FDA recall Z-1484-2024

Fresenius Kabi USA, LLC · Class I · device

Product

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

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.

Key facts

Status
Ongoing
Initiation date
2024-03-07
Report date
2024-04-17
Voluntary/Mandated
Voluntary: Firm initiated
Location
North Andover, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1484-2024