Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004
Reason for Recall / Hazard
Fresenius Kabi has been made aware via customer complaints that dropping or severe jarring of the Ivenix LVP may cause damage to internal components that may not be apparent or readily visible and the devices therefore remained in service. More specifically, drops or jarring on a hard surface can cause the touchscreen input cable to loosen, resulting in unintended touchscreen behavior on the LVP, including random screen touches and/or lack of screen responsiveness to user input. Under the reported failure condition, unintended touch inputs may register at arbitrary screen locations without user interaction. These inputs occur intermittently and without a predictable pattern.
Product Description & Identification
Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004
Additional Source Details
| Field | Value |
|---|---|
| City | North Andover |
| State | MA |
| Event id | 98945 |
| Address 1 | 50 High St Ste 50 |
| Code info | Model Number: LVP-0004; UDI-DI: 00811505030320; All Serial/Lot Numbers: |
| Postal code | 01845-2620 |
| Report date | 20260610 |
| Product type | Devices |
| Product quantity | 18,444 |
| Reason for recall | Fresenius Kabi has been made aware via customer complaints that dropping or severe jarring of the Ivenix LVP may cause damage to internal components that may not be apparent or readily visible and the devices therefore remained in service. More specifically, drops or jarring on a hard surface can cause the touchscreen input cable to loosen, resulting in unintended touchscreen behavior on the LVP, including random screen touches and/or lack of screen responsiveness to user input. Under the reported failure condition, unintended touch inputs may register at arbitrary screen locations without user interaction. These inputs occur intermittently and without a predictable pattern. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260506 |
| Initial firm notification | |
| Center classification date | 20260529 |
Overview
- Recalling FirmFresenius Kabi USA, LLC
- StatusOngoing
- Risk LevelClass I
- DistributionDomestic: CA, CO, FL, GA, ID, IL, MD, MI, MI , MN, MO, MS, NE, NJ, NV, OK, OR, SC, TX, VA, WA, WI, WI;