Nimbus PainPro Ambulatory Infusion Pumps with software version v4 — Class II medical device recall Z-0832-2022
Ongoing recall by InfuTronix LLC, reported 2022-04-06, distributed nationwide. An unreleased Version 4 Protocol Library was installed on Nimbus PainPro (H) infusion pumps in error that may
| Recall number | Z-0832-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | InfuTronix LLC, Natick, MA, United States |
| Recall initiated | 2021-10-19 |
| Classified | 2022-03-29 |
| Reported by FDA | 2022-04-06 |
| Distributed | Nationwide (US) |
| Quantity | 74 units |
| UPC / GTIN / UDI-DI | 00817170020086 |
| Lot numbers | 2009231440 |
| Serial numbers | 807483, 807484, 807485, 807486, 807487, 807489, 807490, 807491, 807492, 807493, 807494, 807495, 807496, 807497, 807498, 807499, 807500, 807502, 807507, 807508, 807509, 807510, 807511, 807512, 807513 and 49 more |
| Model numbers | IT1072 |
Product
Nimbus PainPro Ambulatory Infusion Pumps with software version v4, Model Number IT1072, sold as kit IT1075-DUKE-HSP, IT1076-DUKE-HSP and IT1077-DUKE-HSP
Reason for 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0832-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.