Agency classClass IIOur severity:High FDA (Devices)·Z-0955-2021·Announced 2021-02-17

ICU Medical Recalls Intravascular Administration Sets Due to Filter Assembly Error

ICU Medical is recalling 7,500 intravascular administration sets because of an incorrect filter assembly. The affected devices were distributed in the U.S. and 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 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 involves a medical device with a structural defect (incorrect filter assembly) that poses a risk of harm to patients, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

ICU Medical, Inc. is recalling 7,500 units of 60-inch intravascular administration sets (Model B2209) due to an incorrect filter assembly. The affected product is a single-use, sterile device used to administer fluids from a container to a patient's vascular system.

The recall covers four lots, including Lot Number 4794177. The devices were distributed nationwide in the United States, specifically in Arizona, California, Colorado, Connecticut, Florida, Idaho, Illinois, Louisiana, Massachusetts, Minnesota, North Carolina, New Jersey, New York, Tennessee, Texas, Virginia, Washington, and West Virginia. The products were also distributed in Belgium.

Consumers and healthcare facilities should stop using the affected administration sets and contact ICU Medical for instructions on how to return or dispose of the devices.

The recalled product

Product: 60 IN (152cm) APPX 1.5 ml, PUR YELLOW SMALLBORE SET, FILTER REF B2209 - Product Usage: The intravascular administration set is a single use, sterile, non pyrogenic device, which provides access for the administration of fluids from a container to a patient s vascular system…
Manufacturer: ICU Medical, Inc.
Category: Medical Device — Intravascular Administration Set
Hazard: filter-assembly-error
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 →

Same manufacturer · ICU Medical, Inc.

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Same hazard · filter assembly error