Early Alert: Solution Set Issue from Baxter Healthcare Corporation

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.

Affected Product

The FDA is aware that Baxter Healthcare Corporation has issued a letter to affected health care providers recommending certain lots of Solution Sets with Duo-Vent Spikes be removed from use related to a potentially high-risk device issue. 

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.

Baxter has not reported any injuries associated with this issue.

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.

Unique Device Identifier (UDI)

The unique device identifier (UDI) helps identify individual medical devices sold in the United States from distribution to use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified more quickly, and as a result, problems potentially resolved more quickly.

How do I report a problem?

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.