Device recall
Z-0489-2009: Boston Scientific Easy Core Biopsy Device, 15 ga. x 15 cm, sterile, latex free…
FDA device recall · Class III · Boston Scientific Corp
Key facts
| Recall number (Z-number) | Z-0489-2009 |
|---|---|
| Recall event | 50087 |
| Product | Boston Scientific Easy Core Biopsy Device, 15 ga. x 15 cm, sterile, latex free. Boston Scientific, Spencer, IN; UPN 500-106, REF M0065001060 and M0065001061. For use to endoscopically or percutaneously retrieve tissue samples of soft organs, tumors or masses for histological analysis. Soft tissue… |
| 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