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Sign in to claim this brandWhat 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.
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Catalogue (216)
Page 4 of 5| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Aurora Software Version 1.3 Upgrade Kit | 6R2013 | FDA UDI | Class II | Active |
| CompoDock | 9028721 | FDA UDI | Class II | Active |
| PLASMACELL Xi Disposable Set with SPIKESMART | 6R2600P | FDA UDI | Class II | Active |
| AMICUS Separator Life Extension Software | 6.1.122.0 | FDA UDI | Class II | Active |
| Twin Transfer Set | 2 D | FDA UDI | Class I | Active |
| Fenwal AMICUS Apheresis Kit - Double Needle | 4R2355 | FDA UDI | Class II | Active |
| ATF 40 Fast start kit with AT3 | 9108444 | FDA UDI | Class II | Active |
| CompoMaster Net G5 | 9025571 | FDA UDI | Class I | Active |
| PLASMALINK Bottle, 1000 mL with Locking Luer Adapter | 6R2069 | FDA UDI | Class II | Active |
| Ivenix Infusion System | 4.0.0 | FDA UDI | Class II | Active |
| Volumat™ Line | VL SP40-11 | FDA UDI | Class II | Active |
| AMICUS Separator Software | 5.121 | FDA UDI | Class II | Active |
| DXT Data Management System | 3.0 | FDA UDI | Class II | Active |
| AMICUS Exchange Kit | X6R2339 | FDA UDI | U | Active |
| Ivenix Infusion System | LVP-0004 | FDA UDI | Class II | Active |
| Fenwal Plasma Transfer Sets with Two Spikes | 4C2243 | FDA UDI | Class II | Active |
| Volumat™ Line | VL SP02-PE | FDA UDI | Class II | Active |
| Vigilant Drug'Lib AGILIA US | 1.2 | FDA UDI | Class II | Active |
| P1R Plasma Treatment Set | 9400414 | FDA UDI | U | Active |
| AMICUS Separator Software | 5.12 | FDA UDI | Class II | Active |
| ALYX Plasma Kit | 4R5730 | FDA UDI | Class II | Active |
| Fenwal Hand Sealer | 4R4454W | FDA UDI | Class I | Active |
| Ivenix, Inc. | SET-0019-1 | FDA UDI | Class II | Active |
| C.a.t.s | 9005081 | FDA UDI | Class II | Active |
| Volumat™ Line | VL SP42-PE | FDA UDI | Class II | Active |
| Fenwal Plasma Transfer Sets with Spike and Male Luer Adapter | 4C2240 | FDA UDI | Class II | Active |
| ATV-F140C Vacuum Lines Combi-pack | 9008554 | FDA UDI | Class II | Active |
| K-Zero® | Needleless Connector | FDA UDI | Class II | Active |
| Reinfusion bag 1000 ml | 9005204 | FDA UDI | Class II | Active |
| Volumat™ Line | VL ON 72-1 | FDA UDI | Class II | Active |
| AMICUS Separator Software | 6.0 | FDA UDI | Class II | Active |
| Ivenix Infusion System | 030-0027-06 | FDA UDI | Class II | Active |
| Waste Transfer Set | X6C2172 | FDA UDI | U | Active |
| AMICUS Apheresis Kit - Functionally Closed Double Needle with PAS Spike | 4R2359 | FDA UDI | Class II | Active |
| Aurora Xi Software | 1.1 | FDA UDI | Class II | Active |
| Agilia Duo Us | Z073607 | FDA UDI | Class II | Active |
| Ivenix, Inc. | SET-0016-1 | FDA UDI | Class II | Active |
| Fenwal Transfer Pack Container 150 mL with Coupler | 4R2001 | FDA UDI | Class II | Active |
| Ivenix Infusion System | SET-0034-1 | FDA UDI | Class II | Active |
| ATV-180 Vacuum Line | 9108544 | FDA UDI | Class II | Active |
| Transfer Set | 1 D | FDA UDI | Class I | Active |
| Fenwal Transfer Pack Container 600 mL with 8 couplers | 4R2027 | FDA UDI | Class II | Active |
| Alyx Cart | 6R5728 | FDA UDI | Class I | Active |
| Volumat™ Line | VL PR 22-1 | FDA UDI | Class II | Active |
| AMICUS Single Needle Advanced Kit with 20 mL Platelet Sampling System Assembly | 4R2353G | FDA UDI | Class II | Active |
| Volumat™ Line | VL PA 92-1 | FDA UDI | Class II | Active |
| Transfer Set | 6 D | FDA UDI | Class I | Active |
| AMICUS Separator | 6R4590TH-T | FDA UDI | Class II | Active |
| Blood Component Filter Set with Vented Spike and Luer Adapter | X6C2170 | FDA UDI | U | Active |
| Volumat™ Line | VL ST02-X0 | 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. |