Z-2143-2024 Class II Ongoing
FDA device recall Z-2143-2024 was initiated by Young Dental Manufacturing I, LLC on May 13, 2024 and is designated Class II. Reason for recall: Part number 040032, Lot number, 248607 was incorrectly labeled as part number 045032 The recall status is ongoing. Affected quantity: 534 units.
Recall Details
- Product Type
- Devices
- Report Date
- June 19, 2024
- Initiation Date
- May 13, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 534 units
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
Distribution Pattern
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.