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Fresenius Kabi USA, LLC Recall 95240

Description: Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004, Software Version 5.9.1 and prior. Infusion pump software for infusion management system.

Fresenius Kabi USA, LLC Recall 95240 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-3153-2024
Event ID95240
Event DescriptionIvenix Infusion System (IIS), LVP Software; LVP-SW-0004, Software Version 5.9.1 and prior. Infusion pump software for infusion management system.
Product TypeDevices
DistributionUS Nationwide.
Quantity17 units
Recall ReasonThe software has anomalies that have the potential to cause alarms, nonfunctioning pump, or unresponsive screen while continuing therapy. These could cause serious patient harm or death.
Device Classification20241002
Device Code InfoUDI-DI: 00811505030122; Software Version 5.9.1 and prior
Center Classification Date20240926
Recall Initiation Date20240830
Recalling FirmFresenius Kabi USA, LLC
Initial Notification Letter
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