Baxter Healthcare Corporation is recalling 473,040 CLEARLINK SYSTEM CONTINU-FLO IV Solution Sets sold nationwide to healthcare providers. The IV sets may leak, increasing the risk of improper fluid administration. Stop using the product immediately and contact Baxter Healthcare Corporation or your healthcare provider for 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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CLEARLINK SYSTEM CONTINU-FLO IV Solution Sets are used to deliver IV fluids in medical settings. They include non-vented tubing and Luer activated valves for controlled administration.
Leakage can compromise fluid delivery and may require urgent clinical assessment to prevent under- or over-infusion.
This recall is not part of a broader industry pattern.
The recall affects medical devices used in infusion therapy; patients in facilities could experience delays or changes in IV therapy if devices leak.
Refer to the FDA recall page linked in Baxter communications and the product packaging for identifiers.
Remedy processing can take 4-8 weeks for replacement or instructions.
Keep a copy of the recall notice, take photos of product labels and codes, and save all correspondence with Baxter and healthcare facilities
CLEARLINK SYSTEM CONTINU-FLO IV Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves, Backcheck Valve, 10 drops/mL, 112-inch (2.8 meters). Product Code 2C8519. UDI/DI 00085412048994. Lot numbers: R25A25147, R25B21086, R25C20130, R25C25055, R25C25161, and R25C29185. Sold: 473,040 units. Distribution: US nationwide including AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV. Recall Date: 2025-08-29. Status: Active. Brand: Baxter Healthcare. Cat
No injuries or incidents have been reported.
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