Baxter Continu-Flo Solution Sets Recalled for Tubing Separation

Agency Publication Date: September 19, 2025

Summary

Baxter Healthcare Corporation is recalling 14,400 units of the Continu-Flo Solution Set (Product Code REF 2C8519) due to reports of tubing separation. This recall involves one specific lot of the non-vented intravascular administration set, which is used to deliver fluids and medications to patients. If the tubing separates, it can break the sterile connection or stop the delivery of critical fluids.

Risk

The tubing can separate during use, which may cause medical fluids to leak or result in an interruption of treatment. This defect also poses a risk of exposing the patient's fluid path to contamination, potentially leading to a bloodstream infection.

What You Should Do

This recall involves the Baxter Continu-Flo Solution Set (REF 2C8519), Non-Vented, 2 Clearlink Luer Activated Valves, Backcheck Valve, identified by lot number R24I20079 and an expiration date of 9/21/2026.
Stop using the recalled solution sets immediately to avoid potential device failure or therapy interruption.
Contact Baxter Healthcare Corporation or your medical equipment distributor to arrange for the return, replacement, or correction of the affected product.
Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) for additional questions regarding this recall or to report any adverse events.

Your Remedy Options

Other Action

How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Baster Continu-Flo Solution Set, Non-Vented, 2 Clearlink Luer Activated Valves, Backcheck Valve. 10 drops/mL. 112" (2.8 m)

Model / REF:

2C8519

Lot Numbers:

R24I20079 (Exp 9/21/2026)

UDI:

00085412048994

Intravascular administration set; Recall #: Z-2594-2025

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 97447

Status: Active

Manufacturer: Baxter Healthcare Corporation

Sold By: Medical distributors; Hospital supply chains

Manufactured In: United States

Units Affected: 14400 units

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

This recall involves the Baxter Continu-Flo Solution Set (REF 2C8519), Non-Vented, 2 Clearlink Luer Activated Valves, Backcheck Valve, identified by lot number R24I20079 and an expiration date of 9/21/2026.

Stop using the recalled solution sets immediately to avoid potential device failure or therapy interruption.

Contact Baxter Healthcare Corporation or your medical equipment distributor to arrange for the return, replacement, or correction of the affected product.

Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) for additional questions regarding this recall or to report any adverse events.