Z-2139-2019 Class II Terminated
FDA device recall Z-2139-2019 was initiated by Sage Products Inc on December 5, 2018 and is designated Class II. 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. The recall status is terminated (terminated June 15, 2020). Affected quantity: 39 Cases (50 kits per case).
Recall Details
- Product Type
- Devices
- Report Date
- August 14, 2019
- Initiation Date
- December 5, 2018
- Termination Date
- June 15, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 39 Cases (50 kits per case)
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.
Distribution Pattern
US nationwide distribution in the states CO, CT, GA, IN, CA.
Code Information
Product Code 6004; Lot Number 67924; Reorder Number 6080