Continu-Flo solution sets recalled across six lots because sets may leak
Baxter is recalling 473,040 CLEARLINK System Continu-Flo solution sets across six lots because the IV sets may leak.
What this means for you
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: Scored 3 under the risk-of-harm criterion: a leaking intravenous set can interrupt delivery of fluids or medicines, and no injuries are reported.
Plain-English summary
CLEARLINK System Continu-Flo Solution Sets, non-vented, with two CLEARLINK luer activated valves and a backcheck valve, 10 drops/mL, 112 inches (2.8 m), product code 2C8519, are being recalled because the IV sets may leak.
The recall covers 473,040 units carrying UDI/DI 00085412048994, from lots R25A25147, R25B21086, R25C20130, R25C25055, R25C25161 and R25C29185. The product was distributed nationwide in the United States. The FDA has classified the action as Class II.
The enforcement record states the leak potential and reports no injuries. Facilities holding the affected lots should quarantine them and follow Baxter's instructions.
The recalled product
- Product
- CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves, Backcheck Valve, 10 drops/mL, 112-inch (2.8 meters), Product Code 2C8519
- Manufacturer
- Baxter Healthcare Corporation
- Category
- Medical Device — IV set
- Affected units
- 473,040
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 (7)
- UDI/DI 00085412048994
- Lot numbers: R25A25147
- R25B21086
- R25C20130
- R25C25055
- R25C25161
- and R25C29185
Distribution
Part of a larger recall action
This product is one of 16 recalled by Baxter Healthcare Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 16 products in this recall →Related recalls
Same manufacturer · Baxter Healthcare Corporation
See all →- SevereBaxter Recalls Cefazolin Injection Bags Due to Particulate Matter
FDA (Drugs) · 2026-08-19
- HighBaxter Duo-Vent Solution Set Recalled for Air Bubbles in Tubing
FDA (Devices) · 2026-08-19
- SevereHillrom VOLARA System P.CIRCUIT KIT Medical Device Recall for Oxygen Drop Risk
FDA (Devices) · 2026-07-08
- HighBaxter Head Positioning Adapter May Loosen During Patient Positioning
FDA (Devices) · 2026-07-08
- SevereHillrom VOLARA System patient circuits recalled for nebulizer leakage risk
FDA (Devices) · 2026-07-08
Same hazard · leak
See all →- HighAVID Medical Recalls Halyard LAVH PACK Due to Sterilization Error
FDA (Devices) · 2026-08-26
- HighMedline Convenience Kits with Recalled Swan-Ganz Catheters
FDA (Devices) · 2026-07-08
- HighBicarby dialysate luer-lock connections may leak fluid onto floors
FDA (Devices) · 2026-06-17
- HighSwan-Ganz Pacing Catheter Model D200F7 Recall Due to Leak Risk
FDA (Devices) · 2026-05-27
- HighAnti-siphon smallbore extension sets recalled over port weld separation risk
FDA (Devices) · 2025-11-05