RecallRadar

FDA Drug recall D-0354-2018

QCare RX Q2 Oral Cleansing & Suctioning System with 0.12% Chlorhexidine Gluconate (CHG) Oral Rinse Corinz

On 2018-02-21 the FDA classified a Class II recall of QCare RX Q2 Oral Cleansing & Suctioning System with 0.12% Chlorhexidine Gluconate (CHG) Oral Rinse Corinz 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

AgencyFDA Drug
Recall numberD-0354-2018
ClassificationClass II
Statusterminated
Initiated2017-08-22
Published2018-02-21
Last updated2026-09-13 11:52 UTC
CompanySage Products
DistributionUS

Product

QCare RX Q2 Oral Cleansing & Suctioning System with 0.12% Chlorhexidine Gluconate (CHG) Oral Rinse Corinz. Contains 1 Covered Yankauer and Y-Connector, 2 Untreated Suction Toothbrush packages, 2 Single dose bottles of 0.12% CHG Oral Rinse, 10 Suction Oral Swab packages with Corinz Antiseptic Cleansing and Moisturizing Oral Rinse and 2 Oropharyngeal Suction Catheter packages. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6962, UPC 6 18029 83076 0

Reason

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

Identifiers

upc618029830760
code_info
Product Code: 6962; Lots: 55604, 55619, 56000, 56052 EXP 08/28/2017; 56211, 56282, 56783, EXP 09/26/2017; 57204, 57614,…Product Code: 6962; Lots: 55604, 55619, 56000, 56052 EXP 08/28/2017; 56211, 56282, 56783, EXP 09/26/2017; 57204, 57614, 58027, EXP 11/13/2017; 58549, 58587, EXP 04/03/2018; 59493, EXP 07/16/2018; 60043, 60079, EXP 07/30/2018; 60476, EXPO 08/02/2018; 60490 EXP 09/04/2018; 60790, EXP 09/06/2018; 61405, EXP 09/11/2018; 61456, 61799, EXP 10/16/2018

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-0354-2018%22

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