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Recall Observatory FDA recall evidence

Drug product

Q.Care Oral Cleansing & Suctioning System with 0.12% Chlorhexidine Gluconate (CHG) Oral Rinse q4. Contains 1 Suction Handle, Covered Yankauer and Y-Connector, 2 Untreated Suction Toothbrush packages, 2 Single dose bottles of 0.12% CHG Oral Rinse, 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 6904 UPC 6 18029 83008 1

D-0398-2018

August 22, 2017

Class II

Product summary

Firm
Sage Products Inc
Event
Event 77992
Status
Terminated
Classification
Class II
Quantity
6130 Cases
Official record key
drug-enforcement:D-0398-2018

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: 6904; Lots: 52850, 53281, EXP 08/31/2017; 53300, 53579, EXP 09/30/2017; 54320, EXP 10/31/2017; 54960, EXP 11/30/2017; 55753, EXP 12/31/2017; 56914, EXP 02/28/2018; 57352, EXP 04/30/2018; 57836, EXP 03/31/2018; 58349, EXP 04/30/2018; 59578, EXP 07/31/2018; 60712, EXP 09/30/2018; 61274, EXP 12/31/2018.

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