# FDA recall Z-0362-2019

> **Fresenius Vial Sa** · Class II · device recall initiated 2017-12-02.

## Product

Volumat MC Agilia Volumetric Infusion Pump, Model No. Z021135, Software version 1.7. Product Usage - The Volumat MC Agilia is a piece of transportable medical equipment intended to be used in healthcare facilities environment by healthcare trained professionals according to hospital protocols on adults, pediatrics and neonatal human patient to administer via a single channel or mounted on a multiple channels rack accessory: Intermittent or continuous delivery of parenteral fluids (solutions, colloids, parenteral nutrition) and medications (including but limited to diluted drugs, chemotherapy) through clinically accepted IV routes of administration). Transfusion of blood and blood derivatives products. Note that for transfusion procedures, use of a special administration set is required).

## Reason for recall

Fresenius Kabi initiated a mandatory software upgrade of the Volumat MC Agilia Volumetric Infusion Pump because it was designed to improve customer experience while preventing common software malfunctions.

## Distribution

Worldwide distribution - US Nationwide and countries of Canada and China.

## Key facts

- **Recall number:** Z-0362-2019
- **Recalling firm:** Fresenius Vial Sa
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-12-02
- **Report date:** 2018-11-07
- **Termination date:** 2021-02-11

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Brezins, N/A, France

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0362-2019

## Citation

> AI Analytics. FDA recall Z-0362-2019. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/Z-0362-2019. Source: US FDA. Licensed CC0.

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