Device recall
Z-1044-2016: Nebulizer Masks Opti-Mist and Opti-Mist Clear Nebulizer masks are intended to…
FDA device recall · Class II · ConvaTec, Inc
Key facts
| Recall number (Z-number) | Z-1044-2016 |
|---|---|
| Recall event | 72823 |
| Product | Nebulizer Masks Opti-Mist and Opti-Mist Clear Nebulizer masks are intended to spray liquids in aerosol form into gasses that are delivered directly to a patient. |
| Product code | LCQ |
| Recalling firm | ConvaTec, Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 18, 2016 |
| 510(k) numbers | K801867 |
| FEI number | 3011987967 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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