Z-0661-2020 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- December 18, 2019
- Initiation Date
- October 30, 2019
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- Batch 84702 - 6500 units; Batch 72766 - 6500 units
Product Description
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.
Reason for Recall
Product shelf life may be shorter than that indicated on the label.
Distribution Pattern
US Nationwide distribution in the states of MS, IN, MD, IL, TN, NJ, an ME.
Code Information
Batch 84702; Batch 72766