Intravenous solution sets recalled after customer reports of tubing separation
Baxter is issuing an urgent recall for one lot of Continu-Flo Solution Sets, REF 2C8519, after customer reports of tubing separation. 14,400 units are affected.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: Rubric level 3 covers risk-of-harm products where injury has not yet been reported; tubing separation during an infusion is a potential harm and no injuries are reported.
Plain-English summary
The Baxter Continu-Flo Solution Set, non-vented, with two Clearlink luer activated valves and a backcheck valve, 10 drops/mL, 112 inches (2.8 m), product code REF 2C8519, UDI/DI 00085412048994, is being recalled. The affected product is lot R24I20079 with an expiry of 9/21/2026, and the recall covers 14,400 units distributed nationwide in the United States.
Baxter Healthcare Corporation issued an Urgent Medical Device Recall for this lot of Continu-Flo solution sets because of customer reports of tubing separation. The FDA classified the action as Class II.
Hospitals holding this lot should quarantine it and follow Baxter's instructions for return or replacement.
The recalled product
- Product
- Baster Continu-Flo Solution Set, Non-Vented, 2 Clearlink Luer Activated Valves, Backcheck Valve. 10 drops/mL. 112" (2.8 m), Product Code REF 2C8519; intravascular administration set
- Manufacturer
- Baxter Healthcare Corporation
- Affected units
- 14,400
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 (3)
- UDI/DI 00085412048994
- Lot Number R24I20079
- Exp. 9/21/2026
Distribution
Distributed nationwide across the United States.
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