Recalls / Class II
Class IID-0389-2018
Product
Toothette Oral Care Q Care & Suctioning System. Contains 1 Covered Yankauer, Suction Handle and Y-Connector, 2 Suction Toothbrush packages with Perox-A-Mint solution, 10 Suction Oral Swab packages with Perox-A-Mint solution, 4 Oropharyngeal Suction Catheter packages. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6602 UPC 6 18029 84116 2
- Affected lot / code info
- Product Code: 6602; Lots: 52005, EXP 09/12/2017; 52917, EXP 11/07/2017; 53327, EXP 12/05/2017; 54186, EXP 02/06/2018; 55327, EXP 04/17/2018; 56169, EXP 06/12/2018; 57385, EXP 08/29/2018; 58564, EXP 10/30/2018; 60205, EXP 11/27/2018; 61033, EXP 03/19/2019; 61443, EXP 04/09/2019.
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
- 2408 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-0389-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.