Device recall
Z-0106-2015: Box Label: 3 mm Cueva Electrode Kit, Sterile EO, Rx Only, REF. CNE1-3KDINX…
FDA device recall · Class II · Ad-Tech Medical Instrument Corporation
Key facts
| Recall number (Z-number) | Z-0106-2015 |
|---|---|
| Recall event | 69436 |
| Product | Box Label: 3 mm Cueva Electrode Kit, Sterile EO, Rx Only, REF. CNE1-3KDINX . Pouch labels: Each kit contains 3 pouches. 3 mm Cueva Electrode CNE-3X, Cueva Electrode Applicator Wand CNE-100X, Cueva Electrode Leadwire CNE-LW-2DINX. Box Label: 2 mm Cueva Electrode Kit, Sterile EO, Rx Only, REF… |
| Product code | GZL |
| Recalling firm | Ad-Tech Medical Instrument Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 8, 2015 |
| 510(k) numbers | K944061 |
| FEI number | 2183456 |
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