FDA Drug recall D-0356-2018
Oral Cleansing & Suctioning System q4
- FDA Drug
- Class II
- terminated
- Published 2018-02-21
On 2018-02-21 the FDA classified a Class II recall of Oral Cleansing & Suctioning System q4 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-0356-2018 |
| 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
Oral Cleansing & Suctioning System q4. Contains 1 Covered Yankauer, 2 Untreated Suctino Toothbrush packages with Antiplaque solution, 4)Suction Oral Swab packages with Perox-A-Mint solution, 2 Oropharyngeal Suction Catheter packages, Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6504. UPC 6 18029 83045 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 | 618029830456 |
|---|---|
| code_info | Product Code: 6504; Lots: 58174, EXP 09/11/2017; 59297, EXP 11/13/2017; 60127, EXP 01/02/2018; 60673, EXP 02/05/2018; 6…Product Code: 6504; Lots: 58174, EXP 09/11/2017; 59297, EXP 11/13/2017; 60127, EXP 01/02/2018; 60673, EXP 02/05/2018; 61002, EXP 02/23/2018; 61817, EXP 03/21/2018; 61825, 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-0356-2018%22
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