FDA Enforcement
Class II
Ongoing
Darby Prophylaxis Paste with 1.23% Fluoride Ion, Mint Coarse
Recall: Z-2143-2024
·
Reported June 19, 2024
Enforcement
- Recall Number
- Z-2143-2024
- Event ID
- 94756
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Young Dental Manufacturing I, LLC
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- June 19, 2024
- Initiation Date
- May 13, 2024
- Classification Date
- June 13, 2024
- Address
- 13705 Shoreline Ct E, N/A, Earth City, MO, 63045-1202, United States
Description
Darby Prophylaxis Paste with 1.23% Fluoride Ion, Mint Coarse
Reason
Part number 040032, Lot number, 248607 was incorrectly labeled as part number 045032
Code Info
Unique Device Identifier (UDI)1: 00889813036273; Lot: 248607; Part number 040032 is the Young Dental part number. The Darby Dental Part Number (that is on the label) is 9518637.
Distribution
US Nationwide distribution in the state of TN.
Quantity
534 units