Baxter Healthcare's CLEARLINK SYSTEM CONTIN-FLO IV infusion sets are recalled nationwide in the United States after 106,176 units were distributed to healthcare providers. The defect is that IV sets may leak. Healthcare facilities should stop using the device and follow Baxter's 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 CLEARLINK CONTIN-FLO system comprises non-vented IV infusion sets with a 0.2 micron filter designed for intravascular fluid delivery. It includes two luer activated valves and a backcheck valve in a 104-inch (2.6 m) line.
The device's potential to leak could disrupt sterile fluid delivery and pose risks in clinical use, including under-delivery or contamination of IV administration.
This recall is not described as part of a broader industry pattern.
Hospitals and clinics relying on these sets may need to replace stock quickly to maintain sterile IV therapy and avoid treatment delays.
Recall details and guidance are available on the FDA enforcement page linked to recall Z-0195-2026 and Baxter's official communications.
Hospitals and suppliers may complete replacements within 4-6 weeks after authorization.
Retain recall notice, supplier communications, replacement confirmations, and any supporting purchasing records.
Model numbers/identifiers: UDI/DI 00085412046327; Lot numbers: R25B24055; Product Code 2C8571. Where sold: Nationwide distribution to healthcare providers in the United States. When sold: Unknown. Price: Unknown.
No injuries or incidents have been reported.
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