InfuTronix LLC

FDA Regulatory Profile

Summary

Total Recalls
4 (2 Class I)
510(k) Clearances
0
Inspections
4
Compliance Actions
1

Recent Recalls

NumberClassProductDate
Z-1286-2024Class INimbus II Infusion System; Nimbus II PainPRO IT1053; Nimbus II Flex IT1062; Nimbus II Plus IT107February 21, 2024
Z-1285-2024Class INimbus Administration Set; Nimbus Flex; Nimbus PainPro (a.k.a. Halo Ambulatory Infusion System); February 21, 2024
Z-0832-2022Class IINimbus PainPro Ambulatory Infusion Pumps with software version v4, Model Number IT1072, sold as kit October 19, 2021
Z-2055-2019Class IINimbus Administration Set, REF HS-004, UDI # 00817170020031 Product Usage: Administer fluids/medMay 28, 2019