BIOTROL PURIT Clean-It General Purpose Ultrasonic Cleaner, REF PC016, net contents 16 fl. oz., makes 16 gallons of solut
Summary
The FDA issued a Class II for BIOTROL PURIT Clean-It General Purpose Ultrasonic Cleaner, REF PC016, net conten by Young Dental Manufacturing I, LLC. Reason: The bulk product used in the recalling firm's repackaged finished product was recalled due to bacterial contamination..
Details
Source
Device Recall
External ID
Z-0008-2025
Action Date
2024-10-09
Status
Ongoing
Category
device
Product Description
BIOTROL PURIT Clean-It General Purpose Ultrasonic Cleaner, REF PC016, net contents 16 fl. oz., makes 16 gallons of solution.
Lot/Code Info: Lot numbers 247026, 255361, 234038, and 241667, exp. 6/13/2026; UDI-DI 00302730002089.
Quantity Affected: 1,391 units
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-08-23
Company
Earth City, MO
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 218 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Young Dental Manufacturing I, LLC has 5 FDA actions in our database, including 5 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Young Dental Manufacturing I, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Young Dental Manufacturing I, LLC have FDA actions?
Young Dental Manufacturing I, LLC has 5 FDA actions in our database, including 5 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0008-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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