Fresenius Kabi USA, LLC
North Andover, MA, US
Fresenius Kabi USA, LLC appears in FDA device records in North Andover, MA. FDA records list 5 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 28 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
2 namesFDA records resolved to Fresenius Kabi USA, LLC carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- App Pharmaceuticals, LLC510(k), enforcement report, recall
- Ivenix, Inc.510(k), enforcement report, recall
510(k) clearance history
FDA records hold 5 510(k) clearances for Fresenius Kabi USA, LLC between 2010 and 2021. The busiest year on record is 2010, with 1. The most recent is 2021, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2010 | 1 |
| 2016 | 1 |
| 2018 | 1 |
| 2019 | 1 |
| 2021 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K213089 | Ivenix Infusion System, LVP Epidural Administraion Set NRFit Connector | FPA | Substantially Equivalent | |
| K183311 | Ivenix Infusion System (IIS) | FRN | Substantially Equivalent | |
| K180615 | AMICUS Separator System, AMICUS Exchange Kit - Therapeutics, Waste Transfer Set, Blood Component Filter Set With Vented Spike and Luer Adapter | LKN | Substantially Equivalent | |
| K162462 | AMICUS Separator System, AMICUS Separator System; Refurbished | GKT | Substantially Equivalent | |
| K092938 | HEPARIN LOCK FLUSH SOLUTION USP, MODELS 504401, 504411, 504505, 505701, 504901, 1710 | NZW | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3014732157 | 3014732157 | Fresenius Kabi USA, LLC | 50 High Street, North Andover, MA 01845 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
Showing 25 of 28| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2224-2026 | 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 unintended touchscreen behavior on the LVP, including random screen touches and/or lack of screen responsiveness to user input. Under the reported failure condition, unintended touch inputs may register at arbitrary screen locations without user interaction. These inputs occur intermittently and without a predictable pattern. | Class I | Open, Classified | |
| Z-2223-2026 | 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. | Class I | Open, Classified | |
| Z-2274-2026 | The Large Volume Pump (LVP) of the Ivenix Infusion System (IIS). Model Number: LVP-0004. | Potential for the Cassette Loading Lever to break. | Class II | Open, Classified | |
| Z-1048-2026 | Ivenix Infusion System (IIS), LVP Software: LVP-SW-0005. | Emphasizing instructions for LVP duration programming located in the IFU. | Class II | Open, Classified | |
| Z-0885-2026 | 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. | Class I | Open, Classified | |
| Z-0586-2026 | 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. | Class I | Open, Classified | |
| Z-0848-2026 | 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. | Class II | Open, Classified | |
| Z-0378-2026 | 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. | Class II | Open, Classified | |
| Z-2235-2025 | 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 | Class II | Open, Classified | |
| Z-2234-2025 | LVP Primary Administration Set, Single Outlet Low Sorbing (Qty 25). Product Code: SET-0021-25. | Potential for external cassette leaks | Class II | Open, Classified | |
| Z-2233-2025 | LVP Blood Products Administration Set Dual-Inlet, Low-Sorbing, Y-Site, Mesh Filter (Qty 20). Product Code: SET-0014-20. | Potential for external cassette leaks | Class II | Open, Classified | |
| Z-2232-2025 | 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 | Class II | Open, Classified | |
| Z-1869-2025 | 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. | Class I | Open, Classified | |
| Z-1019-2025 | 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 infusion will infuse at the previously programed primary rate and continue until the infusion is stopped or the bag is empty. | Class I | Open, Classified | |
| Z-0763-2025 | 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. | Class I | Open, Classified | |
| Z-3153-2024 | 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. | Class I | Open, Classified | |
| Z-2721-2024 | 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). | Class I | Open, Classified | |
| Z-1484-2024 | 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. | Class I | Open, Classified | |
| Z-0549-2024 | 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. | Class I | Open, Classified | |
| Z-1283-2024 | 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 the Care Profile Hard Rate Max limit and Rapid Bolus is selected. May lead to over infusion. Both issues were resolved in all fielded product in software version 5.8.0, which was installed in affected units May thru August 2023. | Class II | Completed | |
| Z-1313-2023 | 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. | Class I | Open, Classified | |
| Z-1282-2024 | 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 resolved in all fielded product in software version 5.2.1, which was installed in September 2022. | Class II | Completed | |
| Z-0002-2023 | 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 intervention by the clinician. | Class I | Terminated | |
| Z-2635-2023 | 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 through clinically accepted routes of administration. | 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 | Class II | Open, Classified | |
| Z-1381-2022 | Ivenix Infusion System (IIS) | Downstream occlusion alarm is sometimes immediately followed by a pump problem alarm. | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain