RecallRadar

FDA Drug recall D-0409-2018

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

On 2018-02-21 the FDA classified a Class II recall of Q Care RX Oral Cleansing & Suctioning System with 0.12% Chlorhexidine Gluconate (CHG) Oral Rinse 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-0409-2018
ClassificationClass II
Statusterminated
Initiated2017-08-22
Published2018-02-21
Last updated2026-09-13 11:52 UTC
CompanySage Products
DistributionUS

Product

Q Care RX Oral Cleansing & Suctioning System with 0.12% Chlorhexidine Gluconate (CHG) Oral Rinse. Contains 1 Covered Yankauer and Y-Connector, 1 Untreated Suction Toothbrush packages, 1 Single dose bottle of 0.12% CHG Oral Rinse, 2 Suction Oral Swab packages with Perox-A-Mint, 1 Oropharyngeal Suction Catheter packages. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 9002 UPC 6 18029 83025 8

Reason

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

Identifiers

upc618029830258
code_info
Product Code: 9002; Lots: 52886, EXP 08/31/2017; 53688, EXP 09/30/2017; 54468, EXP 10/31/217; 55221, 55230, EXP 11/30/2…Product Code: 9002; Lots: 52886, EXP 08/31/2017; 53688, EXP 09/30/2017; 54468, EXP 10/31/217; 55221, 55230, EXP 11/30/2017; 56320, EXP 2/28/2018; 57367, 58083, EXP 04/30/2018; 58969, EXP 06/30/2018; 59906, EXP 08/31/2018; 61138, EXP 12/31/2018; 61881, EXP 12/13/2018

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-0409-2018%22

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