FDA-Device2023-04-19Class I
Ivenix Infusion System (IIS), Large Volume Pump, Model No. LVP-0004
Fresenius Kabi USA, LLC
Hazard
Fluid ingress that can cause a loss of electrical funtion and failure of the Set ID Sensory, resulting in the prevention of infusion or halt of infusion.
Sold states
Domestic: CA, CO, NJ, WI, & UT. No foreign distribution.
Affected count
1,546 units
Manufactured in
50 High St Ste 50, N/A, North Andover, MA, United States
Products
Ivenix Infusion System (IIS), Large Volume Pump, Model No. LVP-0004
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1313-2023Don't want to check this manually?
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