FDA Medical Device Recalls (openFDA)
Fresenius Kabi USA, LLC: Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Software for the controlled administration of fluids to patients.
- Recall number
- Z-0885-2026
- Recalling firm
- Fresenius Kabi USA, LLC
- Product
- Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Software for the controlled administration of fluids to patients.
- Status
- Open, Classified
- Initiated
- 2025-11-14
- Posted
- 2025-12-16
- Terminated
- not on file
- Reason
- Software version 5.10.1 and earlier contain anomalies that have the potential to cause serious patient harm or death.
- Root cause
- Software design
- Action
- Consignees were emailed an "URGENT - Medical Device Field Correction" notice dated 11/14/25. The notice instructs consignees to review and become familiar with the provided notification's risk mitigation actions; the notice is to be forwarded if affected units were further distributed and users are to be notified. Consignees are to facilitate the installation of the new Ivenix Infusion Management System (version 5.2.2) and Large Volume Pump (5.10.2) software versions utilizing the provided instructions. Consignees are to note that the LVP will not be available for use during the update. Completed Customer Reply Forms may be sent via email to fkmd.fieldactions@fresenius-kabi.com. Customer questions can be directed to Customer Support via email at Ivenix_support@fresenius-kabi.com or by phone at 1-855-354-6387.
- Quantity
- 30 units
- Distribution
- US (Domestic) distribution: CA, CO, FL, GA, ID, IL, MD, MI, MN, MS, NE, NJ, NV, OK, OR, SC, TX, VA, WA & WI.
- Lot, serial or model codes
- Software Versions 5.10.1 and prior; UDI: 00811505030122.
- 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