HIGH

Baxter Healthcare Recalls IV Solution Set Due to Leakage Risk

Baxter Healthcare recalled 473,040 IV solution sets on August 29, 2025, due to a leak hazard. The affected product is the CLEARLINK SYSTEM CONTINU-FLO Solution Set, Product Code 2C8519. Healthcare providers and patients must stop using this device immediately and follow 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

Product Details

The recalled product is the CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, featuring two CLEARLINK Luer Activated Valves and a Backcheck Valve. It has a flow rate of 10 drops/mL and measures 112 inches (2.8 meters). The product was distributed nationwide in the U.S.

The Hazard

The IV sets may leak, posing a risk to patient safety. This defect can lead to improper medication delivery and potential health complications.

Reported Incidents

No specific incidents or injuries have been reported at this time. The recall is based on the potential for leaks.

What to Do

Patients and healthcare providers should stop using this device immediately. Contact Baxter Healthcare Corporation or your healthcare provider for further instructions.

Contact Information

For more information, contact Baxter Healthcare Corporation at 1-800-XXX-XXXX. Visit the recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0192-2026.

Key Facts

  • Product Code: 2C8519
  • Class II recall
  • Quantity: 473,040 units
  • Nationwide distribution across the U.S.
View Original Recall on FDA - Medical Devices

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Safety Assessment

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

Product Classification

Product TypeIV Solution Set
Sold At
Multiple Retailers

Product Details

Model Numbers
UDI/DI 00085412048994
Lot numbers: R25A25147
R25B21086
R25C20130
R25C25055
+2 more
Affected States
ALL
Report Date
October 22, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE

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