VOLUMAT MC AGILIA US, Infusion Pump, REF Z021135, software… recallZ-2064-2019 · Fenwal Inc · initiated Jun 24, 2019
Class I Terminated All recalls posted in August 2019
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Fenwal Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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
FDA root cause category: Other
What the company is doing
The firm initiated the recall by letter on 06/24/2019. The letter describes the issues and provided supplemental instructions to be implemented until the new software is installed. The firm issued a press release on 06/28/2019.
Recall details
- Recall number
- Z-2064-2019
- Recall class
- Class I (most serious)
- Status
- Terminated
- Initiated by the company
- Jun 24, 2019
- Posted by the FDA
- Aug 12, 2019
- Recalling firm
- Fenwal Inc
- Quantity
- 9461 units
- Product code
- FRN
- FDA submissions
- K121613
- Distribution
- US Nationwide Distribution
Product description
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 professional can then operate the pump for that drug within the upper hard limits defined in the Drug Library.
Code information (models, lots, serial numbers)
All serial numbers distributed in the US
Other devices under the same FDA submission
9 devices cleared under K121613 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- VOLUMAT MC AGILIA US Z021135Fresenius Kabi AG · Pump, Infusion2 deaths102 reports
- Volumat™ Line VL SP40-11Fresenius Kabi AG · Pump, Infusion14 reports
- Volumat™ Line VL PR44-12Fresenius Kabi AG · Pump, Infusion12 reports
- Volumat™ Line VL SL00-XPFresenius Kabi AG · Pump, Infusion10 reports
- Volumat™ Line VL PN 02-1Fresenius Kabi AG · Pump, Infusion4 reports
- Volumat™ Line VL ST 02-0Fresenius Kabi AG · Pump, Infusion3 reports
- Volumat™ Line VL ST 10-0Fresenius Kabi AG · Pump, Infusion3 reports
- Volumat™ Line VL PR 72-11Fresenius Kabi AG · Pump, Infusion2 reports
- Volumat™ Line VL ON 72-1Fresenius Kabi AG · Pump, Infusion1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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