FDA Drug recall D-0394-2018
Q.Care Petite Size Oral Cleansing & Suctioning System
- FDA Drug
- Class II
- terminated
- Published 2018-02-21
On 2018-02-21 the FDA classified a Class II recall of Q.Care Petite Size Oral Cleansing & Suctioning System 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-0394-2018 |
| 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 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
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 | 618029830388 |
|---|---|
| code_info | Product Code: 6714; Lots: 57979, EXP 09/19/2017; 58845, EXP 10/09/2017; 60215, EXP 01/08/2018; 61235, EXP 03/05/2018. |
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-0394-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.