Distributed Nationwide in the USA and Puerto Rico,  Canada, United Kingdom, Ireland, Netherlands, New Zealand
Q Care RX Petite Oral Cleansing & Suctioning System with 0.12% Chlorhexidine Gluconate (CHG) Oral Rinse. Contains 1 Covered Yankauer and Y-Connector, 2 Untreated Petite Suction Toothbrush packages,  2 Single dose bottles of 0.12% CHG Oral Rinse, 4 Petite Suction Oral Swab packages with Corinz Antiseptic Cleansing and Moisturizing Oral Rinse, 2 Oropharyngeal Suction Catheter packages. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6974 UPC 6 18029 83097 5
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 Daily Oral Cleansing Kit Petite Size with Antiseptic Oral Rinse. Contains: 10 Petite Size Oral Swabs, individually wrapped, 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 60013. Product Code 6006 UPC (01)00618029800053
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, Perox-A-Mint solution and Mouth Moisturizer,  2 Oropharyngeal Suction Catheter packages. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6594 UPC 6 18029 82134 1
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
Toothette Oral Care Suction Swabs with Perox-A-Mint solution. Contains 2 Suction Swabs 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 Code 6613
Oral Cleaning and Suctioning System q2. Contains 1 Covered Yankauer, 2 Untreated 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 solution, 2 Oropharyngeal Suction Catheter packages. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6502 UPC 6 18029 80060 2
Q Care Oral Cleansing & Suctioning System compatible with 0.12% Chlorhexidine Gluconate (CHG) Oral Rinse. Contains 1 Covered Yankauer and Y-Connector, 2 Untreated Suction Toothbrush packages,  4  Suction Oral Swab packages with Corinz Antiseptic Cleansing and Moisturizing Oral Rinse, 2 Oropharyngeal Suction Catheter packages. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6994 UPC 6 18029 83094 4
Q.Care Petite Size Oral Cleansing & Suctioning System. Contains 1 Covered Yankauer, Suction Handle and Y-Connector, 2 Petit Size Suction Toothbrush packages with Antiseptic Oral Rinse, 4 Petit Size Untreated Suction Oral Swab packages with Antiseptic Oral Rinse, 2 8 French Oropharyngeal Suction Catheter packages. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6704 UPC 6 18029 84123 0
Q.Care Petite Size Oral Cleansing & Suctioning System. Contains 1 Covered Yankauer, and Y-Connector, 2 Petit Size Suction Toothbrushes, 7ml Antiseptic Oral Rinse, Applicator Swab and 2g Mouth Moisturizer, 4 Petit Size Untreated Suction Oral Swabs, 7ml Antiseptic Oral Rinse, Applicator Swab and 2g Mouth Moisturizer, 2 8 French Oropharyngeal Suction Catheter. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6714 UPC 6 18029 83038 8
Q.Care Oral Cleansing & Suctioning System Suction Toothbrush Compatible with Chlorhexidine Gluconate (CHG) Oral Rinse q4. Contains 1 Covered Yankauer and Y-Connector, 1 Untreated Suction Toothbrush packages,  2 Single dose bottles of 0.12% CHG Oral Rinse, 4 Suction Oral Swab packages with Corinz Antiseptic Cleansing and Moisturizing Oral Rinse, 2 Oropharyngeal Suction Catheter packages. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6964 UPC 6 18029 83075 3
Skin antisepsis and oral cleansing. 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, 1 Applicator Swab treated with Sodium Bicarbonate. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 9009 UPC 6 18029 79140 5
Toothette Suction Toothbrush with Perox-A-Mint solution and Mouth Moisturizer. Includes  0.25 fl.oz./7mL Perox-A-Mint solution, 0.07oz/2g Mouth Moisturizer.  Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. NDC: 53462-922-16
Toothette Short Term Oral Swab System with Perox-A-Mint Solution.  Contains: 20 Individually wrapped Toothette Plus Oral Swabs with sodium bicarbonate,   1.5 fl.oz/44mL bottle of Perox-A-Mint solution and One (1) 0.5 oz/14g tube of Mouth Moisturizer,  Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6002 UPC (01)00618029820921
Toothette Oral Care Short Term Oral Care System with Perox-A-Mint solution, Contains 1.5 fl oz/44 ml bottle of Perox-A-Mint solution, 0.5 oz/14g tube of Mouth Moisturizer, 0.3 oz/9g tube of Sodium Bicarbonate Mouthpaste, 1 Ultra-Soft Toothbrush,  Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6002-D UPC (01)00618029821461
Toothette Oral Care  Single Use System with Perox-A-Mint solution and Mouth Moisturizer. Contains 2 Toothette Plus Swabs with sodium bicarbonate, .25 fl oz/7ml Perox-A-Mint solution and .07 oz/2g Mouth Moisturizer, Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6013 UPC 6 18029 80008 4
Toothette Oral Care Single Use System With Perox-A-Mint solution. Contains: 2 Toothette Plus swabs with sodium bicarbonate, .25 fl oz/7ml tube of Perox-A-Mint solution. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6012 UPC (01)00618029800077
Toothette Oral Care Short Term Oral Swab System with Perox-A- Mint solution. Contains 20 Toothette Plus Oral Swabs with sodium bicarbonate, 1.5 fl.oz/44ml bottle Perox-A-Mint solution, .5 oz/14g tube of Mouth Moisturizer, .3 oz./9g tube of Sodium Bicarbonate Mouthpaste, I Ultra-Soft Toothbrush, Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6001, UPC (01)00618029800039
Oral Cleansing & Suctioning System q2 with 0.12% Chlorexidine Gluconate (CHG) Oral Rinse. Contains 1 Covered Yankauer and Y-Connector, 2 Untreated Suction Toothbrush packages, 2 Single dose bottles of 0.12% CHG Oral Rinse,  packages   SYS W/CHG 10, Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6592
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, IL 60013. Product Code 6572
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
Oral Cleansing & Suctioning System with 0.12% Chlorhexidine Gluconate (CHG) Oral Rinse q2, 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, Perox-A-Mint solution and Mouth Moisturizer, 6 Packages Suction Oral Swab with sodium bicarbonate, Alcohol Free Mouthwash and Mouth Moisturizer, 2 Oropharyngeal Suction Catheter packages. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6592-S UPC 6 18029 82133 1
QCare Rx Oral Cleansing and Suctioning System with 0.12% Chlorhexidine Gluconate (CHG) Oral Rinse q2. 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, 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 6912 UPC 6 18029 83016 6
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 Suction Catheter packages, Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6422 UPC 6 18029 83031 9
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 Oropharyngeal Suction Catheter packages. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 9002  UPC 6 18029 83025 8
Q Care, Oral Cleansing & Suctioning System Corinz. Contains: 1 Covered Yankauer and Y-Connector, 2 Suction Toothbrush packages with Corinz Antiseptic Cleansing & Moisturizing Oral Rinse, 4 Suction Oral Swab packages with Corinz Antiseptic Cleansing & Moisturizing Oral Rinse, 2 Oropharyngeal Suction Cather packages.  Manufactured by:  Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013
Q.CARE Oral Cleansing & Suctioning System q4. Contains 1 Covered Yankauer, Suction Handle and Y-Connector, 2 Toothbrush packages with Antiplaque solution. 4 Suction Oral Swab packages with Perox-A-Mint solution. 2 Oropharyngeal Suction Catheter packages,   Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6804 UPC 6 18029 84121 6
Q.Care, Oral Cleansing & Suctioning System q4. Contains: 1 Covered Yankauer and Y-Connector, 2 Suction Toothbrush packages and Antiplaque solution, 4 Suction Oral Swab packages with Perox-A-Mint solution.    Manufactured by:  Sage Products, LLC., 3909 Three Oaks Road, Cary, IL 60013  Product Code: 6434; UPC 6 18029 83035 7
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 Code 6671
Toothette Oral Care Suction Toothbrushes with Perox-A-Mint solution. Contains 2 Suction Toothbrushes with sodium bicarbonate, 0.25 fl oz/7ml Perox-A-Mint solution. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6570
Toothette Oral Care Perox-A- Mint solution, Oral Debriding Agent 8 fl oz/237 ml. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6060 UPC (01)00618029800152
