FDAFDA · Food and drugs·Recall number D-0387-2018
Oral Cleansing & Suctioning System with 0.12% Chlorhexidine Gluconate (CHG) Oral Rinse q4, 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 UPC 6 18029 82134 1
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: 6594; Lots: 53018, 53824, EXP 08/08/2017; 53023, EXP 08/31/2017; 53833, EXP 09/30/2017; 53949, EXP 10/03/2017; 54045, EXP 10/31/2017; 55087, 55169, EXP 11/30/2017; 54708, 55699; 55730; 55952; 56028; 56042, EXP 12/31/2017; 56540; 56945; 57345, EXP 02/28/2018; 57632; 57672, EXP 03/31/2018; 58428, EXP 04/30/2018; 58463, 58506, 58539, 58590, EXP 06/30/2018; 59137, 59395, 59442, EXP 07/31/2018; 60244, EXP 08/31/2018; 60709, 60778, EXP 09/30/2018; 61828, EXP 12/31/2018.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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