IVENIX INFUSION SYSTEM — Class I medical device recall Z-0586-2026
Ongoing recall by Fresenius Kabi USA, LLC, reported 2025-12-10, distributed nationwide. Incorrect assembly of specific lot of LVP Primary Administration Set that could result in serious patient inju
| Recall number | Z-0586-2026 |
|---|---|
| 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 | 2025-11-03 |
| Classified | 2025-12-03 |
| Reported by FDA | 2025-12-10 |
| Distributed | Nationwide (US) |
| UPC / GTIN / UDI-DI | 00811505030214 |
| Lot numbers | FA25B03126 |
Product
IVENIX INFUSION SYSTEM, LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site (Qty 25). Large Volume Infusion Pump Administration Set.
Reason for recall
Incorrect assembly of specific lot of LVP Primary Administration Set that could result in serious patient injury.
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-0586-2026. 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.