Ivenix Infusion System — Class I medical device recall Z-0002-2023
Terminated recall by Fresenius Kabi USA, LLC, reported 2022-10-12, distributed in NJ, WI. The display screen may become frozen and unresponsive to user input, triggering an alarm that is evidenced by
| Recall number | Z-0002-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Fresenius Kabi USA, LLC, North Andover, MA, United States |
| Recall initiated | 2022-09-08 |
| Classified | 2022-10-06 |
| Reported by FDA | 2022-10-12 |
| Terminated | 2024-09-10 |
| Distributed | NJ, WI |
| Quantity | 4 instances |
| UPC / GTIN / UDI-DI | 00811505030122 |
Product
Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004 version 5.2.0
Reason for recall
The display screen may become frozen and unresponsive to user input, triggering an alarm that is evidenced by a buzzer sound and flashing red LEDs as a secondary notification. However, as the screen goes blank it does not indicate an alarm condition or respond. This issue leads to temporary cessation of flow of a medication or fluid, requiring immediate intervention by the clinician.
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-0002-2023. 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.