Fresenius Kabi USA, LLC Recall 94228
Description: LVP Software of the Ivenix Infusion System (IIS), Version 5.8.0.
Fresenius Kabi USA, LLC Recall 94228 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1484-2024 |
| Event ID | 94228 |
| Event Description | LVP Software of the Ivenix Infusion System (IIS), Version 5.8.0. |
| Product Type | Devices |
| Distribution | US Distribution: CA, CO, ID, MI, NE, NJ, NV, OK, TX, UT, VA, WA, & WI. |
| Quantity | 17 units |
| Recall Reason | Software has anomalies that have the potential to cause underdose, overdose, or delay in therapy which could lead to serious patient harm or death. |
| Device Classification | 20240417 |
| Device Code Info | Product LVP-SW-0004; UDI-DI 00811505030122. |
| Center Classification Date | 20240411 |
| Recall Initiation Date | 20240307 |
| Recalling Firm | Fresenius Kabi USA, LLC |
| Initial Notification | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
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