FDA-Device2024-10-09Class II
BIOTROL PURIT Clean-It General Purpose Ultrasonic Cleaner, REF PC016, net contents 16 fl. oz., makes 16 gallons of solution.
Young Dental Manufacturing I, LLC
Hazard
The bulk product used in the recalling firm's repackaged finished product was recalled due to bacterial contamination.
Sold states
Distribution was made to AZ, ID, MD, NV, NY, PA, SC, TN, TX, WI. There was no government/military/foreign distribution.
Affected count
1,391 units
Manufactured in
13705 Shoreline Ct E, N/A, Earth City, MO, United States
Products
BIOTROL PURIT Clean-It General Purpose Ultrasonic Cleaner, REF PC016, net contents 16 fl. oz., makes 16 gallons of solution.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0008-2025Don't want to check this manually?
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