Reported Jan 21, 2026 · Ongoing
Ivenix Infusion System (IIS), LVP Software: LVP-SW-0005.
Fresenius Kabi USA, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Fresenius Kabi USA, LLC · 50 High St Ste 50 · North Andover, MA · 01845-2620
Is this the product you have?
- Ivenix Infusion System (IIS)
- LVP SoftwareLVP-SW-0005
- Lot codes and dates
- Product CodeLVP-SW-0005
- UDI
00811505030122Software versions 5.10.2 and prior
- Amount recalled
- 30 units
Where it was sold
Why it was recalled
Emphasizing instructions for LVP duration programming located in the IFU.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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