Z-0008-2025 Class II Ongoing
FDA device recall Z-0008-2025 was initiated by Young Dental Manufacturing I, LLC on August 23, 2024 and is designated Class II. Reason for recall: The bulk product used in the recalling firm's repackaged finished product was recalled due to bacterial contamination. The recall status is ongoing. Affected quantity: 1,391 units.
Recall Details
- Product Type
- Devices
- Report Date
- October 9, 2024
- Initiation Date
- August 23, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,391 units
Product Description
BIOTROL PURIT Clean-It General Purpose Ultrasonic Cleaner, REF PC016, net contents 16 fl. oz., makes 16 gallons of solution.
Reason for Recall
The bulk product used in the recalling firm's repackaged finished product was recalled due to bacterial contamination.
Distribution Pattern
Distribution was made to AZ, ID, MD, NV, NY, PA, SC, TN, TX, WI. There was no government/military/foreign distribution.
Code Information
Lot numbers 247026, 255361, 234038, and 241667, exp. 6/13/2026; UDI-DI 00302730002089.