FDA recall Z-0832-2022

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.

Distribution

US Nationwide distribution in the states of NC and OH.

Key facts

Status

Ongoing

Initiation date

2021-10-19

Report date

2022-04-06

Voluntary/Mandated

Voluntary: Firm initiated

Location

Natick, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0832-2022