Device recall
Z-2139-2019: Toothete Oral Care Sodium Bicarbonate Mouthpaste, Net Wt. 1/3 oz/ 9g, included…
FDA device recall · Class II · Sage Products Inc
Key facts
| Recall number (Z-number) | Z-2139-2019 |
|---|---|
| Recall event | 81745 |
| Product | Toothete Oral Care Sodium Bicarbonate Mouthpaste, Net Wt. 1/3 oz/ 9g, included in Independent Care System. The system is an oral care convenience kit which includes: an Ultra-Soft Toothbrush, 0.5 oz. tube of Mouth Moisturizer, 0.33 oz. /9g tube of Sodium Bicarbonate Mouthpaste and 1.5fl.oz. bottle… |
| Product code | NSB |
| Recalling firm | Sage Products Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 15, 2020 |
| FEI number | 1419181 |
At a glance
- None 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