Company: InfuTronix LLC
Date of Enforcement Report: 4/6/2022
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
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.
InfuTronix LLC on 10/19/2021. Voluntary: Firm initiated
VOLUME OF PRODUCT IN COMMERCE