FDA recall Z-2635-2023

Fresenius Kabi USA, LLC · Class II · device

Product

Ivenix Infusion System (IIS), Large Volume Pump (LVP) Software: 5.0.0 and 5.0.1 Part Number: LVP-SW-0004. Indicated for use in a hospital and in outpatient care environments for the controlled administration of fluids through clinically accepted routes of administration.

Reason for recall

Start-up time for the flow rate range greater than 50 ml/hr, and less than 200 ml/hr may exceed the specified 6 minutes, depending on the characteristics of air bubble entrapment within the Intermediate Pumping Chamber (IPC) of the administration set

Distribution

US Nationwide distribution in the states of NJ, WI.

Key facts

Status
Ongoing
Initiation date
2022-04-22
Report date
2023-10-04
Voluntary/Mandated
Voluntary: Firm initiated
Location
North Andover, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2635-2023