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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 Perox-A-Mint solution, 2 Oropharyngeal Suction Catheter packages, Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6424 UPC 6 18029 83027 2

D-0377-2018

August 22, 2017

Class II

Product summary

Firm
Sage Products Inc
Event
Event 77992
Status
Terminated
Classification
Class II
Quantity
9,110 cases
Official record key
drug-enforcement:D-0377-2018

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: 6424; Lots: 57386, EXP 08/14/2017; 58035, EXP 09/11/2017; 58363, 58566, 58582, EXP 10/02/2017; 58760, 58889, EXP 11/03/2017; 59288, EXP 11/13/2017; 59467, EXP 11/27/2017; 59983, 60094, EXP 01/02/2018; 60324, EXP 02/05/2018; 61001, EXP 02/23/2018.

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