Device recall
Z-1058-2019: Sunset Compressor Nebulizer, Model NEB100 - Product Usage: The Sunset Compressor…
FDA device recall · Class II · SANRAI INTERNATIONAL LLC
Key facts
| Recall number (Z-number) | Z-1058-2019 |
|---|---|
| Recall event | 81725 |
| Product | 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… |
| Product code | CAF |
| Recalling firm | SANRAI INTERNATIONAL LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 12, 2020 |
| 510(k) numbers | K091272 |
| FEI number | 3014347367 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database