Device recall
Z-3039-2018: Boston Scientific Wallstent RP Endoprosthesis Tracheobronchial Transhepatic…
FDA device recall · Class II · SPS Sterilization, Inc
Key facts
| Recall number (Z-number) | Z-3039-2018 |
|---|---|
| Recall event | 80317 |
| Product | Boston Scientific Wallstent RP Endoprosthesis Tracheobronchial Transhepatic Biliary Self-Expanding Stent, 8MM X 80MM | 75CM, resterilized. |
| Product code | JCT |
| Recalling firm | SPS Sterilization, Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 27, 2018 |
| 510(k) numbers | K152842 |
| FEI number | 3005057969 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 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