Baxter Healthcare recalled 8,368 IV Solution Sets on August 29, 2025. The recall stems from potential leaks in the devices, posing a risk to patients. Healthcare providers must stop using the product immediately.
IV sets may leak.
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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The recalled product is the CLEARLINK SYSTEM CONTINU-FLO Solution Set, Product Code 2C8593. It includes a 0.2 Micron Filter, three Luer Activated Valves, and a Backcheck Valve. The set measures 102 inches (2.6 meters) and was distributed nationwide across multiple states.
These IV sets may leak, which poses a significant risk to patients receiving treatment. This recall falls under Class II by the FDA, indicating a moderate risk to health.
No specific injury or incident counts were reported. However, the potential for leakage creates a serious hazard during intravenous delivery.
Patients and healthcare providers should stop using the device immediately. Follow the recall instructions provided by Baxter Healthcare Corporation.
For further information, contact Baxter Healthcare Corporation directly. Visit the recall webpage at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0196-2026.
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