Medical Device Recall: Z-0008-2025

FDA Recalls dataset · Firm: Young Dental Manufacturing I, LLC · Status: Open, Classified

Recall Action Class: N/A Date Initiated: 2024-08-23 Recall record compiled from public FDA source records.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0008-2025.

Recall Res Number
Z-0008-2025
Recalling Firm / Manufacturer
Young Dental Manufacturing I, LLC
FEI Number
1941138
Recall Status
Open, Classified
Recall Classification
N/A
Date Initiated
2024-08-23
Date Posted
2024-10-01
Date Terminated
N/A
Product Code
FLG
Event Number
95302
Product Quantity
1,391 units
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.
Action Details The recalling firm issued letters on and dated 8/23/2024 via certified mail informing their direct consignees of the issue, potential health risks, and instructing their consignees to discard or return the affected product. An Acknowledgement and Receipt Form was enclosed to indicate the consignee has read and understands the recall instructions and asks if there have been any adverse events associated with the product. The response form instructs that if the consignee wishes to return the product, it should be sent to Young Dental Manufacturing for reimbursement. Follow-up letters were issued on and dated 9/11/2024 instructing the consignees to notify their downstream consignees to the user level. The letter also offers to notify the downstream consignees if their direct consignee requests it.
Distribution Pattern Distribution was made to AZ, ID, MD, NV, NY, PA, SC, TN, TX, WI. There was no government/military/foreign distribution.
Code Information / Serial Numbers Lot numbers 247026, 255361, 234038, and 241667, exp. 6/13/2026; UDI-DI 00302730002089.

Related Establishments / Registrations

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