Fresenius Kabi USA, LLC recalls Ivenix Infusion System (IIS), Large Volume Pump LVP-0004
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…
Read the official notice →- Date
- 2023-12-27
- Country
- United States
- Brand
- Fresenius Kabi
- Product
- Ivenix Infusion System (IIS), Large Volume Pump LVP-0004
- Classification
- Class I
- Units
- US distribution to states of: CA, CO, NJ, UT, and WI.
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More Fresenius Kabi recalls
- 2024-04-17
USFresenius Kabi USA, LLC recalls LVP Software of the Ivenix Infusion System (IIS), Version 5.8.0.
Software has anomalies that have the potential to cause underdose, overdose, or delay in therapy which could lead to serious patient harm or death.
FDA · DeviceFresenius Kabi USA, LLCUS Distribution: CA, CO, ID, MI, NE, NJ, NV, OK, TX, UT, VA, WA, & WI.Official notice →- 2024-03-20
- US
Fresenius Kabi USA, LLC recalls LVP software of the Ivenix Infusion System (IIS); LVP-SW-0004
Retroactively reported corrections from 2023: 1) A software defect may cause an incorrect (Fail-Stop) alarm when an administration set is loaded or coupled while the pump is executing the power-up sequence. May lead to…
FDA · DeviceFresenius Kabi USA, LLCUS Nationwide distribution to the states of CA, CO, NJ, WI, UT.Official notice → - US
Fresenius Kabi USA, LLC recalls LVP software of the Ivenix Infusion System (IIS), LVP-SW-0004
Retroactively reported correction from 2022: A software defect may cause an incorrect (Fail-Stop) Alarm when an administration set is loaded with an upstream occlusion present, resulting in a non-recoverable…
FDA · DeviceFresenius Kabi USA, LLCUS Nationwide distribution in the states of WI and NJ.Official notice → - 2023-10-04
- US
Fresenius Kabi USA, LLC recalls Ivenix Infusion System (IIS), Large Volume Pump (LVP) Software: 5.0.0 and 5.0.1 Part Number: LVP-SW-0004. Indicated for use in a hospital…
Start-up time for the flow rate range greater than 50 ml/hr, and less than 200 ml/hr may exceed the specified 6 minutes, depending on the characteristics of air bubble entrapment within the Intermediate Pumping Chamber…
FDA · DeviceFresenius Kabi USA, LLCUS Nationwide distribution in the states of NJ, WI.Official notice → - 2023-04-19
- US
Fresenius Kabi USA, LLC recalls Ivenix Infusion System (IIS), Large Volume Pump, Model No. LVP-0004
Fluid ingress that can cause a loss of electrical funtion and failure of the Set ID Sensory, resulting in the prevention of infusion or halt of infusion.
FDA · DeviceFresenius Kabi USA, LLCDomestic: CA, CO, NJ, WI, & UT. No foreign distribution.Official notice → - 2023-01-25
- US
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