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ALYX Plasma Kit

Fresenius Kabi AG · Model 4R5730 · UDI-DI 04086000101028

GKT Prescription
10
510(k) clearances
6,575
Adverse events (264 deaths)
1
Recalls
39
Facilities

Description

For Collection of Plasma Product by Centrifugation. For Use With the ALYX System. Sterile Fluid Path.

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.