The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-0956-2021·Announced 2021-02-17

ICU Medical Recalls Smallbore Intravascular Administration Sets Due to Filter Assembly Error

ICU Medical is recalling 7,500 smallbore intravascular administration sets because of an incorrect filter assembly. The affected lots were distributed nationwide and in Belgium.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II. The source text does not report any illnesses, injuries, or hospitalizations, and the hazard is a manufacturing defect (incorrect filter assembly) rather than a high-risk pathogen or structural failure with reported harm.

Plain-English summary

ICU Medical, Inc. is recalling 7,500 units of the 60-inch Smallbore Ext Set w/MicroClave Clear, 1.2 Micron Filter, 2 Clamps, Luer Lock (REF MC330174). The recall is due to an incorrect filter assembly. The affected product is a single-use, sterile, non-pyrogenic device used to administer fluids from a container to a patient's vascular system.

The affected lots were distributed worldwide, including nationwide in the United States (AZ, CA, CO, CT, FL, ID, IL, LA, MA, MN, NC, NJ, NY, TN, TX, VA, WA, and WV) and in Belgium. The specific lot number is 4799374, with an expiration date of April 1, 2025.

Healthcare facilities and consumers should stop using the affected product and contact ICU Medical for instructions on return or replacement. The FDA has classified this as a Class II recall, indicating a reasonable probability that use of the product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
60" (152 cm) Appx 1.9 ml, Smallbore Ext Set w/MicroClave¿ Clear, 1.2 Micron Filter, 2 Clamps, Luer Lock REF MC330174 - Product Usage: The intravascular administration set is a single use, sterile, non pyrogenic device, which provides access for the administration of fluids from…
Manufacturer
ICU Medical, Inc.
Category
Medical Device — Intravascular Administration Set
Hazard
Affected units
7,500

Distribution

Distributed nationwide across the United States.

The notice also names 19 states specifically:

Part of a larger recall action

This product is one of 4 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 4 products in this recall →

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