Agency classClass IIOur severity:High FDA (Devices)·Z-0263-2021·Announced 2020-10-28

ICU Medical Recalls NanoClave Connectors Due to Manufacturing Defect

ICU Medical is recalling specific lots of NanoClave Connectors due to a potential manufacturing defect on the internal surface that may inhibit a proper seal with the NanoClave 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 hazard involves a potential defect in a medical device that could affect the administration of fluids to a patient's vascular system, representing a risk of harm where injury has not yet been reported.

Plain-English summary

ICU Medical, Inc. is recalling specific lots of NanoClave Connectors. The recall involves a total of 304,735 units, distributed in 100 multivac pouches per case. The affected lots are 4559476, 4711354, 4476111, 4493213, 4510900, and 4749152.

The recall was initiated due to the identification of a potential manufacturing defect on the internal surface of the NanoClave. This defect may inhibit a proper seal with the NanoClave spike. The NanoClave Connector is a single-use, pre-sterilized device that provides access for the administration of fluids from a container to a patient's vascular system.

The affected products were distributed worldwide, including nationwide in the United States and in countries such as Belgium, Brazil, Canada, France, Germany, Ireland, Japan, Martinique, Mexico, Poland, and Saudi Arabia. Healthcare facilities and consumers should stop using the affected products and contact ICU Medical for further instructions.

The recalled product

Product: NanoClave Connector. 1 unit per pouch, 100 multivac pouches per case. UDI:(01)10840619060906(17)250101(30)100(10)4559476; (01)10840619060906(17)250201(30)100(10)4711354; (01)10840619060906(17)241101(30)100(10)4476111…
Manufacturer: ICU Medical, Inc.
Category: Medical Device — Infusion Sets
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 (6)

Lot Numbers:4559476
4711354
4476111
4493213
4510900
4749152.

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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