Young Dental Manufacturing I, LLC Recall 95302
Description: 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 Recall 95302 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0008-2025 |
| Event ID | 95302 |
| Event Description | BIOTROL PURIT Clean-It General Purpose Ultrasonic Cleaner, REF PC016, net contents 16 fl. oz., makes 16 gallons of solution. |
| Product Type | Devices |
| Distribution | Distribution was made to AZ, ID, MD, NV, NY, PA, SC, TN, TX, WI. There was no government/military/foreign distribution. |
| Quantity | 1,391 units |
| Recall Reason | The bulk product used in the recalling firm's repackaged finished product was recalled due to bacterial contamination. |
| Device Classification | 20241009 |
| Device Code Info | Lot numbers 247026, 255361, 234038, and 241667, exp. 6/13/2026; UDI-DI 00302730002089. |
| Center Classification Date | 20241001 |
| Recall Initiation Date | 20240823 |
| Recalling Firm | Young Dental Manufacturing I, LLC |
| Initial Notification | Letter |
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