FDA-Device2025-12-10Class IIPROCESSING DEFECT
Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004.
Hazard
Downstream Occlusion alarms may occur during procedures using low flow infusion rates when a check valve* is added to the Ivenix Administration Set.
Intended for
Adults
Illnesses reported
None reported
Sold states
US Nationwide distribution in the sates of CA, CO, FL, GA, ID, IL, MD, MI, MN, MS, NE, NJ, NV, OK, OR, SC, TX, UT, VA, WA, WI.
Affected count
15,862 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-0848-2026More Fresenius Kabi recalls
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