InfuTronix LLC
InfuTronix LLC has 3 FDA enforcement events on this register (4 product records) between 2019 and 2024: 3 device; the busiest year was 2019 with 1.
33% of its events are Class I; the most common class is Class II (2). 2 events are listed as ongoing; the recalling firm's address is in MA.
Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.
Enforcement events
| Initiated | Product (first record) | Type | Class | Records | Status |
|---|---|---|---|---|---|
| 21 Feb 2024 | Nimbus Administration Set; Nimbus Flex; Nimbus PainPro (a.k.a. Halo Ambulatory Infusion System); Catalog Number IT1025. Ambulatory Infusion Pump and components | Device | Class I | 2 | Ongoing |
| 19 Oct 2021 | Nimbus PainPro Ambulatory Infusion Pumps with software version v4, Model Number IT1072, sold as kit IT1075-DUKE-HSP, IT1076-DUKE-HSP and IT1077-DUKE-HSP | Device | Class II | 1 | Ongoing |
| 28 May 2019 | Nimbus Administration Set, REF HS-004, UDI # 00817170020031 Product Usage: Administer fluids/medication from a container to a patient through a needle or a catheter. | Device | Class II | 1 | Terminated |
By type and class
Class I: 33% of this firm's events; 18% of all events on the register.
Events by year
Questions and answers
How many FDA recalls has InfuTronix LLC had?
3 enforcement events (4 product records) on this register, 2019–2024: 3 device.
Are any InfuTronix LLC recalls ongoing?
2 events are listed as ongoing in the current openFDA export.
What class are InfuTronix LLC recalls?
2 Class II, 1 Class I. 33% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.
Where does this data come from?
openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.
Provenance
Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.