Ivenix Infusion System — Class II medical device recall Z-2635-2023
Ongoing recall by Fresenius Kabi USA, LLC, reported 2023-10-04, distributed nationwide. Start-up time for the flow rate range greater than 50 ml/hr, and less than 200 ml/hr may exceed the specified
| Recall number | Z-2635-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Fresenius Kabi USA, LLC, North Andover, MA, United States |
| Recall initiated | 2022-04-22 |
| Classified | 2023-09-25 |
| Reported by FDA | 2023-10-04 |
| Distributed | Nationwide (US) |
| Quantity | 1,344 pumps |
| UPC / GTIN / UDI-DI | 00811505030122 |
| Model numbers | LVP-SW-0004 |
Product
Ivenix Infusion System (IIS), Large Volume Pump (LVP) Software: 5.0.0 and 5.0.1 Part Number: LVP-SW-0004. Indicated for use in a hospital and in outpatient care environments for the controlled administration of fluids through clinically accepted routes of administration.
Reason for recall
Start-up time for the flow rate range greater than 50 ml/hr, and less than 200 ml/hr may exceed the specified 6 minutes, depending on the characteristics of air bubble entrapment within the Intermediate Pumping Chamber (IPC) of the administration set
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2635-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.