FDA Drug recall D-0395-2018
Q.CareOral Cleansing & Suctioning System q2
- FDA Drug
- Class II
- terminated
- Published 2018-02-21
On 2018-02-21 the FDA classified a Class II recall of Q.CareOral Cleansing & Suctioning System q2 by Sage Products, citing cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0395-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-08-22 |
| Published | 2018-02-21 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Sage Products |
| Distribution | US |
Product
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
Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
Identifiers
| upc | 618029841209 |
|---|---|
| code_info | Product Code: 6802; Lots: 57509, EXP 08/14/2017; 58122, EXP 09/11/2017; 58203, EXP 10/02/2017; 58978, EXP 11/03/2018; 5…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; |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0395-2018%22
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