Oral Cleaning and Suctioning System q2 — Class II drug recall D-0378-2018
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-0378-2018 |
|---|---|
| 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 | 852 cases |
| UPC / GTIN / UDI-DI | 00618029800602 |
| Lot numbers | 57627, 58677, 60110, 61463 |
| Expiration dates | 2017-08-14, 2017-10-02, 2018-01-02, 2018-03-30 |
Product
Oral Cleaning and Suctioning System q2. Contains 1 Covered Yankauer, 2 Untreated Suction Toothbrush packages with Antiplaque solution, 4 Suction Oral Swab packages with Perox-A-Mint- solution, 6 Suction Oral Swab packages with Alcohol-Free Mouthwash solution, 2 Oropharyngeal Suction Catheter packages. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6502 UPC 6 18029 80060 2
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-0378-2018. 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.