Darby Prophylaxis Paste with 1.23% Fluoride Ion, Mint Coarse
FDA Recall #Z-2143-2024 — Class II — May 13, 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
Recalling Firm
Young Dental Manufacturing I, LLC — Earth City, MO
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
534 units
Distribution
US Nationwide distribution in the state of TN.
Code Information
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.
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated