# FDA recall Z-0956-2021

> **ICU Medical, Inc.** · Class II · device recall initiated 2020-12-02.

## 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 a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a vein).

## Reason for recall

Due to the incorrect filter assembly.

## Distribution

Worldwide distribution - U.S. Nationwide distribution including in the states of AZ, CA, CO, CT, FL, ID, IL, LA, MA, MN, NC, NJ, NY, TN, TX, VA, WA and WV. The country of Belgium.

## Key facts

- **Recall number:** Z-0956-2021
- **Recalling firm:** ICU Medical, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-12-02
- **Report date:** 2021-02-17
- **Termination date:** 2023-06-30

- **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-0956-2021

## Citation

> AI Analytics. FDA recall Z-0956-2021. Retrieved 2026-09-03 from https://api.ai-analytics.org/recall/Z-0956-2021. Source: US FDA. Licensed CC0.

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