BEUDAMED
    FDA Recall 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 · Initiated December 5, 2018

    Recall

    Recall Number
    Z-2139-2019
    Event Number
    81745
    Firm
    Sage Products Inc 3909 3 Oaks Rd Cary IL 60013-1804
    FEI Number
    1419181
    Product Code
    NSB
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    December 5, 2018
    Terminated
    June 15, 2020

    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.

    Action

    Sage Products, LLC notified Distributor Partners/Healthcare Facilities on about 11/30/2018, via letter titled, "URGENT: RECALL Independent Care System: Product Code 6004." The letter instructed customers to examine their inventory for the affected lot number, discontinue use and/or further distribution of the affected lot, distributors that have distributed the product to facilities or customers should initiate a sub-recall process down to the facility or customer level, and complete and return the recall return response form. Questions can be directed to Customer Service at (800) 323-2200 Monday through Friday, between the hours of 8:00 a.m. and 5:00 p.m., Central Time. The Recall Response forms should be returned to the following address: Sage Products LLC Attn: Missy Stefan Regulatory Affairs 3909 Three Oaks Road Cary, IL 60013

    Distribution

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

    Quantity

    39 Cases (50 kits per case)