FDAFDA · Food and drugs·Recall number Z-2143-2024
Darby Prophylaxis Paste with 1.23% Fluoride Ion, Mint Coarse
Published June 19, 2024 · Recall initiated: May 13, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Part number 040032, Lot number, 248607 was incorrectly labeled as part number 045032
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Young Dental Manufacturing I, LLC
- Distributor
- US Nationwide distribution in the state of TN.
- Lot
- 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.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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