Fresenius Kabi USA, LLC recalls Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Indicated for use in a hospital and in outpatient care environments for the…
Large Volume Pump Software, version 5.9.2 and earlier has potential for the following anomalies: 1. The pump may become nonfunctional if during an alarm condition the Pause Audio option is repeated 70 time or more. 2.…
Read the official notice →- Date
- 2025-02-12
- Country
- United States
- Brand
- Fresenius Kabi
- Product
- Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Indicated for use in a hospital and in outpatient care environments for the…
- Classification
- Class I
- Units
- US distribution to CA, CO, GA, ID, MI, MS, NE, NJ, NV, OK, TX, UT, VA, WA, 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2025-11-05
USFresenius Kabi USA, LLC recalls Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004.
Potential issue that can cause the device to register "phantom" touches in the lower-left corner of the touchscreen during operation.
FDA · DeviceFresenius Kabi USA, LLCUS Nationwide distribution in the state of Minnesota.Official notice →- 2025-08-06
- US
Fresenius Kabi USA, LLC recalls LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site (Qty 25). Product Code: SET-0032-25.
Potential for external cassette leaks
FDA · DeviceFresenius Kabi USA, LLCUS Nationwide distribution in the states of CA, CO, DE, FL, GA, ID, IL, MA,…Official notice → - 2025-06-18
- US
Fresenius Kabi USA, LLC recalls IVENIX INFUSION SYSTEM LVP Blood Products Administration Set, Dual-Inlet, Low-Sorbing, Y-Site, Mesh Filter, 15 mL. Intravascular…
Mis-assembly error of Blood Products Administrations Sets where the 200-micron drip chamber filter may be incorrectly positioned and unable to filter out large blood particulates.
FDA · DeviceFresenius Kabi USA, LLCUS distribution: CA, CO, DE, GA, IL, MD, MI, MN, MS, NC, NJ, NV, OK, SC, TX,…Official notice → - 2025-01-15
- US
Fresenius Kabi USA, LLC recalls Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004
Potential pneumatic valve failure that may cause the LVP to stop an active infusion and/or could prevent the pump from being used.
FDA · DeviceFresenius Kabi USA, LLCUS distribution to states of: ID, MN, NV, TX, VA, WI.Official notice → - 2024-10-02
- US
Fresenius Kabi USA, LLC recalls Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004, Software Version 5.9.1 and prior. Infusion pump software for infusion management…
The software has anomalies that have the potential to cause alarms, nonfunctioning pump, or unresponsive screen while continuing therapy. These could cause serious patient harm or death.
- 2024-09-11
- US
Fresenius Kabi USA, LLC recalls LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site (Qty 25), Product Code: SET-0013-25. for intravenous…
A defect may cause an uncontrolled medication flow condition which may result in a dose greater than prescribed for the patient (i.e., medication overdose).
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- US
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