FDA-Drug2018-02-21Class II
Q Care RX Petite Oral Cleansing & Suctioning System with 0.12% Chlorhexidine Gluconate (CHG) Oral Rinse. Contains 1 Covered Yankauer and Y-Connector, 2 Untreated Petite Suction Toothbrush packages, 2 Single dose bottles of 0.12% CHG Oral Rinse, 4 Petite Suction Oral Swab packages with Corinz Antiseptic Cleansing and Moisturizing Oral Rinse, 2 Oropharyngeal Suction Catheter packages. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6974 UPC 6 18029 83097 5
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
633 Cases
Manufactured in
3909 3 Oaks Rd, Cary, IL, United States
Products
Q Care RX Petite Oral Cleansing & Suctioning System with 0.12% Chlorhexidine Gluconate (CHG) Oral Rinse. Contains 1 Covered Yankauer and Y-Connector, 2 Untreated Petite Suction Toothbrush packages, 2 Single dose bottles of 0.12% CHG Oral Rinse, 4 Petite Suction Oral Swab packages with Corinz Antiseptic Cleansing and Moisturizing Oral Rinse, 2 Oropharyngeal Suction Catheter packages. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6974 UPC 6 18029 83097 5
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0406-2018Don't want to check this manually?
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