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. Product Code 6173
Q.CareOral Cleansing & Suctioning System q2. Contains 1 Covered Yankauer Suction Handle and Y-Connector, 2 Suction Toothbrush packages with Antiseptic Solution,, 4 Suction Oral Swab packages with Perox-A-Mint solution, 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 6802 UPC 6 18029 84120 9
Q CARE q4 Oral Cleaning & 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. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6404 UPC 6 18029 84133 9
Toothette Oral Care Suction Swabs with Perox-A-Mint solution and Mouth Moisturizer, Contains 2 Suctino Swabs with sodium bicarbonate, 0.25 fl oz/7ml Perox-A-Mint solution, 0.07 oz/2g Mouth Moisturizer. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6513
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, 1 Applicator Swab treated with Sodium Bicarbonate. 1 Bottle of 3M Skin and Nasal Antiseptic (Povidone-Iodine Solution 5%w/w (0.5%available iodine) USP) Patient Preoperative Skin Preparation 0.14 fl oz (4ml), 4 sterile swabs. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 9010  UPC 6 18029 79139 9
Q.Care Oral Cleansing & Suctioning System q8. Contains 1 Covered Yankauer Suction Handle and Y-Connector, 2 Suction Toothbrush packages with Antiseptic Solution,, 1 Suction Oral Swab packages with Perox-A-Mint solution, 1 Oropharyngeal Suction Catheter package. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6808 UPC 6 18029 84122 3
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, 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 6922-B UPC 6 18029 83032 6
Q CARE q4 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,  2 Oropharyngeal Suction Catheter packages, Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6414 UPC 6 18029 84138 4
Toothette Oral Care Suction Toothbrush with Antiseptic Oral Rinse. Contains 1 Suction Toothbrush with sodium bicarbonate, 0.25 fl oz/ 7ml Antiseptic Oral Rinse, 0.07 oz/2g Mouth Moisturizer, 1 Applicator Swab. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6673
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
Toothette Oral Care Suction Toothbrushes with Perox-A-Mint solution. Contains 1 Suction toothbrush with sodium bicarbonate, 0.25 fl oz /7ml Perox-A-Mint solution. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6571
Toothette Oral Care Single Use System with Antiseptic Oral Rinse and Mouth Moisturizer. Contains 2 Toothette Plus swabs with sodium bicarbonate, .25 fl oz/7ml Antiseptic Oral Rinse, 0.7 fl oz/2g Mouth Moisturizer, Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6113 UPC (01)00618029820990
Q Care RX Petite Oral Cleansing & Suctioning System with 0.12% Chlorhexidine Gluconate (CHG) Oral Rinse. Contains 1 Covered Yankauer and Y-Connector, 2 Untreated Petite Suction Toothbrush packages,  2 Single dose bottles of 0.12% CHG Oral Rinse, 4 Petite Suction Oral Swab packages with Corinz Antiseptic Cleansing and Moisturizing Oral Rinse, 2 Oropharyngeal Suction Catheter packages. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6974-S UPC 6 18029 83097 5
Toothette Oral Care Short Term Oral Swab System with Perox-A- Mint solution. Contains 20 Toothette Plus Oral Swabs with sodium bicarbonate, 1.5 fl.oz/44ml bottle Perox-A-Mint solution, .5 oz/14g tube of Mouth Moisturizer, .3 oz./9g tube of Sodium Bicarbonate Mouthpaste, I Ultra-Soft Toothbrush, Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6001-D NDC: 53462-024-30
QCare Oral Cleansing and Suctioning System with Corinz. Includes: Two (2) Suction Toothbrush packages with 0.25fl.oz/7mL Corinz Antiseptic Cleansing and Moisturizing Oral Rinse and Four (4) Suction Oral Swab packages with 0.25 fl.oz/7mL Corinze Antiseptic Cleansing and Moisturizing Oral Rinse.  Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6464 UPC 6 18029 83077 7
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, 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 6922 UPC 6 18029 83032 6
Independent Care System Corinz, Contains: 1.5 fl oz bottle Corinz Mouthwash, 0.5 oz/14g tube of Mouth Moisturizer, 0.3 oz/9g tube of Sodium Bicarbonate Mouthpast, 1 Ultra-Soft toothbrush. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6004 UPC 6 18029 82148 5
Toothette Oral Care Suction Swab System With Antiseptic Oral Rinse and Mouth Moisturizer. Contains 2 Suction Swabs with sodium bicarbonate 0.25 fl oz/7ml Antiseptic Oral Rinse 0.7 oz/2g Mouth Moisturizer, Sage Products, Inc., 3909 Three Oaks Roarald, Cary, IL 60013. Product Code 6115
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 60013. Product Code 6100 UPC (01)00618029820969
Toothette Oral Care Perox-A-Mint Solution, Oral Debriding Agent, 1.5 fl. oz./44 mL. packet. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6065. UPC 6 18029 80018 3
QCare RX Q2 Oral Cleansing & Suctioning System with 0.12% Chlorhexidine Gluconate (CHG) Oral Rinse Corinz. Contains 1 Covered Yankauer and Y-Connector, 2 Untreated Suction Toothbrush packages, 2 Single dose bottles of 0.12% CHG Oral Rinse, 10 Suction Oral Swab packages with Corinz Antiseptic Cleansing and Moisturizing Oral Rinse and 2 Oropharyngeal Suction Catheter packages. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6962, UPC 6 18029 83076 0
Oral Cleansing & Suctioning System with 0.12% Chlorhexidine Gluconate (CHG) Oral Rinse q2, 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, Perox-A-Mint solution and Mouth Moisturizer, , 2 Oropharyngeal Suction Catheter packages. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6594-S UPC 6 18029 82134 1
Q Care Continue Care for the non-ventilated patient. Contains, 1 Covered Yankauer, 2 Suction Toothbrush packages with Corinz Antiseptic Cleansing and Moisturizing Oral Rinse, 2 Suction Oral Swab packages with Corinz Antiseptic Cleansing and Moisturizing Oral Rinse. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6306 UPC 6 18029 83041 8
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, 2 Packages of 1 Suction Toothbrush 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 Road, Cary, IL 60013. Product Code 6552 UPC 6 18029 82115 7
Toothette Oral Care Short-Term Oral Swab System with Perox-A-Mint solution, Contains 20 Toothette Plus Oral Swabs with sodium bicarbonate, 1.5 fl.oz/44ml bottle Perox-A-Mint solution, .5 oz/14g tube of Mouth Moisturizer, Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product code 6000, UPC 6 18029 8001 5
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-S UPC 6 18029 83017 3
Q.Care Oral Cleansing & Suctioning System with 0.12% Chlorhexidine Gluconate (CHG) Oral Rinse q2. 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, 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 6912-S UPC 6 18029 83016 6
Q.Care Oral Cleansing & Suctioning System Suction Toothbrush Compatible with Chlorhexidine Gluconate (CHG) Oral Rinse q4. Contains 1 Covered Yankauer and Y-Connector, 2 Untreated Suction Toothbrush packages, 4 Suction Oral Swab packages with Perox-A-Mint solution, 2 Oropharyngeal Suction Catheter packages. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6924 UPC 6 18029 83033 3
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
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
Oral Cleansing & Suctioning System q4. Contains 1 Covered Yankauer, 2 Untreated Suctino Toothbrush packages with Antiplaque solution, 4)Suction Oral Swab packages with Perox-A-Mint solution, 2 Oropharyngeal Suction Catheter packages, Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6504. UPC 6 18029 83045 6
Q.Care Oral Cleansing & Suctioning System with 0.12% Chlorhexidine Gluconate (CHG) Oral Rinse q4. Contains 1 Suction Handle, 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 Oropharyngeal Suction Catheter packages. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6904 UPC 6 18029 83008 1
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 Road, Cary, IL 60013. Product Code 6550 6 18029 80065 7
Q CARE q4 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,  2 Oropharyngeal Suction Catheter packages, Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6424 UPC 6 18029 83027 2
Worldwide Distribution:  US states of Florida and California, Australia, France, Spain, and United Kingdom.
