FDA Device

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.

Hazard

Product shelf life may be shorter than that indicated on the label.

What You Should Do

Remedy

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.

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Products

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.
Brand
Young Dental Manufacturing Co, LLC
UPC
Batch 84702; Batch 72766

Units Affected

Batch 84702 - 6500 units; Batch 72766 - 6500 units

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