Fresenius Kabi USA, LLC
United Statesfrom the FDA registration address FDA establishment FEI 3014732157
- Devices
- 2
- Registrations
- FDA
- FDA recalls
- 2521 ongoing
What Fresenius Kabi USA, LLC makes
Fresenius Kabi USA, LLC manufactures systems and accessories for apheresis therapy, including blood separation devices like the AMICUS Separator System. Their portfolio includes exchange kits for therapeutic procedures, waste transfer sets, and blood component filter sets with vented spikes and Luer adapters. Refurbished versions of the AMICUS Separator System are also part of their offerings.
These devices are regulated under FDA Class II and Class U classifications, with authorisation primarily through the 510(k) pathway. The company’s products are listed in the FDA’s 510(k) registry, and the manufacturer is based in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
Company details
- FDA FEI number
- 3014732157
- Address
- 50 High Street, North Andover, MA, 01845
FDA recalls
FDA recall records list 25 recalls initiated by Fresenius Kabi USA, LLC, the earliest on 2014-12-19 and the most recent on 2026-05-06. By recorded status: 21 ongoing, 2 terminated and 2 with another status. The reasons filed fall into these groups: software or firmware, electrical or power and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
Recalls initiated per year
- 2017 0
- 2018 0
- 2019 0
- 2020 0
- 2021 0
- 2022 3
- 2023 3
- 2024 4
- 2025 11
- 2026 3
2026
- 6 May 2026 Z-2223-2026 Class I Ongoing 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.
Full distribution text
- 6 May 2026 Z-2224-2026 Class I Ongoing 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.
- 4 Feb 2026 Z-2274-2026 Class II Ongoing Potential for the Cassette Loading Lever to break.
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- 6 May 2026 Z-2223-2026 Class I Ongoing 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.
2025
- 21 Nov 2025 Z-1048-2026 Class II Ongoing Emphasizing instructions for LVP duration programming located in the IFU.
Full distribution text
- 14 Nov 2025 Z-0885-2026 Class I Ongoing Software version 5.10.1 and earlier contain anomalies that have the potential to cause serious patient harm or death.
- 3 Nov 2025 Z-0586-2026 Class I Ongoing Incorrect assembly of specific lot of LVP Primary Administration Set that could result in serious patient injury.
- 3 Nov 2025 Z-0848-2026 Class II Ongoing Downstream Occlusion alarms may occur during procedures using low flow infusion rates when a check valve* is added to the Ivenix Administration Set.
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- 3 Sep 2025 Z-0378-2026 Class II Ongoing Potential issue that can cause the device to register "phantom" touches in the lower-left corner of the touchscreen during operation.
- 24 Jun 2025 Z-2232-2025 Class II Ongoing Potential for external cassette leaks
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- 24 Jun 2025 Z-2233-2025 Class II Ongoing Potential for external cassette leaks
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- 21 Nov 2025 Z-1048-2026 Class II Ongoing Emphasizing instructions for LVP duration programming located in the IFU.
Show all 25 recalls
2025
- 24 Jun 2025 Z-2234-2025 Class II Ongoing Potential for external cassette leaks
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- 24 Jun 2025 Z-2235-2025 Class II Ongoing Potential for external cassette leaks
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- 12 May 2025 Z-1869-2025 Class I Ongoing 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.
- 10 Jan 2025 Z-1019-2025 Class I Ongoing 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.
- 24 Jun 2025 Z-2234-2025 Class II Ongoing Potential for external cassette leaks
2024
- 6 Dec 2024 Z-0763-2025 Class I Ongoing Potential pneumatic valve failure that may cause the LVP to stop an active infusion and/or could prevent the pump from being used.
- 30 Aug 2024 Z-3153-2024 Class I Ongoing 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.
- 1 Aug 2024 Z-2721-2024 Class I Ongoing 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).
- 7 Mar 2024 Z-1484-2024 Class I Ongoing Software has anomalies that have the potential to cause underdose, overdose, or delay in therapy which could lead to serious patient harm or death.
2023
- 29 Nov 2023 Z-0549-2024 Class I Ongoing 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.
- 10 May 2023 Z-1283-2024 Class II Completed 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.
- 10 Mar 2023 Z-1313-2023 Class I Ongoing 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.
2022
- 16 Sep 2022 Z-1282-2024 Class II Completed 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.
- 8 Sep 2022 Z-0002-2023 Class I Terminated 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.
- 22 Apr 2022 Z-2635-2023 Class II Ongoing 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
2014
- 19 Dec 2014 Z-1032-2015 Class II Terminated The lot failed pH specification.
Frequently asked questions
How many devices does Fresenius Kabi USA, LLC have in the registry?
The registry currently lists 2 devices for Fresenius Kabi USA, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Fresenius Kabi USA, LLC's devices?
Among its 2 most recently registered devices, Fresenius Kabi USA, LLC has devices listed in FDA 510(k) (2 devices).
What risk classes do Fresenius Kabi USA, LLC's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Fresenius Kabi USA, LLC's devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Fresenius Kabi USA, LLC?
FDA recall records list 25 recalls initiated by Fresenius Kabi USA, LLC, the most recent initiated on 2026-05-06. 21 of them are recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Fresenius Kabi USA, LLC in the registry?
The most recently registered devices listed for Fresenius Kabi USA, LLC include AMICUS Separator System, AMICUS Exchange Kit - Therapeutics, Waste Transfer Set, Blood Component Filter Set With Vented Spike and Luer Adapter and AMICUS Separator System, AMICUS Separator System; Refurbished.