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NeilMed Sinus Rinse Kit

NEILMED PHARMACEUTICALS, INC. · Model Pediatric, 30ct Packets/Sachets · UDI-DI 00705928014008

KCJ

510(k) clearances

Adverse events

Recalls

134

Facilities

Description

Sinus Rinse products contain pre-weighed and sealed salt-soda mixture packets/sachets. The Kit variants also contain a bottle assembly (bottle, cap and tube that is affixed to the cap). The packets/sachets contain a defined ratio of sodium chloride and sodium bicarbonate that provides a pH balanced isotonic, solution the resulting saline solution is squirted through a bottle assembly designed at NeilMed Products, Inc. The Pediatric Sinus Rinse Kit comes with 120mL bottle and premixed packets containing a mixture of sodium chloride. The concentration of the salt mixture in the Pediatric Sinus Rinse Packets/Sachets produces the same solution as the isotonic sinus rinse packets/sachets, but the net content in the packets/sachets is measured for a mixing with a lower water volume for irrigation.

Recalls

Date	Firm	Reason
2024-12-28	Neilmed Pharmaceuticals Inc	Due to nasal spray stability failure for bioburden.

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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.