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.
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, 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 IV sets may leak, posing a risk to patient safety. This defect can lead to improper medication delivery and potential health complications.
No specific incidents or injuries have been reported at this time. The recall is based on the potential for leaks.
Patients and healthcare providers should stop using this device immediately. Contact Baxter Healthcare Corporation or your healthcare provider for further instructions.
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.
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