Agency classClass IIOur severity:High FDA (Devices)·Z-0261-2021·Announced 2020-10-28

ICU Medical Recalls NanoClave Connectors Due to Manufacturing Defect

ICU Medical is recalling NanoClave Connectors because a manufacturing defect on the internal surface 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 seal failure in a medical device used for administering blood and fluids to high-risk patients, 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 is due to a potential manufacturing defect on the internal surface of the NanoClave, which may inhibit a proper seal with the NanoClave spike.

The NanoClave Neutron is a normally closed, bidirectional connector intended for use as an accessory to an intravascular catheter placed in the vein or artery. The device may be used for the administration of blood and fluids to patients, including pediatrics and immunocompromised patients. The recall covers a total of 304,735 units distributed worldwide, including the United States and countries such as Belgium, Brazil, Canada, France, Germany, Ireland, Japan, Martinique, Mexico, Poland, and Saudi Arabia.

Healthcare providers and facilities should stop using the affected NanoClave Connectors and contact ICU Medical for further instructions. The affected lot numbers are 4573278, 4590919, 4712217, 4537440, 4549906, 4559515, 4719743, 4726897, 4735597, and 4461205.

The recalled product

Product: NanoClave Connector. 1 unit per pouch, 100 multivac pouches per case. UDI:(01)10887709058757(17)250101(30)100(10)4573278; (01)10887709058757(17)250101(30)100(10)4590919; (01)10887709058757(17)250201(30)100(10)4712217; (01)10887709058757(17)241201(30)100(10)4537440…
Manufacturer: ICU Medical, Inc.
Category: Medical Device — Intravascular Catheter Accessory
Hazard: seal-failure
manufacturing-defect

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 (10)

Lot Numbers:4573278
4590919
4712217
4537440
4549906
4559515
4719743
4726897
4735597
4461205.

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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Same hazard · seal failure