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U.S. Department of Health and Human Services

Class 2 Device Recall Darby Prophylaxis Paste with 1.23 Fluoride Ion, Mint Coarse

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 Class 2 Device Recall Darby Prophylaxis Paste with 1.23 Fluoride Ion, Mint Coarsesee related information
Date Initiated by FirmMay 13, 2024
Date PostedJune 13, 2024
Recall Status1 Open3, Classified
Recall NumberZ-2143-2024
Recall Event ID 94756
Product Classification Agent, polishing, abrasive, oral cavity - Product Code EJR
ProductDarby Prophylaxis Paste with 1.23% Fluoride Ion, Mint Coarse
Code Information 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.
Recalling Firm/
Manufacturer		 Young Dental Manufacturing I, LLC
13705 Shoreline Ct E
Earth City MO 63045-1202
For Additional Information ContactJose Espino
224-622-7191
Manufacturer Reason
for Recall		Part number 040032, Lot number, 248607 was incorrectly labeled as part number 045032
FDA Determined
Cause 2		Error in labeling
ActionThe 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.
Quantity in Commerce534 units
DistributionUS Nationwide distribution in the state of TN.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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