Device recall
Z-2649-2011: First Breath Adult Aerosol Mask (Non-latex) 50/CA Reorder Number: 001426…
FDA device recall · Class II · Smiths Medical
Key facts
| Recall number (Z-number) | Z-2649-2011 |
|---|---|
| Recall event | 57906 |
| Product | First Breath Adult Aerosol Mask (Non-latex) 50/CA Reorder Number: 001426 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 cannula (>6L/minute). During inspiration, the patient… |
| 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