Ivenix Infusion System — Class I medical device recall Z-0763-2025
Ongoing recall by Fresenius Kabi USA, LLC, reported 2025-01-15, distributed in ID, MN, NV, TX, VA, WI. Potential pneumatic valve failure that may cause the LVP to stop an active infusion and/or could prevent the p
| Recall number | Z-0763-2025 |
|---|---|
| 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 | 2024-12-06 |
| Classified | 2025-01-08 |
| Reported by FDA | 2025-01-15 |
| Distributed | ID, MN, NV, TX, VA, WI |
| Quantity | 1,520 units |
| UPC / GTIN / UDI-DI | 00811505030320 |
| Serial numbers | 2212200949, 2212200950, 2212200951, 2212200955, 2212200956, 2212200959, 2212200960, 2212200964, 2212200965, 2212200968, 2212200983, 2212200997, 2212200999, 2212201000, 2212201001, 2212201006, 2212201008, 2212201009, 2212201011, 2212201017, 2212201020, 2212201021, 2212201035, 2212201037, 2212201038 and 475 more |
| Model numbers | LVP-0004 |
Product
Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004
Reason for recall
Potential pneumatic valve failure that may cause the LVP to stop an active infusion and/or could prevent the pump from being used.
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-0763-2025. 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.