Drug recall
Sunset Compressor Nebulizer, Model NEB100 - Product Usage: The Sunset Compressor Nebulizer is an AC-powered…
FDA recall event 81725 · Class II · SANRAI INTERNATIONAL LLC
Key facts
| Event ID | 81725 |
|---|---|
| Recall numbers | Z-1058-2019 |
| Recalling firm | SANRAI INTERNATIONAL LLC |
| Product type | Devices |
| Products | 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… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| 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. |
| Initiation date | Aug 29, 2018 |
| Report date | Apr 3, 2019 |
| Termination date | Jun 12, 2020 |
| City | Endicott |
| State | NY |
| Country | United States |
| FEI number | 3014347367 |
At a glance
- 1–9 Products in this recall
- None FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: