Darby Prophylaxis Paste with 1.23% Fluoride Ion, Mint Coarse

Class I - Dangerous

🏥 Medical Devices Recalled: May 13, 2024 Young Dental Manufacturing I Other Medical Devices Nationwide

What Should You Do?

Check if you have this product:
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.
Do not eat it: Even if it looks and smells fine, do not consume this product.
Throw it away or return it: You can return the product to the store for a full refund.
Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:: Young Dental Manufacturing I, LLC
Reason for Recall:: Part number 040032, Lot number, 248607 was incorrectly labeled as part number 045032
Classification:: Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
Status:: ongoing

Product Information

Full Description:

Darby Prophylaxis Paste with 1.23% Fluoride Ion, Mint Coarse

Product Codes/Lot Numbers:

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.