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
QCare Rx Oral Cleansing and Suctioning System with 0.12% Chlorhexidine Gluconate (CHG) Oral Rinse q2. Contains: 1 Covered Yankauer and Y-Connector, 2 Untreated Suction Toothbrush packages, 2 Single dose bottles of 0.12% CHG Oral Rinse, 4 Suction Oral Swab packages with Perox-A-Mint Solution, 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 6912 UPC 6 18029 83016 6
Lot numbers, UPCs & expiration codes
Product Code: 6912; Lots: 52736, 52807, 52878, 52994, 53067, 53084, 53137, 53192, EXP 08/31/2017; 53363, 53459, 53695, 53748, 53868, EXP 9/30/2017; 53916, 54003, 54011, 54012, 54015, 54024, 54049, 54057, 54265, 54279, 54293, EXP 10/31/2017; 54487, 54562, 54613, EXP 12/31/2017; 54686, 54703, 54736, 54745, 54748, 54751, 54817, 54979, 55047, EXP 11/30/2017; 55546, 55561, 55580, 55589, 55602, 55615, 55680, 55709, 55718, 55726, 55735, 55740, 55843, 55857, 55868, 55880, 55900, 55960, EXP 12/31/2017; 56348, 56418, 56604, 56670, 56820, 56944, 56975, 57140, 57201, EXP 02/28/2018; 57506, 57579, 57733, 57900, EXP 03/31/2018; 57925, 58229, 58281, EXP 04/30/2018; 58696, 58762, 59044, EXP 6/30/2018; 59456, 59546, EXP 7/31/2018; 59766, 59830, 60293, 60358, EXP 8/31/2018; 60416, 60563, 60623, 60983, EXP 9/30/2018; 61780, 62118, EXP 12/13/2018
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-0352-2018
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 22, 2017
- FDA report date
- Feb 21, 2018
- Quantity
- 48,003 cases
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Sage Products Inc
Original FDA data
Every field from FDA enforcement report D-0352-2018, 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: 6912; Lots: 52736, 52807, 52878, 52994, 53067, 53084, 53137, 53192, EXP 08/31/2017; 53363, 53459, 53695, 53748, 53868, EXP 9/30/2017; 53916, 54003, 54011, 54012, 54015, 54024, 54049, 54057, 54265, 54279, 54293, EXP 10/31/2017; 54487, 54562, 54613, EXP 12/31/2017; 54686, 54703, 54736, 54745, 54748, 54751, 54817, 54979, 55047, EXP 11/30/2017; 55546, 55561, 55580, 55589, 55602, 55615, 55680, 55709, 55718, 55726, 55735, 55740, 55843, 55857, 55868, 55880, 55900, 55960, EXP 12/31/2017; 56348, 56418, 56604, 56670, 56820, 56944, 56975, 57140, 57201, EXP 02/28/2018; 57506, 57579, 57733, 57900, EXP 03/31/2018; 57925, 58229, 58281, EXP 04/30/2018; 58696, 58762, 59044, EXP 6/30/2018; 59456, 59546, EXP 7/31/2018; 59766, 59830, 60293, 60358, EXP 8/31/2018; 60416, 60563, 60623, 60983, EXP 9/30/2018; 61780, 62118, EXP 12/13/2018
- Postal code
- 60013-1804
- Report date
- Feb 21, 2018
- Product type
- Drugs
- Recall number
- D-0352-2018
- Classification
- Class II
- Recalling firm
- Sage Products Inc
- Product quantity
- 48,003 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
- QCare Rx Oral Cleansing and Suctioning System with 0.12% Chlorhexidine Gluconate (CHG) Oral Rinse q2. Contains: 1 Covered Yankauer and Y-Connector, 2 Untreated Suction Toothbrush packages, 2 Single dose bottles of 0.12% CHG Oral Rinse, 4 Suction Oral Swab packages with Perox-A-Mint Solution, 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 6912 UPC 6 18029 83016 6
- 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