Exactech GPS Total Shoulder Application 3.2mm Vix Bit  Orthopedic surgical tool
Due to FDA's safety communication relating to nontuberculous mycobacteria (NTM) infections related to heater/cooler devices, an updated Instructions For Use includes a more robust cleaning & disinfection procedure.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distributed to CA, DC, DE, FL, GA, IL, MD, NC, NJ, OH, TX, UT, VA, and WA.
Purely Yours Breast Pump.  Model 17070PMW and Model 17070ACA.    Intended to express and collect the mother s milk from the breasts of a nursing woman for the purpose of feeding the collected milk to a baby.
Two specific lots was incorrectly manufactured containing a UK power adapter.
Distributed domestically to AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, ID, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NH, NJ, NV, NY, OH, OK, PA, TN, TX, UT, VA, VT, WA, WI, WV.      Distributed internationally to Algeria, Argentina, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Cambodia, Canada, Chile, China, Colombia, Costa Rica, Cote Di'Viore, Croatia, Czech Republic, Democratic Republic of Congo, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Germany, Greece, Guatemala, Honduras, Hong Kong, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kenya, Korea (Republic of), Kuwait, Latvia, Lebanon, Lithuania, Malaysia, Maldives, Malta, Mauritius, Mexico, Moldova, Morocco, Myanmar, Netherlands, New Zealand, Nigeria, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Russia, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Turkey, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Vietnam, Zimbabwe.
Carestation 620 A2, Carestation 650 A2, and Carestation 650c A2
Possible incomplete seal between the CO2 absorber and the breathing circuit CO2 bypass port assembly of the Carestation 600 Series systems.
Carestation 620 A1, Carestation 650 A1, and Carestation 650c A1
US Distribution and Internationally to Japan
BARD(R) CRITICORE(R) MONITOR, Model: 000002N Series    The CritiCore(R) Automated Urine Output and Temperature Monitor is indicated to monitor urine output and core bladder temperature.
BMD has identified that some lots of CritiCore(R) monitors may experience failures involving urine output volume measurement fluctuations, core bladder temperature measurement fluctuations and alarm errors.
CritiCore(R) Monitor Affected Serial Numbers  DYZIAA001  DYAPAA015  DYAQAA040  DYARAA045  DYBPAA010  DYBRAA020  DYBSAA020  DYBSAA065  DYZIAA002  DYAPAA016  DYARAA001  DYARAA046  DYBPAA011  DYBRAA021  DYBSAA021  DYBSAA066  DYZIAA003  DYAPAA017  DYARAA002  DYARAA047  DYBPAA012  DYBRAA022  DYBSAA022  DYBSAA067  DYZIAA004  DYAPAA018  DYARAA003  DYARAA048  DYBPAA013  DYBRAA023  DYBSAA023  DYBSAA068  DYZIAA005  DYAPAA019  DYARAA004  DYARAA049  DYBPAA014  DYBRAA024  DYBSAA024  DYBSAA069  DYZIAA006  DYAPAA020  DYARAA005  DYARAA050  DYBPAA015  DYBRAA025  DYBSAA025  DYBSAA070  DYZIAA007  DYAQAA001  DYARAA006  DYARAA051  DYBPAA016  DYBRAA026  DYBSAA026  DYBSAA071  DYZIAA008  DYAQAA002  DYARAA007  DYARAA052  DYBPAA017  DYBRAA027  DYBSAA027  DYBSAA072  DYZIAA009  DYAQAA003  DYARAA008  DYARAA053  DYBPAA018  DYBRAA028  DYBSAA028  DYBSAA073  DYZIAA010  DYAQAA004  DYARAA009  DYARAA054  DYBPAA019  DYBRAA029  DYBSAA029  DYBSAA074  DYZJAA001  DYAQAA005  DYARAA010  DYARAA055  DYBPAA020  DYBRAA030  DYBSAA030  DYBSAA075  DYZKAA001  DYAQAA006  DYARAA011  DYARAA056  DYBQAA001  DYBRAA031  DYBSAA031  DYBSAA076  DYZKAA002  DYAQAA007  DYARAA012  DYARAA057  DYBQAA002  DYBRAA032  DYBSAA032  DYBSAA077  DYZKAA003  DYAQAA008  DYARAA013  DYARAA058  DYBQAA003  DYBRAA033  DYBSAA033  DYBSAA078  DYZKAA004  DYAQAA009  DYARAA014  DYARAA059  DYBQAA004  DYBRAA034  DYBSAA034  DYBSAA079  DYZKAA005  DYAQAA010  DYARAA015  DYARAA060  DYBQAA005  DYBRAA035  DYBSAA035  DYBSAA080  DYZKAA006  DYAQAA011  DYARAA016  DYASAA001  DYBQAA006  DYBRAA036  DYBSAA036  DYBSAA081  DYZKAA007  DYAQAA012  DYARAA017  DYASAA002  DYBQAA007  DYBRAA037  DYBSAA037  DYBSAA082  DYZKAA008  DYAQAA013  DYARAA018  DYASAA003  DYBQAA008  DYBRAA038  DYBSAA038  DYBSAA083  DYZKAA009  DYAQAA014  DYARAA019  DYASAA004  DYBQAA009  DYBRAA039  DYBSAA039  DYBSAA084  DYZKAA010  DYAQAA015  DYARAA020  DYASAA005  DYBQAA010  DYBRAA040  DYBSAA040  DYBSAA085  DYZKAA011  DYAQAA016  DYARAA021  DYASAA006  DYBQAA011  DYBRAA041  DYBSAA041  DYBSAA086  DYZKAA012  DYAQAA017  DYARAA022  DYASAA007  DYBQAA012  DYBRAA04
Bull Capsules, 1800 mg/grain, 30 count per tin, Hongkong Jiuyuejiu Biology Technology CO., LTD, BYL Solutions, Inc. dba Nutra Labs, Inc., Palmetto, FL
Marketed without an Approved NDA/ANDA; product found to be tainted with sildenafil
Radial Artery Catheterization Set, 1) NA-04550-1A & 2) NA-04550-X1A, device permits access to the peripheral arterial circulation or to other small vessels.
