FDAFDA · Food and drugs·Recall number D-0385-2018
Oral Cleansing & Suctioning System q2 with 0.12% Chlorexidine Gluconate (CHG) Oral Rinse. Contains 1 Covered Yankauer and Y-Connector, 2 Untreated Suction Toothbrush packages, 2 Single dose bottles of 0.12% CHG Oral Rinse, packages SYS W/CHG 10, Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6592
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: 6592; Lots: 54071, EXP 10/31/2017; 54664, EXP 12/31/2017; 55007, EXP 11/30/2017; 55866, EXP 12/31/2017; 56487, 56516, 57057, EXP 02/28/2018; 58756, 58766, EXP 06/30/2018; 59618, EXP 07/31/2018; 60036, 60346, EXP 08/31/2019.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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