Device recall
Z-2650-2011: First Breath ADULT Elongated Non-Rebreather Oxygen Mask with 1L Reservoir Bag &…
FDA device recall · Class II · Smiths Medical
Key facts
| Recall number (Z-number) | Z-2650-2011 |
|---|---|
| Recall event | 57906 |
| Product | First Breath ADULT Elongated Non-Rebreather Oxygen Mask with 1L Reservoir Bag & Tubing, 213cm (7ft.) 50/CA Reorder Number: 001431 Oxygen/Aerosol Mask For acute use, e.g. Post-op recovery, minimal trauma, patient transfer; used for patients requiring more oxygen than is delivered via a standard nasal… |
| Product code | BYG |
| Recalling firm | Smiths Medical |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 2, 2018 |
| FEI number | 3002807908 |
At a glance
- None Linked 510(k)s
- 10–99 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