Device recall
Z-0705-2020: HydroDot brand: Wave Prep Single use cups, 8.5 gm (0.3 oz) 24/box-Product…
FDA device recall · Class II · Bio-Signal Group Corp.
Key facts
| Recall number (Z-number) | Z-0705-2020 |
|---|---|
| Recall event | 84305 |
| Product | HydroDot brand: Wave Prep Single use cups, 8.5 gm (0.3 oz) 24/box-Product 1700-24 - Product Usage: An electroconductive cream for use with external electrodes to reduce the impedance of the contact between the electrode surface and the skin. The cream is not intended for use with stimulating… |
| Product code | KOY |
| Recalling firm | Bio-Signal Group Corp. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 7, 2021 |
| 510(k) numbers | K970694 |
| FEI number | 3006315274 |
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