Device recall
Z-0368-2019: 3M Fast Release Varnish, 5% Sodium Fluoride, Mint Flavor, Rx Only, single use…
FDA device recall · Class II · 3M Company - Health Care Business
Key facts
| Recall number (Z-number) | Z-0368-2019 |
|---|---|
| Recall event | 80730 |
| Product | 3M Fast Release Varnish, 5% Sodium Fluoride, Mint Flavor, Rx Only, single use. 200 pack, with each package containing 1 0.40 ml varnish and 1 applicator brush. Product is applied to tooth surfaces for sealing dentinal tubules and treatment of hypersensitive teeth. |
| Product code | LBH |
| Recalling firm | 3M Company - Health Care Business |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 26, 2019 |
| 510(k) numbers | K132109 |
| FEI number | 2110898 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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