Agency classClass IIOur severity:High FDA (Devices)·Z-0226-2021·Announced 2020-10-28

ICU Medical Recalls Intravascular Administration Sets Due to Manufacturing Defect

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

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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 (intravascular set) where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products without reported illness.

Plain-English summary

ICU Medical, Inc. is recalling specific lots of 112-inch intravascular administration sets. The recall involves 304,735 units distributed worldwide, including the United States and several international countries. The affected products are identified by lot numbers 4475764 and 4720644.

The recall was initiated due to a potential manufacturing defect on the internal surface of the NanoClave component within the sets. This defect may inhibit a proper seal with the NanoClave spike. The Intravascular Administration Set is a single-use, sterile device used to provide access for the administration of fluids from a container to a patient's vascular system.

Healthcare providers and consumers should check their inventory for the specific lot numbers listed in the recall notice. If the affected products are found, they should be removed from use and returned to the manufacturer or disposed of according to local regulations. 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: 112 IN(284cm) APPX 14.6ml, 15 Drop Set 3 MicroClave, 3-Port NanoClave Manifold, BCV.1 unit per pouch, 25 pouches per case. UDI:(01)10887709088518(17)241101(30)25(10)4475764 (01)10887709088518(17)250201(30)25(10)4720644. The Intravascular Administration Set is a single use…
Manufacturer: ICU Medical, Inc.
Category: Medical Device — Intravascular Administration Set
Hazard: manufacturing-defect
seal-failure

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:4475764
4720644.

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 →

Same manufacturer · ICU Medical, Inc.

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Same hazard · manufacturing defect