Device recall
Z-0482-2016: MicroCutter Xchange 30 Blue Cartridge, FG-025320; The MicroCutter XCHANGE 30…
FDA device recall · Class II · Cardica, Inc.
Key facts
| Recall number (Z-number) | Z-0482-2016 |
|---|---|
| Recall event | 72687 |
| Product | MicroCutter Xchange 30 Blue Cartridge, FG-025320; The MicroCutter XCHANGE 30 Blue Cartridge and MicroCutter XCHANGE 30 Blue Curved Tip Cartridge contain 316L stainless steel staples. The cartridges are used with the MicroCutter XCHANGE 30 Stapler, which is a single patient device. When the… |
| Product code | GDW |
| Recalling firm | Cardica, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 12, 2016 |
| 510(k) numbers | K132581, K140118, K140170 |
| FEI number | 3004114958 |
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