FDA Drug recall D-0402-2018
Q.Care Oral Cleansing & Suctioning System Suction Toothbrush Compatible with Chlorhexidine Gluconate (CHG) Oral Rinse q2
- FDA Drug
- Class II
- terminated
- Published 2018-02-21
On 2018-02-21 the FDA classified a Class II recall of Q.Care Oral Cleansing & Suctioning System Suction Toothbrush Compatible with Chlorhexidine Gluconate (CHG) Oral Rinse 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-0402-2018 |
| 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 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
Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
Identifiers
| upc | 618029830326 |
|---|---|
| code_info | Product Code: 6922; Lots: 51408, EXP 08/10/2017; 51701, EXP 08/22/2017; 52782, EXP 10/31/2018; 53083, EXP 11/14/2017; 5…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 |
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-0402-2018%22
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