The Recall Desk
HighFDA (Devices)·Z-0234-2021·Announced 2020-10-28

ICU Medical Recalls NanoClave Intravascular Sets Due to Seal Defect

ICU Medical is recalling specific lots of NanoClave intravascular administration sets due to a potential 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 is classified as FDA Class II, and the defect in a sterile medical device used for vascular 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 47-inch NanoClave intravascular administration sets. The recall involves a total of 304,735 units distributed worldwide, including across the United States and in countries such as Belgium, Brazil, Canada, France, Germany, Ireland, Japan, Martinique, Mexico, Poland, and Saudi Arabia.

The recall is being conducted due to the identification of a potential manufacturing defect on the internal surface of the NanoClave manifold within specific lots. This defect may inhibit a proper seal with the NanoClave spike. The affected products are identified by lot numbers 4556714 and 4573639.

The intravascular administration sets are single-use, sterile, non-pyrogenic devices used to provide access for the administration of fluids from a container to a patient's vascular system. Healthcare providers and facilities should check their inventory for the affected lot numbers and stop using these devices if found.

The recalled product

Product
47 IN (119cm) APPX 6.7 ml, EXT, STOPCOCK, 3-Port NanoClave MANIFOLD, MicroClave Clear. 1 unit per pouch, 25 pouches per case. UDI:(01)10887709121154(17)250101(30)25(10)4556714; (01)10887709121154(17)250101(30)25(10)4573639. The Intravascular Administration Set is a single u
Manufacturer
ICU Medical, Inc.
Category
Medical Device — Intravascular Administration Set
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 (2)

  • Lot Numbers:4556714
  • 4573639.

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 →

Related recalls

Same manufacturer · ICU Medical, Inc.

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Same hazard · seal defect

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