FDA Drug recall D-0375-2018
Q CARE q4 Oral Cleansing & Suctioning System, Contains 1 Covered Yankauer and Y-Connector, 2 Suction Toothbrush packages with Antiplaque so…
- FDA Drug
- Class II
- terminated
- Published 2018-02-21
On 2018-02-21 the FDA classified a Class II recall of Q CARE q4 Oral Cleansing & Suctioning System, Contains 1 Covered Yankauer and Y-Connector, 2 Suction Toothbrush packages with Antiplaque so… 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-0375-2018 |
| 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 CARE q4 Oral Cleansing & Suctioning System, Contains 1 Covered Yankauer and Y-Connector, 2 Suction Toothbrush packages with Antiplaque solution, 4 Suction Oral Swab packages with Antiseptic Oral Rinse, 2 Oropharyngeal Suction Catheter packages, Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6414 UPC 6 18029 84138 4
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 | 618029841384 |
|---|---|
| code_info | Product Code: 6414; Lots: 57847, EXP 09/18/2017; 57852, 57875, EXP 08/14/2017; 58246, EXP 09/20/2017; 58802, 58851, EXP…Product Code: 6414; Lots: 57847, EXP 09/18/2017; 57852, 57875, EXP 08/14/2017; 58246, EXP 09/20/2017; 58802, 58851, EXP 10/09/2017; 58924, 59091, 59116, EXP 11/03/2017; 59494, EXP 11/27/2017; 60123, EXP 01/02/2018; 60466, 60880, 60925, 01/22/2018; 61364, 03/05/2018; 61705, EXP03/30/2018; 62061, EXP 04/17/2018; 62076, EXP 04/27/2018 |
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-0375-2018%22
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