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FDAFDA · Food and drugs·Recall number D-0389-2018

Toothette Oral Care Q Care & Suctioning System. Contains 1 Covered Yankauer, Suction Handle and Y-Connector, 2 Suction Toothbrush packages with Perox-A-Mint solution, 10 Suction Oral Swab packages with Perox-A-Mint solution, 4 Oropharyngeal Suction Catheter packages. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6602 UPC 6 18029 84116 2

Published February 21, 2018 · Recall initiated: August 22, 2017

Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

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

What to do

Voluntary: Firm initiated · Letter

Recall details

Manufacturer
Sage Products Inc
Distributor
Distributed Nationwide in the USA and Puerto Rico, Canada, United Kingdom, Ireland, Netherlands, New Zealand
Lot
Product Code: 6602; Lots: 52005, EXP 09/12/2017; 52917, EXP 11/07/2017; 53327, EXP 12/05/2017; 54186, EXP 02/06/2018; 55327, EXP 04/17/2018; 56169, EXP 06/12/2018; 57385, EXP 08/29/2018; 58564, EXP 10/30/2018; 60205, EXP 11/27/2018; 61033, EXP 03/19/2019; 61443, EXP 04/09/2019.
Risk classification
Class II
Area (FDA)
drug
Country
United States

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