InfuTronix LLC
FDA Regulatory Profile
InfuTronix LLC has 4 FDA recalls (2 Class I), 4 inspections, 0 510(k) clearances and 1 compliance action on record.
- Latest recall
- Z-1286-2024 · Class I · Feb 21, 2024
- Latest inspection
- Aug 16, 2023 · OAI
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Summary
Record counts and when each FDA source was last refreshed
| Records | Count | Last refreshed | Source as of | Status |
|---|
| Recalls | 4 (2 Class I) | Nov 4, 2026 (checked Nov 8, 2026, unchanged) | File dated Nov 3, 2026 | Current |
|---|
| 510(k) clearances | 0 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
|---|
| Inspections | 4 | Nov 8, 2026 | Newest record Oct 28, 2026 | Current |
|---|
| Compliance actions | 1 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
|---|
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… | Feb 21, 2024 |
| Z-1285-2024 | Class I | Nimbus Administration Set; Nimbus Flex; Nimbus PainPro (a.k.a. Halo Ambulatory Infusion System)… | Feb 21, 2024 |
| Z-0832-2022 | Class II | Nimbus PainPro Ambulatory Infusion Pumps with software version v4, Model Number IT1072, sold as kit… | Oct 19, 2021 |
| Z-2055-2019 | Class II | Nimbus Administration Set, REF HS-004, UDI # 00817170020031 Product Usage: Administer… | May 28, 2019 |
Recent FDA Inspections
NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.
FDA-Inspected Facilities
| Facility | Location | Inspections | Latest |
|---|
| FEI 3011581906 | Natick, MA | 4 | Aug 16, 2023 |