InfuTronix LLC
InfuTronix LLC appears in FDA public data with 4 recalls — including 2 Class I (most serious) —, 0 510(k) clearances, 4 FDA inspections, and 1 compliance action on record. Its most recent recall (Z-1286-2024, Class I) was initiated on February 21, 2024.
Summary
- Total Recalls
- 4 (2 Class I)
- 510(k) Clearances
- 0
- Inspections
- 4
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-1286-2024 | Class I | Nimbus II Infusion System; Nimbus II PainPRO IT1053; Nimbus II Flex IT1062; Nimbus II Plus IT107 | February 21, 2024 |
| Z-1285-2024 | Class I | Nimbus Administration Set; Nimbus Flex; Nimbus PainPro (a.k.a. Halo Ambulatory Infusion System); | February 21, 2024 |
| Z-0832-2022 | Class II | Nimbus PainPro Ambulatory Infusion Pumps with software version v4, Model Number IT1072, sold as kit | October 19, 2021 |
| Z-2055-2019 | Class II | Nimbus Administration Set, REF HS-004, UDI # 00817170020031 Product Usage: Administer fluids/med | May 28, 2019 |