Reported Nov 5, 2025 · Ongoing
Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004.
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), Large Volume Pump
- Model NumberLVP-0004
- Lot codes and dates
- Model NumberLVP-0004
- UDI-DI00811505030320
- Serial Numbers
231860037823216001762333300359240300138392427564309243097443
- Amount recalled
- 6 units
Where it was sold
- Nationwide
- MN
Why it was recalled
Potential issue that can cause the device to register "phantom" touches in the lower-left corner of the touchscreen during operation.
This product could cause temporary or reversible health problems — stop using it.
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