Darby Prophylaxis Paste with 1.23% Fluoride Ion, Mint Coarse
Recall
- Recall Number
- Z-2143-2024
- Event Number
- 94756
- Firm
- Young Dental Manufacturing I, LLC
- FEI Number
- 1941138
- Product Code
- EJR
- Status
- Open, Classified
- Root Cause
- Error in labeling
- Initiated
- May 13, 2024
- Posted
- June 13, 2024
- Address
- 13705 Shoreline Ct E, Earth City, MO, 63045-1202
Description
Darby Prophylaxis Paste with 1.23% Fluoride Ion, Mint Coarse
Part number 040032, Lot number, 248607 was incorrectly labeled as part number 045032
The FSN was sent to the consignee on ___ via certified mail. The consignee was asked to: 1. Please forward this notification to any customers who purchased the affected devices from you; 2. Reformat this notification to a header indicating the company's and part number; 3. If the customer wishes to receive a replacement or refund as reimbursement they should contact the distributor directly. Young Dental will then credit or replace the item; 4. If the customer wants the firm to contact their customers directly, please send us a list of the customers and their contact details. The firm will send this letter to them.
US Nationwide distribution in the state of TN.
534 units