RecallRadar

FDA Drug recall D-0378-2018

Oral Cleaning and Suctioning System q2

On 2018-02-21 the FDA classified a Class II recall of Oral Cleaning and Suctioning System q2 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-0378-2018
ClassificationClass II
Statusterminated
Initiated2017-08-22
Published2018-02-21
Last updated2026-09-13 11:52 UTC
CompanySage Products
DistributionUS

Product

Oral Cleaning and Suctioning System q2. Contains 1 Covered Yankauer, 2 Untreated Suction Toothbrush packages with Antiplaque solution, 4 Suction Oral Swab packages with Perox-A-Mint- solution, 6 Suction Oral Swab packages with Alcohol-Free Mouthwash solution, 2 Oropharyngeal Suction Catheter packages. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6502 UPC 6 18029 80060 2

Reason

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

Identifiers

upc618029800602
code_infoProduct Code: 6502; Lots: 57627, EXP 08/14/2017; 58677, EXP 10/02/2017; 60110, EXP 01/02/2018; 61463, EXP 03/30/2018.

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-0378-2018%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.