Class I
Medical Device Recall: LVP Software of the Ivenix Infusion System (IIS), Version 5.8.0.
Fresenius Kabi USA, LLC · March 7, 2024
Reason for Recall
Software has anomalies that have the potential to cause underdose, overdose, or delay in therapy which could lead to serious patient harm or death.
Distribution
US Distribution: CA, CO, ID, MI, NE, NJ, NV, OK, TX, UT, VA, WA, & WI.
States Affected
CA, CO, ID, MI, NE, NJ, NV, OK, TX, UT, VA, WA, WI
Quantity Affected
17 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1484-2024
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.