FDA recall Z-0008-2025

Young Dental Manufacturing I, LLC · Class II · device

Product

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.

Distribution

Distribution was made to AZ, ID, MD, NV, NY, PA, SC, TN, TX, WI. There was no government/military/foreign distribution.

Key facts

Status
Ongoing
Initiation date
2024-08-23
Report date
2024-10-09
Voluntary/Mandated
Voluntary: Firm initiated
Location
Earth City, MO, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0008-2025