FDA recall Z-2143-2024
Young Dental Manufacturing I, LLC · Class II · device
Product
Darby Prophylaxis Paste with 1.23% Fluoride Ion, Mint Coarse
Reason for recall
Part number 040032, Lot number, 248607 was incorrectly labeled as part number 045032
Distribution
US Nationwide distribution in the state of TN.
Key facts
- Status
- Ongoing
- Initiation date
- 2024-05-13
- Report date
- 2024-06-19
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Earth City, MO, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2143-2024