D-0395-2018 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- February 21, 2018
- Initiation Date
- August 22, 2017
- Termination Date
- December 13, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2970 Cases
Product Description
Q.CareOral Cleansing & Suctioning System q2. Contains 1 Covered Yankauer Suction Handle and Y-Connector, 2 Suction Toothbrush packages with Antiseptic Solution,, 4 Suction Oral Swab packages with Perox-A-Mint solution, 6 Suction Oral Swab packages with Alcohol-Free Mouthwash, 4 Oropharyngeal Suction Catheter packages. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6802 UPC 6 18029 84120 9
Reason for Recall
Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
Distribution Pattern
Distributed Nationwide in the USA and Puerto Rico, Canada, United Kingdom, Ireland, Netherlands, New Zealand
Code Information
Product Code: 6802; Lots: 57509, EXP 08/14/2017; 58122, EXP 09/11/2017; 58203, EXP 10/02/2017; 58978, EXP 11/03/2018; 59724, EXP 11/27/2017; 60556, EXP 02/05/2018; 61241, EXP 02/23/2018;