Sage Products Inc recalls Oral Cleansing & Suctioning System with 0.12% Chlorhexidine Gluconate (CHG) Oral Rinse q2, Contains 1 Covered Yankauer…

Recall date

August 22, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0388-2018

FDA classification

Class II

Brand / firm

Sage Products Inc

Sold / distributed

Distributed Nationwide in the USA and Puerto Rico, Canada, United Kingdom, Ireland, Netherlands, New Zealand

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Oral Cleansing & 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 Packages Suction Oral Swab with sodium bicarbonate, Perox-A-Mint solution and Mouth Moisturizer, , 2 Oropharyngeal Suction Catheter packages. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6594-S UPC 6 18029 82134 1