Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

REF MC330209 6' (15 cm) Appx 0.09 ml Recalled by ICU Medical, Inc. Due to Incorrect filter assemblies in IV administration set.

Date: July 1, 2020
Company: ICU Medical, Inc.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact ICU Medical, Inc. directly.

Affected Products

REF MC330209 6' (15 cm) Appx 0.09 ml, Smallbore Trifuse Ext Set w/3 MicroClave Clear, 0.2 Micron Filter, 1.2 Micron Filter, 3 Clamps (Blue, Yellow, White), Rotating Luer - 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 through the administration set s needle catheter (which is inserted into a vein). Directions for Use: icumedical IV Extension Sets Clave/MicroClave/NanoClave Connectors Antimicrobial Clave/MicroClave Connectors Spiros Closed Male Luer.

Quantity: 1100 units

Why Was This Recalled?

Incorrect filter assemblies in IV administration set.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About ICU Medical, Inc.

ICU Medical, Inc. has 592 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report