The Recall Desk
HighFDA (Devices)·Z-0236-2021·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 with the spike.

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 involves a risk-of-harm product where injury has not yet been reported, meeting the criteria for a High severity score.

Plain-English summary

ICU Medical, Inc. is recalling specific lots of 7-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 was initiated due to a potential manufacturing defect on the internal surface of the NanoClave manifold within the affected lots. This defect may inhibit a proper seal with the NanoClave spike. The affected lot numbers are 4548270, 4558614, 4733732, and 4493665.

Healthcare providers and facilities should stop using the affected products and contact ICU Medical for instructions on return or replacement. The source text does not report any illnesses or injuries associated with this defect.

The recalled product

Product
7 IN (18cm) APPX 1.2ml Ext Set w/6-Port NanoClave Manifold, Check Valve. 1 unit per pouch, 50 pouches per case. UDI:(01)10887709067582(17)241201(30)50(10)4548270; (01)10887709067582(17)250101(30)50(10)4558614; (01)10887709067582(17)250201(30)50(10)4733732; (01)108877090675
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 (4)

  • Lot Numbers:4548270
  • 4558614
  • 4733732
  • 4493665.

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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