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Haemonetics EZ Prime

HAEMONETICS CORPORATION · Model RCEZ1T · UDI-DI 10887691000161

CAK Prescription
10
510(k) clearances
1,660
Adverse events (7 deaths)
1
Recalls
14
Facilities

Description

EZ Prime Self-Priming High Efficiency Leukocyte Reduction Filter Set for Single Unit Blood Transfusion

Recalls

DateFirmReason
2025-11-03GVS TM, IncDue to products being released for distribution prior to completion of the required quality control release process the sterility assurance cannot be confirmed.

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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.