Fenwal Recalls Vigilant Agilia and Volumat MC Agilia Infusion Pump Software
Fenwal Inc is recalling 83 units of Vigilant Agilia and Volumat MC Agilia software to correct four anomalies and an alarm priority issue.
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 classification is FDA Class I, which mandates a minimum severity score of 4 according to the rubric.
Plain-English summary
Fenwal Inc is recalling 83 units of Vigilant Agilia and Volumat MC Agilia software, specifically versions 1.0 and 1.1 of Vigilant DrugLib and versions 1.7 and 1.9a of Volumat MC Agilia Software. The recall covers all serial numbers distributed in the US.
The firm is correcting four software anomalies and a KVO (keep vein open) end of infusion alarm priority issue. Vigilant DrugLib is dose error reduction software intended to be used with Volumat MC Agilia infusion pumps to reduce drug administration errors at the bedside. The software is intended for patients weighing between 250g and 250 kg.
The agency has classified this recall as Class I. Users should contact Fenwal Inc for further instructions on correcting the software anomalies.
The recalled product
- Product
- Vigilant Agilia, Vigilant Drug'Lib, REF Z073476, versions 1.0 and 1.1 Product Usage: Vigilant Drug Lib is Dose Error Reduction Software that, when used in combination with Volumat MC Agilia infusion pumps, is intended to reduce drug administration errors at the bedside.…
- Manufacturer
- Fenwal Inc
- Affected units
- 83
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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