Drug product
Q.Care Petite Size Oral Cleansing & Suctioning System. Contains 1 Covered Yankauer, and Y-Connector, 2 Petit Size Suction Toothbrushes, 7ml Antiseptic Oral Rinse, Applicator Swab and 2g Mouth Moisturizer, 4 Petit Size Untreated Suction Oral Swabs, 7ml Antiseptic Oral Rinse, Applicator Swab and 2g Mouth Moisturizer, 2 8 French Oropharyngeal Suction Catheter. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6714 UPC 6 18029 83038 8
D-0394-2018
Product summary
- Event
- Event 77992
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2017 Cases
- Official record key
drug-enforcement:D-0394-2018
Official wording
Reason: Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
Code information: Product Code: 6714; Lots: 57979, EXP 09/19/2017; 58845, EXP 10/09/2017; 60215, EXP 01/08/2018; 61235, EXP 03/05/2018.
Distribution pattern: Distributed Nationwide in the USA and Puerto Rico, Canada, United Kingdom, Ireland, Netherlands, New Zealand
Derived failure modes
-
Unknown
Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products