Needle supplier indicated the presence of loose polypropylene foreign matter above release specification.
Worldwide Distribution in the states of AL, AK, AZ, AK, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IO, KS, KY, LA, MA, MD, MA, MI, MN, MO, NE, NV, NH, NJ, NY, NM, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VI, WA, WV, WI, and WY  and the countries of Brazil, Canada, Costa Rica, El Salvador, Guam, Paraguay, and Peru
Lyophilized Chemistry Calibrator Level 1     Product Usage:  Beckman Coulter Chemistry Calibrators are intended for use when calibrating methods run on the Beckman Coulter AU series of chemistry analyzers. Beckman Coulter Chemistry Calibrators are lyophilized, human serum based products formulated for use as a reference material when calibrating Beckman Coulter AU clinical chemistry system assays. The calibrators are used to calibrate the following assays: Albumin (ALB), Bicarbonate (CO2), Direct Bilirubin (DBIL), Total Bilirubin (TBIL), Calcium Arsenazo (CALA), Calcium (CAL oCPC), Cholesterol (CHOL), Creatinine (CREA), Glucose (GLU), Phosphorus (PHOS), Iron, Lactate, Magnesium (MG), Total Protein (TP), Triglyceride (TRIG), Unbound Iron Binding Capacity (UIBC), Urea Nitrogen (BUN), and Uric Acid. Only lots 6101K51 and 6101K61 were subject to recall.
Unpaired lots of AU lyophilized chemistry calibrator level 1 and 2 have been distributed. Calibrator level 1 and 2 must be paired when used for calibration and cannot be used in any other combination. If lot numbers are not correctly paired, calibration can be run using incorrect set points which may generate erroneous results. QC failures could occur if incorrect pairs of calibrators are used.
Distributed to the states of AL, AZ & MS.
Blastomyces dermatitidis Antiserum 1 mL vial GIBSON BIOSCIENCE.  Catalog 200265    Intended for identification of the systemic fungal pathogens.
The firm information that the product was reporting false positive results
Worldwide Distribution: US (nationwide) to AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, including Guam; and countries to Australia, Brazil, Canada, Chile, China, Denmark, Dominican, El Salvador, England, Finland, France, Hong Kong, India, Italy, Japan, Malaysia, Mexico, Netherlands, Panama, Singapore, Sweden, Taiwan, and Thailand..
A.T.S. 2200TS Tourniquet Systems, Personalized Pressure.  Zimmer Surgical, Inc. Dover, OH 44622     Intended to be used by qualified professionals to temporarily occlude blood flow in a patient's extremities during surgical procedures on those extremities.
Updated on-device label and 3 pages of an updated Operator/Service Manual.  Also, decrease from 3.8 meters (m) to 1.0 separation distance between the device and RF communication equipment.
A.T.S. 4000TS Tourniquet Systems, Personalized Pressure.     Intended to be used by qualified professionals to temporarily occlude blood flow in a patient's extremities during surgical procedures on those extremities.       .
Lot Number: 7RSL021  Expiration Date: 2020-05-31
Famciclovir Tablets, 500 mg, 30-count bottles, Rx Only, Manufactured For: Camber Pharmaceuticals. Inc. Piscataway, NJ 08854 By: HETERO, Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Nagar-509 301, India. NDC 31722-708-30
Temperature Abuse: Complaints of tablets being wet and stuck together with tablet coating peeled and disintegrated.
Distribution was made to DC, FL, GA, MD, MI, NJ, NY, OH, PA, SC, and VA.  There was also military/government distribution.  There was no foreign distribution.
Vado Bi-Directional Steerable Sheath 8.8F, REF SS8FMB74, packaged in a lidded tray that is within a pouch which is inserted into a shelf carton, Sterile, Rx.  The firm name on the label is Kalila Medical, Campbell, CA.
Torn sheath liner material was detected at the proximal end of the device during internal product testing which may be the result of damage incurred during the manufacturing process.
Vado Steerable Sheath 8.8F, REF SS8FMU67, packaged in a lidded tray that is within a pouch which is inserted into a shelf carton, Sterile, Rx.  The firm name on the label is Kalila Medical, Campbell, CA.
Medtronic ANGLED DRILL, REF 6630902, QTY: 1 EA Rx only
Medtronic has discovered the product lot in question was noted as having a longer drill tip extension than what is indicated on the print specification.
PENCAN Spinal Anesthesia Tray. Product Catalog Number: 560590.     Local anesthesia of the skin prior to insertion of the regional anesthesia needle.
B. Braun Medical Inc. (BBMI) initiated this recall of various BBMI convenience kits containing the 22GA 1-1/2in SafetyGlide Needle due to the presence of loose polypropylene foreign matter was above release specification. This foreign matter has been  identified as a product hub material which has been tested for biocompatibility per ISO 10993 during the product  development process.
Customer Epidural Anesthesia Tray. Product Catalog Number: 555234.     Local anesthesia of the skin prior to insertion of the regional anesthesia needle.
Perifix Single Dose Epidural Anesthesia Tray. Product Catalog Number: 332252.     Local anesthesia of the skin prior to insertion of the regional anesthesia needle.
B. Braun Medical Inc. (BBMI) initiated this recall of various BBMI convenience kits containing the 22GA 1-1/2in SafetyGlide Needle due tothe presence of loose polypropylene foreign matter was above release specification. This foreign matter has been  identified as a product hub material which has been tested for biocompatibility per ISO 10993 during the product  development process.
Contiplex Nerve Block Tray. Product Catalog Number: 570205.    Local anesthesia of the skin prior to insertion of the regional anesthesia needle.
Pain Management Tray. Product Catalog Number: 560602.    Local anesthesia of the skin prior to insertion of the regional anesthesia needle.
Spinal & Epidural Anesthesia Tray. Product Catalog Number: 555172.     Local anesthesia of the skin prior to insertion of the regional anesthesia needle.
Pencan Spinal Needle Tray. Product Catalog Number: 333865.     Local anesthesia of the skin prior to insertion of the regional anesthesia needle.
Perifix Continuous Epidural Anesthesia Tray. Product Catalog Numbers: 332075, 332266.     Local anesthesia of the skin prior to insertion of the regional anesthesia needle.
Perifix Epidural AnesthesiaTray. Product Catalog Numbers: 551879, 551994, 552024.     Local anesthesia of the skin prior to insertion of the regional anesthesia needle.
