Oral-B, Practitioner Series, 5% Sodium Fluoride Varnish, 500 units (40mL/each) - Product Usage: For dentinal hypersensitivity and for the reduction of post-operative sensitivity.
FDA Recall Z-0661-2020 · Posted None
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Recalling FirmYoung Dental Manufacturing Co, LLC
Recall StatusOpen, Classified
Product CodeLBH
Date Initiated2019-10-30
Product QuantityBatch 84702 - 6500 units; Batch 72766 - 6500 units
Reason for Recall
Product shelf life may be shorter than that indicated on the label.
Firm Action
Notification by letter to be made to customer via certified mail. Customers are instructed to return or scrap the affected product. Multiple attempts will be made to contact customers. Returned product will be destroyed. For recall inquiries, contact 224-622-7191.
Root Cause
Process control
Distribution Pattern
US Nationwide distribution in the states of MS, IN, MD, IL, TN, NJ, an ME.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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