Device recall
Z-1598-2010: ev3 Protg EverFlex Self-Expanding Biliary Stent System, Sterile EO, (REF…
FDA device recall · Class II · Ev3, Inc.
Key facts
| Recall number (Z-number) | Z-1598-2010 |
|---|---|
| Recall event | 55303 |
| Product | ev3 Protg EverFlex Self-Expanding Biliary Stent System, Sterile EO, (REF: PRB35-06-150-080, REF PRB35-06-120-120 and PRB35-06-150-120), 4.5 - 5.5mm, Expiration: 2011-10-01, Rx only. ev3 Inc., 4500 Nathan Lane North, Plymouth, MN 55442-2929. Intended as a palliative treatment of malignant neoplasms… |
| Product code | FGE |
| Recalling firm | Ev3, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 8, 2012 |
| 510(k) numbers | K060057 |
| FEI number | 2183870 |
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