Perifix FX Epidural Anesthesia Tray. Product Catalog Numbers: 551993, 552051, 552083, 552119, 555569.     Local anesthesia of the skin prior to insertion of the regional anesthesia needle.
EMS products from Graham Medical, SnugFit(R) Expandable Mattress Cover, Code 72930, UPC 1 07 47036 72930 3
The secondary supplier provided material was within specification but did not meet our design needs compared to the primary manufacturer.  The product is designed for patient transfer, not lifting. However, we recognize that the product may be utilized outside of its intended design scope, and lifting may occur.  Lifting could lead tearing of the equipment cover and the potential for patient falling through.
US Distribution to the states of  :CA and TX.
Total Knee Replacement , Catalog/Model # TPS-111-1111, UDI: +M572TPS1111111021/$$+31712310398482- and +M572TPS1111111021/$$+31712310399917/    Intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be solely addressed by the use of a prosthetic device that treats only one or two of the three knee compartments, such as a unicondylar, patellofemoral, or bicompartmental prosthesis.
Serial numbers: 0398482 & 0399917  Expiration Date: 12/31/2017
Worldwide Distribution -- USA, Puerto Rico, and Haiti.
Xpert CT/NG Catalog GXCT/NG-120 Batch 1000049568, Catalog GXCT/NG-10 Batch 1000053075, Catalog GXCT/NG-10 Batch 1000056156 and Catalog GXCT/NG-10 Batch 1000056157.    Is a qualitative in vitro real-time PCR test.
Cepheid has received reports that some of our customers have experienced a higher number of  temperature drift errors than would typically be expected when using this test and its intended use  specimen types. Investigation of the issue also revealed an occasional probability of false  negative results which remains consistent with package insert claims.
Senna Laxative (sennosides) tablets, 8.6 mg, 100-count bottles, Manufactured for: Basic Drugs, Inc., Vandalia, Ohio 45377, UPC Code 3 07610 22020 1.
Labeling: Label Mix-Up: Customer complaint received that a bottle labeled as Senna Laxative contained only tablets of Naproxen Sodium 220 mg.
11MM/130 Degree Titanium Trochanteric Fixation Nail 380MM/Right, Sterile
The locking mechanism and protective cap were missing from the sterile packed nails of the affected lot.
US Distribution to the states of :  AR, MO, NY, IN, AR, TX , NC, PA, MI, LA, WA, CA and AL.
Artis oneFloor-mounted system for uncompromised imaging; Artis one, Interventional fluoroscopic x-ray system, Artis one is an angiography system developed for diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. X-ray generator POLYDOROS A100 Plus
The possibility exists for the monitor display of Artis one systems with a DP Transceiver below revision 03 to experience blinking and/or a blue/black screen
ArrowADVANTAGE 5 Pressure Injectable Peripherally Inserted Central Catheter (PICC). Product Codes: PR-35041-HPHNM and CDA-35041-HPK1A.
Finished good kits may contain incorrect components. Kits that should contain a 5 FR 2 lumen catheter may contain a 4 FR single lumen catheter and kits that should contain a 4 FR single lumen catheter may contain a 5 FR 2 lumen catheter. This may cause a delay in treatment while a replacement catheter is obtained.
ARROW PICC powered by ARROW VPS Stylet, Product Codes: CDC-35052-VPS and CDC-35041-VPS.  Peripherally Inserted Central Catheter
Domestic: SC, IL, IN    Foreign: None  VA/DOD: None
Firm is recalling multiple products following a supplier's recall of yeast ingredient due to potential contamination with metal fragments.
#6600 TJ TORTILLA, Net Wt. 50 Lbs, Code: 6600, MADE ON 01.05.18 LOT CODE 005B8002
BROLITE PRODUCT #5015 SPONGE AND DOUGH, Net Wt. 50 Lbs
BROLITE PRODUCT #5015 SPONGE AND DOUGH, Net Wt. 50 Lbs, Code: 5015  MADE ON 01.09.18 LOT CODE 009B8001   MADE ON 01.10.18 LOT CODE 010B7003
BROLITE PRODUCT #6109 BREAD FLAVOR R, Net Wt. 50 Lbs
BROLITE PRODUCT #6109 BREAD FLAVOR R, Net Wt. 50 Lbs, Code: 6109  MADE ON 12.26.17 LOT CODE 360B7002    MADE ON 01.02.18 LOT CODE 002B8002   MADE ON 01.03.18 LOT CODE 003B8001   MADE ON 01.08.18 LOT CODE 008B8001   MADE ON 01.09.18 LOT CODE 009B8001   MADE ON 01.10.18 LOT CODE 010B8001 & 010B8002
Product may be contaminated with Salmonella.
Algeria, Armenia, Australia, Canada, Cyprus, Egypt, Germany, Ghana, Greece, Guam, Iceland, Indonesia, Iran, Italy, Jordan, New Zealand, Poland, Portugal, Puerto Rica, Russian Federation, Saudi Arabia, Singapore, South Africa, Spain, Swaziland, Sweden, Switzerland, Syria, Tunisia, Turkey, UAE, UK, USA, Yemen
Model #: CG8900, Medtronic Clip Gun Scalp Clip Kit (Qty 1); Model #: CG8901, Medtronic Clip Gun Scalp Clip Kit (Qty 10); Model #: CG8901A, Medtronic Clip Gun Applicator (Qty 10)
Medtronic is initiating a voluntary recall because the products identified above did not adequately demonstrate acceptable packaging performance to current standards.
Accu-Chek Connect Diabetes Management App, Catalog number 07562462001 / GTIN number 00365702700000 & Catalog number 07250452001 / GTIN number 00365702700017
Certain iOS and Android App versions contain a program error (bug) in the Bolus Advisor feature.  Due to a software bug, when the OS region of the phone setting is changed, the unit of measure within the app may unexpectedly change. This creates a risk the app might not transfer the blood glucose result or the user might not correctly input numerical values for carbohydrate used for bolus advice.
3m Center 2510 Conway Ave , B# 275-5-W-6
Worldwide Distribution: US (nationwide) and countries of: Australia, Canada, Chile, Costa Rica, Deutschland GMBH, Dominican,  Ecuador, Hong Kong, Indonesia, Japan, Korea, Paraguay, Philippines, New Zealand, Shanghai, Thailand,  and Uruguay.
3M Bair Hugger(M) Normothermia System, Sterile Full Access Underbody, Model 63700     The 3M Bair Hugger Temperature Management System is intended to prevent and treat hypothermia. In addition, the temperature management system can be used to provide patient thermal comfort when conditions exist that may cause patients to become too warm or too cold. The temperature management system can be used with adult and pediatric patients.
Adesign change to 3M(TM) Bair Hugger(TM) Full Access Underbody Warming Blanket, Models 63500 and 63700, can make these blankets more susceptible to unintended occlusion of airflow resulting in limited or partial inflation during use.
3M Bair Hugger(M) Normothermia System, Full Access Underbody Warming Blanket, REF 63500     The 3M Bair Hugger Temperature Management System is intended to prevent and treat hypothermia. In addition, the temperature management system can be used to provide patient thermal comfort when conditions exist that may cause patients to become too warm or too cold. The temperature management system can be used with adult and pediatric patients.
