Recall Z-0832-2022— InfuTronix LLC

Name: FDA recall Z-0832-2022
Creator: U.S. Food and Drug Administration
Published: 2021-10-19

Class II · Ongoing

Class II FDA medical device recall by InfuTronix LLC, initiated 2021-10-19. It names one FDA 510(k) clearance: K153193. 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: 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: InfuTronix LLC
Classification: Class II
Status: Ongoing
Initiated: 2021-10-19
Firm location: Natick, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K153193 — Halo II Ambulatory Infusion System (also with trade names Nimbus II Ambulatory Infusion System, EVAA Ambulatory Infusion System)Zyno Medical, LLC·cleared 2016-08-30

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.