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
Reported: April 6, 2022 Initiated: October 19, 2021 #Z-0832-2022
Product Description
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.
Details
- Recalling Firm
- InfuTronix LLC
- Units Affected
- 74 units
- Distribution
- US Nationwide distribution in the states of NC and OH.
- Location
- Natick, MA
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by InfuTronix LLC. Units affected: 74 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 6, 2022. Severity: Moderate. Recall number: Z-0832-2022.
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