FDA recall Z-0002-2023

Fresenius Kabi USA, LLC · Class I · device

Product

Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004 version 5.2.0

Reason for recall

The display screen may become frozen and unresponsive to user input, triggering an alarm that is evidenced by a buzzer sound and flashing red LEDs as a secondary notification. However, as the screen goes blank it does not indicate an alarm condition or respond. This issue leads to temporary cessation of flow of a medication or fluid, requiring immediate intervention by the clinician.

Distribution

Domestic distribution to NJ and WI.

Key facts

Status: Terminated
Initiation date: 2022-09-08
Report date: 2022-10-12
Termination date: 2024-09-10
Voluntary/Mandated: Voluntary: Firm initiated
Location: North Andover, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0002-2023