Recall Z-1058-2019 ยท CAF Nebulizer (Direct Patient Interface)
SANRAI INTERNATIONAL LLC
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.
| Date | Aug 29, 2018 |
| Status | Terminated |
| 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. |
| Root cause | Device Design |
| Action | Notification letters were distributed to customers on 8/29/18. |
| Quantity | 150 units |
| Distribution | International distribution in the country of South Africa. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K091272 | BESMED JET NEBULIZER BOTTLE SET Besmed Health Business Corp, Nov 10, 2009 |