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
Product description
Oral Cleansing & Suctioning System q2 with 0.12% Chlorexidine Gluconate (CHG) Oral Rinse. Contains 1 Covered Yankauer and Y-Connector, 2 Untreated Suction Toothbrush packages, 2 Single dose bottles of 0.12% CHG Oral Rinse, packages SYS W/CHG 10, Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6592
Lot numbers, UPCs & expiration codes
Product Code: 6592; Lots: 54071, EXP 10/31/2017; 54664, EXP 12/31/2017; 55007, EXP 11/30/2017; 55866, EXP 12/31/2017; 56487, 56516, 57057, EXP 02/28/2018; 58756, 58766, EXP 06/30/2018; 59618, EXP 07/31/2018; 60036, 60346, EXP 08/31/2019.
Where it was sold
Distributed Nationwide in the USA and Puerto Rico, Canada, United Kingdom, Ireland, Netherlands, New Zealand
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0385-2018
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 22, 2017
- FDA report date
- Feb 21, 2018
- Quantity
- 2424 Cases
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Sage Products Inc
Original FDA data
Every field from FDA enforcement report D-0385-2018, exactly as published.
Show all FDA fields
- City
- Cary
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 77992
- Address
- 3909 3 Oaks Rd
- Code information
- Product Code: 6592; Lots: 54071, EXP 10/31/2017; 54664, EXP 12/31/2017; 55007, EXP 11/30/2017; 55866, EXP 12/31/2017; 56487, 56516, 57057, EXP 02/28/2018; 58756, 58766, EXP 06/30/2018; 59618, EXP 07/31/2018; 60036, 60346, EXP 08/31/2019.
- Postal code
- 60013-1804
- Report date
- Feb 21, 2018
- Product type
- Drugs
- Recall number
- D-0385-2018
- Classification
- Class II
- Recalling firm
- Sage Products Inc
- Product quantity
- 2424 Cases
- Termination date
- Dec 13, 2018
- Reason for recall
- Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Oral Cleansing & Suctioning System q2 with 0.12% Chlorexidine Gluconate (CHG) Oral Rinse. Contains 1 Covered Yankauer and Y-Connector, 2 Untreated Suction Toothbrush packages, 2 Single dose bottles of 0.12% CHG Oral Rinse, packages SYS W/CHG 10, Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6592
- Distribution pattern
- Distributed Nationwide in the USA and Puerto Rico, Canada, United Kingdom, Ireland, Netherlands, New Zealand
- Recall initiation date
- Aug 22, 2017
- Initial firm notification
- Letter
- Center classification date
- Feb 9, 2018