Z-1697-2023 Class II Ongoing
FDA device recall Z-1697-2023 was initiated by Young Dental Manufacturing I, LLC on May 23, 2023 and is designated Class II. Reason for recall: The Iris 5% Fluoride Varnish White Mint package lot 207540 may contain units of 5% Fluoride Varnish Bubblegum. The recall status is ongoing. Affected quantity: 344 boxes.
Recall Details
- Product Type
- Devices
- Report Date
- June 14, 2023
- Initiation Date
- May 23, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 344 boxes
Product Description
BencoDental iris 5% NaF varnish, WHITE MINT ITEM # 4323-635; cavity varnish
Reason for Recall
The Iris 5% Fluoride Varnish White Mint package lot 207540 may contain units of 5% Fluoride Varnish Bubblegum.
Distribution Pattern
US distribution to Florida, Nevada, and Pennsylvania.
Code Information
UDI/DI 00366975000590, Lot number 207540, Exp. 20240930