Darby Prophylaxis Paste with 1.23% Fluoride Ion, Mint Coarse
Summary
The FDA issued a Class II for Darby Prophylaxis Paste with 1.23% Fluoride Ion, Mint Coarse by Young Dental Manufacturing I, LLC. Reason: Part number 040032, Lot number, 248607 was incorrectly labeled as part number 045032.
Details
Source
Device Recall
External ID
Z-2143-2024
Action Date
2024-06-19
Status
Ongoing
Category
device
Product Description
Darby Prophylaxis Paste with 1.23% Fluoride Ion, Mint Coarse
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.
Quantity Affected: 534 units
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-05-13
Company
Earth City, MO
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 197 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Young Dental Manufacturing I, LLC has 5 FDA actions in our database, including 5 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Young Dental Manufacturing I, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Young Dental Manufacturing I, LLC have FDA actions?
Young Dental Manufacturing I, LLC has 5 FDA actions in our database, including 5 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2143-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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