Fenwal Volumat MC Agilia Infusion Pump Software Recall
Fenwal Inc is recalling Volumat MC Agilia infusion pumps to correct four software anomalies and an alarm priority issue in specific software versions.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class I, which typically indicates a low risk of adverse health consequences. The source text describes software corrections without reporting any specific injuries, illnesses, or deaths, fitting the criteria for a moderate severity score.
Plain-English summary
Fenwal Inc is recalling 9,461 units of the Volumat MC Agilia infusion pump, reference number Z021135. The recall covers devices distributed nationwide in the United States that are running software versions 1.7 and 1.9a of the Volumat MC Agilia software, as well as versions 1.0 and 1.1 of the Vigilant DrugLib software.
The recall is being conducted to correct four software anomalies and a specific issue regarding the priority of the Keep Vein Open (KVO) end-of-infusion alarm. The Volumat MC Agilia is a transportable medical device used in healthcare facilities by trained professionals to administer parenteral fluids, medications, and blood products to adult, pediatric, and neonatal patients.
Healthcare facilities should contact Fenwal Inc for instructions on how to correct the software anomalies and alarm priority issues. The source text does not specify a deadline for the correction or report any specific injuries or illnesses associated with these software versions.
The recalled product
- 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 hospit
- Manufacturer
- Fenwal Inc
- Category
- Medical Device — Infusion Pump
- Affected units
- 9,461
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All serial numbers distributed in the US
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Fenwal Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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