Ivenix Infusion System (IIS), LVP Software: LVP-SW-0005.
Pending LLM rewrite. Source: FDA_DEVICE Z-1048-2026.
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
Emphasizing instructions for LVP duration programming located in the IFU.
The recalled product
- Product
- Ivenix Infusion System (IIS), LVP Software: LVP-SW-0005.
- 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 (3)
- Product Code: LVP-SW-0005
- UDI: 00811505030122
- Software versions 5.10.2 and prior.
Distribution
Distributed nationwide across the United States.
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