# FDA recall Z-0511-2021

> **ICU Medical, Inc.** · Class II · device recall initiated 2020-07-01.

## Product

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.

## Reason for recall

Incorrect filter assemblies in IV administration set.

## Distribution

U.S. Nationwide distribution including in the states of WI, MA, CA, FL, MN, IL, NY.

## Key facts

- **Recall number:** Z-0511-2021
- **Recalling firm:** ICU Medical, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-07-01
- **Report date:** 2020-12-09
- **Termination date:** 2022-12-01

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** San Clemente, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0511-2021

## Citation

> AI Analytics. FDA recall Z-0511-2021. Retrieved 2026-08-24 from https://api.ai-analytics.org/recall/Z-0511-2021. Source: US FDA. Licensed CC0.

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