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InfuTronix LLC FDA Recalls
3 recalls on file across devices, 2 of them Class I and 3 still open. This firm is not matched to a listed company.
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Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| Nimbus Administration Set; Nimbus Flex; Nimbus PainPro (a.k.a. Halo Ambulatory Infusion System); Catalog Number IT10Class IFeb 21, 2024InfuTronix is removing the Nimbus Infusion Pump Systems from |
| Nimbus II Infusion System; Nimbus II PainPRO IT1053; Nimbus II Flex IT1062; Nimbus II Plus IT1078; Nimbus II EpiD IClass IFeb 21, 2024InfuTronix is removing the Nimbus Infusion Pump Systems from |
| Nimbus PainPro Ambulatory Infusion Pumps with software version v4, Model Number IT1072, sold as kit IT1075-DUKE-HSP, IT1Class IIOct 19, 2021An unreleased Version 4 Protocol Library was installed on Ni |