Ivenix Infusion System (IIS), Large Volume Pump LVP-0004
Reported: December 27, 2023 Initiated: November 29, 2023 #Z-0549-2024
Product Description
Ivenix Infusion System (IIS), Large Volume Pump LVP-0004
Reason for Recall
The device may experience mechanical interference on the Fluid Valve pins, which will trigger a Pump Problem alarm. The issue may lead to delay or interruption of therapy. Depending on the therapy and duration of delay/interruption, the issue may lead to serious harm or death.
Details
- Recalling Firm
- Fresenius Kabi USA, LLC
- Units Affected
- 938 US
- Distribution
- US distribution to states of: CA, CO, NJ, UT, and WI.
- Location
- North Andover, MA
Frequently Asked Questions
What product was recalled? ▼
Ivenix Infusion System (IIS), Large Volume Pump LVP-0004. Recalled by Fresenius Kabi USA, LLC. Units affected: 938 US.
Why was this product recalled? ▼
The device may experience mechanical interference on the Fluid Valve pins, which will trigger a Pump Problem alarm. The issue may lead to delay or interruption of therapy. Depending on the therapy and duration of delay/interruption, the issue may lead to serious harm or death.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 27, 2023. Severity: Critical. Recall number: Z-0549-2024.
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