Baxter Healthcare recalled 8,368 CLEARLINK SYSTEM CONTINU-FLO IV sets nationwide after reports the devices may leak. The non-vented sets include a 0.2-micron filter, three CLEARLINK luer activated valves and a backcheck valve, and measure 102 inches in length. Hospitals and clinicians should stop using these units immediately 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 SYSTEM CONTINU-FLO IV set is a non-vented intravenous administration set used to deliver IV fluids in clinical settings. It includes a 0.2 micron filter and multiple valves for controlled flow.
Leakage can alter flow rate and volume, potentially resulting in under- or over-delivery of IV medications and fluids, posing patient safety risks.
This recall is not part of a broader industry pattern.
Hospitals and clinics must replace affected sets to maintain safe IV therapy and avoid treatment delays or dosing errors.
Visit Baxter’s recall notices and the FDA enforcement page linked in the recall document.
4-8 weeks for refunds or replacements after verification and return processing.
Keep the recall notice, take clear photos of lot codes and product codes, retain purchase receipts, and log all communications with Baxter.
Model numbers: UDI/DI 00085412071664; Lot numbers R25D01161. Where sold: Nationwide US distribution 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, WV. When sold: Unknown. Price: Unknown.
No injuries or incidents have been reported.
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