Z-1697-2023 Class II Ongoing

Recalled by Young Dental Manufacturing I, LLC — Earth City, MO

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