Device product
BIOTROL PURIT Clean-It General Purpose Ultrasonic Cleaner, REF PC016, net contents 16 fl. oz., makes 16 gallons of solution.
Z-0008-2025
Product summary
- Event
- Event 95302
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1,391 units
- Official record key
device-enforcement:Z-0008-2025
Official wording
Reason: The bulk product used in the recalling firm's repackaged finished product was recalled due to bacterial contamination.
Code information: Lot numbers 247026, 255361, 234038, and 241667, exp. 6/13/2026; UDI-DI 00302730002089.
Distribution pattern: Distribution was made to AZ, ID, MD, NV, NY, PA, SC, TN, TX, WI. There was no government/military/foreign distribution.
Derived failure modes
-
Microbial contamination
bacterial contamination