FDA-Device2023-12-27Class I
Ivenix Infusion System (IIS), Large Volume Pump LVP-0004
Fresenius Kabi USA, LLC
Hazard
The device may experience mechanical interference on the Fluid Valve pins, which will trigger a Pump Problem alarm. The issue may lead to delay or interruption of therapy. Depending on the therapy and duration of delay/interruption, the issue may lead to serious harm or death.
Sold states
US distribution to states of: CA, CO, NJ, UT, and WI.
Affected count
938 US
Manufactured in
50 High St Ste 50, N/A, North Andover, MA, United States
Products
Ivenix Infusion System (IIS), Large Volume Pump LVP-0004
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0549-2024Don't want to check this manually?
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