Darby Prophylaxis Paste with 1.23% Fluoride Ion, Mint Coarse

FDA device recall Z-2143-2024 · posted 2024-06-13 · Open, Classified

Recall details

Recalling firm

Young Dental Manufacturing I, LLC

Reason for recall

Part number 040032, Lot number, 248607 was incorrectly labeled as part number 045032

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.

Root cause

Error in labeling

Status

Open, Classified

Product code

EJR

Quantity affected

534 units

Distribution

US Nationwide distribution in the state of TN.

Date initiated

2024-05-13

Date posted

2024-06-13

Location

Earth City, MO