Oral Cleansing & Suctioning System with 0 — Class II drug recall D-0386-2018

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-0386-2018`
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	25 cases
UPC / GTIN / UDI-DI	`00618029821331`
Lot numbers	`62154`
Expiration dates	`2019-02-19`

Product

Oral Cleansing & Suctioning System with 0.12% Chlorhexidine Gluconate (CHG) Oral Rinse q2, 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, 6 Packages Suction Oral Swab with sodium bicarbonate, Alcohol Free Mouthwash and Mouth Moisturizer, 2 Oropharyngeal Suction Catheter packages. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6592-S UPC 6 18029 82133 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-0386-2018. 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.