🔍 RecallPedia

QCare RX Q2 Oral Cleansing & Suctioning System with 0.12% Chlorhexidine Gluconate (CHG) Oral Rinse Corinz. Contains 1 Covered Yankauer and Y-Connector, 2 Untreated Suction Toothbrush packages, 2 Single dose bottles of 0.12% CHG Oral Rinse, 10 Suction Oral Swab packages with Corinz Antiseptic Cleansing and Moisturizing Oral Rinse and 2 Oropharyngeal Suction Catheter packages. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6962, UPC 6 18029 83076 0

Class I - Dangerous
💊 Drugs Recalled: August 22, 2017 Sage Products Prescription Drugs Nationwide

What Should You Do?

  1. Check if you have this product:
    Product Code: 6962; Lots: 55604, 55619, 56000, 56052 EXP 08/28/2017; 56211, 56282, 56783, EXP 09/26/2017; 57204, 57614, 58027, EXP 11/13/2017; 58549, 58587, EXP 04/03/2018; 59493, EXP 07/16/2018; 60043, 60079, EXP 07/30/2018; 60476, EXPO 08/02/2018; 60490 EXP 09/04/2018; 60790, EXP 09/06/2018; 61405, EXP 09/11/2018; 61456, 61799, EXP 10/16/2018
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Sage Products Inc
Reason for Recall:
Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

QCare RX Q2 Oral Cleansing & Suctioning System with 0.12% Chlorhexidine Gluconate (CHG) Oral Rinse Corinz. Contains 1 Covered Yankauer and Y-Connector, 2 Untreated Suction Toothbrush packages, 2 Single dose bottles of 0.12% CHG Oral Rinse, 10 Suction Oral Swab packages with Corinz Antiseptic Cleansing and Moisturizing Oral Rinse and 2 Oropharyngeal Suction Catheter packages. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6962, UPC 6 18029 83076 0

Product Codes/Lot Numbers:

Product Code: 6962; Lots: 55604, 55619, 56000, 56052 EXP 08/28/2017; 56211, 56282, 56783, EXP 09/26/2017; 57204, 57614, 58027, EXP 11/13/2017; 58549, 58587, EXP 04/03/2018; 59493, EXP 07/16/2018; 60043, 60079, EXP 07/30/2018; 60476, EXPO 08/02/2018; 60490 EXP 09/04/2018; 60790, EXP 09/06/2018; 61405, EXP 09/11/2018; 61456, 61799, EXP 10/16/2018

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-0354-2018

Related Recalls

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.

Sage Products

Class I - Dangerous

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

Dec 5, 2018 Other Medical Devices Nationwide View Details →