Device product
Darby Prophylaxis Paste with 1.23% Fluoride Ion, Mint Coarse
Z-2143-2024
Product summary
- Event
- Event 94756
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 534 units
- Official record key
device-enforcement:Z-2143-2024
Official wording
Reason: Part number 040032, Lot number, 248607 was incorrectly labeled as part number 045032
Code information: 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 pattern: US Nationwide distribution in the state of TN.
Derived failure modes
-
Labeling or packaging
incorrectly labeled