|
|
Fresenius Kabi USA, LLC Recalls Ivenix Infusion Pump LVP Software for Anomalies That Have the Potential to Cause Serious Patient Harm or Death
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.
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Please be aware, this recall is a correction, not a product removal.
Questions?
If you have questions about this recall, contact Fresenius Kabi at 1-978-775-8100.
|
|
|
|
