Recall Z-2143-2024— Young Dental Manufacturing I, LLC
Class II · Ongoing
Class II FDA medical device recall by Young Dental Manufacturing I, LLC, initiated 2024-05-13. FDA's recall record names no specific 510(k) clearance for this event. Product: Darby Prophylaxis Paste with 1.23% Fluoride Ion, Mint Coarse. Reason: Part number 040032, Lot number, 248607 was incorrectly labeled as part number 045032.
- Recalling firm
- Young Dental Manufacturing I, LLC
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-05-13
- Firm location
- Earth City, MO, United States
Product description
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.