Device recall
Z-1236-2016: Ambu, Aura Gain - Single Use Laryngeal Mask- Sterile for use as an alternative…
FDA device recall · Class II · Ambu Inc.
Key facts
| Recall number (Z-number) | Z-1236-2016 |
|---|---|
| Recall event | 73366 |
| Product | Ambu, Aura Gain - Single Use Laryngeal Mask- Sterile for use as an alternative to a face mask for achieving and maintaining control of the airway during routine emergency anesthetic procedures. |
| Product code | BTO |
| Recalling firm | Ambu Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 22, 2016 |
| FEI number | 1121788 |
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