter that recommended health care providers not use certain lots of Solution Sets with Duo-Vent Spikes due to a potentially high-risk issue. Baxter reported that some affected products were incorrectly assembled with inverted slide clamps.
The affected products include:
- Solution Set with Duo-Vent Spike, lot DR24C22079, expiration March 24, 2026, and lot DR24H23086, expiration Aug. 26, 2026.
- Clearlink System Solution Set with Duo-Vent Spike, lot DR24C15109, expiration March 16, 2026.
- Continu-Flo Solution Set with Duo-Vent Spike, 2 Luer Activated Valves, Male Luer Lock Adapter with Retractable Collar, lot DR24B21017, expiration Feb. 28, 2026.
To view the full report, click here.
What to Do
- On December 20, 2024, Baxter sent all affected customers an Urgent Medical Device Recall letter recommending the following actions:
- Immediately check your stock for the affected product and lot numbers listed above and do not use. The product code and lot number can be found on the individual product and shipping carton.
- Check this web page for updates. The FDA is currently collecting information about this potentially high-risk device issue and will keep the public informed as significant new information becomes available.
Reason for Early Alert
Baxter reports that some Solution Sets with Duo-Vent Spikes were incorrectly assembled with inverted slide clamps. If a solution set with an inverted slide clamp is loaded on an infusion pump, the medication may not be delivered and the patient’s blood may backflow into the set and source container. Critical adverse health consequences may occur if the patient does not receive life-sustaining medication or if a significant amount of blood is removed from the patient, especially for high-risk populations, such as neonates or critically ill patients.
Device Use
These solution sets are used to administer fluids from a container to patients through a vascular access device, such as an infusion pump. The slide clamp is a feature of these solution sets designed to shut off fluid flow and interact with the infusion pump to load the set into the pump correctly.
Contact Information
Customers in the U.S. with adverse reactions, quality problems, or questions about this recall should contact Baxter Healthcare Center for Service at 888-229-0001 or corporate_product_complaints_round_lake@baxter.com.
This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program. The FDA has become aware of a potentially high-risk device issue. The FDA will keep the public informed and update this web page as significant new information becomes available.
