FDAFDA · Food and drugs·Recall number Z-1058-2019
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.
Published April 3, 2019 · Recall initiated: August 29, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- SANRAI INTERNATIONAL LLC
- Distributor
- International distribution in the country of South Africa.
- Lot
- Lot number 180223
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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