# FDA recall D-0389-2018

> **Sage Products Inc** · Class II · drug recall initiated 2017-08-22.

## Product

Toothette Oral Care Q Care & Suctioning System. Contains  1 Covered Yankauer, Suction Handle and Y-Connector, 2 Suction Toothbrush packages with Perox-A-Mint solution, 10 Suction Oral Swab packages with Perox-A-Mint solution, 4 Oropharyngeal Suction Catheter packages. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6602 UPC 6 18029 84116 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

## Distribution

Distributed Nationwide in the USA and Puerto Rico,  Canada, United Kingdom, Ireland, Netherlands, New Zealand

## Key facts

- **Recall number:** D-0389-2018
- **Recalling firm:** Sage Products Inc
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2017-08-22
- **Report date:** 2018-02-21
- **Termination date:** 2018-12-13

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Cary, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0389-2018

## Citation

> AI Analytics. FDA recall D-0389-2018. Retrieved 2026-06-16 from https://api.ai-analytics.org/recall/D-0389-2018. Source: US FDA. Licensed CC0.

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