Device recall
Z-1837-2021: SUNSTAR G.U.M PERIOSHIELD Oral Health Rinse, 300mL, SKU numbers 1775P, 1775R…
FDA device recall · Class II · Sunstar Americas, Inc.
Key facts
| Recall number (Z-number) | Z-1837-2021 |
|---|---|
| Recall event | 87976 |
| Product | SUNSTAR G.U.M PERIOSHIELD Oral Health Rinse, 300mL, SKU numbers 1775P, 1775R - Product Usage: Help prevent and treat gingivitis caused by plaque build up Significantly reduce bleeding gums Protect teeth and gums from plaque causing bacteria. |
| Product code | NTO |
| Recalling firm | Sunstar Americas, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 4, 2024 |
| FEI number | 1413787 |
At a glance
- None 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