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AMICUS Separator Software
Fresenius Kabi AG · Model 5.121 · UDI-DI 04086000101653
GKT
Prescription
10
510(k) clearances
6,575
Adverse events (264 deaths)
1
Recalls
39
Facilities
Description
Software version for Amicus Separator.
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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