FDA-Device2026-01-21Class IIPROCESSING DEFECT
Fresenius Kabi Ivenix Infusion System recalled for LVP duration programming instructions clarification
What this means
Fresenius Kabi is issuing a recall for the Ivenix Infusion System (IIS) with LVP Software version 5.10.2 and earlier. The manufacturer is emphasizing instructions for LVP duration programming in the device manual to ensure proper use. No injuries have been reported.
- Review the updated instructions for LVP duration programming in your device manual
- Contact Fresenius Kabi or your healthcare provider if you have questions about proper programming
- Check your device software version against the recall notice
The agency's original wording
Hazard
Emphasizing instructions for LVP duration programming located in the IFU.
Intended for
Adults
Illnesses reported
None reported
Sold states
US Nationwide distribution in the states of CA, CO, FL, GA, ID, IL, MD, MI, MI, MN, MS, NE, NJ, NV, OK, OR, SC, TX, VA, WA, WI, WI.
Affected count
30 units
Manufactured in
50 High St Ste 50, North Andover, MA, United States
Products
Ivenix Infusion System (IIS), LVP Software: LVP-SW-0005.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1048-2026More Fresenius Kabi recalls
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