🔍 RecallPedia

Q CARE q2 Oral Cleansing & Suctioning System, Contains 1 Covered Yankauer and Y-Connector, 2 Suction Toothbrush packages with Antiplaque solution, 4 Suction Oral Swab packages with Antiseptic Oral Rinse, 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 6412 UPC 6 18029 84137 7

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: 6412; Lots: 58432, EXP 10/02/2017; 59402, EXP 11/13/2017; 59864, EXP 01/02/2018; 60799, EXP 01/22/2018; 61115 EXP 02/23/2018; 61557, EXP 03/30/2018.
  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:

Q CARE q2 Oral Cleansing & Suctioning System, Contains 1 Covered Yankauer and Y-Connector, 2 Suction Toothbrush packages with Antiplaque solution, 4 Suction Oral Swab packages with Antiseptic Oral Rinse, 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 6412 UPC 6 18029 84137 7

Product Codes/Lot Numbers:

Product Code: 6412; Lots: 58432, EXP 10/02/2017; 59402, EXP 11/13/2017; 59864, EXP 01/02/2018; 60799, EXP 01/22/2018; 61115 EXP 02/23/2018; 61557, EXP 03/30/2018.

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-0374-2018

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 →