Recalls / Class II

Class IID-0351-2018

Product

QCare Oral Cleansing and Suctioning System with Corinz. Includes: Two (2) Suction Toothbrush packages with 0.25fl.oz/7mL Corinz Antiseptic Cleansing and Moisturizing Oral Rinse and Four (4) Suction Oral Swab packages with 0.25 fl.oz/7mL Corinze Antiseptic Cleansing and Moisturizing Oral Rinse. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6464 UPC 6 18029 83077 7

Affected lot / code info

Product Code: 6464; Lots: 55175 EXP 8/28/2017; 57086, 58011, EXP 11/13/2017; 58604, EXP 4/3/2018; 60373, EXP 8/2/2018; 60590, EXP 9/4/2018; 61540, EXP 10/16/2018.

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

1680 KITS

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-0351-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.