Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Software for the controlled administration of fluids to patients
FDA device recall Z-0885-2026 · posted 2025-12-16 · Open, Classified
Recall details
- Recalling firm
- Fresenius Kabi USA, LLC
- Reason for recall
- Software version 5.10.1 and earlier contain anomalies that have the potential to cause serious patient harm or death.
- Action taken
- 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.
- Root cause
- Software design
- Status
- Open, Classified
- Product code
- FRN
- Quantity affected
- 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.
- Date initiated
- 2025-11-14
- Date posted
- 2025-12-16
- 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 |