Fenwal recalls Vigilant Drug Lib software versions 1.0 and 1.1 due to potential dose errors in patient medication administration. This software works with Volumat MC Agilia infusion pumps to reduce errors but requires specific patient weight ranges.
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
Fenwal is recalling Vigilant Drug Lib software versions 1.0 and 1.1 that can cause dose errors when used with Volumat MC Agilia infusion pumps. This software is designed to reduce medication errors but may not function correctly for patients outside the specified weight range.
The software may not correctly calculate medication doses for patients outside the specified weight range (0.6 lbs to 551 lbs), potentially leading to incorrect medication administration. This could result in dose errors if the software is used improperly or with incompatible patient weights.
Patients using Vigilant Drug Lib software with Volumat MC Agilia pumps for medication administration. Those with patients weighing outside the 0.6 lbs to 551 lbs range are at higher risk of dose errors.
Check for Vigilant Drug Lib software versions 1.0 and 1.1 installed on Volumat MC Agilia infusion pumps. The software is intended for patients weighing between 0.6 lbs and 551 lbs.
Install the corrected software version from Fenwal to ensure proper dose calculations for patients within the specified weight range.
The software is intended for patients weighing between 0.6 lbs and 551 lbs.
The recall addresses potential dose errors, but no specific serious injury mechanism is described in the record.
Check for Vigilant Drug Lib software versions 1.0 and 1.1 installed on Volumat MC Agilia infusion pumps.
We’ve drafted a message you can send Fenwal to request your refund or repair — edit it as you like.
Subject: Recall Z-2065-2019 — Fenwal Fenwal Hello, I own a Fenwal that is covered by recall Z-2065-2019 from Fenwal. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
