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.
Read the official notice →- Date
- 2025-01-15
- Country
- United States
- Brand
- Fresenius Kabi
- Product
- Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004
- Classification
- Class I
- Units
- US distribution to states of: ID, MN, NV, TX, VA, 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2025-08-06
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 →- 2025-02-12
US
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.…
FDA · DeviceFresenius Kabi USA, LLCUS distribution to CA, CO, GA, ID, MI, MS, NE, NJ, NV, OK, TX, UT, VA, WA, 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).
- 2024-04-17
US
Fresenius 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 →
Other drugs & medical recalls in the United States
- 2025-01-15
US
Greiner Bio-One GmbH recalls VACUETTE SAFELINK, REF: 450210
The VACUETTE SAFELINK Holder with male luer lock may leak blood due to the protective rubber sleeve bunching up and not retracting when using the device.
FDA · DeviceGreiner Bio-One GmbHUS Nationwide distribution in the states of IL, PA.Official notice →US
Fresenius Medical Care Holdings, Inc. recalls Dialyzer Optiflux 160NRe
Potential for internal blood leaks due to cracked polyurethane
US
JIANGSU JUMAO X-CARE MEDICAL EQUIPMENT CO LTD recalls JMC5A Ni/TruAire-5 Oxygen Concentrator, Model: O2C5L
Oxygen concentrator may melt or catch on fire during use.
US
Maquet Cardiovascular, LLC recalls VasoView HemoPro 2 Endoscopic Vessel Harvesting System. Model Numbers: VH-4000. Indicated for use in minimally invasive surgery…
Potential for two issues: 1. Bent or detached heater wire; 2. Silicone peeling or detaching from the Jaws of the Harvesting Tool
FDA · DeviceMaquet Cardiovascular, LLCNationwide distribution. International distribution to Australia, Austria,…Official notice →US
Granules Pharmaceuticals Inc. recalls Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 1000-count bottles, Rx Only, Manufactured by: Granules India…
Presence of Foreign Tablets/Capsules: A Paracetamol 500 mg tablet was found in a 1000-count bottle of Metformin HCL ER Tablets USP, 500 mg.
US