D-0396-2018 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
- 5085 Cases
Product Description
Q.CARE Oral Cleansing & Suctioning System q4. Contains 1 Covered Yankauer, Suction Handle and Y-Connector, 2 Toothbrush packages with Antiplaque solution. 4 Suction Oral Swab packages with Perox-A-Mint solution. 2 Oropharyngeal Suction Catheter packages, Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6804 UPC 6 18029 84121 6
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: 6804; Lots: 57567, EXP 08/14/2017; 58163, EXP 09/11/2017; 59009, EXP 11/03/2017; 59637, EXP 11/27/2017; 60241, 60263, EXP 01/02/2018; 60631, EXP 02/05/2018; 61294,EXP 02/23/2018; 61321, EXP 03/30/2018.