Baxter Healthcare recalled 12,720 CONTINU-FLO Solution Sets on August 29, 2025, due to a risk of leakage. The recall affects various states across the U.S. Healthcare providers and patients 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
The recalled product is the CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, with three CLEARLINK Luer Activated Valves and a Backcheck Valve. It has a drop rate of 10 drops/mL and a length of 120 inches (3.0 meters). The product code is 2R8537.
The recalled IV sets may leak, which can pose a risk of infection or inadequate medication delivery. This risk categorizes the recall as Class II, indicating a potential but not immediate threat to health.
As of now, no specific incidents or injuries related to this leakage have been reported. The risk of leakage could lead to serious health complications if not addressed.
Stop using the affected IV sets immediately. Follow the recall instructions provided by Baxter Healthcare Corporation. Contact your healthcare provider for further guidance.
For more information, contact Baxter Healthcare Corporation or visit the FDA's recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0202-2026.
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