Natick, MA, United States
InfuTronix LLC recalls
3 recalls recorded since 2018, most recently on 21 February 2024. 2 are listed as ongoing. Status and classification are as published by the FDA.
Recalls3
Ongoing (FDA)2
Terminated or completed1
Class I (FDA)1
Ongoing Class I Medical devices
- Recall started
- 21 February 2024
- Reason
- InfuTronix is removing the Nimbus Infusion Pump Systems from the market due to multiple potential failure modes, including battery failure, upstream occlusion, system errors, drug product leakage, high or low flow rate, or damaged pump housing. The device will not be available or supported after June 20, 2024.
- Distribution
- Domestic US distribution nationwide. No international distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1285-2024, Z-1286-2024
- Nimbus Administration Set; Nimbus Flex; Nimbus PainPro (a.k.a. Halo Ambulatory Infusion System); Catalog Number IT1025. Ambulatory Infusion Pump and components
- Nimbus II Infusion System; Nimbus II PainPRO IT1053; Nimbus II Flex IT1062; Nimbus II Plus IT1078; Nimbus II EpiD IT1124; Nimbus II EMS IT1063; Ambulatory Infusion Pump and components
Ongoing Class II Medical devices
- Recall started
- 19 October 2021
- 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.
- Distribution
- US Nationwide distribution in the states of NC and OH.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0832-2022
- 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
Terminated Class II Medical devices
- Recall started
- 28 May 2019
- Terminated
- 22 June 2020
- Reason
- Potential for tube leakage
- Distribution
- US distribution in the state of MA
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2055-2019
- Nimbus Administration Set, REF HS-004, UDI # 00817170020031 Product Usage: Administer fluids/medication from a container to a patient through a needle or a catheter.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.