The Recall Desk
HighFDA (Devices)·Z-0269-2021·Announced 2020-10-28

ICU Medical Recalls NanoClave Administration Sets Due to Manufacturing Defect

ICU Medical is recalling specific lots of NanoClave 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 is classified as FDA Class II and involves a risk-of-harm product where injury has not yet been reported, fitting the High severity criteria.

Plain-English summary

ICU Medical, Inc. is recalling specific lots of 20 cm (8 IN) APPX 1.0ml, PUR EXT SET, 3-PORT, NanoClave MANIFOLD, BCV, NanoClave administration sets. The recall involves a total of 304,735 units distributed worldwide, including the United States and several international countries.

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 lot numbers are 4584874 and 4565685.

Healthcare facilities and consumers should check their inventory for these specific lot numbers and stop using the affected products. The administration sets are single-use, pre-sterilized devices used to provide access for the administration of fluids to a patient's vascular system.

The recalled product

Product
20 cm (8 IN) APPX 1.0ml, PUR EXT SET, 3-PORT, NanoClave MANIFOLD, BCV, NanoClave.1 unit per pouch, 50 pouches per case. UDI:(01)10840619092754(17)250101(30)50(10)4584874; (01)10840619092754(17)250101(30)50(10)4565685 Administration sets and their accessories are single use, p
Manufacturer
ICU Medical, Inc.
Category
Medical Device — Administration 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 (2)

  • Lot Numbers:4584874
  • 4565685.

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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