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).
Read the official notice →- Date
- 2024-09-11
- Country
- United States
- Brand
- Fresenius Kabi
- Product
- LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site (Qty 25), Product Code: SET-0013-25. for intravenous…
- Classification
- Class I
- Units
- US Distribution to states of: CO, ID, NJ, 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2025-02-12
USFresenius 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 →- 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.
- 2024-04-17
- 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 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 →
Other drugs & medical recalls in the United States
- 2024-09-11
- US
CareFusion 303, Inc. recalls BKIT BD Pyxis QFill Replenishment Station, REF: 155197-01, medication cabinet system
Due to software issue, there is a potential when a restock label is printed for a medication stored in a non-CUBIE location, that the incorrect bin for the medication is printed on the label.
FDA · DeviceCareFusion 303, Inc.US Nationwide distribution in the states of CA, FL, KS, MN, NJ, NY, PA.Official notice → - US
W L Gore & Associates, Inc. recalls Heparin, Gore Viabahn VBX, Balloon Expandable Endoprosthesis, for the following Reference numbers: United States: BXB051501A…
Due to packaging defects, sterility assurance and heparin activity may be compromised.
FDA · DeviceW L Gore & Associates, Inc.Worldwide - US Nationwide distribution including in the states of AK, AL, AR,…Official notice → - US
Philips Respironics, Inc. recalls Trilogy Evo; Model No./Model Description -- AU2110X15B Trilogy Evo, Australia BL2110X15B Trilogy Evo, Benelux BR2110X18B Trilogy Evo,…
Firm has released a mandatory software update Version 1.05.10.00 and a User Manual addendum for affected ventilators. These updates resolve safety issues identified in earlier recalls.
FDA · DevicePhilips Respironics, Inc.Worldwide distribution: US (nationwide) and OUS (foreign) countries of: AU,…Official notice → - US
Breas Medical, Inc. recalls Vivo 45 LS, pressure and volume ventilator capable of delivering continuous or intermittent ventilatory support for patients who require…
There is a potential for short term (<7 days) elevated levels of formaldehyde emitted from the device into the patient breathing airpath in specific conditions.
- US
Beckman Coulter, Inc. recalls DxI 9000 Access Immunoassay Analyzer, REF C11137, vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative…
Beckman Coulter manufacturing discovered cracks around a threaded insert on the bottom of the Internal Wash Buffer Tank that is used within the Wash Buffer Supply Drawer on the DxI 9000.This can result in leaking,…
FDA · DeviceBeckman Coulter, Inc.Worldwide - US Nationwide distribution in the state of New Hampshire and the…Official notice → - US