FDA (Drugs) recall action 77992

Sage Products Inc recalled 64 products on 2018-02-21

The FDA (Drugs) publishes a recall like this one as 64 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 64 pages.

Products: 64
Announced: 2018-02-21
Critical: 0
Units: 470,694

Why these products were recalled

Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

51–64 of 64

ModerateFDA (Drugs)··2018-02-21
Sage Q Care RX Oral System Recalled for Cross-Contamination Risk
Sage Products is recalling Q Care RX Oral Cleansing Systems because they were manufactured on equipment shared with non-pharmaceutical products, posing a cross-contamination risk.
Product
Q Care RX Oral Cleansing & Suctioning System with 0.12% Chlorhexidine Gluconate (CHG) Oral Rinse. Contains 1 Covered Yankauer and Y-Connector, 1 Untreated Suction Toothbrush packages, 1 Single dose bottle of 0.12% CHG Oral Rinse, 2 Suction Oral Swab packages with Perox-A-Mint, 1
Category
Distribution
1 state
ModerateFDA (Drugs)··2018-02-21
Sage Products Recalls Toothette Oral Care Suction Toothbrushes
Sage Products Inc. is recalling Toothette Oral Care Suction Toothbrushes due to cross-contamination with non-pharmaceutical products during manufacturing.
Product
Toothette Oral Care Suction Toothbrushes with Antiseptic Oral Rinse and Mouth Moisturizer, Contains 2 Suction Toothbrushes with sodium bicarbonate. 0.25 fl oz/7ml Antiseptic Oral Rinse, 0.07 oz/2g Mouth Moisturizer, Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Produ
Category
Distribution
1 state
ModerateFDA (Drugs)··2018-02-21
Sage Products Recalls Q Care Oral Care Kits Due to Cross-Contamination
Sage Products is recalling Q Care Continue Care kits because oral care solutions were manufactured on equipment shared with non-pharmaceutical products.
Product
Q Care Continue Care for the non-ventilated patient. Contains, 1 Covered Yankauer, 3 Suction Toothbrush packages with Corinz Antiseptic Cleansing and Moisturizing Oral Rinse. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6308 UPC 6 18029 83040 1
Category
Distribution
1 state
ModerateFDA (Drugs)··2018-02-21
Sage Products Recalls Toothette Oral Care Systems Due to Cross-Contamination
Sage Products Inc. is recalling Toothette Oral Care Q Care & Suctioning Systems because oral care solutions were manufactured on equipment shared with non-pharmaceutical products.
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 Produc
Category
Distribution
1 state
ModerateFDA (Drugs)··2018-02-21
Sage Products Recalls Nose to Toes Skin Antisepsis System Due to Cross-Contamination
Sage Products Inc. is recalling the Nose to Toes Skin Antisepsis System because oral care components were manufactured on equipment shared with non-pharmaceutical products.
Product
Nose to Toes Skin Antisepsis, Oral Cleansing and Nasal Antisepsis System. Contains: Three 2-packs of 2% Chlorhexidine Gluconate Cloth Patient Preoperative Skin Preparation and One 7ml Burst Pouch of Corinz Antiseptic Cleansing and Moisturizing Oral Rinse, I Ultra-Soft Toothbrush,
Category
Distribution
1 state
SevereFDA (Drugs)··2018-02-21
Sage Q CARE Oral Cleansing System Recalled for Cross-Contamination
Sage Products Inc. is recalling Q CARE q2 Oral Cleansing & Suctioning Systems because oral care solutions were manufactured on equipment shared with non-pharmaceutical products.
Product
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 Perox-A-Mint solution, 6 Suction Oral Swab packages with Alcohol-Free mouthwash, 4 Oropharyngeal
Category
Distribution
1 state
ModerateFDA (Drugs)··2018-02-21
Sage Products Recalls Oral Care Systems Due to Cross-Contamination
Sage Products Inc. is recalling Oral Cleansing & Suctioning Systems because they were manufactured on equipment shared with non-pharmaceutical products, posing a cross-contamination risk.
Product
