🔍 RecallPedia

QCare Rx Oral Cleansing and Suctioning System with 0.12% Chlorhexidine Gluconate (CHG) Oral Rinse q2. Contains: 1 Covered Yankauer and Y-Connector, 2 Untreated Suction Toothbrush packages, 2 Single dose bottles of 0.12% CHG Oral Rinse, 4 Suction Oral Swab packages with Perox-A-Mint Solution, 6 Suction Oral Swab packages with Alcohol-Free Mouthwash, 4 Oropharyngeal Suction Catheter packages. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013 Product Code 6912 UPC 6 18029 83016 6

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: 6912; Lots: 52736, 52807, 52878, 52994, 53067, 53084, 53137, 53192, EXP 08/31/2017; 53363, 53459, 53695, 53748, 53868, EXP 9/30/2017; 53916, 54003, 54011, 54012, 54015, 54024, 54049, 54057, 54265, 54279, 54293, EXP 10/31/2017; 54487, 54562, 54613, EXP 12/31/2017; 54686, 54703, 54736, 54745, 54748, 54751, 54817, 54979, 55047, EXP 11/30/2017; 55546, 55561, 55580, 55589, 55602, 55615, 55680, 55709, 55718, 55726, 55735, 55740, 55843, 55857, 55868, 55880, 55900, 55960, EXP 12/31/2017; 56348, 56418, 56604, 56670, 56820, 56944, 56975, 57140, 57201, EXP 02/28/2018; 57506, 57579, 57733, 57900, EXP 03/31/2018; 57925, 58229, 58281, EXP 04/30/2018; 58696, 58762, 59044, EXP 6/30/2018; 59456, 59546, EXP 7/31/2018; 59766, 59830, 60293, 60358, EXP 8/31/2018; 60416, 60563, 60623, 60983, EXP 9/30/2018; 61780, 62118, EXP 12/13/2018
  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 Oral Cleansing and Suctioning System with 0.12% Chlorhexidine Gluconate (CHG) Oral Rinse q2. Contains: 1 Covered Yankauer and Y-Connector, 2 Untreated Suction Toothbrush packages, 2 Single dose bottles of 0.12% CHG Oral Rinse, 4 Suction Oral Swab packages with Perox-A-Mint Solution, 6 Suction Oral Swab packages with Alcohol-Free Mouthwash, 4 Oropharyngeal Suction Catheter packages. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013 Product Code 6912 UPC 6 18029 83016 6

Product Codes/Lot Numbers:

Product Code: 6912; Lots: 52736, 52807, 52878, 52994, 53067, 53084, 53137, 53192, EXP 08/31/2017; 53363, 53459, 53695, 53748, 53868, EXP 9/30/2017; 53916, 54003, 54011, 54012, 54015, 54024, 54049, 54057, 54265, 54279, 54293, EXP 10/31/2017; 54487, 54562, 54613, EXP 12/31/2017; 54686, 54703, 54736, 54745, 54748, 54751, 54817, 54979, 55047, EXP 11/30/2017; 55546, 55561, 55580, 55589, 55602, 55615, 55680, 55709, 55718, 55726, 55735, 55740, 55843, 55857, 55868, 55880, 55900, 55960, EXP 12/31/2017; 56348, 56418, 56604, 56670, 56820, 56944, 56975, 57140, 57201, EXP 02/28/2018; 57506, 57579, 57733, 57900, EXP 03/31/2018; 57925, 58229, 58281, EXP 04/30/2018; 58696, 58762, 59044, EXP 6/30/2018; 59456, 59546, EXP 7/31/2018; 59766, 59830, 60293, 60358, EXP 8/31/2018; 60416, 60563, 60623, 60983, EXP 9/30/2018; 61780, 62118, EXP 12/13/2018

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-0352-2018

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 →