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NOVO Health Services, LLC

SRI Healthcare, LLC · Model 128016 · UDI-DI 00810019802072

FNY Prescription
9
510(k) clearances
12
Adverse events
1
Recalls
224
Facilities

Description

Basin Set, Cardiac

Recalls

DateFirmReason
2023-05-30DeRoyal Industries IncThe outer package seal could be open, or compromised which affects the sterility of the procedure pack inside.

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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.