Recall Z-0008-2025— Young Dental Manufacturing I, LLC
Class II · Ongoing
Class II FDA medical device recall by Young Dental Manufacturing I, LLC, initiated 2024-08-23. FDA's recall record names no specific 510(k) clearance for this event. Product: BIOTROL PURIT Clean-It General Purpose Ultrasonic Cleaner, REF PC016, net contents 16 fl. oz., makes 16 gallons of solution.. Reason: The bulk product used in the recalling firm's repackaged finished product was recalled due to bacterial contamination..
- Recalling firm
- Young Dental Manufacturing I, LLC
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-08-23
- Firm location
- Earth City, MO, United States
Product description
BIOTROL PURIT Clean-It General Purpose Ultrasonic Cleaner, REF PC016, net contents 16 fl. oz., makes 16 gallons of solution.
Reason for recall
The bulk product used in the recalling firm's repackaged finished product was recalled due to bacterial contamination.
Data sourced from openFDA. This site is unofficial and independent of the FDA.