Baxter CLEARLINK and CONTINU-FLO Solution Sets Recalled for Possible Leaks

Agency Publication Date: October 16, 2025

Summary

Approximately 3,111,023 Baxter Healthcare CLEARLINK and CONTINU-FLO solution and extension sets have been recalled because they may leak. The recall includes various IV sets used to deliver fluids and medications to patients, including paclitaxel sets and non-DEHP models. These devices were distributed nationwide in the United States between late 2024 and 2025.

Risk

A leak in an intravenous (IV) solution set can cause an interruption in therapy, potentially leading to under-dosing or ineffective treatment. In some cases, leaks may also introduce air or environmental contaminants into the sterile fluid path, posing a risk of infection or air embolism to the patient.

What You Should Do

This recall involves millions of Baxter Healthcare solution sets and extension sets, including CONTINU-FLO, CLEARLINK, and Paclitaxel models. The products are identified by specific codes like 2C6255, 2C8419, 2C8537, 2C8541, and others with lot numbers starting with 'R25'. See the Affected Products section below for the full list of affected codes.
Stop using the recalled devices immediately. Contact Baxter Healthcare Corporation or your clinical distributor to arrange for a return, replacement, or correction of the products in your inventory.
Call the FDA Consumer Complaint hotline at 1-888-463-6332 if you have additional questions regarding this recall.

Your Remedy Options

Other Action

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

Affected Products

Product: CONTINU-FLO Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves, Backcheck Valve, Plus 4-Way Stopcock Extension Set

Variants: Non-Vented

Model / REF:

2C6255

Lot Numbers:

R25C26161

R25D01031

UDI:

00085412046310

Recall #: Z-0189-2026

Product: CLEARLINK System Solution Set, DUO-VENT, CLEARLINK Luer Activated Valve

Variants: DUO-VENT, 10 drops/mL, 92-inch (2.3 meters)

Model / REF:

2C8419

Lot Numbers:

R25C03055

R25C04062

R25C29086

UDI:

00085412048956

Recall #: Z-0190-2026

Product: CLEARLINK SYSTEM Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves

Variants: Non-Vented, 10 drops/mL, 100-inch (2.5 meters)

Model / REF:

2C8425

Lot Numbers:

R25C27086

UDI:

00085412071190

Recall #: Z-0191-2026

Product: CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves, Backcheck Valve

Variants: Non-Vented, 10 drops/mL, 112-inch (2.8 meters)

Model / REF:

2C8519

Lot Numbers:

R25A25147

R25B21086

R25C20130

R25C25055

R25C25161

R25C29185

UDI:

00085412048994

Recall #: Z-0192-2026

Product: CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, three CLEARLINK Luer Activated Valves, Backcheck Valve, Retractable Collar

Variants: Non-Vented, 10 drops/mL, 120-inch (3.0 meters)

Model / REF:

2C8537

Lot Numbers:

R25A13055

R25B24024

R25B25154

R25C05017

R25C13147

R25C18017

R25C18024

R25C25116

R25C26093

R25C31079

R25D03055

R25D12123

R25D19024

UDI:

00085412048970

Recall #: Z-0193-2026

Product: CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, three CLEARLINK Luer Activated Valves, Backcheck Valve, Retractable Collar (Variant 2)

Variants: Non-Vented, 10 drops/mL, 120-inch (3.0 meters)

Model / REF:

2C8541

Lot Numbers:

R25A17123

R25B20048

R25B21024

R25B24093

R25B26154

R25B27123

R25B27161

R25C04055

R25C05048

R25C05109

R25C06123

R25C08154

R25C10079

R25C11062

R25C18093

R25D12208

R25D21024

UDI:

00085412071107

Recall #: Z-0194-2026

Product: CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, 0.2 Micron Filter, two CLEARLINK Luer Activated Valves

Variants: 0.2 Micron Filter, 10 drops/mL, 104-inch (2.6 meters)

Model / REF:

2C8571

Lot Numbers:

R25B24055

UDI:

00085412046327

Recall #: Z-0195-2026

Product: CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, 0.2 Micron Filter, three CLEARLINK Luer Activated Valves

Variants: 0.2 Micron Filter, 10 drops/mL, 102-inch (2.6 meters)

Model / REF:

2C8593

Lot Numbers:

R25D01161

UDI:

00085412071664

Recall #: Z-0196-2026

Product: CLEARLINK SYSTEM EXTENSION SET, Straight-Type, Standard Bore, 44-inch

Variants: Retractable Collar, 44-inch (111 centimeters)

Model / REF:

2C8610

Lot Numbers:

