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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Personal Care & Cosmetics/Oral Care

Young Dental Manufacturing I, LLC: Darby Prophylaxis Paste Recalled for Incorrect Part Number Labeling

Agency Publication Date: June 13, 2024
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Summary

Young Dental Manufacturing I, LLC is recalling 534 units of Darby Prophylaxis Paste with 1.23% Fluoride Ion (Mint Coarse flavor) because they were labeled with the wrong part number. The product, identified as part number 040032, was incorrectly labeled as part number 045032. This labeling error could lead to the use of a product that does not match the specifications intended for the patient or dental procedure.

Risk

The incorrect labeling of dental prophylaxis paste can result in a clinician using a product that has different characteristics or concentrations than intended. This pose a moderate risk to patients if the error leads to improper treatment or unexpected clinical outcomes during dental cleaning.

What You Should Do

  1. Check your dental supplies for Darby Prophylaxis Paste with 1.23% Fluoride Ion, Mint Coarse flavor with Lot number 248607.
  2. Verify the part numbers on the label: identify if the product displays part number 045032 while actually being Young Dental part number 040032 (which may also be listed as Darby Dental Part Number 9518637).
  3. If you identify affected product from Lot 248607, immediately stop using it in dental procedures and set it aside.
  4. Contact Young Dental Manufacturing I, LLC or your healthcare provider to discuss the labeling error and arrange for replacement or further instructions.
  5. For additional information, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Manufacturer Notification

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: Darby Prophylaxis Paste with 1.23% Fluoride Ion, Mint Coarse
Model / REF:
040032 (Young Dental Part Number)
9518637 (Darby Dental Part Number)
045032 (Incorrectly Labeled Part Number)
UPC Codes:
00889813036273
Lot Numbers:
248607

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94756
Status: Active
Manufacturer: Young Dental Manufacturing I, LLC
Sold By: Darby Dental Supply
Manufactured In: United States
Units Affected: 534 units
Distributed To: Tennessee

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.