# FDA recall Z-2064-2019

> **Fenwal Inc** · Class I · device recall initiated 2019-06-24.

## Product

VOLUMAT MC AGILIA US, Infusion Pump, REF Z021135, software versions 1.7 and 1.9a    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. Volumat MC Agilia can be used with the Dose Error Reduction Software (DERS) Vigilant Drug  Lib to define the default and upper hard limits for the Bolus Volume, or dose, by drug. The health care prof

## Reason for recall

The firm is correcting four software anomalies and KVO (keep vein open) end of infusion alarm priority in Software versions 1.7 and 1.9a of Volumat MC Agilia Software and versions 1.0 and 1.1 of Vigilant DrugLib

## Distribution

US Nationwide Distribution

## Key facts

- **Recall number:** Z-2064-2019
- **Recalling firm:** Fenwal Inc
- **Classification:** Class I
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-06-24
- **Report date:** 2019-08-21
- **Termination date:** 2023-03-06

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Lake Zurich, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2064-2019

## Citation

> AI Analytics. FDA recall Z-2064-2019. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/Z-2064-2019. Source: US FDA. Licensed CC0.

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