Endicott, NY, United States
SANRAI INTERNATIONAL LLC recalls
1 recall recorded since 2018, most recently on 29 August 2018. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 29 August 2018
- Terminated
- 12 June 2020
- 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.
- Distribution
- International distribution in the country of South Africa.
- Initiated
- Voluntary: Firm initiated
- 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 h
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.