Recalls / Class II
Class IID-0371-2018
Product
Q Care Continue Care for the non-ventilated patient. Contains, 1 Covered Yankauer, 2 Suction Toothbrush packages with Corinz Antiseptic Cleansing and Moisturizing Oral Rinse, 2 Suction Oral Swab packages with Corinz Antiseptic Cleansing and Moisturizing Oral Rinse. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6306 UPC 6 18029 83041 8
- Affected lot / code info
- Product Code: 6306; Lots: 55203, 55207, 55505, EXP 08/28/2017; 56466, 56502, 56508, 56515, EXP 09/26/2017; 57265, EXP 11/13/2017; 58129, EXP 12/11/2017; 59085, EXP 6/15/2018; 59742, EXP 7/16/2018 60163, EXP 08/02/2018; 60834, 61371, 61402, EXP 09/11/2018; 61913, EXP 11/12/2018.
Why it was recalled
Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
Recalling firm
- Firm
- Sage Products Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 3909 3 Oaks Rd, Cary, Illinois 60013-1804
Distribution
- Quantity
- 5,217 cases
- Distribution pattern
- Distributed Nationwide in the USA and Puerto Rico, Canada, United Kingdom, Ireland, Netherlands, New Zealand
Timeline
- Recall initiated
- 2017-08-22
- FDA classified
- 2018-02-09
- Posted by FDA
- 2018-02-21
- Terminated
- 2018-12-13
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0371-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.