Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004
Reported: January 15, 2025 Initiated: December 6, 2024 #Z-0763-2025
Product Description
Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004
Reason for Recall
Potential pneumatic valve failure that may cause the LVP to stop an active infusion and/or could prevent the pump from being used.
Details
- Recalling Firm
- Fresenius Kabi USA, LLC
- Units Affected
- 1,520 units
- Distribution
- US distribution to states of: ID, MN, NV, TX, VA, 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: 1,520 units.
Why was this product recalled? ▼
Potential pneumatic valve failure that may cause the LVP to stop an active infusion and/or could prevent the pump from being used.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 15, 2025. Severity: Critical. Recall number: Z-0763-2025.
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