Ivenix Infusion System — Class I medical device recall Z-1313-2023
Ongoing recall by Fresenius Kabi USA, LLC, reported 2023-04-19, distributed in CA, CO, NJ, UT, WI. Fluid ingress that can cause a loss of electrical funtion and failure of the Set ID Sensory, resulting in the
| Recall number | Z-1313-2023 |
|---|---|
| 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 | 2023-03-10 |
| Classified | 2023-04-11 |
| Reported by FDA | 2023-04-19 |
| Distributed | CA, CO, NJ, UT, WI |
| Quantity | 1,546 units |
| UPC / GTIN / UDI-DI | 00811505030320 |
| Serial numbers | 2118200008, 2118200011, 2119300411, 2119300412, 2119300414, 2119300415, 2119300416, 2119300417, 2119300418, 2119300421, 2119300422, 2119300424, 2119300426, 2119300427, 2119300428, 2119300429, 2119300430, 2119300431, 2119300432, 2119300434, 2119300435, 2119300436, 2119300437, 2119300438, 2119300439 and 475 more |
| Model numbers | LVP-0004 |
Product
Ivenix Infusion System (IIS), Large Volume Pump, Model No. LVP-0004
Reason for recall
Fluid ingress that can cause a loss of electrical funtion and failure of the Set ID Sensory, resulting in the prevention of infusion or halt of infusion.
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-1313-2023. 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.