Device recall
Z-2169-2008: Ev3 Protege GPS Biliary Stent Systems 6 mm, 60 mm, 120cm,.35, 6Fr, OTW Ev3 4600…
FDA device recall · Class II · Ev3, Inc
Key facts
| Recall number (Z-number) | Z-2169-2008 |
|---|---|
| Recall event | 48614 |
| Product | Ev3 Protege GPS Biliary Stent Systems 6 mm, 60 mm, 120cm, .35, 6Fr, OTW Ev3 4600 Nathan Lane North, Plymouth, MN 55442-2920 REF SERB65-06-60-120 Lot 2675311 Use before 2009-01-01 Sterile EO Intended as a palliative treatment of malignant neoplasms in the biliary tree. |
| Product code | FGE |
| Recalling firm | Ev3, Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 10, 2011 |
| 510(k) numbers | K032580 |
| 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