LVP Software of the Ivenix Infusion System (IIS), Version 5.8.0.

Reason: Software has anomalies that have the potential to cause underdose, overdose, or delay in therapy which could lead to serious patient harm or death.

Code information: Product LVP-SW-0004; UDI-DI 00811505030122.

Distribution pattern: US Distribution: CA, CO, ID, MI, NE, NJ, NV, OK, TX, UT, VA, WA, & WI.