The Recall Desk
HighFDA (Devices)·Z-0262-2021·Announced 2020-10-28

ICU Medical Recalls CLAVE Neutron Connectors Due to Manufacturing Defect

ICU Medical is recalling specific lots of CLAVE Neutron intravascular catheter connectors due to a manufacturing defect that may inhibit a proper seal.

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 involves a medical device used in immunocompromised patients where a seal defect could lead to serious harm, but the source text does not report any specific injuries or illnesses, fitting the 'risk-of-harm products where injury has not yet been reported' criterion.

Plain-English summary

ICU Medical, Inc. is recalling specific lots of CLAVE Neutron intravascular catheter connectors. The recall involves a potential manufacturing defect on the internal surface of the NanoClave component within these sets. This defect may inhibit a proper seal with the NanoClave spike.

The affected product is an 8-inch extension set with a 3-Port NanoClave Manifold and Check Valve. The device is intended for use as an accessory to an intravascular catheter placed in the vein or artery 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 several international countries.

Consumers and healthcare providers should stop using the affected lots immediately and contact ICU Medical for instructions on return or replacement. The specific lot number identified in the recall is 4605676.

The recalled product

Product
8 IN (20CM) APPX 1.3ml, EXT SET w/3-Port NanoClave Manifold, Check Valve.1 unit per pouch, 50 pouches per case. UDI:(01)10887709085814(17)250101(30)50(10)4605676. CLAVE Neutron is a normally closed, bidirectional connector intended for use as an accessory to an Intravascular
Manufacturer
ICU Medical, Inc.
Category
Medical Device — Intravascular Catheter Accessories
Hazard

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:4605676.

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 →

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Same hazard · manufacturing defect

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