Sunset Compressor Nebulizer recalled over fire hazard

Recall date

August 29, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

SANRAI INTERNATIONAL LLC recalls Sunset Compressor Nebulizer, Model NEB100 - Product Usage: The Sunset Compressor Nebulizer is an AC-powered air nebuliz…

Recall number

Z-1058-2019

FDA classification

Class II

Brand / firm

SANRAI INTERNATIONAL LLC

Sold / distributed

International distribution in the country of South Africa.

Why it was recalled

The product was designed for 120V usage and is being used in South Africa with 220V. There is a potential for the device to overheat and the mouthpiece can pop off.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Sunset Compressor Nebulizer, Model NEB100 - Product Usage: The Sunset Compressor Nebulizer is an AC-powered air nebulizer compressor system intended to provide a source of compressed air for medical purposes for use in home healthcare. It is to be used with a nebulizer kit to produce medicated aerosol particles for respiratory therapy for both children and adults.