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Recall Observatory FDA recall evidence

Drug product

Q CARE q4 Oral Cleansing & Suctioning System, Contains 1 Covered Yankauer and Y-Connector, 2 Suction Toothbrush packages with Antiplaque solution, 4 Suction Oral Swab packages with Antiseptic Oral Rinse, 2 Oropharyngeal Suction Catheter packages, Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6414 UPC 6 18029 84138 4

D-0375-2018

August 22, 2017

Class II

Product summary

Firm
Sage Products Inc
Event
Event 77992
Status
Terminated
Classification
Class II
Quantity
13,041 cases
Official record key
drug-enforcement:D-0375-2018

Official wording

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

Code information: Product Code: 6414; Lots: 57847, EXP 09/18/2017; 57852, 57875, EXP 08/14/2017; 58246, EXP 09/20/2017; 58802, 58851, EXP 10/09/2017; 58924, 59091, 59116, EXP 11/03/2017; 59494, EXP 11/27/2017; 60123, EXP 01/02/2018; 60466, 60880, 60925, 01/22/2018; 61364, 03/05/2018; 61705, EXP03/30/2018; 62061, EXP 04/17/2018; 62076, EXP 04/27/2018

Distribution pattern: Distributed Nationwide in the USA and Puerto Rico, Canada, United Kingdom, Ireland, Netherlands, New Zealand

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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