Baxter Healthcare Corporation issued an urgent medical device recall for one lot of Continu-Flo intravascular solution sets, 14,400 units distributed nationwide in the United States. Customer reports indicate tubing separation. Health care providers and patients should stop using the device immediately and follow recall instructions.
Baxter Healthcare Corporation is issuing an Urgent Medical Device Recall for one lot of Continu-Flo solution sets listed below due to customer reports of tubing separation.
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. Notification method: Letter
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Continu-Flo intravascular solution sets are used to administer IV fluids and medications through a sterile tubing system in clinical settings. They connect to IV catheters and infusion pumps to deliver controlled doses.
Tubing separation can disrupt infusion, risking incorrect dosing or agents entering unintended pathways. In some cases it could lead to air embolism or patient harm if not detected promptly.
This recall is not described as part of a broader industry pattern.
Hospitals and clinics may need to halt use of affected lots, review inventory, and coordinate replacements or refunds with Baxter.
Recall notice and FDA enforcement page. Contact Baxter Healthcare for instructions and potential replacement/refund details.
Typical recall processing may take several weeks. Baxter will provide specific timelines in the recall notice.
Keep the recall letter, note the affected lot numbers, take photos of packaging and labels, preserve used devices for potential investigation.
Product: Continu-Flo Solution Set, Non-Vented, 112" (2.8 m). 10 drops/mL. 2 Clearlink Luer Activated Valves. Backcheck Valve. Product Code REF 2C8519. Intravascular administration set. Brand: Baxter Healthcare. UDI/DI: 00085412048994. Lot Number: R24I20079. Exp. 9/21/2026.
No injuries or incidents have been reported.
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