Update on Alert: Solution Set Issue from Baxter Healthcare Corporation
This communication was initially issued as part of the Communications Pilot to Enhance the Medical Device Recall Program. The FDA has since determined that this device may cause temporary or reversible health problems, or—though unlikely—serious health problems. This recall involves removing certain devices from where they are used or sold. The affected products and recommendations for what to do with the devices below have not changed.
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.
| Baxter Product Code | Description | Lot Number | Expiration Date | UDI |
|---|---|---|---|---|
| 2R8404 | Solution Set with Duo-Vent Spike | DR24C22079 | 3/24/2026 | 00085412676630 |
| 2R8404 | Solution Set with Duo-Vent Spike | DR24H23086 | 8/26/2026 | 00085412676630 |
| 2R8538 | Clearlink System Solution Set with Duo-Vent Spike | DR24C15109 | 3/16/2026 | 00085412676647 |
| UC8519 | Continu-Flo Solution Set with Duo-Vent Spike, 2 Luer Activated Valves, Male Luer Lock Adapter with Retractable Collar | DR24B21017 | 2/28/2026 | 00085412486512 |
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.
Reason for 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.
Additional FDA Resources
- Early Alert: Solution Set Issue from Baxter Healthcare Corporation [Archived] (12/31/2024)
- FDA’s Enforcement Report
- Medical Device Recall Database
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 recognize a UDI on a label?
- AccessGUDID database - Identify Your Medical Device
- Benefits of a UDI System
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.