Recall Z-2139-2019 ยท NSB Patient Personal Hygiene Kit
Sage Products Inc
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.
| Date | Dec 5, 2018 |
| Status | Terminated |
| Reason | A voluntary recall of a lot (67924) of Independent Care System due to the potential for damaged Sodium Bicarbonate Mouthpaste (cosmetic) tubes. |
| 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) 323-2 |
| Quantity | 39 Cases (50 kits per case) |
| Distribution | US nationwide distribution in the states CO, CT, GA, IN, CA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.