Recall Z-2143-2024 ยท EJR Agent, Polishing, Abrasive, Oral Cavity
Young Dental Manufacturing I, LLC
Darby Prophylaxis Paste with 1.23% Fluoride Ion, Mint Coarse
| Date | Jun 13, 2024 (initiated May 13, 2024) |
| Status | Open, Classified |
| Reason | Part number 040032, Lot number, 248607 was incorrectly labeled as part number 045032 |
| Root cause | Error in labeling |
| Action | 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 sen |
| Quantity | 534 units |
| Distribution | US Nationwide distribution in the state of TN. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.