FDAFDA · Food and drugs·Recall number Z-0008-2025
BIOTROL PURIT Clean-It General Purpose Ultrasonic Cleaner, REF PC016, net contents 16 fl. oz., makes 16 gallons of solution.
Published October 9, 2024 · Recall initiated: August 23, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The bulk product used in the recalling firm's repackaged finished product was recalled due to bacterial contamination.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Young Dental Manufacturing I, LLC
- Distributor
- Distribution was made to AZ, ID, MD, NV, NY, PA, SC, TN, TX, WI. There was no government/military/foreign distribution.
- Lot
- Lot numbers 247026, 255361, 234038, and 241667, exp. 6/13/2026; UDI-DI 00302730002089.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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