FDA-Device2022-04-06Class II
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
InfuTronix LLC
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.
Sold states
US Nationwide distribution in the states of NC and OH.
Affected count
74 units
Manufactured in
177 Pine St, N/A, Natick, MA, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0832-2022Don't want to check this manually?
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