Z-1058-2019 Class II Terminated
FDA device recall Z-1058-2019 was initiated by SANRAI INTERNATIONAL LLC on August 29, 2018 and is designated Class II. 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. The recall status is terminated (terminated June 12, 2020). Affected quantity: 150 units.
Recall Details
- Product Type
- Devices
- Report Date
- April 3, 2019
- Initiation Date
- August 29, 2018
- Termination Date
- June 12, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 150 units
Product 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 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 Pattern
International distribution in the country of South Africa.
Code Information
Lot number 180223