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AMICUS Separator Life Extension Software

Fresenius Kabi AG · Model 6.1.122.0 · UDI-DI 00810020441192

GKTLKN Prescription
10
510(k) clearances
6,581
Adverse events (266 deaths)
1
Recalls
39
Facilities

Description

Software version for AMICUS Separator Life Extension Device

Recalls

DateFirmReason
2021-02-25Fenwal IncSome 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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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.