medical Class II Updated 2019-04-03

SANRAI INTERNATIONAL LLC recalls Sunset Compressor Nebulizer, Model NEB100 - Product Usage: T

Recalled 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.


Hazard / Issue

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.

Issued by

FDA

Distribution: International distribution in the country of South Africa.
Lot/Code Info: Lot number 180223
View official government recall

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