FDA-Drug2018-02-21Class II

Q.Care Oral Cleansing & Suctioning System Suction Toothbrush Compatible with Chlorhexidine Gluconate (CHG) Oral Rinse q4. Contains 1 Covered Yankauer and Y-Connector, 2 Untreated Suction Toothbrush packages, 4 Suction Oral Swab packages with Perox-A-Mint solution, 2 Oropharyngeal Suction Catheter packages. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6924 UPC 6 18029 83033 3

Sage Products Inc
Hazard

Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products

Sold states
Distributed Nationwide in the USA and Puerto Rico, Canada, United Kingdom, Ireland, Netherlands, New Zealand
Affected count
16639 Cases
Manufactured in
3909 3 Oaks Rd, Cary, IL, United States
Products
Q.Care Oral Cleansing & Suctioning System Suction Toothbrush Compatible with Chlorhexidine Gluconate (CHG) Oral Rinse q4. Contains 1 Covered Yankauer and Y-Connector, 2 Untreated Suction Toothbrush packages, 4 Suction Oral Swab packages with Perox-A-Mint solution, 2 Oropharyngeal Suction Catheter packages. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6924 UPC 6 18029 83033 3

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0404-2018

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