FDA Drug recall D-0389-2018
Toothette Oral Care Q Care & Suctioning System
- FDA Drug
- Class II
- terminated
- Published 2018-02-21
On 2018-02-21 the FDA classified a Class II recall of Toothette Oral Care Q Care & Suctioning System by Sage Products, citing cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0389-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-08-22 |
| Published | 2018-02-21 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Sage Products |
| Distribution | US |
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
Reason
Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
Identifiers
| upc | 618029841162 |
|---|---|
| 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; 5…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. |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0389-2018%22
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