HIGH

Baxter Healthcare Recalls IV Solution Set Due to Leakage Risk

Baxter Healthcare recalled 106,176 units of the CLEARLINK SYSTEM CONTINU-FLO Solution Set on August 29, 2025. The recall follows reports that the IV sets may leak, posing a high risk to patients. Healthcare providers and patients must stop using the device 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 CONTINU-FLO Solution Set, Non-Vented, with a 0.2 Micron Filter. It features two CLEARLINK Luer Activated Valves, a Backcheck Valve, and is 104 inches long. The product code is 2C8571.

The Hazard

The IV solution sets may leak, which can result in serious complications for patients. This poses a high risk as it can lead to medication errors or inadequate fluid delivery.

Reported Incidents

There are no specific reported injuries or deaths associated with this recall. However, the potential for leakage presents a significant safety concern.

What to Do

Patients and healthcare providers should stop using the recalled IV solution sets immediately. Follow the manufacturer's recall instructions and contact Baxter Healthcare Corporation or your healthcare provider for further instructions.

Contact Information

For more information, contact Baxter Healthcare Corporation. Visit their website or call their customer service for detailed instructions on returns and refunds.

Key Facts

  • Product Code: 2C8571
  • Quantity Recalled: 106,176 units
  • Recall Date: August 29, 2025
  • Hazard: IV sets may leak
  • Classification: Class II

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Safety Assessment

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

Product Classification

Product Details

Model Numbers
UDI/DI 00085412046327
Lot numbers: R25B24055
Affected States
ALL
Report Date
October 22, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE

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