The Recall Desk
HighFDA (Devices)·Z-0273-2021·Announced 2020-10-28

ICU Medical Recalls NanoClave Administration Sets Due to Seal 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. Per the rubric, risk-of-harm products where injury has not yet been reported are rated as High (3).

Plain-English summary

ICU Medical, Inc. is recalling specific lots of PROXIMALE 28 cm administration sets equipped with a 6-PORT NanoClave MANIFOLD. The recall involves a total of 304,735 units distributed nationwide in the United States and in several international countries, including 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 component. This defect may inhibit a proper seal with the NanoClave spike. The affected lot numbers are 4600271 and 4537220.

Healthcare facilities and consumers should check their inventory for these specific lot numbers and stop using the affected devices. The FDA has classified this as a Class II recall, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.

The recalled product

Product
PROXIMALE, 28 cm (11 IN) APPX 1.0ml, EXT Set, 6-PORT NanoClave MANIFOLD, NanoClave. 1 unit per pouch, 50 pouches per case. UDI:(01)10840619093195(17)250101(30)50(10)4600271; (01)10840619093195(17)241201(30)50(10)4537220. Administration sets and their accessories are single us
Manufacturer
ICU Medical, Inc.
Category
Medical Device — IV 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:4600271
  • 4537220.

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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