BencoDental iris 5% NaF varnish, WHITE MINT ITEM # 4323-635; cavity varnish
FDA device recall Z-1697-2023 · posted 2023-06-08 · Open, Classified
Recall details
- Recalling firm
- Young Dental Manufacturing I, LLC
- Reason for recall
- The Iris 5% Fluoride Varnish White Mint package lot 207540 may contain units of 5% Fluoride Varnish Bubblegum.
- Action taken
- Young Dental notified the single customer via certified mail on 05/23/2023. The customer was instructed to discard or return the affected product and complete and return the response form.
- Root cause
- Employee error
- Status
- Open, Classified
- Product code
- LBH
- Quantity affected
- 344 boxes
- Distribution
- US distribution to Florida, Nevada, and Pennsylvania.
- Date initiated
- 2023-05-23
- Date posted
- 2023-06-08
- Location
- Earth City, MO
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Oral-B 5% Sodium Fluoride Varnish (K153334) | Young Dental Manufacturing Co. 1, LLC | 2016-05-20 |