Device recall
Z-0861-2015: UroSeal Adjustable Endoscopic Valve. Model/Catalog # 00913410 The primary…
FDA device recall · Class II · US Endoscopy Group Inc
Key facts
| Recall number (Z-number) | Z-0861-2015 |
|---|---|
| Recall event | 69809 |
| Product | UroSeal Adjustable Endoscopic Valve. Model/Catalog # 00913410 The primary packaging is a Tyvek pouch. The secondary package is a corrugate box. 5 units per box. Used to cover the opening to the biopsy/suction channel of an endoscope. |
| Product code | KOG |
| Recalling firm | US Endoscopy Group Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 1, 2015 |
| 510(k) numbers | K070420 |
| FEI number | 1000122656 |
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