Device recall
Z-2396-2012: Infinity sampling device, Cytology Brush, United States Endoscopy Group, Inc…
FDA device recall · Class II · US Endoscopy Group Inc
Key facts
| Recall number (Z-number) | Z-2396-2012 |
|---|---|
| Recall event | 63047 |
| Product | Infinity sampling device, Cytology Brush, United States Endoscopy Group, Inc., 5976 Heisley Road, Mentor, OH 44060 The Infinity sampling device is a disposable cytology brush used to retrieve cytological cell samples in the gastrointestinal tract. |
| Product code | KOG |
| Recalling firm | US Endoscopy Group Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 22, 2013 |
| 510(k) numbers | K103437 |
| 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