HIGH

Baxter Healthcare Recalls 136,512 CLEARLINK IV Sets DUO-VENT for Leak Risk (2025)

Baxter Healthcare recalled 136,512 CLEARLINK System Solution Set DUO-VENT IV sets distributed nationwide in the United States after detecting a leak risk. The Luer Activated Valve design may leak, potentially compromising IV administration. Hospitals and patients should stop using the device immediately and follow Baxter recall instructions.

Quick Facts at a Glance

Recall Date
August 29, 2025
Hazard Level
HIGH
Brand
Baxter Healthcare
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL

Hazard Information

IV sets may leak.

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Baxter Healthcare Corporation or your healthcare provider for instructions

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About This Product

The CLEARLINK System Solution Set DUO-VENT is an IV administration set used to deliver fluids and medications via IV therapy. It includes a Luer Activated Valve and long tubing. This recall concerns leakage risk.

Why This Is Dangerous

A leak in the IV set could result in unintended loss of IV fluids, inaccurate dosing, or potential contamination of the administration line.

Industry Context

This recall is not described as part of a broader industry pattern in the notice.

Real-World Impact

Hospitals and clinics may need to halt use of affected lots, procure replacements, and document returns, potentially impacting patient care temporarily.

Practical Guidance

How to identify if yours is affected

  1. 1. Check product code 2C8419 on the device and packaging.
  2. 2. Verify UDI 00085412048956.
  3. 3. Confirm lot codes R25C03055, R25C04062, or R25C29086.

Where to find product info

Identification codes are printed on the packaging and on the device label.

What timeline to expect

Refunds or replacements typically take 4-6 weeks after submission.

If the manufacturer is unresponsive

  • Escalate to Baxter Healthcare via the FDA recall page.
  • File a complaint with the CPSC if needed.

How to prevent similar issues

  • Verify recall status before procurement of IV sets.
  • Request recall documentation from suppliers.
  • Use only approved, non-recalled IV sets for patient care.

Documentation advice

Keep copies of the recall notice, purchase receipts, correspondence with Baxter, and photos of the product codes.

Product Details

Brand: Baxter Healthcare Product: CLEARLINK System Solution Set DUO-VENT with CLEARLINK Luer Activated Valve Specifications: 10 drops/mL, 92-inch (2.3 m) tubing Product code: 2C8419 UDI/DI: 00085412048956 Lot codes: R25C03055, R25C04062, R25C29086 Quantity: 136,512 units Sold/distributed: Nationwide in the United States Sold since: Unknown Price: Unknown Manufacturer: Baxter Healthcare

Reported Incidents

No injuries or incidents have been reported.

Key Facts

  • 136,512 units recalled
  • Product code 2C8419
  • Udi/DI: 00085412048956
  • Lot codes: R25C03055, R25C04062, R25C29086
  • Nationwide distribution in the U.S.
  • High-hazard recall with potential leakage risk

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Details

Model Numbers
00085412048956
R25C03055
R25C04062
R25C29086
Affected States
ALL
Report Date
October 22, 2025
Recall Status
ACTIVE

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