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…
Read the official notice →- Date
- 2024-03-20
- Country
- United States
- Brand
- Fresenius Kabi
- Product
- LVP software of the Ivenix Infusion System (IIS); LVP-SW-0004
- Classification
- Class II
- Units
- US Nationwide distribution to the states of CA, CO, NJ, WI, UT.
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2024-10-02
USFresenius 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 → - 2024-03-20
- 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 → - 2023-12-27
- US
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…
FDA · DeviceFresenius Kabi USA, LLCUS distribution to states of: CA, CO, NJ, UT, and WI.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 →
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- 2024-03-20
- US
Baxter Healthcare Corporation recalls STERIS Boot Assembly, Traction Device, OT 1000, Part Number REF 10009192
Three lots of the Boot Assembly, Traction Device are being recalled due to due to a customer report of an incorrectly oriented locking pin which caused the boot to detach from the traction system. If an impacted device…
FDA · DeviceBaxter Healthcare CorporationUS Nationwide distribution in the state of Alabama.Official notice → - US
Peter Lazic Gmbh recalls L-Aneurysm Clip TITANIUM Paddle-Clip, permanent, 11 mm straight, Sterile
Wrong product coloring. The paddle clips should be blank, but they are colored blue.
- US
Medos International Sarl recalls CERENOVUS CEREBASE DA Guide Sheath, Part Numbers: a) GS9080SD; b) GS9090SD; c) GS9095SD; Vascular guide-catheter, single-use
Medos has received an increase in complaints for CEREBASE DA Guide Sheath with reports of fractures at the distal end, which may result in surgical procedural delay, vascular injury and in extreme rare occasions it may…
- 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 → - US
Siemens Healthcare Diagnostics, Inc. recalls Atellica IM Erythropoietin (EPO) Assay (100 Test)
Siemens Healthcare Diagnostics has confirmed an average negative bias of -35% compared to the 3rd World Health Organization (WHO) International Standard (NIBSC code: 11/170) that is proportional across the assay…
FDA · DeviceSiemens Healthcare Diagnostics, Inc.Worldwide - US Nationwide distribution in the states of AL, CA, IA, IL, MI,…Official notice → - US
Peter Lazic Gmbh recalls D-Clip Standard/Mini Applier, 230mm bayonet, jaw rigid, double action.
Customer complaint received that reported the applier failed during surgery. The applier did not release the clip. The applier remained attached to the clip.