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FDAFDA · Food and drugs·Recall number D-0408-2018

Q Care Oral Cleansing & Suctioning System compatible with 0.12% Chlorhexidine Gluconate (CHG) Oral Rinse. Contains 1 Covered Yankauer and Y-Connector, 2 Untreated Suction Toothbrush packages, 4 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 6994 UPC 6 18029 83094 4

Published February 21, 2018 · Recall initiated: August 22, 2017

Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

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

What to do

Voluntary: Firm initiated · Letter

Recall details

Manufacturer
Sage Products Inc
Distributor
Distributed Nationwide in the USA and Puerto Rico, Canada, United Kingdom, Ireland, Netherlands, New Zealand
Lot
Product Code: 6994; Lots: 58092, EXP 12/11/2017; 60090, EXP 07/30/2018; 60663, EXP 09/06/2018; 61261, EXP 09/11/2018; 61947, EXP 11/12/2018
Risk classification
Class II
Area (FDA)
drug
Country
United States

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