Medical device recalls Moderate risk

Young Dental Manufacturing I, LLC recalls BIOTROL PURIT Clean-It General Purpose Ultrasonic Cleaner, REF PC016, net contents 16 fl. oz., makes 16 gallons of solu…

Recall date
August 23, 2024
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0008-2025
FDA classification
Class II
Brand / firm
Young Dental Manufacturing I, LLC
Sold / distributed
Distribution was made to AZ, ID, MD, NV, NY, PA, SC, TN, TX, WI. There was no government/military/foreign distribution.

Why it was recalled

The bulk product used in the recalling firm's repackaged finished product was recalled due to bacterial contamination.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

BIOTROL PURIT Clean-It General Purpose Ultrasonic Cleaner, REF PC016, net contents 16 fl. oz., makes 16 gallons of solution.

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