Recall Z-0008-2025 ยท FLG Cleaner, Ultrasonic, Medical Instrument
Young Dental Manufacturing I, LLC
BIOTROL PURIT Clean-It General Purpose Ultrasonic Cleaner, REF PC016, net contents 16 fl. oz., makes 16 gallons of solution.
| Date | Oct 1, 2024 (initiated Aug 23, 2024) |
| Status | Open, Classified |
| Reason | The bulk product used in the recalling firm's repackaged finished product was recalled due to bacterial contamination. |
| Root cause | Material/Component Contamination |
| Action | The recalling firm issued letters on and dated 8/23/2024 via certified mail informing their direct consignees of the issue, potential health risks, and instructing their consignees to discard or return the affected product. An Acknowledgement and Receipt Form was enclosed to indicate the consignee has read and understands the recall instructions and asks if there have been any adverse events associated with the product. The response form instructs that if the consignee wishes to return the product, it should be sent to Young Dental Manufacturing for reimbursement. Follow-up letters were is |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.