Fresenius Kabi AB
Uppsala, SE
FRESENIUS KABI AB appears in FDA device records in Uppsala, SE. FDA records list 14 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 5 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 14 510(k) clearances for Fresenius Kabi AB between 2013 and 2026. The busiest year on record is 2022, with 4. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2013 | 1 |
| 2016 | 1 |
| 2018 | 1 |
| 2019 | 2 |
| 2020 | 1 |
| 2021 | 1 |
| 2022 | 4 |
| 2023 | 2 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K251139 | KabiHelp® Uno; KabiHelp® Advance plus | KPE | Substantially Equivalent | |
| K221121 | Volumat Polyethylene I.V. Administration Set | FPA | Substantially Equivalent | |
| K220301 | Volumat Line | FPA | Substantially Equivalent | |
| K212445 | freeflex+ Transfer Adapter | LHI | Substantially Equivalent | |
| K210075 | Vigilant Software Suite – Vigilant Master Med | PHC | Substantially Equivalent | |
| K210074 | Agilia SP Infusion System, Agilia SP MC WIFI Infusion Pump, Agilia Link, Agilia Duo, Agilia USB Cable | FRN | Substantially Equivalent | |
| K210073 | Agilia VP Infusion System, Agilia VP MC WIFI Infusion Pump, Volumat Lines Administration Sets, Agilia Link, Agilia Duo | FRN | Substantially Equivalent | |
| K210089 | CATSmart, Automated Blood Processing Autotransfusion System | CAC | Substantially Equivalent | |
| K200530 | AMICUS Separator System | GKT | Substantially Equivalent | |
| K192150 | AMICUS Separator System | LKN | Substantially Equivalent | |
| K192368 | CATSmart | CAC | Substantially Equivalent | |
| K180831 | CATSmart | CAC | Substantially Equivalent | |
| K160735 | CATSmart | CAC | Substantially Equivalent | |
| K121613 | AGILIA INFUSION SYSTEM | FRN | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3002631703 | 3002631703 | FRESENIUS KABI AB | Fresenius Kabi AB, Uppsala 75174 SE | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- CACApparatus, Autotransfusion
- MCXCatheter, Coronary, Atherectomy
- MCWCatheter, Peripheral, Atherectomy
- KPEContainer, I.V.
- PHCInfusion Safety Management Software
- FRNPump, Infusion
- LKNSeparator, Automated, Blood Cell And Plasma, Therapeutic
- GKTSeparator, Automated, Blood Cell, Diagnostic
- FPASet, Administration, Intravascular
- LHISet, I.V. Fluid Transfer
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2199-2011 | The Operating Manual contains the Operating Instructions for AS 104 Blood Cell Separator and has a Software Version 4.71. The AS 104 Blood Cell Separator Device has a Catalog Number 9007031. Used for depletion or exchange of red blood cells during therapeutic apheresis procedures on the Fresenius AS 104 Blood Cell Separator Device. This set is used with a single stage separation chamber. | 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. | Terminated | ||
| Z-0616-2011 | Fresenius Red Blood Cell Set, Catalog Number 9007601. The product is labeled in part: "RBC 9007601...STERILE...FRESENIUS KABI...Made in the Netherlands". Intended use: The Fresenius RBC red blood cell set (Art./Cat. No. 9007601) is used for depletion or exchange of red blood cells during therapeutic apheresis procedures on the Fresenius AS104 Blood Cell Separator Device. This set is used with a single stage separation chamber. | Potential for patient hematocrit dropped to levels lower than expected post-treatment. | Terminated | ||
| Z-0342-2011 | The box label states: "ATF 120 Fast Start Kit 9108501...STERILE...FRESENIUS KABI...Fresenius Kabi AG 61345 Bad Hamburg Germany...Federal (USA) Law restricts this device to sale by or on order of a physician". The ATF120 Fast Start Kit contains one each AT1 Autotransfusion Set, ATS Suction Line, and the ATR120 Autotransfusion Reservoir. ATS is a suction line to aspirate and add anticoagulate to shed blood from the surgical field into an autotransfusion reservoir (ATR). The ATS has a 1/4 inch. suction port and is connected to a vacuum source. ATR is an autotransfusion reservoir to collect, de-foam, filter, and store blood prior to processing. The ATR reservoirs are offered with either a 120 micron or a 40 micron filter. ATF 120 Autotransfusion set is a disposable set, dedicated component of the Fresenius CATS Continuous Autotransfusion System, which in turn is an Autotransfusion device for the processing of autologous shed blood collected intraoperatively and postoperatively to obtain washed packed red blood cells for reinfusion. | 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. | Terminated | ||
| Z-0341-2011 | The box label states: "ATF 40 Fast Start Kit 9108491...STERILE...FRESENIUS KABI...Fresenius Kabi AG 61345 Bad Hamburg Germany...Federal (USA) Law restricts this device to sale by or on order of a physician". The ATF 40 Fast Start Kit contains one each AT1 Autotransfusion Set, ATS Suction Line, and the ATR40 Autotransfusion Reservoir. ATS is a suction line to aspirate and add anticoagulate to shed blood from the surgical field into an autotransfusion reservoir (ATR). The ATS has a inch. suction port and is connected to a vacuum source. ATR is an autotransfusion reservoir to collect, de-foam, filter, and store blood prior to processing. The ATR reservoirs are offered with either a 120 micron or a 40 micron filter. ATF 40 Autotransfusion set is a disposable set, dedicated component of the Fresenius CATS Continuous Autotransfusion System, which in turn is an Autotransfusion device for the processing of autologous shed blood collected intraoperatively and postoperatively to obtain washed packed red blood cells for reinfusion. | 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. | Terminated | ||
| Z-0340-2011 | The box label states: "AT1 Autotransfusion Set 9005101 STERILE...FRESENIUS KABI...Fresenius Kabi AG 61345 Bad Hamburg Germany...Federal (USA) Law restricts this device to sale by or on order of a physician". The AT1 Autotransfusion Set is distributed by Fresenius Kabi on its own or as part of a ATF40 kit or ATF120 kit. AT1 Autotransfusion set is a disposable set, dedicated component of the Fresenius CATS Continuous Autotransfusion System, which in turn is an Autotransfusion device for the processing of autologous shed blood collected intraoperatively and postoperatively to obtain washed packed red blood cells for reinfusion. | 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. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain