ICU Medical Recalls Intravascular Administration Sets Due to Manufacturing Defect
ICU Medical is recalling specific lots of intravascular administration sets because a manufacturing defect may prevent the NanoClave spike from sealing properly.
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 is classified as FDA Class II, and the defect poses a risk of harm to patients by potentially compromising the sterile seal of the device, although no specific injuries or illnesses are reported in the source text.
Plain-English summary
ICU Medical, Inc. is recalling specific lots of 12-inch smallbore Hexafuse intravascular administration sets. The recall involves 304,735 units distributed worldwide, including in the United States and several international countries. The affected products are identified by lot numbers 4572779 and 4548202.
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. The device is a single-use, sterile, non-pyrogenic set used to administer fluids from a container to a patient's vascular system.
Healthcare facilities and distributors should check their inventory for the specific lot numbers listed in the recall notice. If the affected products are found, they should be removed from use and returned to ICU Medical, Inc. according to the instructions provided in the official recall documentation.
The recalled product
- Product
- 12 IN(30cm) APPX 2.1ml, SMALLBORE HEXAFUSE SET, 6 MicroClave Clear, NanoClave 6 Check Valves;1 unit per pouch, 50 pouches per case. UDI: (01)10887709070100(17)250101(30)50(10)4572779; (01)10887709070100(17)250101(30)50(10)4548202. The Intravascular Administration Set is a sin
- 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 (2)
- Lot Numbers:4572779
- 4548202.
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 · manufacturing defect
See all →- HighBeak & Skiff Alcohol Antiseptic Sanitizer recalled for acetaldehyde contamination
FDA (Drugs) · 2026-09-02
- HighSun Pharmaceutical Recalls Carbamazepine Tablets Due to Manufacturing Deviations
FDA (Drugs) · 2026-08-26
- HighKnee Prosthesis Trial Recall for Manufacturing Defect
FDA (Devices) · 2026-08-12
- HighUnited Orthopedic Corp. Recalls Femoral Valgus Offset Adaptors for U2 Total Knee System
FDA (Devices) · 2026-08-12
- HighU2 Total Knee System Femoral Valgus Adaptor Recall
FDA (Devices) · 2026-08-12