The Recall Desk
SevereFDA (Devices)·Z-0222-2021·Announced 2020-10-28

ICU Medical Recalls Intravascular Administration Sets Due to Seal Defect

ICU Medical is recalling specific lots of intravascular administration sets because a manufacturing defect may prevent a proper seal.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The source explicitly states the agency classification is Class II. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), as they involve a reasonable probability of temporary or medically reversible adverse health consequences.

Plain-English summary

ICU Medical, Inc. is recalling specific lots of 123-inch intravascular administration sets. The recall involves a total of 304,735 units distributed worldwide, including in the United States and various international countries.

The recall is 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 4536733 and 4573641.

The FDA has classified this as a Class II recall. Consumers and healthcare providers should check their inventory for these specific lot numbers and stop using the affected devices. They should contact ICU Medical for instructions on returning or replacing the products.

The recalled product

Product
123 IN (312cm) APPX 16.1 ml, 10 DROP SET w/3 MicroClave, 3-Port NanoClave; UDI:(01)10887709085432(17)241201(30)25(10)4536733;(01)10887709085432(17)250101(30)25(10)4573641. The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which provides acces
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:4536733
  • 4573641.

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 →

Related recalls

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Same hazard · seal defect

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