ICU Medical Recalls Smallbore Intravascular Administration Sets Due to Seal Defect
ICU Medical is recalling specific lots of smallbore intravascular administration sets because a manufacturing defect may prevent the NanoClave spike from sealing properly.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source text explicitly identifies the agency classification as Class II. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when the defect involves a critical functional component like a seal in a medical device.
Plain-English summary
ICU Medical, Inc. is recalling specific lots of 8.5-inch smallbore intravascular administration sets. The recall involves a total of 304,735 units of the product, which is a single-use, sterile device used to administer fluids to a patient's vascular system. The affected product is identified by Lot Number 4557524.
The recall was initiated due to a potential manufacturing defect on the internal surface of the NanoClave component within the sets. This defect may inhibit a proper seal with the NanoClave spike. The agency has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The affected products were distributed worldwide, including nationwide in the United States and in several international countries such as Belgium, Brazil, Canada, France, Germany, Ireland, Japan, Martinique, Mexico, Poland, and Saudi Arabia. Healthcare facilities and distributors should stop using the affected lots and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- 8.5" (22 cm) Appx 0.57 ml, Smallbore Ext Set w/NanoClave, 0.2 Micron Filter, Clamp, Rotating Luer;1 unit per pouch, 50 multivac pouches per case.UDI:(01)10887709077671(17)250101(30)50(10)4557524. The Intravascular Administration Set is a single use, sterile, non-pyrogenic…
- 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)
- Lot Number:4557524.
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 IV Sets with Potential Drip Chamber Discoloration
FDA (Devices) · 2026-09-23
- HighICU Medical Recalls IV Sets with Potential Drip Chamber Discoloration
FDA (Devices) · 2026-09-23
- HighICU Medical Recalls IV Sets with Potential Drip Chamber Discoloration
FDA (Devices) · 2026-09-23
- ModerateICU Medical Recalls IV Administration Sets with Drip Chamber Specks
FDA (Devices) · 2026-09-23
- ModerateICU Medical Recalls Oncology Sets with Potential Drip Chamber Discoloration
FDA (Devices) · 2026-09-23
Same hazard · manufacturing defect
See all →- HighBeak & Skiff Alcohol Antiseptic Sanitizer recalled for acetaldehyde contamination
FDA (Drugs) · 2026-10-14
- HighFDA Recalls Opportunity Pro Nitrile Gloves Due to Manufacturing Defects
FDA (Devices) · 2026-10-07
- HighWright Medical Recalls Charlotte Claw Screws Due to Missing Threads
FDA (Devices) · 2026-10-07
- ModerateCustom Interventional Pain Management Recalls Mastisol Skin Adhesive Trays
FDA (Devices) · 2026-10-07
- HighNOxBOXi Nitric Oxide Delivery System Recalled for Oxygen Sensor Defect
FDA (Devices) · 2026-10-07
Similar recalls
- ModerateICU Medical Recalls Smallbore Intravascular Administration Sets Due to Filter Assembly Error
FDA (Devices) · 2021-02-17
- ModerateICU Medical Recalls Smallbore Extension Sets with Incorrect Spin Collars
FDA (Devices) · 2018-04-18
- ModerateICU Medical Recalls MicroCLAVE Intravascular Administration Sets Due to Filter Assembly Error
FDA (Devices) · 2021-02-17
- ModerateICU Medical Recalls Smallbore Extension Sets Due to Incorrect Spin Collar
FDA (Devices) · 2018-04-18
- ModerateICU Medical Recalls IV Administration Sets with Incorrect Filter Assemblies
FDA (Devices) · 2020-12-09
- HighICU Medical Recalls 7-inch Intravascular Administration Sets with Incorrect Spin Collar
FDA (Devices) · 2018-04-18