Non-DEHP solution sets recalled from one lot because IV sets may leak
Baxter is recalling 18,720 CLEARLINK System non-DEHP Continu-Flo solution sets from one lot 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 non-DEHP Continu-Flo Solution Sets, 96 inches (2.4 m), product code 2H8519, are being recalled because the IV sets may leak.
The recall covers 18,720 units carrying UDI/DI 00085412625553, from lot R25C08147. 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 lot should quarantine it and follow Baxter's instructions.
The recalled product
- Product
- CLEARLINK SYSTEM NON-DEHP CONTINU-FLO SOLN SET, 96" (2,4 m), Product Code: 2H8519
- Manufacturer
- Baxter Healthcare Corporation
- Category
- Medical Device — IV set
- Affected units
- 18,720
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 (2)
- UID/DI 00085412625553
- Lot numbers: R25C08147
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