IV Solution Sets Recalled for Potential Leakage Risk Nationwide
Baxter Healthcare has recalled approximately 48,000 CLEARLINK SYSTEM CONTINU-FLO IV solution sets nationwide due to potential leakage. The voluntary recall affects lot R25C26116 distributed across all U.S. states.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This FDA Class II recall involves a potential leakage hazard in IV administration sets. While no reported illnesses or injuries are mentioned in the source, IV leakage poses a risk to therapy integrity and potential infection. Classification as a risk-of-harm product without reported incidents justifies a High severity score.
Plain-English summary
Baxter Healthcare Corporation has initiated a voluntary recall of CLEARLINK SYSTEM CONTINU-FLO Solution Sets (Non-Vented, with two CLEARLINK Luer Activated Valves, 10 drops/mL, 96-inch). The recalled devices are product code 2R8519 with UDI/DI 00085412565682. Approximately 48,096 units have been affected.
The recall was initiated due to a potential leakage issue in the IV solution sets. The affected lot number is R25C26116.
The recalled solution sets were distributed nationwide to healthcare facilities across all U.S. states.
Healthcare providers should discontinue use of recalled lot R25C26116 and contact Baxter Healthcare Corporation for replacement or disposal instructions. Patients currently or recently treated with these IV sets should consult with their healthcare provider with any questions about their infusion therapy.
The recalled product
- Product
- CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves. 10 drops/mL, 96-inch (2.4 meters). Non-DEHP, Product Code 2R8519
- Manufacturer
- Baxter Healthcare Corporation
- Hazard
- leakage
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI/DI 00085412565682
- Lot numbers: R25C26116
Distribution
Distributed nationwide across the United States.
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