Hologic Panther(R) Fusion(TM), Catalog number ASY-09600    Product Usage:  The Panther instrument is a fully automated sample-to-result instrument, eliminating the need for batch processing and automates all aspects of nucleic acid testing on a single, integrated platform. The Panther can be test samples with random access or batch managed; can perform multiple assays on the same patient sample with up to 4 different assays simultaneously.
The Panther or the Panther Fusion glass panel separates from the 19 inch touch screen monitor and could potentially fall and hit an operator.
Worldwide Distribution - US Distribution to the states of : CA, OH, IL, PA and NY.
Ingenuity TF PET/CT (model 882442) running software version 4.0.2      This device is a diagnostic imaging system that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The CT subsystem produces cross-sectional images of the body by computer reconstruction of x-ray transmission data. The PET subsystem produces images of the distribution of PET radiopharmaceuticals in the patient body (specific radiopharmaceuticals are used for whole body, brain, heart and other organ imaging). CT data is applied to the PET data for attenuation correction. The PET subsystem also provides for list mode, dynamic, and gated acquisitions. This system is intended for patients of all ages
on the Acquisition Workflow window during reconstruction after the patient scan has been completed.  In both scenarios, the acquisition data will not be able to be reconstructed and will therefore be unusable.
Nationally; US Consignees for this recall are the affected are US Distributors and US Medical Facilities (Hospitals/User Facilities) that may have purchased, used, or received the affected device.
CORAIL COXA VARA HIGH OFFSET STEM Collared Size 9
Incorrect device in the package. A package that was labeled as the CORAIL COXA VARA HIGH OFFSET STEM Collared Size 9 (Part No. 3L93709 / Lot No. 5291990), contained the CORAIL HIGH OFFSET STEM Collarless SIZE 14 (Part No. L20314 / Lot No. 5292130).
CORAIL HIGH OFFSET STEM Collarless SIZE 14
Larabar Chocolate Chip Cookie Dough, 5 - 1.6 oz (45g) bars Net Wt 8.0 oz(226g), UPC 21908-48817.  Case UPC 000-21908-41675-5
Larabar Chocolate Chip Cookie Dough, 5 count, are being recalled because they may contain individually wrapped and labeled Coconut Cream Pie Bars.
Coblentz Distributing Inc dba Walnut Creek Foods
Product was shipped to the following states: FL, ID, IN, KY, MI, MT, NC, NY, OH, PA, TN, VA & WV.
WALNUT CREEK FOODS Caramel Popcorn NET WT 15 OZ (425g) Ingredients: Evaporated Can Juice, Popcorn, Butter (cream, salt), Salt, Sodium Bicarbonate, Cream of Tartar Contains: Milk Distributed by: Walnut Creek Foods, Walnut Creek, OH 44687 UPC 25555 99857 2
Aripiprazole Tablets, USP, 10 mg, 100 Tablets (10 x 10) unit dose blisters [NDC60687-179-11; UPC (01) 003 60687 179 11 7] per carton (NDC 60687-179-01), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217.
Failed Dissolution Specifications: Sub-recall of the manufacturer's recall due to dissolution failure.
US Nationwide Distribution in the states of ND, NJ & MA
Abutments are unable to accept the final abutment screw
REF - 45324K  Lot Number - 33006  Expiry Date - March 31, 2022
NS357R Vega PS Tibia Trial/Preparation Plateau size T4 (Component of the Vega Knee System Set #ST0468)    The affected part is provided in the Vega Knee System Set #ST0468. The Vega Knee System is used for reconstruction of the diseased knee joint.
The NS357R Vega PS Tibia Trial/Preparation Plateau size T4 may be incorrectly labeled.  If the incorrect size trial is used the potential risk is implantation of the incorrect implant size which may lead to injury of ligaments, pain and possible revision surgery.
The product is located in the Vega Tibia preparation Tray (NS803) in the Vega Instrument Set (ST0468).
The contract supplier notified DePuy Synthes on June 16, 2017 that the kit expiration dates do not align with the earliest expiration date of the component lots within the kit. Some kit expiration dates were later than the earliest expiration date of the component lots. The expiration dates of some components are earlier than that listed on the kit.
Product Number: 07.704.010S  Lot Number: DSE0733
Product Number: 07.704.003S  Lot Number: DSD9110
Frozen Sliced (blanched) Squash packed in 1400 lb. plastic totes.
Routine analysis by consignee found one lot of 12 positive for Listeria monocytogenes. Original microbiological analysis conducted in 2016, by Hanover found all lots negative for Listeria monocytogenes.
Custom Made Tracheostomy Device    The CADD Administration Sets with Flow Stop are designed to be used with a variety of CADD ambulatory infusion pumps to allow fluid delivery from an IV bag.
Smiths Medical determined that a single custom Tracheostomy device had been shipped to the customer without required sterilization.
Worldwide distribution -  US Nationwide in the states of: AL, CA, CO, FL, GA, IA, IL, KY, LA, MD, MI, MN, MO, NC, NY, OH, OK, OR, PA, RI, TN, TX, UT, VA, WA, WI; the District of Columbia and the countries of  Belgium, India Italy, Spain, and United Kingdom.
Central Venous Tray Triple Lumen Polyurethane Catheter, Catalog Identifier: C-UTLMY-501J-CCT    Product Usage:  The central venous catheter is designed for treatment of critically ill patients and is suggested for: 1. Continuous or intermittent drug infusions; 2. Central venous blood pressure monitoring (CVP); 3. Acute hyperalimentation; 4. Blood sampling; 5. Delivery of whole blood or blood products; 6. Simultaneous, separate infusion of drugs
Central venous catheters may not fit over guide wire potentially causing procedure delay.
Lot Number (Expiration date): 5901462 (30-January-2018)
Central Venous Catheter Tray Triple Lumen Polyurethane, Catalog Identifier: C-UTLMYJ-501J    Product Usage:  The central venous catheter is designed for treatment of critically ill patients and is suggested for: 1. Continuous or intermittent drug infusions; 2. Central venous blood pressure monitoring (CVP); 3. Acute hyperalimentation; 4. Blood sampling; 5. Delivery of whole blood or blood products; 6. Simultaneous, separate infusion of drugs
Lot Number (Expiration date): 5919800 (30-May-2018)
Central Venous Catheter Set Triple Lumen Polyurethane, Catalog Identifier: C-UTLM-501J    Product Usage:  The central venous catheter is designed for treatment of critically ill patients and is suggested for: 1. Continuous or intermittent drug infusions; 2. Central venous blood pressure monitoring (CVP); 3. Acute hyperalimentation; 4. Blood sampling; 5. Delivery of whole blood or blood products; 6. Simultaneous, separate infusion of drugs
Spectrum Central Venous Catheter Tray Minocycline/Rifampin Antibiotic Impregnated, Catalog Identifiers: C-UTLMY-501J-ABRM-HC-FST and C-UTLMY-501J-ABRM-HC-IHI-FST    Usage:  The Spectrum Central Venous Catheter is used for the intravenous administration of nutrient fluids, chemotherapeutic agents, and other drugs for therapy, blood sampling, blood delivery, and venous pressure monitoring
Central Venous Catheter Set Heparin Coated Triple Lumen Polyurethane, Catalog Identifiers: C-UTLM-501J-25-6.5-WCE-BH, C-UTLM-501J-BH    Product Usage:  The central venous catheter is designed for treatment of critically ill patients and is suggested for: 1. Continuous or intermittent drug infusions; 2. Central venous blood pressure monitoring (CVP); 3. Acute hyperalimentation; 4. Blood sampling; 5. Delivery of whole blood or blood products; 6. Simultaneous, separate infusion of drugs
Limbrel250 (flavocoxid and citrated zinc bisglycinate) 250 mg/50 mg capsules,  60-count bottle, Rx only, Manufactured for: Primus Pharmaceuticals, Inc., Scottsdale, AZ  85253; Manufactured by: Cornerstone Research and Development, Ogden, UT  84404, NDC 68040-605-16.
