The Recall Desk
HighFDA (Devices)·Z-0227-2021·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 the hazard involves a risk-of-harm product (improper seal on an intravascular device) where injury has not yet been reported.

Plain-English summary

ICU Medical, Inc. is recalling specific lots of 142-inch (361cm) MicroClave CLEAR intravascular administration sets equipped with a NanoClave connector. The recall involves a total of 304,735 units distributed worldwide, including the United States and countries such as Belgium, Brazil, Canada, France, Germany, Ireland, Japan, Martinique, Mexico, Poland, and Saudi Arabia.

The recall is being conducted due to a potential manufacturing defect on the internal surface of the NanoClave connector. This defect may inhibit a proper seal with the NanoClave spike. The affected lot numbers are 4573948, 4603380, 4711169, 4493653, 4536737, and 4733710.

Healthcare facilities and distributors should check their inventory for the specific lot numbers listed above. If the affected products are found, they should be removed from use and returned to ICU Medical, Inc. according to the recall instructions.

The recalled product

Product
142 IN (361cm) APPX 18.8 ml, 15 DROP SET 4 MicroClave CLEAR, REMV 3-PORT NanoClave w/ BCV. 1 unit per pouch, 25 pouches per case. UDI:(01)10887709089393(17)250101(30)25(10)4573948;(01)10887709089393(17)250101(30)25(10)4603380; (01)10887709089393(17)250101(30)25(10)4711169; (01
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 (5)

  • Lot Numbers:4573948
  • 4603380
  • 4711169
  • 4493653
  • 4536737 4733710.

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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