Recalls / Class II
Class IID-0372-2018
Product
Q Care Continue Care for the non-ventilated patient. Contains, 1 Covered Yankauer, 3 Suction Toothbrush packages with Corinz Antiseptic Cleansing and Moisturizing Oral Rinse. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6308 UPC 6 18029 83040 1
- Affected lot / code info
- Product Code: 6308; Lots: 55134, EXP 08/28/2017, 56144, 56521, EXP 09/26/2017; 57495, EXP 11/13/2017; 58716, EXP 04/03/2018; 59486, EXP 06/15/2018; 59504, EXP 07/16/2018; 60426, EXP 08/02/2018; 61665,EXP 10/16/2018; 62033, 62058, 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
- 2,938 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-0372-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.