Z-2139-2019Class II

Toothete Oral Care Sodium Bicarbonate Mouthpaste, Net Wt. 1/3 oz/ 9g, included in Independent Care System...

Name: Z-2139-2019 Toothete Oral Care Sodium Bicarbonate Mouthpaste, Net Wt. 1/3 oz/ 9g, included in Independent Care System...
Creator: Sage Products Inc
Published: 2018-12-05
License: https://open.fda.gov/license/

Sage Products LLC / initiated 2018-12-05 / Terminated / root cause: manufacturing process

FDA source

Sage Products Inc began a recall of 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... on 2018-12-05. FDA classified it as Class II and gives the reason as "A voluntary recall of a lot (67924) of Independent Care System due to the potential for damaged Sodium Bicarbonate Mouthpaste (cosmetic) tubes". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2139-2019
Classification: Class II
Status: Terminated
Initiated: 2018-12-05
Posted: 2019-08-02
Terminated: 2020-06-15
Recalling firm: Sage Products LLC
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.
Product code: NSB Patient Personal Hygiene Kit
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.
Root cause tag: manufacturing process
FDA root 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.
Product codes and lots: Product Code 6004; Lot Number 67924; Reorder Number 6080

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2139-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2139-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-14	2019-08-02

Product code NSB

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)