CLASS II Drug recall · Reported 21 Feb 2018 · FDA Enforcement Report
Q CARE q2 Oral Cleansing & Suctioning System recalled by Sage Products
Sage Products is recalling Q CARE q2 Oral Cleansing & Suctioning System, Contains 1 Covered Yankauer and Y-Connector, distributed nationwide in the US. The recall was initiated on 22 Aug 2017 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0374-2018
- FDA event ID
- 77992
- Recalling firm
- Sage Products, Cary, IL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 22 Aug 2017
- FDA classified
- 9 Feb 2018
- Reported
- 21 Feb 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Drug class
- Sunscreen & Personal Care
Timeline
| 22 Aug 2017 | Recall initiated by company | |
| 9 Feb 2018 | Classified by FDA | +171 days |
| 21 Feb 2018 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Q CARE q2 Oral Cleansing & Suctioning System, Contains 1 Covered Yankauer and Y-Connector, 2 Suction Toothbrush packages with Antiplaque solution, 4 Suction Oral Swab packages with Antiseptic Oral Rinse, 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 6412 UPC 6 18029 84137 7
Where it was distributed
Distributed Nationwide in the USA and Puerto Rico, Canada, United Kingdom, Ireland, Netherlands, New Zealand
Questions about this recall
Is Q CARE q2 Oral Cleansing & Suctioning System, Contains 1 Covered Yankauer and Y-Connector recalled?
Yes. Sage Products recalled Q CARE q2 Oral Cleansing & Suctioning System, Contains 1 Covered Yankauer and Y-Connector on 22 Aug 2017. The recall is Class II and its status is Terminated. Recall number D-0374-2018.
Why was it recalled?
Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
Which lots are affected?
Product Code: 6412; Lots: 58432, EXP 10/02/2017; 59402, EXP 11/13/2017; 59864, EXP 01/02/2018; 60799, EXP 01/22/2018; 61115 EXP 02/23/2018; 61557, EXP 03/30/2018.
Where was it sold?
Distributed Nationwide in the USA and Puerto Rico, Canada, United Kingdom, Ireland, Netherlands, New Zealand
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Sage Products
All 72| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | 2% Chlorhexidine Gluconate* Cloth, Non-sterile recalled by Sage ProductsChlorhexidine Gluconate | Sage Products | Sterility | Nationwide |
| Device | CLASS II | stryker Sage PrimaFit External Urine Management System recalled | Sage Products | Labeling Errors | IL |
| Device | CLASS II | Toothete Oral Care Sodium Bicarbonate Mouthpaste recalled | Sage Products | Other | Nationwide |
| Drug | CLASS II | Q CARE q4 Oral Cleaning & Suctioning System Contains recalled | Sage Products | Packaging Defects | Nationwide |
| Drug | CLASS II | Toothette Oral Care Suction Toothbrushes with Perox-A-Mint solution recalled | Sage Products | Other | Nationwide |