BEUDAMED
    FDA Enforcement Class II Terminated

    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.

    Recall: Z-2139-2019 · Reported August 14, 2019

    Enforcement

    Recall Number
    Z-2139-2019
    Event ID
    81745
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Sage Products Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 14, 2019
    Initiation Date
    December 5, 2018
    Classification Date
    August 2, 2019
    Termination Date
    June 15, 2020
    Address
    3909 3 Oaks Rd, N/A, Cary, IL, 60013-1804, United States

    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

    A voluntary recall of a lot (67924) of Independent Care System due to the potential for damaged Sodium Bicarbonate Mouthpaste (cosmetic) tubes.

    Code Info

    Product Code 6004; Lot Number 67924; Reorder Number 6080

    Distribution

    US nationwide distribution in the states CO, CT, GA, IN, CA.

    Quantity

    39 Cases (50 kits per case)