Device recall
Z-0121-2015: The Aeroneb Professional Nebulizer System is a portable medical device for…
FDA device recall · Class II · Aerogen Ltd.
Key facts
| Recall number (Z-number) | Z-0121-2015 |
|---|---|
| Recall event | 69236 |
| Product | The Aeroneb Professional Nebulizer System is a portable medical device for multiple patient use that is intended to aerosolize physician-prescribed solutions for inhalation to patients on and off ventilation or other positive pressure breathing assistance. The Aeroneb Professional Nebulizer System… |
| Product code | CAF |
| Recalling firm | Aerogen Ltd. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 25, 2016 |
| 510(k) numbers | K021175 |
| FEI number | 3003399703 |
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