Recalls / Class II

Class IID-0377-2018

Product

Q CARE q4 Oral Cleansing & Suctioning System, Contains 1 Covered Yankauer and Y-Connector, 2 Suction Toothbrush packages with Antiplaque solution, 4 Suction Oral Swab packages with Perox-A-Mint solution, 2 Oropharyngeal Suction Catheter packages, Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6424 UPC 6 18029 83027 2

Affected lot / code info

Product Code: 6424; Lots: 57386, EXP 08/14/2017; 58035, EXP 09/11/2017; 58363, 58566, 58582, EXP 10/02/2017; 58760, 58889, EXP 11/03/2017; 59288, EXP 11/13/2017; 59467, EXP 11/27/2017; 59983, 60094, EXP 01/02/2018; 60324, EXP 02/05/2018; 61001, EXP 02/23/2018.

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

9,110 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-0377-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.