HIGH

Baxter Healthcare Recalls IV Solution Set Due to Leak Risk

Baxter Healthcare recalled 1,167,120 units of its CLEARLINK SYSTEM CONTINU-FLO Solution Set on August 29, 2025. The recall affects IV sets due to a risk of leakage that could pose serious health risks. Patients and healthcare providers should 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

This recall involves the CLEARLINK SYSTEM CONTINU-FLO Solution Set, Product Code 2C8541. It features three CLEARLINK Luer Activated Valves and a Backcheck Valve. These products were distributed nationwide in various U.S. states.

The Hazard

The recalled IV sets may leak, which could lead to serious complications for patients receiving medication or fluids. As a Class II recall, the risk level is considered high due to potential adverse health effects.

Reported Incidents

There have been no specific injury reports associated with this recall yet. However, the potential for leaks raises concern for patient safety.

What to Do

Patients and healthcare providers must stop using the recalled IV sets immediately. They should follow the recall instructions provided by Baxter Healthcare Corporation or consult their healthcare provider for further guidance.

Contact Information

For more information, contact Baxter Healthcare Corporation at 1-800-XXX-XXXX or visit their website.

Key Facts

  • Recall date: August 29, 2025
  • 1,167,120 units affected
  • IV sets may leak
  • Class II recall
  • Stop using the devices immediately

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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 00085412071107
Lot numbers: R25A17123
R25B20048
R25B21024
R25B24093
+13 more
Affected States
ALL
Report Date
October 22, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE

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