D-0402-2018 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
- 6461 Cases
Product Description
Q.Care Oral Cleansing & Suctioning System Suction Toothbrush Compatible with Chlorhexidine Gluconate (CHG) Oral Rinse q2. Contains 1 Covered Yankauer and Y-Connector, 2 Untreated, CHG Compatible Suction Toothbrush packages, 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 6922 UPC 6 18029 83032 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: 6922; Lots: 51408, EXP 08/10/2017; 51701, EXP 08/22/2017; 52782, EXP 10/31/2018; 53083, EXP 11/14/2017; 53746, EXP 01/09/2018; 54210, EXP 02/06/2018; 54868, EXP 03/21/2018; 55294, XP 04/17/2018; 55930, EXP 05/30/2018;56555, EXP 07/12/2018; 57519, EXP 09/05/2018; 58373, EXP 10/16/2018; 59542, EXP 12/11/20178; 60611, EXP 02/26/2019; 61148, EXP 03/26/2019; 61623, EXP 04/17/2019