Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Software for the controlled administration o
Pending LLM rewrite. Source: FDA_DEVICE Z-0885-2026.
Severity not yet assessed
We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.
Plain-English summary
Software version 5.10.1 and earlier contain anomalies that have the potential to cause serious patient harm or death.
The recalled product
- Product
- Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Software for the controlled administration of fluids to patients.
- Manufacturer
- Fresenius Kabi USA, LLC
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Software Versions 5.10.1 and prior
- UDI: 00811505030122.
Distribution
Distributed in 20 states:
- CA
- CO
- FL
- GA
- ID
- IL
- MD
- MI
- MN
- MS
- NE
- NJ
- NV
- OK
- OR
- SC
- TX
- VA
- WA
- WI
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