Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004.
FDA device recall Z-0378-2026 · posted 2025-10-28 · Open, Classified
Recall details
- Recalling firm
- Fresenius Kabi USA, LLC
- Reason for recall
- Potential issue that can cause the device to register "phantom" touches in the lower-left corner of the touchscreen during operation.
- Action taken
- Fresenius Kabi notified the consignee on 09/03/2025 via email. The consignee was instructed to review the list of affected units and identify any on hand for return, remove all affected units from circulation pending repair and isolate them to avoid use, notify customers/personnel if the units were further distributed or transferred, and ensure all relevant personnel are aware. A Fresenius Kabi service representative will contact the consignee arrange for the return of affected units for repair.
- Root cause
- Process change control
- Status
- Open, Classified
- Product code
- FRN
- Quantity affected
- 6 units
- Distribution
- US Nationwide distribution in the state of Minnesota.
- Date initiated
- 2025-09-03
- Date posted
- 2025-10-28
- Location
- North Andover, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Ivenix Infusion System (IIS) (K183311) | Ivenix, Inc. | 2019-06-07 |