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AMICUS Apheresis Kit – Single Needle with Platelet Additive Solution Connector

Fresenius Kabi AG · Model L6R2337 · UDI-DI 04086000100052

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

Description

For Collection of Platelets with Optional Plasma and/or Red Blood Cells. For Platelet Storage in Plasma or Platelet Additive Solution Plus Plasma. For use with the AMICUS Separator.

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.