Device recall
Z-2093-2014: Oxygen Mask, Model No. 8120-7 Product Usage: Oxygen Mask, High Concentration…
FDA device recall · Class II · Salter Labs
Key facts
| Recall number (Z-number) | Z-2093-2014 |
|---|---|
| Recall event | 68701 |
| Product | Oxygen Mask, Model No. 8120-7 Product Usage: Oxygen Mask, High Concentration partial rebreather, with 7 foot (2.1 m) supply tube, Elastic Strap Fixation, Single patient use. |
| Product code | BYG |
| Recalling firm | Salter Labs |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 10, 2014 |
| FEI number | 1314417 |
At a glance
- None 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