Agency classClass IOur severity:Severe FDA (Devices)·Z-2064-2019·Announced 2019-08-21

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.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "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"

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…
Manufacturer: Fenwal Inc
Category: Medical Device — Infusion Pump
Hazard: software-defect
alarm-priority
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.

See all 2 products in this recall →

Same manufacturer · Fenwal Inc

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Same hazard · software defect