Device product
Toothete Oral Care Sodium Bicarbonate Mouthpaste, Net Wt. 1/3 oz/ 9g, included in Independent Care System. The system is an oral care convenience kit which includes: an Ultra-Soft Toothbrush, 0.5 oz. tube of Mouth Moisturizer, 0.33 oz. /9g tube of Sodium Bicarbonate Mouthpaste and 1.5fl.oz. bottle of Corinz oral rinse. Product Usage: The mouthpaste is used to clean teeth, gums, and the tongue.
Z-2139-2019
Product summary
- Event
- Event 81745
- Status
- Terminated
- Classification
- Class II
- Quantity
- 39 Cases (50 kits per case)
- Official record key
device-enforcement:Z-2139-2019
Official wording
Reason: A voluntary recall of a lot (67924) of Independent Care System due to the potential for damaged Sodium Bicarbonate Mouthpaste (cosmetic) tubes.
Code information: Product Code 6004; Lot Number 67924; Reorder Number 6080
Distribution pattern: US nationwide distribution in the states CO, CT, GA, IN, CA.
Derived failure modes
-
Unknown
A voluntary recall of a lot (67924) of Independent Care System due to the potential for damaged Sodium Bicarbonate Mouthpaste (cosmetic) tubes.