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 Packages Suction Oral Swab with sodium bicarbonate, Pe
Category
Distribution
1 state
ModerateFDA (Drugs)··2018-02-21
Sage Products Recalls Toothette Oral Care Suction Toothbrush Due to Cross Contamination
Sage Products Inc. is recalling Toothette Oral Care Suction Toothbrush kits because oral care solutions were manufactured on equipment shared with non-pharmaceutical products.
Product
Toothette Oral Care Suction Toothbrush with Perox-A-Mint solution and Mouth Moisturizer. Contains 1 Suction Toothbrush with sodium Bicarbonate, 0.25 fl oz /7ml Perox-A-Mint solution, 0.07 oz/2g Mouth Moisturizer, 1 Applicator Swab, Sage Products, Inc., 3909 Three Oaks Road, Cary,
Category
Distribution
1 state
ModerateFDA (Drugs)··2018-02-21
Sage Products Recalls Toothette Oral Care Suction Swab System
Sage Products Inc. is recalling the Toothette Oral Care Suction Swab System because oral care solutions were manufactured on equipment shared with non-pharmaceutical products.
Product
Toothette Oral Care Suction Swab System with Perox-A-Mint Solution, Contains 6 Packages of 2 Suction Swabs with sodium, bicarbonate and a .25 fl oz/7ml pouch of Perox-A-Mint solution, 10 Applicator Swabs, .5 oz/14g tube of Mouth Moisturizer. Sage Products, Inc., 3909 Three Oaks R
Category
Distribution
1 state
ModerateFDA (Drugs)··2018-02-21
Toothette Oral Rinse Recalled for Cross-Contamination Risk
Sage Products Inc. is recalling Toothette Oral Care Antiseptic Oral Rinse because it was manufactured on equipment shared with non-pharmaceutical products.
Product
Toothette Oral Care Antiseptic Oral Rinse 1.5 fl.oz/44 ml. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6122 UPC 6 18029 80079 4
Category
Distribution
1 state
ModerateFDA (Drugs)··2018-02-21
Sage Products Recalls Toothette Oral Care Suction Toothbrush
Sage Products is recalling Toothette Oral Care Suction Toothbrush kits due to cross-contamination with non-pharmaceutical products during manufacturing.
Product
Toothette Oral Care Suction Toothbrush with Perox-A-Mint solution. Contains 1 Suction Toothbrush with sodium bicarbonate, 0.25 fl oz/ 7ml Perox-A-Mint solution, 0.07 oz/2g Mouth Moisturizer, 1 Applicator Swab. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Cod
Category
Distribution
1 state
ModerateFDA (Drugs)··2018-02-21
Sage Q.Care Oral Cleansing System Recalled for Cross-Contamination
Sage Products is recalling Q.Care Oral Cleansing & Suctioning Systems because oral care solutions were manufactured on equipment shared with non-pharmaceutical products.
Product
Q.Care Oral Cleansing & Suctioning System Suction Toothbrush Compatible with Chlorhexidine Gluconate (CHG) Oral Rinse q2. Contains 1 Covered Yankauer and Y-Connector, 2 Untreated, CHG Compatible Suction Toothbrush packages, 4 Suction Oral Swab packages with Perox-A-Mint solution,
Category
Distribution
1 state
ModerateFDA (Drugs)··2018-02-21
Sage Q CARE Oral Cleansing System Recalled for Cross-Contamination
Sage Products is recalling Q CARE q2 Oral Cleansing & Suctioning Systems because oral care solutions were manufactured on equipment shared with non-pharmaceutical products.
Product
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
Category
Distribution
1 state
ModerateFDA (Drugs)··2018-02-21
Sage Products Recalls Toothette Oral Care Swab System Due to Cross-Contamination
Sage Products Inc. is recalling 2,548 cases of Toothette Oral Care Short Term Oral Swab Systems because they were manufactured on equipment shared with non-pharmaceutical products.
Product
Toothette Oral Care Short Term Oral Swab System with Antiseptic Oral Rinse, Contains 20 Toothette Plus Oral Swabs with sodium bicarbonate, 1.5 fl oz/44ml bottle of Antiseptic Oral Rinse, .5 oz.14g tube of Mouth Moisturizer. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 6001
Category
Distribution
1 state