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HAEMONETICS PCS 2 APHERESIS SYSTEM

HAEMONETICS CORPORATION · Model 06002-CP-220-EW · UDI-DI 30812747011833

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

Description

PCS2, LIST NO, LN06002-CP-220-EW

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.