Device recall
Z-3094-2011: Encision AEM Suction Irrigation Electrode, Spatula, REF ES3882, Encision Inc…
FDA device recall · Class II · Encision, Inc.
Key facts
| Recall number (Z-number) | Z-3094-2011 |
|---|---|
| Recall event | 59781 |
| Product | Encision AEM Suction Irrigation Electrode, Spatula, REF ES3882, Encision Inc., Boulder, CO 80301. The Suction Irrigation Electrodes and Adapters combine AEM shielding technology with suction and irrigation of fluids during laparoscopic electrosurgery to cut and coagulate tissue. The electrodes… |
| Product code | GEI |
| Recalling firm | Encision, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 4, 2012 |
| 510(k) numbers | K100711 |
| FEI number | 1000117361 |
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