Sage Products recalls
Sage Products appears in 72 official U.S. recall notices indexed by RecallRadar.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
- Q Care Continue Care for the non-ventilated patient
FDA Drug · Class II · 2018-02-21 · Sage Products
Reason: Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products - Toothette Oral Care Suction Toothbrushes with Perox-A-Mint solution
FDA Drug · Class II · 2018-02-21 · Sage Products
Reason: Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products - Q.Care Oral Cleansing & Suctioning System with 0.12% Chlorhexidine Gluconate (CHG) Oral Rinse q4
FDA Drug · Class II · 2018-02-21 · Sage Products
Reason: Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products - Q.Care, Oral Cleansing & Suctioning System q4
FDA Drug · Class II · 2018-02-21 · Sage Products
Reason: Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products - Toothette Oral Care Single Use System With Perox-A-Mint solution
FDA Drug · Class II · 2018-02-21 · Sage Products
Reason: Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products - Toothette Oral Care Suction Swabs with Perox-A-Mint solution
FDA Drug · Class II · 2018-02-21 · Sage Products
Reason: Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products - Toothette Oral Care Suction Toothbrush with Perox-A-Mint solution and Mouth Moisturizer
FDA Drug · Class II · 2018-02-21 · Sage Products
Reason: Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products - Q CARE q4 Oral Cleaning & Suctioning System Contains 1 Covered Yankauer and Y-Connector, 2 Suction Toothbrush packages with Antiplaque solu…
FDA Drug · Class II · 2018-02-21 · Sage Products
Reason: Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products - Q Care RX Petite Oral Cleansing & Suctioning System with 0.12% Chlorhexidine Gluconate (CHG) Oral Rinse
FDA Drug · Class II · 2018-02-21 · Sage Products
Reason: Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products - Toothette Oral Care Suction Swabs with Perox-A-Mint solution and Mouth Moisturizer, Contains 2 Suctino Swabs with sodium bicarbonate, 0.25…
FDA Drug · Class II · 2018-02-21 · Sage Products
Reason: Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products - Toothette Oral Care Suction Swab System With Antiseptic Oral Rinse and Mouth Moisturizer
FDA Drug · Class II · 2018-02-21 · Sage Products
Reason: Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products - QCare RX Q2 Oral Cleansing & Suctioning System with 0.12% Chlorhexidine Gluconate (CHG) Oral Rinse Corinz
FDA Drug · Class II · 2018-02-21 · Sage Products
Reason: Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products - Toothette Oral Care Single Use System with Antiseptic Oral Rinse and Mouth Moisturizer
FDA Drug · Class II · 2018-02-21 · Sage Products
Reason: Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products - Q.Care Oral Cleansing & Suctioning System Suction Toothbrush Compatible with Chlorhexidine Gluconate (CHG) Oral Rinse q2
FDA Drug · Class II · 2018-02-21 · Sage Products
Reason: Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products - Q.CareOral Cleansing & Suctioning System q2
FDA Drug · Class II · 2018-02-21 · Sage Products
Reason: Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products - Toothette Oral Care Short Term Oral Swab System with Perox-A- Mint solution
FDA Drug · Class II · 2018-02-21 · Sage Products
Reason: Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products - Q.Care Oral Cleansing & Suctioning System Suction Toothbrush Compatible with Chlorhexidine Gluconate (CHG) Oral Rinse q2
FDA Drug · Class II · 2018-02-21 · Sage Products
Reason: Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products - Q Care Continue Care Kit for the non-ventilated patient
FDA Drug · Class III · 2017-03-01 · Sage Products
Reason: Labeling: Incorrect or Missing Lot and/or Exp Date: The expiration date of the Q Care Continue Care kit is printed with an expiration date of November 13, 2017; rather than the correct date of August 28, 2017 (date of e… - 2% Chlorhexidine Gluconate* Cloth, 2 disposable cloths per package, further packaged into 96 packages per case, labeled as a) Reorder #9705…
FDA Drug · Class II · 2016-12-28 · Sage Products
Reason: CGMP Deviations: potential contamination of products manufactured on the same equipment and lines as the contaminated product. - COMFORT SHIELD (dimethicone) Barrier Cream Cloths, 3%, packaged as impregnated cloths wrapped in flexible packaging, further packed into in…
FDA Drug · Class II · 2016-12-28 · Sage Products
Reason: CGMP Deviations: potential contamination of products manufactured on the same equipment and lines as the contaminated product. - COMFORT SHIELD (dimethicone) Barrier Cream Cloths, 3%, packaged as impregnated cloths wrapped in flexible packaging, further packed into in…
FDA Drug · Class I · 2016-12-28 · Sage Products
Reason: Microbial Contamination of Non-Sterile Products: contamination with the bacteria, Burkholderia cepacia. - Comfort Shield Barrier Cream Cloths with dimethicone a) 8 count NDC 53462-915-80, b) 24 count NDC 53462-915-60, OTC, SAGE PRODUCTS INC., 39…
FDA Drug · Class II · 2014-09-10 · Sage Products
Reason: Microbial Contamination of Non-Sterile Products: Comfort Shield Barrier Cream Cloth packages tested positive for bacterial contamination.