Agency classClass IIOur severity:High FDA (Devices)·Z-0252-2021·Announced 2020-10-28

ICU Medical Recalls NanoClave Sets Due to Potential Manufacturing Defect

ICU Medical is recalling specific lots of NanoClave sets because a manufacturing defect may prevent a proper seal, potentially affecting intravascular administration.

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 involves a risk-of-harm product (medical device) where injury has not yet been reported, fitting the 'High' severity criteria.

Plain-English summary

ICU Medical, Inc. is recalling specific lots of NanoClave T-Connector sets. The recall involves a total of 304,735 units distributed worldwide, including the United States and several international countries such as Belgium, Brazil, Canada, France, Germany, Ireland, Japan, Martinique, Mexico, Poland, and Saudi Arabia.

The recall is due to a potential manufacturing defect on the internal surface of the NanoClave within specific lots. This defect may inhibit a proper seal with the NanoClave spike. The SmartValve is a single-use, sterile, non-pyrogenic pressure-activated check valve system intended for use as an accessory to intravascular administration sets.

The affected lot number is 4573652. The agency classifies this recall as Class II. Consumers and healthcare facilities should stop using the affected products and contact the manufacturer for further instructions or replacement.

The recalled product

Product: 120 IN (305cm)APPX 15.4ml, 10 DROP, 2 Clave STOPCOCK, NanoClave T-Connector, 2 CHECK VALVES. 1 unit per pouch, 50 pouches per case. UDI:(01)10887709040141(17)250101(30)25(10)4573652. The SmartValve is a single use, sterile, non-pyrogenic pressure activated check valve…
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 (1)

Lot Number:4573652.

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 · manufacturing defect