FDA Recall
Terminated
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.
Recall: Z-1058-2019
·
Initiated August 29, 2018
Recall
- Recall Number
- Z-1058-2019
- Event Number
- 81725
- Firm
- SANRAI INTERNATIONAL LLC
- FEI Number
- 3014347367
- Product Code
- CAF
- Status
- Terminated
- Root Cause
- Device Design
- Initiated
- August 29, 2018
- Terminated
- June 12, 2020
- Address
- 1701 North St, Ste 40, Endicott, NY, 13760-5587
Description
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
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.
Action
Notification letters were distributed to customers on 8/29/18.
Distribution
International distribution in the country of South Africa.
Quantity
150 units