Recalls / Class II

Class IID-0403-2018

Product

Q.Care Oral Cleansing & Suctioning System Suction Toothbrush Compatible with Chlorhexidine Gluconate (CHG) Oral Rinse q2. Contains 1 Covered Yankauer and Y-Connector, 2 Untreated, CHG Compatible Suction Toothbrush packages, 4 Suction Oral Swab packages with Perox-A-Mint solution, 6 Suction Oral Swab packages with Alcohol-Free Mouthwash, 4 Oropharyngeal Suction Catheter packages. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6922-B UPC 6 18029 83032 6

Affected lot / code info

Product Code: 6922-B; Lots: 53070, EXP 08/31/2017; 54452, EXP 10/31/2017; 56283, EXP 12/31/2017; 57710, EXP 02/28/2018; 58350, EXP 04/30/2018; 59528, 59539 EXP 07/31/2018; 60468, EXP 08/31/2018.

Why it was recalled

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

Recalling firm

Firm

Sage Products Inc

Notification channel

Letter

Type

Voluntary: Firm initiated

Address

3909 3 Oaks Rd, Cary, Illinois 60013-1804

Distribution

Quantity

480 Cases

Distribution pattern

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

Timeline

Recall initiated

2017-08-22

FDA classified

2018-02-09

Posted by FDA

2018-02-21

Terminated

2018-12-13

Status

Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-0403-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.