The Recall Desk
HighFDA (Devices)·Z-0239-2021·Announced 2020-10-28

ICU Medical Recalls APPX NanoClave Manifold Sets Due to Seal Defect

ICU Medical is recalling APPX 0.75 ml, 6-Port NanoClave Manifold 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 the hazard involves a potential seal defect in a medical device where injury has not yet been reported, fitting the criteria for a High severity score.

Plain-English summary

ICU Medical, Inc. is recalling specific lots of APPX 0.75 ml, 6-Port NanoClave Manifold, Check Valve 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 within specific lots. This defect may inhibit a proper seal with the NanoClave spike. The affected lot numbers are 4542066, 4549203, 4558619, 4589971, 4605186, and 4733735.

The source text does not specify instructions for consumers or healthcare providers on how to handle the recalled devices, nor does it report any illnesses or injuries associated with the defect.

The recalled product

Product
APPX 0.75 ml, 6-Port NanoClave Manifold, Check Valve. 1 unit per pouch, 50 pouches per case. UDI:(01)10887709070551(17)241201(30)50(10)4542066; (01)10887709070551(17)241201(30)50(10)4549203; (01)10887709070551(17)250101(30)50(10)4558619; (01)10887709070551(17)250101(30)50(10)
Manufacturer
ICU Medical, Inc.
Category
Medical Device — Infusion Sets
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 (6)

  • Lot Numbers:4542066
  • 4549203
  • 4558619
  • 4589971
  • 4605186
  • 4733735.

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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