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NOVA

NOVA BIOMEDICAL CORPORATION · Model 16 · UDI-DI 00385480170925

JJC CGZ JIX CDS JPK JFL CGA CGL CEM JPI Prescription

510(k) clearances

354

Adverse events (2 deaths)

Recalls

Facilities

Description

NOVA 16 TUBING HARNESS WITH DILUTOR

Recalls

Date	Firm	Reason
2005-08-24	Hamilton Co	The product valve has a high probability of deforming and may result in leakage during use.

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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.