Skip to content
Recall Observatory FDA recall evidence

Drug product

Q.Care Oral Cleansing & Suctioning System q8. Contains 1 Covered Yankauer Suction Handle and Y-Connector, 2 Suction Toothbrush packages with Antiseptic Solution,, 1 Suction Oral Swab packages with Perox-A-Mint solution, 1 Oropharyngeal Suction Catheter package. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6808 UPC 6 18029 84122 3

D-0397-2018

August 22, 2017

Class II

Product summary

Firm
Sage Products Inc
Event
Event 77992
Status
Terminated
Classification
Class II
Quantity
2468 Cases
Official record key
drug-enforcement:D-0397-2018

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: 6808; Lots: 57592, EXP 08/14/2017; 58202, EXP 10/02/2017; 59213, EXP 11/13/2017; 60274, EXP 01/02/2018; 60718 EXP 02/05/2018; 61745, EXP 03/21/2018.

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