FDA DevicesClass II
The Large Volume Pump (LVP) of the Ivenix Infusion System (IIS). Model Number: L...
Published: June 10, 2026Recall ID: Z-2274-2026Category: devicesCountry: US
Reason for Recall / Hazard
Potential for the Cassette Loading Lever to break.
Product Description & Identification
The Large Volume Pump (LVP) of the Ivenix Infusion System (IIS). Model Number: LVP-0004.
Additional Source Details
| Field | Value |
|---|---|
| City | North Andover |
| State | MA |
| Event id | 98699 |
| Address 1 | 50 High St Ste 50 |
| Code info | Model Number: LVP-0004. UDI-DI: 00811505030320 |
| Postal code | 01845-2620 |
| Report date | 20260610 |
| Product type | Devices |
| Product quantity | 18,444 installed bases |
| Reason for recall | Potential for the Cassette Loading Lever to break. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260204 |
| Initial firm notification | |
| Center classification date | 20260529 |
Overview
- Recalling FirmFresenius Kabi USA, LLC
- StatusOngoing
- Risk LevelClass II
- DistributionUS Nationwide distribution in the states of CA, CO, FL, GA, ID, IL, MA, MD, ME, MI, MN, MS, NE, NJ, NV, OK, OR, SC, TX, VA, WA, WI.