Device recall
Z-1943-2015: Velocity" Biopsy Valve, 25 units per box, Product Usage: The disposable Velocity…
FDA device recall · Class II · US Endoscopy Group Inc
Key facts
| Recall number (Z-number) | Z-1943-2015 |
|---|---|
| Recall event | 71336 |
| Product | Velocity" Biopsy Valve, 25 units per box, Product Usage: The disposable Velocity biopsy valve is used to cover the opening of the biopsy inlet port of a flexible gastrointestinal endoscope. The Velocity biopsy valve provides access for endoscopic device passage and exchange, helps maintain… |
| Product code | OCX |
| Recalling firm | US Endoscopy Group Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 21, 2015 |
| 510(k) numbers | K092461 |
| FEI number | 1000122656 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 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