Device recall
Z-0498-2013: Reusable, non-sterile, self-adhering electrodes for use with TENS/NMES,. Made…
FDA device recall · Class II · Covidien LLC dba Uni-Patch
Key facts
| Recall number (Z-number) | Z-0498-2013 |
|---|---|
| Recall event | 61209 |
| Product | Reusable, non-sterile, self-adhering electrodes for use with TENS/NMES, . Made in the U.S.A. Cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation. |
| Product code | GXY |
| Recalling firm | Covidien LLC dba Uni-Patch |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 3, 2013 |
| 510(k) numbers | K901575 |
| FEI number | 1000116809 |
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