Darby Prophylaxis Paste with 1.23% Fluoride Ion, Mint Coarse
- Recall Initiated
- May 13, 2024
- Posted
- June 13, 2024
- Recall Number
- Z-2143-2024
- Quantity
- 534 units
- Firm Location
- Earth City, MO
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.
Lot / Code Info
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.
Root Cause
Error in labeling
Action Taken
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.