Recalls / Class II
Class IID-0374-2018
Product
Q CARE q2 Oral Cleansing & Suctioning System, Contains 1 Covered Yankauer and Y-Connector, 2 Suction Toothbrush packages with Antiplaque solution, 4 Suction Oral Swab packages with Antiseptic Oral Rinse, 6 Suction Oral Swab packages with Alcohol-Free mouthwash, 4 Oropharyngeal Suction Catheter packages, Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6412 UPC 6 18029 84137 7
- Affected lot / code info
- Product Code: 6412; Lots: 58432, EXP 10/02/2017; 59402, EXP 11/13/2017; 59864, EXP 01/02/2018; 60799, EXP 01/22/2018; 61115 EXP 02/23/2018; 61557, EXP 03/30/2018.
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
- 6,200 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-0374-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.