FDA Drug recall D-0398-2018

Q.Care Oral Cleansing & Suctioning System with 0.12% Chlorhexidine Gluconate (CHG) Oral Rinse q4

FDA Drug
Class II
terminated
Published 2018-02-21

On 2018-02-21 the FDA classified a Class II recall of Q.Care Oral Cleansing & Suctioning System with 0.12% Chlorhexidine Gluconate (CHG) Oral Rinse q4 by Sage Products, citing cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products.

Read the official FDA Drug notice

Agency	FDA Drug
Recall number	D-0398-2018
Classification	Class II
Status	terminated
Initiated	2017-08-22
Published	2018-02-21
Last updated	2026-09-13 11:52 UTC
Company	Sage Products
Distribution	US

Product

Q.Care Oral Cleansing & Suctioning System with 0.12% Chlorhexidine Gluconate (CHG) Oral Rinse q4. Contains 1 Suction Handle, Covered Yankauer and Y-Connector, 2 Untreated Suction Toothbrush packages, 2 Single dose bottles of 0.12% CHG Oral Rinse, 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 6904 UPC 6 18029 83008 1

Reason

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

Identifiers

upc	618029830081
code_info	Product Code: 6904; Lots: 52850, 53281, EXP 08/31/2017; 53300, 53579, EXP 09/30/2017; 54320, EXP 10/31/2017; 54960, EXP… Product Code: 6904; Lots: 52850, 53281, EXP 08/31/2017; 53300, 53579, EXP 09/30/2017; 54320, EXP 10/31/2017; 54960, EXP 11/30/2017; 55753, EXP 12/31/2017; 56914, EXP 02/28/2018; 57352, EXP 04/30/2018; 57836, EXP 03/31/2018; 58349, EXP 04/30/2018; 59578, EXP 07/31/2018; 60712, EXP 09/30/2018; 61274, EXP 12/31/2018.

upc

618029830081

code_info

Product Code: 6904; Lots: 52850, 53281, EXP 08/31/2017; 53300, 53579, EXP 09/30/2017; 54320, EXP 10/31/2017; 54960, EXP…

Product Code: 6904; Lots: 52850, 53281, EXP 08/31/2017; 53300, 53579, EXP 09/30/2017; 54320, EXP 10/31/2017; 54960, EXP 11/30/2017; 55753, EXP 12/31/2017; 56914, EXP 02/28/2018; 57352, EXP 04/30/2018; 57836, EXP 03/31/2018; 58349, EXP 04/30/2018; 59578, EXP 07/31/2018; 60712, EXP 09/30/2018; 61274, EXP 12/31/2018.

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0398-2018%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.