Recalls / Class II
Class IID-0404-2018
Product
Q.Care Oral Cleansing & Suctioning System Suction Toothbrush Compatible with Chlorhexidine Gluconate (CHG) Oral Rinse q4. Contains 1 Covered Yankauer and Y-Connector, 2 Untreated Suction Toothbrush packages, 4 Suction Oral Swab packages with Perox-A-Mint solution, 2 Oropharyngeal Suction Catheter packages. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6924 UPC 6 18029 83033 3
- Affected lot / code info
- Product Code: 6924; Lots: 51601, EXP 08/15/2017; 52138, EXP 09/19/2017; 52836, 52935, EXP 11/07/2017; 53531, EXP 12/12/2017; 53788, EXP 01/09/2018; 54388, EXP 02/20/2018; 54796, 54816, EXP 3/13/2018; 55130, 55171, EXP 04/03/2018; 55323, EXP 04/17/2018; 55400, EXP 04/24/2018; 56049, EXP 06/05/2018; 56191, EXP 06/12/2018; 56330, EXP 06/19/2018; 56856, EXP 07/31/2018; 57437, EXP 08/29/2018; 57876, EXP 09/25/2018; 58707, EXP 11/06/2018; 59126, EXP 11/13/2018; 59607, EXP 12/11/2018; 60255, EXP 11/27/2018; 60273, EXP 01/22/2019; 60871, 03/05/2019; 61058, EXP 03/19/2019; 61676, EXP 04/23/2019.
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
- 16639 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-0404-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.