Device recall
Z-2174-2015: Tool, Stripper W/BLD, 12S, Nonautoclavable; The Fiber Stripper is a tool…
FDA device recall · Class II · American Medical Systems Innovation Center - Silicon Valley
Key facts
| Recall number (Z-number) | Z-2174-2015 |
|---|---|
| Recall event | 71534 |
| Product | Tool, Stripper W/BLD, 12S, Nonautoclavable; The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat or SureFlex Fiber. The Fiber Stripper does not come in to direct contact with the patient. It is available in several sizes, corresponding to the Endostat… |
| Product code | GEX |
| Recalling firm | American Medical Systems Innovation Center - Silicon Valley |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 19, 2016 |
| FEI number | 2937094 |
At a glance
- None Linked 510(k)s
- 10–99 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