Device recall
Z-2687-2011: The product is the "FASTx Sternal Intraosseous Device". The expiration date for…
FDA device recall · Class II · Pyng Medical Corporation
Key facts
| Recall number (Z-number) | Z-2687-2011 |
|---|---|
| Recall event | 59019 |
| Product | The product is the "FASTx Sternal Intraosseous Device". The expiration date for the recalled products is end of June, 2012. The device is used to insert an infusion tube into the manubrium (upper portion of the sternum) of a patient. It is intended for intraosseous infusion as an alternative to… |
| Product code | FMI |
| Recalling firm | Pyng Medical Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 10, 2011 |
| 510(k) numbers | K100124 |
| FEI number | 3003437923 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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