R25C31024

UDI:

00085412048963

Recall #: Z-0197-2026

Product: CLEARLINK SYSTEM EXTENSION SET, Straight-Type, Standard Bore, 14-inch

Variants: Retractable Collar, 14-inch (35 centimeters)

Model / REF:

2C8632

Lot Numbers:

R25C31031

UDI:

00085412049007

Recall #: Z-0198-2026

Product: CLEARLINK SYSTEM EXTENSION SET, Straight-Type, Standard Bore, 7.9-inch

Variants: Retractable Collar, 7.9-inch (20 centimeters)

Model / REF:

2C8634

Lot Numbers:

R25A21024

UDI:

00085412049021

Recall #: Z-0199-2026

Product: CLEARLINK System Non_DEHP Extension Set, Straight-Type, 1.2 Micron Filter

Variants: Non-DEHP, 1.2 Micron Filter, 19-inch (47 centimeters)

Model / REF:

2H8603

Lot Numbers:

R25C26154

R25C27079

UDI:

00085412046433

Recall #: Z-0200-2026

Product: CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, two CLEARLINK Valves, Non-DEHP

Variants: Non-DEHP, 10 drops/mL, 96-inch (2.4 meters)

Model / REF:

2R8519

Lot Numbers:

R25C26116

UDI:

00085412565682

Recall #: Z-0201-2026

Product: CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, three CLEARLINK Valves, Non-DEHP

Variants: Non-DEHP, 10 drops/mL, 120-inch (3.0 meters)

Model / REF:

2R8537

Lot Numbers:

R25C28048

UDI:

00085412565743

Recall #: Z-0202-2026

Product: CLEARLINK System Paclitaxel Set, Non-Vented, 0.2 Micron Filter

Variants: Polyethylene Lined Tubing, 10 drops/mL, 107-inch (2.7 meters)

Model / REF:

2R8858

Lot Numbers:

R25A13024

UDI:

00085412565774

Recall #: Z-0203-2026

Product: CLEARLINK SYSTEM NON-DEHP CONTINU-FLO SOLN SET, 96-inch

Variants: Non-DEHP, 96-inch (2.4 meters)

Model / REF:

2H8519

Lot Numbers:

R25C08147

UDI:

00085412625553

Recall #: Z-0204-2026

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 97604

Status: Active

Manufacturer: Baxter Healthcare Corporation

Sold By: Hospitals; Surgical Centers; Infusion Centers; Healthcare Distributors

Manufactured In: United States

Units Affected: 16 products (49200; 136512; 1440; 473040; 958351; 1167120; 106176; 8368; 15552; 2304; 16416; 69936; 48096; 12720; 27072; 18720 units)

Distributed To: Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia

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

Risk

What You Should Do

This recall involves millions of Baxter Healthcare solution sets and extension sets, including CONTINU-FLO, CLEARLINK, and Paclitaxel models. The products are identified by specific codes like 2C6255, 2C8419, 2C8537, 2C8541, and others with lot numbers starting with 'R25'. See the Affected Products section below for the full list of affected codes.

Stop using the recalled devices immediately. Contact Baxter Healthcare Corporation or your clinical distributor to arrange for a return, replacement, or correction of the products in your inventory.

Call the FDA Consumer Complaint hotline at 1-888-463-6332 if you have additional questions regarding this recall.

Affected Products

Product: CONTINU-FLO Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves, Backcheck Valve, Plus 4-Way Stopcock Extension Set

Variants: Non-Vented

Model / REF:

2C6255

Lot Numbers:

R25C26161

R25D01031

UDI:

00085412046310

Recall #: Z-0189-2026

Product: CLEARLINK System Solution Set, DUO-VENT, CLEARLINK Luer Activated Valve

Variants: DUO-VENT, 10 drops/mL, 92-inch (2.3 meters)

Model / REF:

2C8419

Lot Numbers:

R25C03055

R25C04062

R25C29086

UDI:

00085412048956

Recall #: Z-0190-2026

Product: CLEARLINK SYSTEM Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves

Variants: Non-Vented, 10 drops/mL, 100-inch (2.5 meters)

Model / REF:

2C8425

Lot Numbers:

R25C27086

UDI:

00085412071190

Recall #: Z-0191-2026

Product: CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves, Backcheck Valve

Variants: Non-Vented, 10 drops/mL, 112-inch (2.8 meters)

Model / REF:

2C8519

Lot Numbers:

R25A25147

R25B21086

R25C20130

R25C25055

R25C25161

R25C29185

UDI:

