PlainRecalls
FDA Drug Moderate Class II Terminated

Q.Care Petite Size Oral Cleansing & Suctioning System. Contains 1 Covered Yankauer, Suction Handle and Y-Connector, 2 Petit Size Suction Toothbrush packages with Antiseptic Oral Rinse, 4 Petit Size Untreated Suction Oral Swab packages with Antiseptic Oral Rinse, 2 8 French Oropharyngeal Suction Catheter packages. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6704 UPC 6 18029 84123 0

Reported: February 21, 2018 Initiated: August 22, 2017 #D-0393-2018

Product Description

Q.Care Petite Size Oral Cleansing & Suctioning System. Contains 1 Covered Yankauer, Suction Handle and Y-Connector, 2 Petit Size Suction Toothbrush packages with Antiseptic Oral Rinse, 4 Petit Size Untreated Suction Oral Swab packages with Antiseptic Oral Rinse, 2 8 French Oropharyngeal Suction Catheter packages. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6704 UPC 6 18029 84123 0

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

Details

Recalling Firm
Sage Products Inc
Units Affected
6726 Cases
Distribution
Distributed Nationwide in the USA and Puerto Rico, Canada, United Kingdom, Ireland, Netherlands, New Zealand
Location
Cary, IL

Frequently Asked Questions

What product was recalled? ▼
Q.Care Petite Size Oral Cleansing & Suctioning System. Contains 1 Covered Yankauer, Suction Handle and Y-Connector, 2 Petit Size Suction Toothbrush packages with Antiseptic Oral Rinse, 4 Petit Size Untreated Suction Oral Swab packages with Antiseptic Oral Rinse, 2 8 French Oropharyngeal Suction Catheter packages. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6704 UPC 6 18029 84123 0. Recalled by Sage Products Inc. Units affected: 6726 Cases.
Why was this product recalled? ▼
Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on February 21, 2018. Severity: Moderate. Recall number: D-0393-2018.

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