D-0348-2018 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
- 1182 kits
Product Description
Q.Care, Oral Cleansing & Suctioning System q4. Contains: 1 Covered Yankauer and Y-Connector, 2 Suction Toothbrush packages and Antiplaque solution, 4 Suction Oral Swab packages with Perox-A-Mint solution. Manufactured by: Sage Products, LLC., 3909 Three Oaks Road, Cary, IL 60013 Product Code: 6434; UPC 6 18029 83035 7
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: 6434; Lots: 58519, 58536, EXP 10/02/2017; 59366, EXP 11/13/2017; 60250, 60266, EXP 01/02/2018; 60974, EXP 02/23/2018; 61427, EXP 03/30/2018.