Ivenix Infusion System (IIS), LVP Software: LVP-SW-0005.
Reported: January 21, 2026 Initiated: November 21, 2025 #Z-1048-2026
Product Description
Ivenix Infusion System (IIS), LVP Software: LVP-SW-0005.
Reason for Recall
Emphasizing instructions for LVP duration programming located in the IFU.
Details
- Recalling Firm
- Fresenius Kabi USA, LLC
- Units 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.
- Location
- North Andover, MA
Frequently Asked Questions
What product was recalled? ▼
Ivenix Infusion System (IIS), LVP Software: LVP-SW-0005.. Recalled by Fresenius Kabi USA, LLC. Units affected: 30 units.
Why was this product recalled? ▼
Emphasizing instructions for LVP duration programming located in the IFU.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 21, 2026. Severity: Moderate. Recall number: Z-1048-2026.
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