Device recall
Z-0029-2009: Applied Medical, Lap Roux-EN-Y Kit, REF: K2129 Contains: (1) C0Q04, 5x100mm…
FDA device recall · Class II · Applied Medical Resources Corp
Key facts
| Recall number (Z-number) | Z-0029-2009 |
|---|---|
| Recall event | 49445 |
| Product | Applied Medical, Lap Roux-EN-Y Kit, REF: K2129 Contains: (1) C0Q04, 5x100mm Threaded Kii Access System (1) C0130, 12x100mm Optical Separator System, Non-handled (2) C0Q10, 5x100mm Threaded Kii Cannula and Seal (1) C0605, 15mmx100mm Threaded Cannula System, for laparoscopic procedures. |
| Product code | GCJ |
| Recalling firm | Applied Medical Resources Corp |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 26, 2012 |
| 510(k) numbers | K012884 |
| FEI number | 2027111 |
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