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Recall Observatory FDA recall evidence

Drug product

Q Care, Oral Cleansing & Suctioning System Corinz. Contains: 1 Covered Yankauer and Y-Connector, 2 Suction Toothbrush packages with Corinz Antiseptic Cleansing & Moisturizing Oral Rinse, 4 Suction Oral Swab packages with Corinz Antiseptic Cleansing & Moisturizing Oral Rinse, 2 Oropharyngeal Suction Cather packages. Manufactured by: Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013

D-0349-2018

August 22, 2017

Class II

Product summary

Firm
Sage Products Inc
Event
Event 77992
Status
Terminated
Classification
Class II
Quantity
Unavailable
Official record key
drug-enforcement:D-0349-2018

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: 6462; Lots: 55152, EXP 08/28/2017; 57055, EXP 09/26/2017; 57078, EXP 11/13/2017; 58213, EXP 12/22/2017; 58255, EXP 04/02/2018, 59031, EXP 04/03/2018; 59036, 59087, EXP 06/15/2018; 59781, EXP 07/30/2018; 59803, EXP 07/16/2018.

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