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Fresenius Kabi

Last updated May 24, 2026

What Fresenius Kabi makes

Fresenius Kabi manufactures single-use tubing sets and components for electric infusion pumps, including administration lines like the Volumat™ Line, as well as bedside infusion systems such as the Ivenix Infusion System. Their portfolio also includes apheresis and autotransfusion systems, such as the AMICUS Separator and ALYX 2RBC-LR Kit, alongside blood storage and transfer containers like the Fenwal Transfer Pack and Twin Transfer Set. The company produces infusion pump software for medication dosage applications and specialized blood component processing kits.

These devices are regulated under FDA classifications, including Class I, Class II, and Unclassified (U), with submissions documented through 510(k) clearances and Unique Device Identifiers (UDIs). The products are listed in the FDA’s regulatory databases, and the company operates with a US headquarters.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Information

Country: US
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Catalogue (216)

Page 2 of 5

Device	Model / Reference	Registries	Class	Status
Atr Cap Set	9108574	FDA UDI	Class II	Active
Fenwal AMICUS Apheresis Kit - Single Needle	4R2357	FDA UDI	Class II	Active
Fenwal AMICUS RBC Set w/SEPACELL R-3000 RBC Leukocyte Reduction Filter	4C2304	FDA UDI	Class II	Active
Donor Tube Stripper	6R4452	FDA UDI	Class I	Active
Volumat™ Line	VL SL00-XP	FDA UDI	Class II	Active
Amicus Single Needle Advanced Kit with Platelet Additive Solution Connector	4R2351	FDA UDI	Class II	Active
Aurora Software Version 2.1C Upgrade	Version 2.1C	FDA UDI	Class II	Active
Aurora Xi	Software Version 2.1	FDA UDI	Class II	Active
Twin Transfer Set	2 D/X	FDA UDI	Class I	Active
Fenwal Product Sample Pack	4R2335H	FDA UDI	Class II	Active
Fenwal PLASMACELL-C Disposable Set For Use With SPIKESMART System	4R2256	FDA UDI	Class II	Active
CompoSeal Mobilea II	9027011	FDA UDI	Class II	Active
Ivenix Infusion System	3.0.0	FDA UDI	Class II	Active
Fenwal AMICUS Apheresis Kit- SingleNeedle w/Platelet Additive Solution Connector	4R2337	FDA UDI	Class II	Active
Ivenix Infusion System	030-0028-08	FDA UDI	Class II	Active
Volumat™ Line	VL PR 42-21	FDA UDI	Class II	Active
Blood Component Filter Set with Vented Spike and Luer Adapter	X6C2170	FDA UDI	U	Active
Fresenius Kabi Adjustable Automatic Donor Scale Support Stand	Version A	FDA UDI	Class I	Active
Ivenix Infusion System	030-0028-07	FDA UDI	Class II	Active
Amicus Apheresis Kit - Functionally Closed Single Needle with PAS Spike and Dual	4R2360	FDA UDI	Class II	Active
ATV-70 Vacuum Line	9108554	FDA UDI	Class II	Active
Agilia Sp Mc Wifi Us	Z018735	FDA UDI	Class II	Active
Fenwal Red Cell Freezing Pack 2000 mL	4R2422	FDA UDI	Class II	Active
CompoMat G5	9025561	FDA UDI	Class I	Active
Fenwal Transfer Pack Container 600 mL with Coupler	4R2023	FDA UDI	Class II	Active
ATF 120 Fast start kit with AT3	9104444	FDA UDI	Class II	Active
Fenwal AMICUS Single Needle Advanced Kit	4R2353	FDA UDI	Class II	Active
Aurora Plasmapheresis System	6R4601	FDA UDI	Class II	Active
Plastic Storage Container	X6R2350	FDA UDI	Class II	Active
Com.tec	9008031	FDA UDI	U	Active
Fenwal Quadruple Transfer Pack Container 150 mL with Coupler	4R2004	FDA UDI	Class II	Active
Ivenix Infusion System	030-0027-05	FDA UDI	Class II	Active
Ivenix Infusion System	5.0.0	FDA UDI	Class II	Active
Aurora Xi Plasmapheresis System	6R4612R	FDA UDI	Class II	Active
ALYX Component Collection System	6R5725	FDA UDI	Class II	Active
AMICUS Separator	6R4580R	FDA UDI	Class II	Active
ATS Suction Line	9108484	FDA UDI	Class II	Active
AMICUS Separator Legacy Software	6.1.13.0	FDA UDI	Class II	Active
Aurora Xi Plasmapheresis System	1.3	FDA UDI	Class II	Active
Volumat™ Line	VL ST 02-0	FDA UDI	Class II	Active
AMICUS Separator Life Extension Software	6.0	FDA UDI	Class II	Active
ATO Oxygenator line	9108434	FDA UDI	Class II	Active
Fenwal PlasmaLink Transfer-Pack Container with Luer Adapter and No Outlet Ports	4R2088P	FDA UDI	Class II	Active
Volumat™ Line	VL PR 42-11	FDA UDI	Class II	Active
ATY Y-Adapter	9108404	FDA UDI	Class II	Active
Fenwal Triple TRANSFER-PACK Container with Male Luer Adapter	4R2258	FDA UDI	Class II	Active
Aurora Xi Plasmapheresis System	6R4612	FDA UDI	Class II	Active
Ivenix, Inc.	2.0	FDA UDI	Class II	Unknown
AMICUS Separator	6R4590	FDA UDI	Class II	Active
Glycerolyte 57 Solution	4A7831	FDA UDI	Class II	Active

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FDA Recalls (5)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Fresenius Kabi has five FDA recall records initiated between March 29, 2010, and April 19, 2011, all of which are recorded as terminated. The reasons cited include potential deviations in patient hematocrit levels post-treatment, updates to the operating manual of the AS 104 Blood Cell Separator to remove references to specific blood set types, and issues with the AT1 Autotransfusion Set and CATS Continuous Autotransfusion device combination resulting in insufficient suction and triggering an alarm.

AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.

Date	Recall No.	Class	Status	Reason
Apr 19, 2011	Z-2199-2011	—	terminated	Operating Manual of the AS 104 Blood Cell Separator is being updated to eliminate any reference to Red Blood Cell (RBC), C4Y, P1Y and BMSC sets. This is a corrective action and recall expansion of Z-0616-2011.
Oct 18, 2010	Z-0616-2011	—	terminated	Potential for patient hematocrit dropped to levels lower than expected post-treatment.
Mar 29, 2010	Z-0341-2011	—	terminated	Using AT1 Autotransfusion Set from specific batches in combination with the auto transfusion device CATS Continuous Autotransfusion has led to insufficient suction of shed blood from the collection reservoir. The results in the failure message "alarm blood flow" and the CATS device stops in a secure mode.
Mar 29, 2010	Z-0342-2011	—	terminated	Using AT1 Autotransfusion Set from specific batches in combination with the auto transfusion device CATS Continuous Autotransfusion has led to insufficient suction of shed blood from the collection reservoir. The results in the failure message "alarm blood flow" and the CATS device stops in a secure mode.
Mar 29, 2010	Z-0340-2011	—	terminated	Using AT1 Autotransfusion Set from specific batches in combination with the auto transfusion device CATS Continuous Autotransfusion has led to insufficient suction of shed blood from the collection reservoir. The results in the failure message "alarm blood flow" and the CATS device stops in a secure mode.