Device recall
Z-0655-2010: Complete SE Biliary Stent System, SC680L (6 mm x 120 mm), lot number 0000983806…
FDA device recall · Class II · Medtronic CardioVascular
Key facts
| Recall number (Z-number) | Z-0655-2010 |
|---|---|
| Recall event | 53199 |
| Product | Complete SE Biliary Stent System, SC680L (6 mm x 120 mm), lot number 0000983806, UPC code 006133994186669, use by date 03/17/2011, manufactured by Medtronic CardioVascular, Santa Rosa, CA. Indicated for use in the palliation of malignant neoplasms in the biliary tree. |
| Product code | FGE |
| Recalling firm | Medtronic CardioVascular |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 21, 2010 |
| 510(k) numbers | K062264 |
| FEI number | 3001452571 |
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