Ivenix Infusion System — Class I medical device recall Z-0549-2024
Ongoing recall by Fresenius Kabi USA, LLC, reported 2023-12-27, distributed in CA, CO, NJ, UT, WI. The device may experience mechanical interference on the Fluid Valve pins, which will trigger a Pump Problem a
| Recall number | Z-0549-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Fresenius Kabi USA, LLC, North Andover, MA, United States |
| Recall initiated | 2023-11-29 |
| Classified | 2023-12-20 |
| Reported by FDA | 2023-12-27 |
| Distributed | CA, CO, NJ, UT, WI |
| Quantity | 938 us |
| UPC / GTIN / UDI-DI | 00811505030320 |
| Serial numbers | 2118200008, 2118200011, 2119300411, 2119300414, 2119300415, 2119300417, 2119300421, 2119300422, 2119300424, 2119300426, 2119300428, 2119300429, 2119300430, 2119300431, 2119300432, 2119300434, 2119300435, 2119300436, 2119300437, 2119300438, 2119300439, 2119300442, 2124300052, 2124300058, 2124300060 and 475 more |
Product
Ivenix Infusion System (IIS), Large Volume Pump LVP-0004
Reason for recall
The device may experience mechanical interference on the Fluid Valve pins, which will trigger a Pump Problem alarm. The issue may lead to delay or interruption of therapy. Depending on the therapy and duration of delay/interruption, the issue may lead to serious harm or death.
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-0549-2024. 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.