BIOTROL PURIT Clean-It General Purpose Ultrasonic Cleaner, REF PC016, net contents 16 fl. oz., makes 16 gallons of solution.
Recall
- Recall Number
- Z-0008-2025
- Event Number
- 95302
- Firm
- Young Dental Manufacturing I, LLC
- FEI Number
- 1941138
- Product Code
- FLG
- Status
- Open, Classified
- Root Cause
- Material/Component Contamination
- Initiated
- August 23, 2024
- Posted
- October 1, 2024
- Address
- 13705 Shoreline Ct E, Earth City, MO, 63045-1202
Description
BIOTROL PURIT Clean-It General Purpose Ultrasonic Cleaner, REF PC016, net contents 16 fl. oz., makes 16 gallons of solution.
The bulk product used in the recalling firm's repackaged finished product was recalled due to bacterial contamination.
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 issued on and dated 9/11/2024 instructing the consignees to notify their downstream consignees to the user level. The letter also offers to notify the downstream consignees if their direct consignee requests it.
Distribution was made to AZ, ID, MD, NV, NY, PA, SC, TN, TX, WI. There was no government/military/foreign distribution.
1,391 units