The Recall Desk
HighFDA (Devices)·Z-0224-2021·Announced 2020-10-28

ICU Medical Recalls NanoClave Manifold Sets Due to Seal Defect

ICU Medical is recalling specific lots of 3-Port NanoClave Manifold sets due to a potential manufacturing defect that may inhibit 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 manufacturing defect in a medical device that may inhibit a proper seal, representing a risk of harm where injury has not yet been reported.

Plain-English summary

ICU Medical, Inc. is recalling specific lots of 3-Port NanoClave Manifold w/Check Valve, Rotating Luer sets. The recall involves a total of 304,735 units distributed worldwide, including nationwide in 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 the identification of 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 product is a single-use, sterile, non-pyrogenic device used for the administration of fluids from a container to a patient's vascular system.

Healthcare facilities and distributors should identify the affected lots by checking the lot numbers 4556715, 4579939, 4592179, 4610925, 4547212, 4712946, and 4720392. Users should stop using these specific units and contact the manufacturer for further instructions.

The recalled product

Product
3-Port NanoClave Manifold w/Check Valve, Rotating Luer. 1 unit per pouch, 50 pouches per case. UDI:(01)10887709087153(17)250101(30)50(10)4556715; (01)10887709087153(17)250101(30)50(10)4579939; (01)10887709087153(17)250101(30)50(10)4592179; (01)10887709087153(17)250101(30)50(1
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 (7)

  • Lot Numbers:4556715
  • 4579939
  • 4592179
  • 4610925
  • 4547212
  • 4712946
  • 4720392.

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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