The Recall Desk
HighFDA (Devices)·Z-0210-2021·Announced 2020-10-28

ICU Medical Recalls NanoClave Sets Due to Potential 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 involves a risk-of-harm product (medical device) where the defect may inhibit a proper seal, but no injuries or illnesses are reported in the source text.

Plain-English summary

ICU Medical, Inc. is recalling specific lots of 13-inch Pentafuse Smallbore Sets featuring the NanoClave component. 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 the identification of a potential manufacturing defect on the internal surface of the NanoClave. This defect may inhibit a proper seal with the NanoClave spike. The affected products 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.

The affected lot numbers are 4557533 and 4572968. The agency classification for this recall is Class II. Healthcare providers and consumers should check their inventory for these specific lot numbers and stop using the affected devices.

The recalled product

Product
13 IN (33cm) APPX 0.96 ml, PENTAFUSE SMALLBORE SET, NanoClave, 3 MicroClave Clear. 1 unit per pouch, 50 pouches per case. UDI:(01)10887709090245(17)250101(30)50(10)4557533; (01)10887709090245(17)250101(30)50(10)4572968. The Intravascular Administration Set is a single use, s
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:4557533
  • 4572968.

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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Same hazard · seal defect

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