Oral Cleansing & Suctioning System with 0 — Class II drug recall D-0387-2018
Terminated recall by Sage Products Inc, reported 2018-02-21, distributed nationwide. Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on eq
| Recall number | D-0387-2018 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Sage Products Inc, Cary, IL, United States |
| Recall initiated | 2017-08-22 |
| Classified | 2018-02-09 |
| Reported by FDA | 2018-02-21 |
| Terminated | 2018-12-13 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, GB, IE, NL, NZ |
| Quantity | 5,138 cases |
| Lot numbers | 53018, 53023, 53824, 53833, 53949, 54045, 54708, 55087, 55169, 55699, 55730, 55952, 56028, 56042, 56540, 56945, 57345, 57632, 57672, 58428, 58463, 58506, 58539, 58590, 59137, 59395, 59442, 60244, 60709, 60778, 61828 |
| Expiration dates | 2017-08-08, 2017-08-31, 2017-09-30, 2017-10-03, 2017-10-31, 2017-11-30, 2017-12-31, 2018-02-28, 2018-03-31, 2018-04-30, 2018-06-30, 2018-07-31, 2018-08-31, 2018-09-30, 2018-12-31 |
Product
Oral Cleansing & Suctioning System with 0.12% Chlorhexidine Gluconate (CHG) Oral Rinse q4, Contains 1 Covered Yankauer and Y-Connector, 2 Untreated Suction Toothbrush packages, 2 Single dose bottles of 0.12% CHG Oral Rinse, 4 Packages Suction Oral Swab with sodium bicarbonate, Perox-A-Mint solution and Mouth Moisturizer, 2 Oropharyngeal Suction Catheter packages. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6594 UPC 6 18029 82134 1
Reason for recall
Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0387-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.