FDA-Device2025-01-15Class I
Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004
Fresenius Kabi USA, LLC
Hazard
Potential pneumatic valve failure that may cause the LVP to stop an active infusion and/or could prevent the pump from being used.
Sold states
US distribution to states of: ID, MN, NV, TX, VA, WI.
Affected count
1,520 units
Manufactured in
50 High St Ste 50, 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-0763-2025Don't want to check this manually?
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