Reported Dec 24, 2025 · Ongoing
Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Software for the controlled administration of fluids to…
Fresenius Kabi USA, LLC
High riskUsing this product could cause serious injury, illness or death — stop using it now.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 Software LVP-SW-0005. Software for the controlled administration of fluids to patients.
- Lot codes and dates
- Software Versions 5.10.1 and prior
- UDI00811505030122
- Amount recalled
- 30 units
Where it was sold
Why it was recalled
Stop using this product now
Software version 5.10.1 and earlier contain anomalies that have the potential to cause serious patient harm or death.
Using this product could cause serious injury, illness or death — stop using it now.
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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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