ICU Medical Flush Kits Recalled for Stopcock Molding Defect
ICU Medical is recalling Flush Kits with 3 Way Off Stopcocks due to a molding defect that may occlude side ports.
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: The recall involves a medical device defect that could lead to a risk of harm (occluded ports) without reported injuries, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
ICU Medical, Inc. is recalling Flush Kits with 3 Way Off Stopcocks (Part Number AG8137, 510(k) K052865, Lot number 2466161). The recall was initiated due to a molding defect in the high pressure stopcock.
The defect may cause a small percentage of the side ports to become totally occluded. The product was distributed nationwide.
Healthcare facilities should stop using the affected units and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- Flush Kit w 3 Way Off Stopcock Product Usage: Flush Kit
- Manufacturer
- ICU Medical, Inc.
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 (1)
- Part Number AG8137 510(k) K052865 Lot number 2466161
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by ICU Medical, Inc. 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 4 products in this recall →Related recalls
Same manufacturer · ICU Medical, Inc.
See all →- HighICU Medical Recalls Hotline Fluid Warming Sets Due to Leakage Risk
FDA (Devices) · 2026-07-29
- SevereICU Medical Plum Duo Infusion Pump Software Defect Affecting Drug Delivery
FDA (Devices) · 2026-07-22
- SevereICU Medical Plum Solo Precision IV Pump May Deliver Excess Medication
FDA (Devices) · 2026-07-22
- HighPlum Duo Precision IV pumps may not display soft limit alerts
FDA (Devices) · 2026-06-17
- HighPlum Solo Precision IV pumps may not display soft limit alerts
FDA (Devices) · 2026-06-17
Same hazard · defective component
See all →- HighBeckman Coulter Sample Probes with Defective Tips Clinical Chemistry
FDA (Devices) · 2025-06-11
- SevereMedline Medical Convenience Kits Recalled for Defective Endotracheal Tubes
FDA (Devices) · 2025-04-16
- SevereMedline Medical Procedure Kits with Medtronic Aortic Cannula Recalled
FDA (Devices) · 2025-04-16
- SevereExactech AcuMatch XLE Hip Implant Liner Recall
FDA (Devices) · 2025-02-19
- ModerateMedline Medical Convenience Kits Recall Due to Recalled Component
FDA (Devices) · 2024-12-11