CLASS I Device recall · Reported 21 Aug 2019 · FDA Enforcement Report
Volumat MC Agilia US, Infusion Pump recalled by Fenwal
Fenwal is recalling Volumat MC Agilia US, Infusion Pump, distributed nationwide in the US. The recall was initiated on 24 Jun 2019 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2064-2019
- FDA event ID
- 83138
- Recalling firm
- Fenwal, Lake Zurich, IL
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 24 Jun 2019
- FDA classified
- 12 Aug 2019
- Reported
- 21 Aug 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Infusion Pumps
Timeline
| 24 Jun 2019 | Recall initiated by company | |
| 12 Aug 2019 | Classified by FDA | +49 days |
| 21 Aug 2019 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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.
Where it was distributed
US Nationwide Distribution
Questions about this recall
Why was it 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
Which lots are affected?
All serial numbers distributed in the US
Where was it sold?
US Nationwide Distribution
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 83138This product is part of a recall event; the main page for the event is Vigilant Agilia, Vigilant Drug'Lib recalled by Fenwal.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS I | Vigilant Agilia, Vigilant Drug'Lib recalled by Fenwal | Fenwal | Device Malfunction | Nationwide |
More recalls from Fenwal
All 10| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Amicus MNC Apheresis Kit Double Needle recalled by Fenwal | Fenwal | Packaging Defects | Nationwide |
| Device | CLASS II | Amicus Exchange Kit Therapeutics recalled by Fenwal | Fenwal | Packaging Defects | Nationwide |
| Device | CLASS II | Amicus Exchange Kit Therapeutics recalled by Fenwal | Fenwal | Packaging Defects | Nationwide |
| Device | CLASS II | Amicus MNC Apheresis Kit - Double Needle recalled by Fenwal | Fenwal | Packaging Defects | Nationwide |
| Device | CLASS II | Amicus Exchange Kit recalled by Fenwal | Fenwal | Packaging Defects | Nationwide |
Other Infusion Pumps recalls
All 546| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Baxter Novum IQ Syringe Pump, Loaner recalled by Baxter Healthcare | Baxter Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Baxter Novum IQ Syringe Pump recalled by Baxter Healthcare | Baxter Healthcare | Device Malfunction | Nationwide |
| Device | CLASS I | Baxter Duo-Vent Solution Set and Male Luer Lock Adapter recalled | Baxter Healthcare | Other | Nationwide |
| Device | CLASS II | Plum Solo Precision IV Pump, v1.0.3 recalled by ICU Medical | ICU Medical | Other | Nationwide |
| Device | CLASS II | Intera Oncology Intera 3000 Hepatic Artery Infusion Pump recalled | Boston Scientific | Packaging Defects | Nationwide |