Device recall
Z-0494-2009: Boston Scientific Easy Core Biopsy System, 15 ga. x 15 cm, sterile, latex free…
FDA device recall · Class III · Boston Scientific Corp
Key facts
| Recall number (Z-number) | Z-0494-2009 |
|---|---|
| Recall event | 50087 |
| Product | Boston Scientific Easy Core Biopsy System, 15 ga. x 15 cm, sterile, latex free. Boston Scientific, Spencer, IN; UPN 1213, REF M00512130 and M00512131. For use to endoscopically or percutaneously retrieve tissue samples of soft organs, tumors or masses for histological analysis. Soft tissue sampling… |
| Product code | FCG |
| Recalling firm | Boston Scientific Corp |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Dec 15, 2009 |
| 510(k) numbers | K040893 |
| FEI number | 1828132 |
At a glance
- 1–9 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