Class 2 Device Recall Independent Care System

• Date Initiated by Firm: December 05, 2018
• Create Date: August 02, 2019
• Recall Status: Terminated on June 15, 2020
• Recall Number: Z-2139-2019
• Recall Event ID: 81745
• Product Classification: Patient personal hygiene kit - Product Code NSB
• 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.
• Code Information: Product Code 6004; Lot Number 67924; Reorder Number 6080
• FEI Number: 1419181
• Recalling Firm/ Manufacturer: Sage Products Inc; 3909 3 Oaks Rd; Cary IL 60013-1804
• For Additional Information Contact: 800-323-2220
• Manufacturer 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.
• FDA Determined Cause: Nonconforming Material/Component
• 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
• Quantity in Commerce: 39 Cases (50 kits per case)
• Distribution: US nationwide distribution in the states CO, CT, GA, IN, CA.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.