PlainRecalls
FDA Devices Moderate Class II Ongoing

Darby Prophylaxis Paste with 1.23% Fluoride Ion, Mint Coarse

Reported: June 19, 2024 Initiated: May 13, 2024 #Z-2143-2024

Product Description

Darby Prophylaxis Paste with 1.23% Fluoride Ion, Mint Coarse

Reason for Recall

Part number 040032, Lot number, 248607 was incorrectly labeled as part number 045032

Details

Units Affected
534 units
Distribution
US Nationwide distribution in the state of TN.
Location
Earth City, MO

Frequently Asked Questions

What product was recalled?
Darby Prophylaxis Paste with 1.23% Fluoride Ion, Mint Coarse. Recalled by Young Dental Manufacturing I, LLC. Units affected: 534 units.
Why was this product recalled?
Part number 040032, Lot number, 248607 was incorrectly labeled as part number 045032
Which agency issued this recall?
This recall was issued by the FDA Devices on June 19, 2024. Severity: Moderate. Recall number: Z-2143-2024.