Ivenix Infusion System (IIS), LVP Software: LVP-SW-0005.
FDA Recall Z-1048-2026 · Posted 2026-01-12
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Recalling FirmFresenius Kabi USA, LLC
Recall StatusOpen, Classified
Product CodeFRN
Date Initiated2025-11-21
Product Quantity30 units
Reason for Recall
Emphasizing instructions for LVP duration programming located in the IFU.
Firm Action
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 [email protected] or by phone at 1-855-354-6387.
Root Cause
Use error
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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