FDA-Device2025-11-05Class IIPROCESSING DEFECT
Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004.
Hazard
Potential issue that can cause the device to register "phantom" touches in the lower-left corner of the touchscreen during operation.
Who it affects
Adults
Illnesses reported
None reported
Sold states
US Nationwide distribution in the state of Minnesota.
Affected count
6 units
Manufactured in
50 High St Ste 50, N/A, North Andover, MA, United States
Products
Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0378-2026More Fresenius Kabi recalls
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