Device recall
Z-0289-2017: Vari-Safe Injection Needle US endoscopy 5976 Heisley Road Mentor, Ohio 44060 A…
FDA device recall · Class II · US Endoscopy Group Inc
Key facts
| Recall number (Z-number) | Z-0289-2017 |
|---|---|
| Recall event | 74590 |
| Product | Vari-Safe Injection Needle US endoscopy 5976 Heisley Road Mentor, Ohio 44060 A sterile, single use, flexible sheath device intended to be used for the injection of various types of media through flexible endoscopes |
| Product code | FBK |
| Recalling firm | US Endoscopy Group Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 10, 2017 |
| 510(k) numbers | K971842 |
| 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