FDA recall Z-0549-2024

Product

Ivenix Infusion System (IIS), Large Volume Pump LVP-0004

Reason for recall

The device may experience mechanical interference on the Fluid Valve pins, which will trigger a Pump Problem alarm. The issue may lead to delay or interruption of therapy. Depending on the therapy and duration of delay/interruption, the issue may lead to serious harm or death.

Distribution

US distribution to states of: CA, CO, NJ, UT, and WI.

Key facts

Status

Ongoing

Initiation date

2023-11-29

Report date

2023-12-27

Voluntary/Mandated

Voluntary: Firm initiated

Location

North Andover, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0549-2024