InfuTronix recalls

2 official recalls and safety alerts involving InfuTronix since 2022-04, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.

This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with InfuTronix or the relevant agency.

1. 2024-04-03
2. US
   Drugs & medicalClass I

   InfuTronix LLC recalls Nimbus Administration Set; Nimbus Flex; Nimbus PainPro (a.k.a. Halo Ambulatory Infusion System); Catalog Number IT1025. Ambulatory…

   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…

   FDA · DeviceInfuTronix LLCDomestic US distribution nationwide. No international distribution.Official notice →
3. 2022-04-06
4. US
   Drugs & medicalClass II

   InfuTronix LLC recalls Nimbus PainPro Ambulatory Infusion Pumps with software version v4, Model Number IT1072, sold as kit IT1075-DUKE-HSP, IT1076-DUKE-HSP and…

   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.

   FDA · DeviceInfuTronix LLCUS Nationwide distribution in the states of NC and OH.Official notice →