Lower risk Medical device recall · FDA · Published October 19, 2021

InfuTronix Nimbus PainPro Pumps with v4 Software May Impact Patient Safety

InfuTronix recalls Nimbus PainPro Ambulatory Infusion Pumps with software version v4 (Model IT1072) sold as kits IT1075-DUKE-HSP, IT1076-DUKE-HSP, and IT1077-DUKE-HSP. Unreleased Version 4 Protocol Library may impact patient safety if used on patients.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0832-2022Medical device InfuTronix ›

Lower-risk recall

An unreleased Version 4 Protocol Library was installed on Nimbus PainPro (H) infusion pumps in error that may impact patient safety if used on patients.

Take action

Contact the company

Recalling firmInfuTronix LLC177 Pine St · Natick, MA 01760-1331

✎ GovInfoNow plain-language explainer

InfuTronix is recalling Nimbus PainPro Ambulatory Infusion Pumps with software version v4 (Model IT1072) sold as specific kits. The recall is due to an unreleased Version 4 Protocol Library that could impact patient safety if used on patients. This affects patients receiving pain management through these pumps. Read more at govinfonow.com/recall/61660-infutronix-nimbus-painpro-pumps-with-v4-software-may-impact-patient.

Source Summary by GovInfoNow · govinfonow.com/recall/61660-infutronix-nimbus-painpro-pumps-with-v4-software-may-impact-patient · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0832-2022

Cite this page

“InfuTronix Nimbus PainPro Pumps with v4 Software May Impact Patient Safety.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61660-infutronix-nimbus-painpro-pumps-with-v4-software-may-impact-patient. Based on FDA recall #Z-0832-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0832-2022%22&limit=1).

InfuTronix LLC voluntarily recalled Nimbus PainPro Ambulatory Infusion Pumps with software version v4, Model Number IT1072, due to an error installing an unreleased Version 4 Protocol Library that may impact patient safety. The Food and Drug Administration announced the Class II recall on October 19, 2021.

How to tell if you have it

Brand: InfuTronix
Product: Nimbus PainPro Ambulatory Infusion Pumps with software version v4
Model Number: IT1072
Kit: IT1075-DUKE-HSP, IT1076-DUKE-HSP and IT1077-DUKE-HSP
UPC: 00817170020086
Lot: 2009231440
Serial Numbers: 807483, 807484, 807485, 807486, 807487, 807489, 807490, 807491, 807492, 807493, 807494, 807495, 807496, 807497, 807498, 807499, 807500, 807502, 807651, 807652, 807653, 807507, 807508, 807509, 807510, 807511, 807512, 807513, 807514, 807515, 807516, 807517, 807518, 807519, 807520, 807521, 807522, 807523, 807524, 807525, 807526, 807527, 807528, 807529, 807530, 807531, 807532, 807533, 807534, 807535, 807536, 807537, 807538, 807539, 807540, 807541, 807542, 807543, 807544, 807545, 807546, 807547, 807548, 807549, 807550, 807551, 807552, 807553, 807554, 807654, 807655, 807656, 807657, 807658
Distribution: US Nationwide distribution in the states of NC and OH

The hazard

An unreleased Version 4 Protocol Library was installed on Nimbus PainPro (H) infusion pumps in error that may impact patient safety if used on patients.

Context

GovInfoNow's records show InfuTronix LLC has 2 other recalls on record since 2019-05-28. Other recent recalls of similar products include Fresenius Kabi Ivenix Infusion System Software Recall (2025-11-14), Baxter Novum IQ Syringe Pump Recall (2026-08-11) and B Braun Medical: Infusomat pumps may cause medication backflow in IV systems (2025-10-29).

How to tell if you have this one

Check for software version v4 on Nimbus PainPro pumps with Model Number IT1072. The kits sold include IT1075-DUKE-HSP, IT1076-DUKE-HSP, and IT1077-DUKE-HSP. Serial numbers listed in the recall include 807483 to 807554 (with some exceptions).

Brand
InfuTronix
Product
Nimbus PainPro Ambulatory Infusion Pumps with software version v4, Model Number IT1072, sold as kit IT1075-DUKE-HSP
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Software Version
Verify the software version on your pump; affected units have version v4.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 2 states.

FDA distribution: “US Nationwide distribution in the states of NC and OH.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: North Carolina, Ohio.

Recall timeline

FDA published this recall 6 months after the firm started it.

Oct 19, 2021Firm started the recall
Mar 29, 2022FDA classified it Class II
Apr 6, 2022Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

Similar recalls

Latest medical device recalls

Keep exploring

More InfuTronix recalls

Link to this recall

<a href="https://govinfonow.com/recall/61660-infutronix-nimbus-painpro-pumps-with-v4-software-may-impact-patient">InfuTronix Nimbus PainPro Pumps with v4 Software May Impact Patient Safety (GovInfoNow)</a>

Where this comes from

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.

Official source: FDA Recall #Z-0832-2022 (October 19, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0832-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.