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

FDA device recall Z-0008-2025 · posted 2024-10-01 · Open, Classified

Recall details

Recalling firm

Young Dental Manufacturing I, LLC

Reason for recall

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

Action taken

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.

Root cause

Material/Component Contamination

Status

Open, Classified

Product code

FLG

Quantity affected

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.

Date initiated

2024-08-23

Date posted

2024-10-01

Location

Earth City, MO