Company: Fresenius Kabi USA, LLC
Date of Enforcement Report: March 7, 2024
Class I
PRODUCT
LVP Software of the Ivenix Infusion System (IIS), Version 5.8.0.
Recall Number:
Z-1484-2024
REASON:
Fresenius Kabi USA, LLC. is recalling their Ivenix Infusion System (IIS), LVP Software, an infusion pump software. The recall will take the form of a software update. The reason for the recall is that multiple software anomalies were occurring that have the potential to result in serious patient harm or death.
To remedy this issue, Fresenius Kabi is releasing a new software version (5.9.1) for the Ivenix Large Volume Pump (LVP).
There have been no reports of injuries or deaths associated with this issue.
RECALLING FIRM/MANUFACTURER:
Fresenius Kabi USA, LLC
VOLUME OF PRODUCT IN COMMERCE:
17
DISTRIBUTION:
US Distribution: CA, CO, ID, MI, NE, NJ, NV, OK, TX, UT, VA, WA, & WI.
