Agency classClass IIOur severity:High FDA (Devices)·Z-0237-2021·Announced 2020-10-28

ICU Medical Recalls NanoClave Intravascular Administration Sets Due to Seal Defect

ICU Medical is recalling specific lots of NanoClave intravascular administration sets because a manufacturing defect may prevent a proper seal with the spike.

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 3/5 (High).

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 in a medical device used for intravascular access presents a risk of harm where injury has not yet been reported, fitting the 'High' severity criteria.

Plain-English summary

ICU Medical, Inc. is recalling specific lots of 20-inch NanoClave intravascular administration sets. The recall involves a total of 304,735 units distributed nationwide in the United States and in several countries including Belgium, Brazil, Canada, France, Germany, Ireland, Japan, Martinique, Mexico, Poland, and Saudi Arabia.

The recall was initiated due to a potential manufacturing defect on the internal surface of the NanoClave manifold within the affected lots. This defect may inhibit a proper seal with the NanoClave spike. The affected lot numbers are 4742130, 4803158, 4558617, and 4589967.

Healthcare providers and facilities should check their inventory for these specific lot numbers and stop using the affected products. Consumers should not use these devices if they have them in their possession.

The recalled product

Product: 20 IN(51cm) APPX 2.5ml, Ext w/6-Port NanoClave Manifold, Check Valve.1 unit per pouch, 50 pouches per case. UDI:(01)10887709069203(17)250201(30)50(10)4742130; (01)10887709069203(17)250401(30)50(10)4803158; (01)10887709069203(17)250101(30)50(10)4558617…
Manufacturer: ICU Medical, Inc.
Category: Medical Device — Intravascular Administration Set
Hazard: manufacturing-defect
seal-failure

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 (4)

Lot Numbers:4742130
4803158
4558617
4589967.

Distribution

Distributed nationwide across the United States.

The notice also names 37 states specifically:

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 →

Same manufacturer · ICU Medical, Inc.

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