FDA Medical Device Recalls (openFDA)
Fresenius Kabi USA, LLC: Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004.
- Recall number
- Z-0378-2026
- Recalling firm
- Fresenius Kabi USA, LLC
- Product
- Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004.
- Status
- Open, Classified
- Initiated
- 2025-09-03
- Posted
- 2025-10-28
- Terminated
- not on file
- Reason
- Potential issue that can cause the device to register "phantom" touches in the lower-left corner of the touchscreen during operation.
- Root cause
- Process change control
- Action
- 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.
- Quantity
- 6 units
- Distribution
- US Nationwide distribution in the state of Minnesota.
- Lot, serial or model codes
- Model Number: LVP-0004. UDI-DI: 00811505030320. Serial Numbers: 2318600378, 2321600176, 2333300359, 2403001383, 9242756430, 9243097443.
- 510(k) numbers
- ["K183311"]
- PMA numbers
- not on file
- Product code
- FRN
- Firm FEI
- 3014732157
- Firm city
- North Andover
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28