Marketed Without An Approved NDA/ANDA: Based on the labeling claims, these products are unapproved drugs for which the safety and efficacy have not been established and, therefore, subject to recall.
Limbrel500 (flavocoxid and citrated zinc bisglycinate) 500 mg/50 mg capsules, 60-count bottle, Rx only, Manufactured for: Primus Pharmaceuticals, Inc., Scottsdale, AZ  85253; Manufactured by: Cornerstone Research and Development, Ogden, UT  84404, NDC 68040-606-16.
Limbrel (flavocoxid 500 mg) capsules, 60-count bottle, Rx only, Manufactured for: Primus Pharmaceuticals, Inc., Scottsdale, AZ  85253; Manufactured by: Cornerstone Research and Development, Ogden, UT  84404, NDC 68040-602-16.
Limbrel (flavocoxid 250 mg) capsules, 60-count bottle, Rx only, Manufactured for: Primus Pharmaceuticals, Inc., Scottsdale, AZ  85253; Manufactured by: Cornerstone Research and Development, Ogden, UT  84404, NDC 68040-601-16.
Response 5.5/6.0 Spine System   7.0mm x 40mm  Pedicle Screw    Product Usage:  Posterior non-cervical pedicle screw fixation
The 7mm diameter uniaxial pedicle screws have been color anodized with the same color utilized on 5 mm diameter screws.
Distributed to 4 hospitals in the following states: NM, OH, TX, WV
ELAN 4 Blade: ELAN 4 1-RING PIN CUTTER D1.0  ELAN 4 1-RING NEURO CUTTER+ SOFT D1.5  ELAN 4 1-RING NEURO CUTTER+ SOFT D2.0  ELAN 4 1-RING NEURO CUTTER+ SOFT D2.5   ELAN 4 1-RING NEURO CUTTER SOFT D3.0  ELAN 4 1-RING NEURO CUTTER+ SOFT D3.0  ELAN 4 1-RING NEURO CUTTER D2.0   ELAN 4 1-RING NEURO CUTTER D2.5   ELAN 4 1-RING NEURO CUTTER D3.0   ELAN 4 1-RING NEURO CUTTER TC D3.0  ELAN 4 1-RING NEURO CUTTER DIAM.D1.5  ELAN 4 1-RING NEURO CUTTER+ DIAM.D1.5  ELAN 4 1-RING NEURO CUTTER DIAM.D2.0  ELAN 4 1-RING NEURO CUTTER+ DIAM.D2.0  ELAN 4 1-RING NEURO CUTTER DIAM.D2.5  ELAN 4 1-RING NEURO CUTTER+ DIAM.D2.5  ELAN 4 1-RING NEURO CUTTER DIAM.D3.0  ELAN 4 1-RING NEURO CUTTER+ DIAM.D3.0  ELAN 4 1-RING NEURO CUTTER DIAM.D4.0  ELAN 4 1-RING NEURO CUTTER+ DIAM.D4.0  ELAN 4 2-RING CRANIOTOME CUTTER PAED  ELAN 4 2-RING CRANIOTOME CUTTER STANDARD  ELAN 4 2-RING CRANIOTOME CUTTER LONG ELAN 4 2-RING CRANIOTOME CUTTER PAED  ELAN 4 2-RING CRANIOTOME CUTTER STANDARD  ELAN 4 2-RING CRANIOTOME CUTTER LONG  ELAN 4 2-RING NEURO CUTTER SOFT D2,0  ELAN 4 2-RING NEURO CUTTER SOFT D2,5  ELAN 4 2-RING NEURO CUTTER SOFT D3,0  ELAN 4 2-RING NEURO CUTTER+ SOFT D3,0  ELAN 4 2-RING NEURO CUTTER SOFT D3,0  ELAN 4 2-RING NEURO CUTTER TC D3,0  ELAN 4 2-RING NEURO CUTTER DIAM. D3,0  ELAN 4 2-RING NEURO CUTTER+ DIAM. D3,0  ELAN 4 2-RING DIAMOND DISC  ELAN 4 2-RING SIDE CUTTER TC D3,0  SAW BLADE S sagittal 11/13/0,3  SAW BLADE S sagittal 15/5/0,3  SAW BLADE S sagittal 20/5/0,3  SAW BLADE S sagittal 20/10/0,3  SAW BLADE S sagittal 20/15/0,3  SAW BLADE S sagittal 25/5/0,3  SAW BLADE S sagittal 25/12/0,3  RECIPROCATING SAW BLADE MICRO 13/0.3  RECIPROCATING SAW BLADE MICRO 20/0.3  RECIPROCATING SAW BLADE MICRO 13/0.3  RECIPROCATING SAW BLADE MICRO 20/0.3  ELAN 4 1-RING NEURO CUTTER D1.5+  ELAN 4 1-RING NEURO CUTTER D2.0+  ELAN 4 1-RING NEURO CUTTER D2.5+  ELAN 4 1-RING NEURO CUTTER D3.0+  ELAN 4 1-RING SIDE CUTTING, CARBIDE D2.0  ELAN 4 1-RING NEURO PRECISE D1.5  ELAN 4 1-RING NEURO PRECISE D2.0  ELAN 4 1-RING NEURO PRECISE D2.5  ELAN 4 1-RING NEURO PRECI
ELAN 4 burr/blade accessories were marketed without 510(k) premarket notification clearance.
