Ivenix Infusion System (IIS), LVP Software: LVP-SW-0005.
FDA device recall Z-1048-2026 · posted 2026-01-12 · Open, Classified
Recall details
- Recalling firm
- Fresenius Kabi USA, LLC
- Reason for recall
- Emphasizing instructions for LVP duration programming located in the IFU.
- Action taken
- An URGENT MEDICAL DEVICE CORRECTION notification dated 11/21/25 was sent to consignees notifying them of this safety alert. The notification reiterates instructions for administering infusions included in the device's IFU. Fresenius Kabi asks consignees to disseminate the notification to all users and any facilities where devices may have been further distributed for their awareness. Consignees with any questions are to contact Customer Support by email at Ivenix_support@fresenius-kabi.com or by phone at 1-855-354-6387.
- Root cause
- Use error
- Status
- Open, Classified
- Product code
- FRN
- Quantity affected
- 30 units
- Distribution
- US Nationwide distribution in the states of CA, CO, FL, GA, ID, IL, MD, MI, MI, MN, MS, NE, NJ, NV, OK, OR, SC, TX, VA, WA, WI, WI.
- Date initiated
- 2025-11-21
- Date posted
- 2026-01-12
- 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 |