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
| Status | Completed |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0002-2023 |
| Event ID | 90845 |
| Event Description | Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004 version 5.2.0 |
| Product Type | Devices |
| Distribution | Domestic distribution to NJ and WI. |
| Quantity | 4 instances |
| Recall Reason | The 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 Classification | 20221012 |
| Device Code Info | UDI-DI: 00811505030122 version 5.2.0 |
| Center Classification Date | 20221006 |
| Recall Initiation Date | 20220908 |
| Recalling Firm | Fresenius Kabi USA, LLC |
| Initial Notification | Telephone |
| Similar To |