Recalls / Class II

Class IID-0385-2018

Product

Oral Cleansing & Suctioning System q2 with 0.12% Chlorexidine Gluconate (CHG) Oral Rinse. Contains 1 Covered Yankauer and Y-Connector, 2 Untreated Suction Toothbrush packages, 2 Single dose bottles of 0.12% CHG Oral Rinse, packages SYS W/CHG 10, Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6592

Affected lot / code info

Product Code: 6592; Lots: 54071, EXP 10/31/2017; 54664, EXP 12/31/2017; 55007, EXP 11/30/2017; 55866, EXP 12/31/2017; 56487, 56516, 57057, EXP 02/28/2018; 58756, 58766, EXP 06/30/2018; 59618, EXP 07/31/2018; 60036, 60346, EXP 08/31/2019.

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

2424 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-0385-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.