Product Safety Recalls

Product Recall Tracker

Fresenius Kabi USA, LLC Recall 90845

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

Fresenius Kabi USA, LLC Recall 90845 Information

Mandated?Voluntary: Firm initiated
Recall NumberZ-0002-2023
Event ID90845
Event DescriptionIvenix Infusion System (IIS), LVP Software; LVP-SW-0004 version 5.2.0
Product TypeDevices
DistributionDomestic distribution to NJ and WI.
Quantity4 instances
Recall ReasonThe 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.
Device Classification20221012
Device Code InfoUDI-DI: 00811505030122 version 5.2.0
Center Classification Date20221006
Recall Initiation Date20220908
Recalling FirmFresenius Kabi USA, LLC
Initial Notification Telephone
Similar To

© 2022 Recall.Report / Contact / Privacy Policy

This site's data is aggregated programmatically and provided "as is" without any representations or warranties, express or implied. is not affiliated with the Consumer Product Safety Commision, FDA, or US government in any way.