Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004.
Reported: December 10, 2025 Initiated: November 3, 2025 #Z-0848-2026
Product Description
Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004.
Reason for Recall
Downstream Occlusion alarms may occur during procedures using low flow infusion rates when a check valve* is added to the Ivenix Administration Set.
Details
- Recalling Firm
- Fresenius Kabi USA, LLC
- Units Affected
- 15,862 units
- Distribution
- US Nationwide distribution in the sates of CA, CO, FL, GA, ID, IL, MD, MI, MN, MS, NE, NJ, NV, OK, OR, SC, TX, UT, VA, WA, WI.
- Location
- North Andover, MA
Frequently Asked Questions
What product was recalled? ▼
Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004.. Recalled by Fresenius Kabi USA, LLC. Units affected: 15,862 units.
Why was this product recalled? ▼
Downstream Occlusion alarms may occur during procedures using low flow infusion rates when a check valve* is added to the Ivenix Administration Set.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 10, 2025. Severity: Moderate. Recall number: Z-0848-2026.
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