Class 2 Device Recall BIOTROL PURIT

• Date Initiated by Firm: August 23, 2024
• Date Posted: October 01, 2024
• Recall Status: Open, Classified
• Recall Number: Z-0008-2025
• Recall Event ID: 95302
• Product Classification: Cleaner, ultrasonic, medical instrument - Product Code FLG
• Product: BIOTROL PURIT Clean-It General Purpose Ultrasonic Cleaner, REF PC016, net contents 16 fl. oz., makes 16 gallons of solution.
• Code Information: Lot numbers 247026, 255361, 234038, and 241667, exp. 6/13/2026; UDI-DI 00302730002089.
• FEI Number: 1941138
• Recalling Firm/ Manufacturer: Young Dental Manufacturing I, LLC; 13705 Shoreline Ct E; Earth City MO 63045-1202
• For Additional Information Contact: Jose Espino; 224-622-7191
• Manufacturer Reason for Recall: The bulk product used in the recalling firm's repackaged finished product was recalled due to bacterial contamination.
• FDA Determined 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 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.
• Quantity in Commerce: 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.