HIGH

Baxter Healthcare Recalls IV Sets Due to Leak Risk

Baxter Healthcare recalled 136,512 IV sets on August 29, 2025, due to potential leaks. The recall affects products distributed nationwide across the United States. Patients and healthcare providers must stop using these devices immediately.

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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Product Details

The recalled product is the CLEARLINK System Solution Set, DUO-VENT, with product code 2C8419. It features a CLEARLINK Luer Activated Valve and measures 92 inches (2.3 meters). The affected lot codes include R25C03055, R25C04062, and R25C29086.

The Hazard

The IV sets may leak, posing a risk of inadequate medication delivery. This defect can compromise patient care and safety.

Reported Incidents

No specific incidents or injuries have been reported as of now. However, the potential for leaks introduces a high risk to patient safety.

What to Do

Stop using the affected IV sets immediately. Follow the recall instructions provided by Baxter Healthcare. Contact your healthcare provider for guidance.

Contact Information

For further information, contact Baxter Healthcare Corporation. Visit their website or call for specific instructions related to this recall.

Key Facts

  • Recalls 136,512 IV sets
  • Potential leak risk may affect patient safety
  • Distributed nationwide in the US
  • Contact Baxter Healthcare for more information

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Safety Assessment

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

Product Details

Model Numbers
UDI/DI: 00085412048956
Lot Codes: R25C03055
R25C04062
R25C29086
Affected States
ALL
Report Date
October 22, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE

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