IV Administration Set Recalled Due to Potential Leakage Risk
Baxter Healthcare Corporation is recalling CLEARLINK SYSTEM Solution Sets (IV administration sets) because they may leak. The voluntary recall affects 1,440 units distributed nationwide.
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 is a Class II medical device recall involving a product essential to patient care. Although no illnesses or injuries have been reported, IV set leakage represents a risk-of-harm scenario where proper fluid and medication delivery could be compromised during administration.
Plain-English summary
Baxter Healthcare Corporation has voluntarily recalled CLEARLINK SYSTEM Solution Sets, Non-Vented, featuring two CLEARLINK Luer Activated Valves (Product Code 2C8425). These IV administration sets are designed to deliver fluids and medications directly into patients' veins. The recall was initiated because the sets may leak during use.
The affected product is distributed nationwide across all 50 states. A total of 1,440 units have been identified in the recall. The specific lot number affected is R25C27086, identified by UDI/DI 00085412071190.
Patients and healthcare providers who have received these IV sets should stop using them immediately and contact Baxter Healthcare Corporation for replacement or guidance. Healthcare facilities should quarantine any remaining stock of the affected lot and ensure proper handling of products already in patient use. No illnesses or injuries have been reported at this time.
The recalled product
- Product
- CLEARLINK SYSTEM Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves, 10 drops/mL, 100-inch (2.5 meters), Product Code 2C8425
- Manufacturer
- Baxter Healthcare Corporation
- Hazard
- iv-leak
- delivery-failure
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 00085412071190
- Lot numbers: R25C27086
Distribution
Distributed nationwide across the United States.
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