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
Status | Ongoing |
Mandated? | Voluntary: Firm initiated |
Recall Number | Z-3153-2024 |
Event ID | 95240 |
Event Description | Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004, Software Version 5.9.1 and prior. Infusion pump software for infusion management system. |
Product Type | Devices |
Distribution | US Nationwide. |
Quantity | 17 units |
Recall Reason | The 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 Classification | 20241002 |
Device Code Info | UDI-DI: 00811505030122; Software Version 5.9.1 and prior |
Center Classification Date | 20240926 |
Recall Initiation Date | 20240830 |
Recalling Firm | Fresenius Kabi USA, LLC |
Initial Notification | Letter |
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