06
Apr
2022

Recall – Unreleased infusion pump software installed

,
0

Company: InfuTronix LLC
Date of Enforcement Report: 4/6/2022
Class II

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

Recall Number:

Z-0832-2022

REASON

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.

RECALLING FIRM/MANUFACTURER

InfuTronix LLC on 10/19/2021. Voluntary: Firm initiated

VOLUME OF PRODUCT IN COMMERCE

74 units

DISTRIBUTION

U.S. Nationwide

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