Device recall
Z-3002-2020: Personelle OTC Skin Tag Remover, Canada Catalog Number: 1001-0314 - Product…
FDA device recall · Class III · OraSure Technologies, Inc.
Key facts
| Recall number (Z-number) | Z-3002-2020 |
|---|---|
| Recall event | 86312 |
| Product | Personelle OTC Skin Tag Remover, Canada Catalog Number: 1001-0314 - Product Usage: indicated for over-the-counter a cryosurgical system for the treatment of skin tags. |
| Product code | GEH |
| Recalling firm | OraSure Technologies, Inc. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Mar 14, 2022 |
| 510(k) numbers | K023487 |
| FEI number | 3004142665 |
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