The Recall Desk
HighFDA (Devices)·Z-0216-2021·Announced 2020-10-28

ICU Medical Recalls NanoClave Intravascular Administration Sets Due to Seal Defect

ICU Medical is recalling specific lots of NanoClave intravascular administration sets because a manufacturing defect may prevent 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 with a defect that may compromise sterility or function, representing a risk of harm where injury has not yet been reported, consistent with the High severity criteria.

Plain-English summary

ICU Medical, Inc. is recalling specific lots of 54-inch NanoClave 4-Way Stopcock intravascular administration sets. The recall is due to a potential manufacturing defect on the internal surface of the NanoClave component, which may inhibit a proper seal with the NanoClave spike.

The affected product is a single-use, sterile, non-pyrogenic device used to administer fluids from a container to a patient's vascular system. The recall covers a total of 304,735 units from Lot Number 4718579. These products were distributed nationwide in the United States and in several countries including Belgium, Brazil, Canada, France, Germany, Ireland, Japan, Martinique, Mexico, Poland, and Saudi Arabia.

Healthcare facilities and consumers should stop using the affected lots and contact ICU Medical for further instructions or a replacement.

The recalled product

Product
54 IN (137 cm) APPX 7.2 ml EXT SET w NanoClave 4-Way Stopcock ;UDI:(01)10840619082526(17)250201(30)50(10)4718579. The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a p
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 (1)

  • Lot Number:4718579.

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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