BIOTROL PURIT Clean-It General Purpose Ultrasonic Cleaner, REF PC016, net contents 16 fl. oz., ma...
FDA Recall #Z-0008-2025 — Class II — August 23, 2024
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.
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
1,391 units
Distribution
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.
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated