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SANRAI INTERNATIONAL LLC recalls Sunset Compressor Nebulizer, Model NEB100 - Product Usage: The Sunset Compressor Nebulizer is an AC-powered air nebulize
Recalled April 3, 2019 · FDA recall Z-1058-2019 · SANRAI INTERNATIONAL
Hazard
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. · FDA Class II
Units
150 units
Sold at
International distribution in the country of South Africa.
Description
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.
Product
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.
Manufacturer(s)
SANRAI INTERNATIONAL LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →