Recalls / Class II

Class IID-0387-2018

Product

Oral Cleansing & Suctioning System with 0.12% Chlorhexidine Gluconate (CHG) Oral Rinse q4, Contains 1 Covered Yankauer and Y-Connector, 2 Untreated Suction Toothbrush packages, 2 Single dose bottles of 0.12% CHG Oral Rinse, 4 Packages Suction Oral Swab with sodium bicarbonate, Perox-A-Mint solution and Mouth Moisturizer, 2 Oropharyngeal Suction Catheter packages. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6594 UPC 6 18029 82134 1

Affected lot / code info

Product Code: 6594; Lots: 53018, 53824, EXP 08/08/2017; 53023, EXP 08/31/2017; 53833, EXP 09/30/2017; 53949, EXP 10/03/2017; 54045, EXP 10/31/2017; 55087, 55169, EXP 11/30/2017; 54708, 55699; 55730; 55952; 56028; 56042, EXP 12/31/2017; 56540; 56945; 57345, EXP 02/28/2018; 57632; 57672, EXP 03/31/2018; 58428, EXP 04/30/2018; 58463, 58506, 58539, 58590, EXP 06/30/2018; 59137, 59395, 59442, EXP 07/31/2018; 60244, EXP 08/31/2018; 60709, 60778, EXP 09/30/2018; 61828, EXP 12/31/2018.

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

5138 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-0387-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.