FDA Drug recall D-0397-2018
Q.Care Oral Cleansing & Suctioning System q8
- 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 q8 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-0397-2018 |
| 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 q8. Contains 1 Covered Yankauer Suction Handle and Y-Connector, 2 Suction Toothbrush packages with Antiseptic Solution,, 1 Suction Oral Swab packages with Perox-A-Mint solution, 1 Oropharyngeal Suction Catheter package. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6808 UPC 6 18029 84122 3
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 | 618029841223 |
|---|---|
| code_info | Product Code: 6808; Lots: 57592, EXP 08/14/2017; 58202, EXP 10/02/2017; 59213, EXP 11/13/2017; 60274, EXP 01/02/2018;…Product Code: 6808; Lots: 57592, EXP 08/14/2017; 58202, EXP 10/02/2017; 59213, EXP 11/13/2017; 60274, EXP 01/02/2018; 60718 EXP 02/05/2018; 61745, EXP 03/21/2018. |
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-0397-2018%22
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