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
Q.Care Oral Cleansing & Suctioning System with 0.12% Chlorhexidine Gluconate (CHG) Oral Rinse q4. 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, 2 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 6914 UPC 6 18029 83017 3
Lot numbers, UPCs & expiration codes
Product Code: 6914; Lots: 52775, 52877, 52932, 53050, 53143, 53290, 53337, EXP 08/31/2017; 53345, 53418, 53454, 53488, 53609, 53830, 55373 EXP 09/30/2017; 53869, 53982, 53991, 53992, 53995, 54004, 54016, 54025, 54126, 54241, 54292, 54380, 54471, 54490, EXP 10/31/2017; 54504, 54594, 54674, EXP 12/31/2017; 54841, 54867, 54974, 55108, EXP 11/30/2017; 55237, 55307, 55362, 55392, 55652, 55684, 55774, 55842, 56003, 56099, 56149, 56212, 56244, EXP 12/31/2017; 56285, 56467, 56538, 56545, 56553, 56563, 56578, 56720, 56747, 56758, 56768, 56779, 56798, 56811, 56881, 56935, 56990, 57038, 57103, 57266, 57470, 57327, EXP 02/28/2018; 57380, 57444, 57476, 57640, 57699, 57769, 57810, EXP 03/31/2018; 57862, 57990, 58055, 58128, 58172, 58333, 58390, 58418, EXP 04/30/2018; 58460, 58538, 58589, 58645, 58887, 58941, EXP 06/30/2018; 59171, 59275, 59350, 59403, 59616, 59684, EXP 07/31/2018; 59745, 59916, 59964, 60015, 60095, 60180, 60254, EXP 08/31/2018; 60451, 60521, 60763, 60833, 60885, 61045, EXP 09/30/2018; 61069, 61618, 61697, 61879, 61932, 61979, 62026, 62057, 62246, 61128, EXP 12/31/2018
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-0400-2018
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 22, 2017
- FDA report date
- Feb 21, 2018
- Quantity
- 82072 Cases
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Sage Products Inc
Original FDA data
Every field from FDA enforcement report D-0400-2018, 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: 6914; Lots: 52775, 52877, 52932, 53050, 53143, 53290, 53337, EXP 08/31/2017; 53345, 53418, 53454, 53488, 53609, 53830, 55373 EXP 09/30/2017; 53869, 53982, 53991, 53992, 53995, 54004, 54016, 54025, 54126, 54241, 54292, 54380, 54471, 54490, EXP 10/31/2017; 54504, 54594, 54674, EXP 12/31/2017; 54841, 54867, 54974, 55108, EXP 11/30/2017; 55237, 55307, 55362, 55392, 55652, 55684, 55774, 55842, 56003, 56099, 56149, 56212, 56244, EXP 12/31/2017; 56285, 56467, 56538, 56545, 56553, 56563, 56578, 56720, 56747, 56758, 56768, 56779, 56798, 56811, 56881, 56935, 56990, 57038, 57103, 57266, 57470, 57327, EXP 02/28/2018; 57380, 57444, 57476, 57640, 57699, 57769, 57810, EXP 03/31/2018; 57862, 57990, 58055, 58128, 58172, 58333, 58390, 58418, EXP 04/30/2018; 58460, 58538, 58589, 58645, 58887, 58941, EXP 06/30/2018; 59171, 59275, 59350, 59403, 59616, 59684, EXP 07/31/2018; 59745, 59916, 59964, 60015, 60095, 60180, 60254, EXP 08/31/2018; 60451, 60521, 60763, 60833, 60885, 61045, EXP 09/30/2018; 61069, 61618, 61697, 61879, 61932, 61979, 62026, 62057, 62246, 61128, EXP 12/31/2018
- Postal code
- 60013-1804
- Report date
- Feb 21, 2018
- Product type
- Drugs
- Recall number
- D-0400-2018
- Classification
- Class II
- Recalling firm
- Sage Products Inc
- Product quantity
- 82072 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
- Q.Care Oral Cleansing & Suctioning System with 0.12% Chlorhexidine Gluconate (CHG) Oral Rinse q4. 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, 2 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 6914 UPC 6 18029 83017 3
- 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