Key Takeaway

Q.Care Petite Size Oral Cleansing & Suctioning System. Contains 1 Covered Yankauer, and Y-Connector, 2 Petit Size Suction Toothbrushes, 7ml Antiseptic Oral Rinse, Applicator Swab and 2g Mouth Moisturi by Sage Products Inc was recalled on August 22, 2017. The hazard: Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical p...

FDA Drug Class II Terminated

Q.Care Petite Size Oral Cleansing & Suctioning System. Contains 1 Covered Yankauer, and Y-Connector, 2 Petit Size Suction Toothbrushes, 7ml Antiseptic Oral Rinse, Applicator Swab and 2g Mouth Moisturi

Recalled: August 22, 2017 ~2017 Cases units affected D-0394-2018

Description

Q.Care Petite Size Oral Cleansing & Suctioning System. Contains 1 Covered Yankauer, and Y-Connector, 2 Petit Size Suction Toothbrushes, 7ml Antiseptic Oral Rinse, Applicator Swab and 2g Mouth Moisturizer, 4 Petit Size Untreated Suction Oral Swabs, 7ml Antiseptic Oral Rinse, Applicator Swab and 2g Mouth Moisturizer, 2 8 French Oropharyngeal Suction Catheter. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6714 UPC 6 18029 83038 8

Hazard / Reason

Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products

Class II: Product that may cause temporary or medically reversible health consequences.

Class II indicates the product may cause temporary or medically reversible health effects. The probability of serious harm is considered remote.

Products Affected

Q.Care Petite Size Oral Cleansing & Suctioning System. Contains 1 Covered Yankauer, and Y-Connector, 2 Petit Size Suction Toothbrushes, 7ml Antiseptic Oral Rinse, Applicator Swab and 2g Mouth Moisturi

Drugs

Company Information

Sage Products Inc

Cary, IL, United States

View all 66 recalls by Sage Products Inc →

Distribution

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

Related Recalls

Frequently Asked Questions

Is this recall still active?

Check the status badge at the top of this page. "Ongoing" means the recall is still active and you should follow the remedy instructions. "Completed" or "Terminated" means the recall process has concluded, though the safety issue remains relevant for any unrepaired products.

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Compare the model number, lot code, serial number, or date range listed in the recall notice with the information on your product's label or packaging. For vehicles, check your VIN at NHTSA.gov/Recalls.

What remedy is available for this recall?

Check the remedy section above or contact the manufacturer directly for current remedy options.

Where can I find the original recall notice?

This recall was issued by FDA Drug. Visit the agency's official website for the original notice.

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