Data / Medical devices / United States / Fresenius Kabi USA, LLC
Fresenius Kabi USA, LLC: FDA-registered device maker in North Andover, MA, United States, 2 510(k) clearances
Fresenius Kabi USA, LLC is registered with the FDA (registration 3014732157) in North Andover, MA, United States. It lists 3 device types. The FDA files 2 510(k) clearances under its listings, the newest dated November 10, 2021. 22 recall events name it as the recalling firm (13 Class I). Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3014732157
- Address
- 50 High Street Suite 50, North Andover, MA, United States, 01845
- Owner or operator
- Fresenius Kabi AG (9027285)
- Roles
- Manufacturer, Specification developer
- First device listed
- May 4, 2022
- Registered through
- 2026
- Brand names listed
- Ivenix Infusion System (IIS)
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Infusion Safety Management Software | PHC | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Pump, Infusion | FRN | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Set, Administration, Intravascular | FPA | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| November 10, 2021 | K213089 | Ivenix Infusion System, LVP Epidural Administraion Set NRFit Connector | FPA | Substantially Equivalent | Ivenix, Inc. | accessdata.fda.gov |
| June 7, 2019 | K183311 | Ivenix Infusion System (IIS) | FRN | Substantially Equivalent | Ivenix, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| May 6, 2026 | 98945 | Class I | Ongoing | Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004 | Fresenius Kabi has been made aware via customer complaints that dropping or severe jarring of the Ivenix LVP may cause damage to internal components that may not be apparent or readily visible and the devices therefore remained in service. More specifically, drops or jarring on a hard surface can cause the touchscreen input cable to loosen, resulting in unin | accessdata.fda.gov |
| May 6, 2026 | 98929 | Class I | Ongoing | LVP software of the Ivenix Infusion System (IIS); Product Code LVP-SW-0005. | Potential software anomaly that can cause the pump to report a false battery-health value (typically 69%) and trigger a battery-depletion alarm that will shut down the pump unless it is reconnected to AC mains power. | accessdata.fda.gov |
| February 4, 2026 | 98699 | Class II | Ongoing | The Large Volume Pump (LVP) of the Ivenix Infusion System (IIS). Model Number: LVP-0004. | Potential for the Cassette Loading Lever to break. | accessdata.fda.gov |
| November 21, 2025 | 98106 | Class II | Ongoing | Ivenix Infusion System (IIS), LVP Software: LVP-SW-0005. | Emphasizing instructions for LVP duration programming located in the IFU. | accessdata.fda.gov |
| November 14, 2025 | 98009 | Class I | Ongoing | Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Software for the controlled administration of fluids to patients. | Software version 5.10.1 and earlier contain anomalies that have the potential to cause serious patient harm or death. | accessdata.fda.gov |
| November 3, 2025 | 97941 | Class I | Ongoing | IVENIX INFUSION SYSTEM, LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site (Qty 25). Large Volume Infusion Pump Administration Set. | Incorrect assembly of specific lot of LVP Primary Administration Set that could result in serious patient injury. | accessdata.fda.gov |
| November 3, 2025 | 97939 | Class II | Ongoing | Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004. | Downstream Occlusion alarms may occur during procedures using low flow infusion rates when a check valve* is added to the Ivenix Administration Set. | accessdata.fda.gov |
| September 3, 2025 | 97554 | Class II | Ongoing | 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. | accessdata.fda.gov |
| June 24, 2025 | 97165 | Class II | Ongoing | LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site (Qty 25). Product Code: SET-0013-25. | Potential for external cassette leaks | accessdata.fda.gov |
| May 12, 2025 | 96880 | Class I | Ongoing | IVENIX INFUSION SYSTEM LVP Blood Products Administration Set, Dual-Inlet, Low-Sorbing, Y-Site, Mesh Filter, 15 mL. Intravascular Administration Set. | 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. | accessdata.fda.gov |
| January 10, 2025 | 96085 | Class I | Ongoing | Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Indicated for use in a hospital and in outpatient care environments for the controlled administration of fluids through clinically accepted routes of administration | 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. If a secondary infusion is started at the exact moment a primary infusion completes and VTBI reaches 0, it will switch to primary. The primary | accessdata.fda.gov |
| December 6, 2024 | 95891 | Class I | Ongoing | 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. | accessdata.fda.gov |
| August 30, 2024 | 95240 | Class I | Ongoing | Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004, Software Version 5.9.1 and prior. Infusion pump software for infusion management system. | 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. | accessdata.fda.gov |
| August 1, 2024 | 95113 | Class I | Ongoing | LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site (Qty 25), Product Code: SET-0013-25. for intravenous infusion. | 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). | accessdata.fda.gov |
| March 7, 2024 | 94228 | Class I | Ongoing | 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. | accessdata.fda.gov |
| November 29, 2023 | 93474 | Class I | Ongoing | 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 delay/interruption, the issue may lead to serious harm or death. | accessdata.fda.gov |
| May 10, 2023 | 93968 | Class II | Completed | 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 delay in therapy. 2) Alert is not annunciated informing the clinician that the bolus cannot be delivered when the entered bolus dose exceeds | accessdata.fda.gov |
| March 10, 2023 | 91783 | Class I | Ongoing | 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. | accessdata.fda.gov |
| September 16, 2022 | 93958 | Class II | Completed | 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 (Fail-Stop) Pump Problem alarm. This may lead to delay of therapy, and patient may experience from no to minimal to serious harm. This issue was resolve | accessdata.fda.gov |
| September 8, 2022 | 90845 | Class I | Terminated | Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004 version 5.2.0 | The display screen may become frozen and unresponsive to user input, triggering an alarm that is evidenced by a buzzer sound and flashing red LEDs as a secondary notification. However, as the screen goes blank it does not indicate an alarm condition or respond. This issue leads to temporary cessation of flow of a medication or fluid, requiring immediate inte | accessdata.fda.gov |
| April 22, 2022 | 92973 | Class II | Ongoing | 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 and in outpatient care environments for the controlled administration of fluids th | 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 (IPC) of the administration set | accessdata.fda.gov |
| April 22, 2022 | 90314 | Class II | Terminated | Ivenix Infusion System (IIS) | Downstream occlusion alarm is sometimes immediately followed by a pump problem alarm. | accessdata.fda.gov |
Compare with other makers
- All makers of Set, Administration, Intravascular
- All makers of Infusion Safety Management Software
- All makers of Pump, Infusion
Updated May 29, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.