BencoDental iris 5% NaF varnish, WHITE MINT ITEM # 4323-635; cavity varnish
Summary
The FDA issued a Class II for BencoDental iris 5% NaF varnish, WHITE MINT ITEM # 4323-635; cavity varnish by Young Dental Manufacturing I, LLC. Reason: The Iris 5% Fluoride Varnish White Mint package lot 207540 may contain units of 5% Fluoride Varnish Bubblegum..
Details
Source
Device Recall
External ID
Z-1697-2023
Action Date
2023-06-14
Status
Ongoing
Category
device
Product Description
BencoDental iris 5% NaF varnish, WHITE MINT ITEM # 4323-635; cavity varnish
Lot/Code Info: UDI/DI 00366975000590, Lot number 207540, Exp. 20240930
Quantity Affected: 344 boxes
Reason for Recall
The Iris 5% Fluoride Varnish White Mint package lot 207540 may contain units of 5% Fluoride Varnish Bubblegum.
Distribution
US distribution to Florida, Nevada, and Pennsylvania.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-05-23
Company
Earth City, MO
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 139 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Young Dental Manufacturing I, LLC has 5 FDA actions in our database, including 5 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Young Dental Manufacturing I, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Young Dental Manufacturing I, LLC have FDA actions?
Young Dental Manufacturing I, LLC has 5 FDA actions in our database, including 5 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1697-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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