Recall Z-2139-2019— Sage Products Inc
Class II · Terminated
Class II FDA medical device recall by Sage Products Inc, initiated 2018-12-05, terminated 2020-06-15. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: A voluntary recall of a lot (67924) of Independent Care System due to the potential for damaged Sodium Bicarbonate Mouthpaste (cosmetic) tubes..
- Recalling firm
- Sage Products Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-12-05
- Terminated
- 2020-06-15
- Firm location
- Cary, IL, United States
Product description
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.
Reason for recall
A voluntary recall of a lot (67924) of Independent Care System due to the potential for damaged Sodium Bicarbonate Mouthpaste (cosmetic) tubes.
Data sourced from openFDA. This site is unofficial and independent of the FDA.