medical Class II Updated 2023-10-04

Fresenius Kabi USA, LLC recalls Ivenix Infusion System (IIS), Large Volume Pump (LVP) Softwa

Recalled 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.


Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: (UDI): 00811505030122 Software Version: 5.0.0 and 5.0.1
View official government recall

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