ICU Medical Recalls NanoClave Pressure Infusion Extension Sets Due to Seal Defect
ICU Medical is recalling specific lots of NanoClave pressure infusion extension sets because a manufacturing defect may prevent a proper seal.
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 with a defect that may inhibit a proper seal, posing a risk of harm (loss of sterility or infusion failure) where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
ICU Medical, Inc. is recalling specific lots of 9.5-inch (24 cm) Smallbore Pressure Infusion Extension Sets with MicroClave and NanoClave components. The recall involves a total of 304,735 units distributed worldwide, including the United States and several international countries.
The recall was initiated due to a potential manufacturing defect on the internal surface of the NanoClave component. This defect may inhibit a proper seal with the NanoClave spike, which could compromise the sterile fluid pathway or the delivery of fluids from an electronic or manual injector.
Healthcare facilities and distributors should identify the affected product by checking for Lot Number 4603265. The affected units are packaged as 1 unit per pouch, with 50 multivac pouches per case. Users should stop using the affected lots and contact ICU Medical for instructions on return or replacement.
The recalled product
- Product
- 9.5" (24 cm) Appx 0.45 ml, Smallbore Pressure Infusion (400 psig) Ext Set w/MicroClave, 2 NanoClave, NanoClave T-Connector, 3 Purple Clamps, Rotating Luer. 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709049496(17)250101(30)50(10)4603265. The high pressure e
- Manufacturer
- ICU Medical, Inc.
- Category
- Medical Device — Infusion Sets
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)
- Lot Number:4603265.
Distribution
Part of a larger recall action
This product is one of 99 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 99 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 · seal defect
See all →- HighMedical Action Industries Recalls Dialysis Change Tray Kits Due to Seal Defect
FDA (Devices) · 2026-08-12
- HighHalyard STANDARD LINE INSERTION PACK Recall for Silicone Seal Defect
FDA (Devices) · 2026-07-29
- ModerateMedline Kits with Zimmer Biomet Mixing Bowls Recalled for Seal Defects
FDA (Devices) · 2026-07-22
- ModerateMedline Kits with Zimmer Biomet Mixing Bowls and Spatulas Recalled
FDA (Devices) · 2026-07-22
- HighMedline Kits with Tego Connectors Recalled Due to Silicone Seal Defects
FDA (Devices) · 2026-03-04