Recall Z-1058-2019
Sanrai International LLC · initiated August 29, 2018
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: Lot number 180223
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.
FDA-determined cause: Device Design
Action taken
Notification letters were distributed to customers on 8/29/18.
Details
- Recall number
- Z-1058-2019
- Initiated
- August 29, 2018
- Terminated
- June 12, 2020
- Product code
- CAF – Nebulizer (Direct Patient Interface)
- Quantity
- 150 units
- Distribution
- International distribution in the country of South Africa.
- Recalling firm
- Sanrai International LLC, Endicott, NY