FDAClass IIOctober 9, 2024

BIOTROL PURIT Clean-It General Purpose Ultrasonic recall: Contamination

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

Why was BIOTROL PURIT Clean-It General Purpose Ultrasonic recalled?

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

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot numbers 247026, 255361, 234038, and 241667, exp. 6/13/2026; UDI-DI 00302730002089.

Product
BIOTROL PURIT Clean-It General Purpose Ultrasonic Cleaner, REF PC016, net contents 16 fl. oz., makes 16 gallons of solution.
Recalling firm
Young Dental Manufacturing I, LLC
Quantity
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.
Recall date
October 9, 2024
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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