00085412048994

Recall #: Z-0192-2026

Product: CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, three CLEARLINK Luer Activated Valves, Backcheck Valve, Retractable Collar

Variants: Non-Vented, 10 drops/mL, 120-inch (3.0 meters)

Model / REF:

2C8537

Lot Numbers:

R25A13055

R25B24024

R25B25154

R25C05017

R25C13147

R25C18017

R25C18024

R25C25116

R25C26093

R25C31079

R25D03055

R25D12123

R25D19024

UDI:

00085412048970

Recall #: Z-0193-2026

Product: CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, three CLEARLINK Luer Activated Valves, Backcheck Valve, Retractable Collar (Variant 2)

Variants: Non-Vented, 10 drops/mL, 120-inch (3.0 meters)

Model / REF:

2C8541

Lot Numbers:

R25A17123

R25B20048

R25B21024

R25B24093

R25B26154

R25B27123

R25B27161

R25C04055

R25C05048

R25C05109

R25C06123

R25C08154

R25C10079

R25C11062

R25C18093

R25D12208

R25D21024

UDI:

00085412071107

Recall #: Z-0194-2026

Product: CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, 0.2 Micron Filter, two CLEARLINK Luer Activated Valves

Variants: 0.2 Micron Filter, 10 drops/mL, 104-inch (2.6 meters)

Model / REF:

2C8571

Lot Numbers:

R25B24055

UDI:

00085412046327

Recall #: Z-0195-2026

Product: CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, 0.2 Micron Filter, three CLEARLINK Luer Activated Valves

Variants: 0.2 Micron Filter, 10 drops/mL, 102-inch (2.6 meters)

Model / REF:

2C8593

Lot Numbers:

R25D01161

UDI:

00085412071664

Recall #: Z-0196-2026

Product: CLEARLINK SYSTEM EXTENSION SET, Straight-Type, Standard Bore, 44-inch

Variants: Retractable Collar, 44-inch (111 centimeters)

Model / REF:

2C8610

Lot Numbers:

R25C31024

UDI:

00085412048963

Recall #: Z-0197-2026

Product: CLEARLINK SYSTEM EXTENSION SET, Straight-Type, Standard Bore, 14-inch

Variants: Retractable Collar, 14-inch (35 centimeters)

Model / REF:

2C8632

Lot Numbers:

R25C31031

UDI:

00085412049007

Recall #: Z-0198-2026

Product: CLEARLINK SYSTEM EXTENSION SET, Straight-Type, Standard Bore, 7.9-inch

Variants: Retractable Collar, 7.9-inch (20 centimeters)

Model / REF:

2C8634

Lot Numbers:

R25A21024

UDI:

00085412049021

Recall #: Z-0199-2026

Product: CLEARLINK System Non_DEHP Extension Set, Straight-Type, 1.2 Micron Filter

Variants: Non-DEHP, 1.2 Micron Filter, 19-inch (47 centimeters)

Model / REF:

2H8603

Lot Numbers:

R25C26154

R25C27079

UDI:

00085412046433

Recall #: Z-0200-2026

Product: CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, two CLEARLINK Valves, Non-DEHP

Variants: Non-DEHP, 10 drops/mL, 96-inch (2.4 meters)

Model / REF:

2R8519

Lot Numbers:

R25C26116

UDI:

00085412565682

Recall #: Z-0201-2026

Product: CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, three CLEARLINK Valves, Non-DEHP

Variants: Non-DEHP, 10 drops/mL, 120-inch (3.0 meters)

Model / REF:

2R8537

Lot Numbers:

R25C28048

UDI:

00085412565743

Recall #: Z-0202-2026

Product: CLEARLINK System Paclitaxel Set, Non-Vented, 0.2 Micron Filter

Variants: Polyethylene Lined Tubing, 10 drops/mL, 107-inch (2.7 meters)

Model / REF:

2R8858

Lot Numbers:

R25A13024

UDI:

00085412565774

Recall #: Z-0203-2026

Product: CLEARLINK SYSTEM NON-DEHP CONTINU-FLO SOLN SET, 96-inch

Variants: Non-DEHP, 96-inch (2.4 meters)

Model / REF:

2H8519

Lot Numbers:

R25C08147

UDI:

00085412625553

Recall #: Z-0204-2026

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 97604

Status: Active

Manufacturer: Baxter Healthcare Corporation

Sold By: Hospitals; Surgical Centers; Infusion Centers; Healthcare Distributors

Manufactured In: United States

Units Affected: 16 products (49200; 136512; 1440; 473040; 958351; 1167120; 106176; 8368; 15552; 2304; 16416; 69936; 48096; 12720; 27072; 18720 units)