Home › Fresenius Kabi AG › Aurora Software Version 1.3 Upgrade Kit
Aurora Software Version 1.3 Upgrade Kit
Fresenius Kabi AG · Model 6R2013 · UDI-DI 04086000101059
10
510(k) clearances
6,575
Adverse events (264 deaths)
1
Recalls
39
Facilities
Description
A software upgrade package (accessory) to the Aurora Plasmapheresis System (primary device). For collection of plasma by membrane filtration.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2021-02-25 | Fenwal Inc | Some lots of Amicus MNC Apheresis and Amicus Exchange kits have leaking centrifuge packs during a procedure on the Amicus Separator using therapeutic protocols only. The defect is |
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