FDA recall Z-1058-2019

SANRAI INTERNATIONAL LLC · Class II · device

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.

Reason for recall

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.

Distribution

International distribution in the country of South Africa.

Key facts

Status
Terminated
Initiation date
2018-08-29
Report date
2019-04-03
Termination date
2020-06-12
Voluntary/Mandated
Voluntary: Firm initiated
Location
Endicott, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1058-2019