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InfuTronix LLC recalls Nimbus PainPro Ambulatory Infusion Pumps with software version v4, Model Number IT1072, sold as kit IT1075-DUKE-HSP, IT1
Recalled April 6, 2022 · FDA recall Z-0832-2022 · InfuTronix
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. · FDA Class II
Units
74 units
Sold at
US Nationwide distribution in the states of NC and OH.
Description
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.
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
Manufacturer(s)
InfuTronix LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →