FDA DevicesClass II
Ivenix Infusion System (IIS), LVP Software: LVP-SW-0005.
Published: January 21, 2026Recall ID: Z-1048-2026Category: devicesCountry: US
Reason for Recall / Hazard
Emphasizing instructions for LVP duration programming located in the IFU.
Product Description & Identification
Ivenix Infusion System (IIS), LVP Software: LVP-SW-0005.
Additional Source Details
| Field | Value |
|---|---|
| City | North Andover |
| State | MA |
| Event id | 98106 |
| Address 1 | 50 High St Ste 50 |
| Code info | Product Code: LVP-SW-0005; UDI: 00811505030122; Software versions 5.10.2 and prior. |
| Postal code | 01845-2620 |
| Report date | 20260121 |
| Product type | Devices |
| Product quantity | 30 units |
| Reason for recall | Emphasizing instructions for LVP duration programming located in the IFU. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20251121 |
| Initial firm notification | Letter |
| Center classification date | 20260112 |
Overview
- Recalling FirmFresenius Kabi USA, LLC
- StatusOngoing
- Risk LevelClass II
- DistributionUS Nationwide distribution in the states of CA, CO, FL, GA, ID, IL, MD, MI, MI, MN, MS, NE, NJ, NV, OK, OR, SC, TX, VA, WA, WI, WI.