All lots, Model Number: GP190R  GP201R  GP202R  GP203R  GP204R  GP205R  GP208R  GP209R  GP210R  GP210TC  GP211R  GP212R  GP213R  GP214R  GP215R  GP216R  GP217R  GP218R  GP219R  GP220R  GP341R  GP342R  GP343R  GP351R  GP352R  GP353R  GP361R  GP362R  GP363R  GP364R  GP367R  GP367TC  GP370R  GP371R  GP398SU  GP399TC-SU  GP491R  GP492R  GP493R  GP494R  GP495R  GP496R  GP497R  GP542R  GP543R  GP544R  GP545R  US779R  US780R  US781R  US782R  US784TC  US792R  US793R  US794R  US795R  US798TC  US799TC  US800R
ELAN 4 Burr: ELAN 4 1-RING ROSEN BURR+ D0.6  ELAN 4 1-RING ROSEN BURR+ D0.8  ELAN 4 1-RING ROSEN BURR D1.0  ELAN 4 1-RING ROSEN BURR TC D1.0  ELAN 4 1-RING ROSENBURR+ D1.0  ELAN 4 1-RING ROSEN BURR D1.4  ELAN 4 1-RING ROSENBURR+ D1.4  ELAN 4 1-RING ROSEN BURR D1.8  ELAN 4 1-RING ROSEN BURR+ D1.8  ELAN 4 1-RING ROSEN BURR TC D2.0  ELAN 4 1-RING ROSEN BURR D2.3  ELAN 4 1-RING ROSEN BURR+ D2.3  ELAN 4 1-RING ROSEN BURR D2.7  ELAN 4 1-RING ROSEN BURR+ D2.7  ELAN 4 1-RING ROSEN BURR D3.0  ELAN 4 1-RING ROSEN BURR TC D3.0  ELAN 4 1-RING ROSEN BURR D3.5
All lots, Model Number: GP111R  GP112R  GP113R  GP113TC  GP114R  GP115R  GP116R  GP117R  GP118R  GP119TC  GP120R  GP121R  GP122R  GP123R  GP124R  GP124TC  GP125R  GP126R  GP126TC  GP127R  GP128R  GP128TC  GP129R  GP129TC  GP133R  GP134R  GP135R  GP136R  GP141R  GP142R  GP143R  GP144R  GP145R  GP146R  GP147R  GP148R  GP149R  GP150R  GP151R  GP152R  GP153R  GP154R  GP155R  GP156R  GP157R  GP158R  GP161R  GP162R  GP163R  GP164R  GP165R  GP166R  GP167R  GP168R  GP169R  GP170R  GP173R  GP174R  GP175R  GP176R  GP177R  GP184R  GP185R  GP186R  GP187R  GP193R  GP194R  GP195R  GP196R  GP224R  GP225R  GP226R  GP228R  GP229R  GP230R  GP232R  GP233R  GP234R  GP235R  GP236R  GP238R  GP240R  GP241R  GP242R  GP243R  GP301R  GP301TC  GP302R  GP302TC  GP303R  GP304R  GP304TC  GP305R  GP306R  GP306TC  GP307R  GP307TC  GP308R  GP308TC  GP309R  GP309TC  GP311R  GP312R  GP313R  GP314R  GP315R  GP316R  GP317R  GP321R  GP322R  GP323R  GP324R  GP325R  GP328R  GP329R  GP330R  GP335R  GP336R  GP337R  GP338R  GP339R  GP350R  GP355R  GP356R  GP357R  GP358R  GP374R  GP375R  GP376R  GP378R  GP379R  GP380R  GP382R  GP384R  GP385R  GP386R  GP388R  GP389R  GP391R  GP392R  GP393R  GP395TC  GP397R  US792R  US793R  US794R  US771R  US772R  US773R  US774R  US775R  US776R  US777R  US783TC  US785TC  US787R  US788TC  US790TC  US800R  US801R  US807R  US852TC  US853R  US861R  US825R  US831R
ELAN 4 Drill: ELAN 4 1-RING TWIST DRILL D1.5  ELAN 4 1-RING TWIST DRILL D2.0  ELAN 4 2-RING TWIST DRILL D1,0/4,0MM  ELAN 4 2-RING TWIST DRILL D1,1/4,0MM  ELAN 4 2-RING TWIST DRILL D1,2/4,0MM  ELAN 4 2-RING TWIST DRILL D1,5/4,0MM  ELAN 4 2-RING TWIST DRILL D1,5  ELAN 4 2-RING TWIST DRILL D2,0  ELAN 4 2-RING WIRE PASS DRILL D1.0  ELAN 4 2-RING WIRE PASS DRILL D1.5  ELAN 4 2-RING WIRE PASS DRILL D2.0  ELAN 4 2-RING WIRE PASS DRILL D1.0  ELAN 4 2-RING WIRE PASS DRILL D1.5  ELAN 4 2-RING WIRE PASS DRILL D2.0
All lots, Model Number: GP188R  GP189R  GP344R  GP345R  GP346R  GP347R  GP348R  GP349R  US804R  US805R  US806R  US828R  US829R  US830R
NORCO (Hydrocodone Bitartrate and Acetaminophen) Tablets, USP, 10 mg/325 mg, 100-count bottles, Rx Only, Distributed by: Allergan USA, Inc., Irvine, CA 92612, NDC 0023-6022-01.
controlled drug classification indication on the primary label.
Distributed in 29 states: AZ, CA, CO, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, MI, MO, MT, NC, NE, NJ, NY, OH, OR, PA, SC, TN, TX, VA, WV and Washington, DC. Distributed to 1 Veteran's Administration hospital in MO. Distributed in Netherland, Peru, and Switzerland.
BlockAid Cut Resistant Surgical Glove Liners, combine stainless steel and synthetic fibers woven together to form a cut resistant glove material. Blockaid Cut Resistant Surgical Glove Liners are to be worn between two layers of surgical gloves. Item Number: 650126, 650127, 650128, 650129, 650130, 650131
Cut resistant surgical glove liners lack sterility assurance.
CVS Distribution Centers in the following states: Alabama, Florida, Indian, Michigan, New Jersey, New York, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Virginia.
Live Better Drug Free Black Elderberry Syrup, 4 FL OZ (118 mL); DIETARY SUPPLEMENT, UPC 050428581186
The JS Series SterilContainer S2 System was released to the market place prior to an authorized FDA 510K clearance. No other Aesculap SterilContainer System products are impacted by this recall.
JS440 S2 1/1CONT.BOTTON PERFOR.H88MM H202  JS441 S2 1/1 CONT.BOTTOMPERFOR.H1118MM H202  JS442 S2 1/1-CONT.BOTTOM PERFOR.H133MM H202  JS444 S2 1/1 CONT.BOTTOM PEFOR.H185MM H202  JS489 S2 1/1-CONTAINER LID H202  JS740 S2 3/4 CONT.BOTTOM PERFOR.H88MMH202  JS741 S2 3/4 CONT.BOTTOM PERFOR.H118MM H202  JS742 S2 3/4 CONT.BOTTOM PERFOR.H133MM H202  JS789 S2 3/4 CONTAINER LID H202  JS340 S2 1/2 CONT.BOTTOM PERFOR.H88MM H202  JS341 S2 1/2 CONT.BOTTOM PERFOR.H118MM H202  JS342 S2 1/2 CONT.BOTTOM PERFOR.H133MM H202  JS389 S2 1/2 CONTAINER LID H202
The ELAN 4 Air System is intended for high speed cutting, sawing and drilling of bone in fields of Spine, ENT, Neuro, and Maxillofacial Surgery.
The ELAN 4 Air System was released to the market place prior to an authorized FDA 510K clearance.   This issue does not affected sales outside the United States (OUS).
ELAN 4 Air System   ST0607 ELAN 4 Air Control Set   ST0608 ELAN 4 Air Neuro Crani Set   ST0609 ELAN 4 Air Spine Set   ST06411 ELAN 4 Air HD Spine Set   ST0614 ELAN 4 Air Micro Saw Set   ST0615 ELAN 4 Air Hand Control Set   ST0638 ELAN 4 Air Large Saw Set
US Nationwide Distribution to IN, MO, NY, TX.
AGC 2000 LP Patella, labeled as AGC Porous Patellar Med, Model Number 150804.    Product Usage:  For use in Total Knee Arthroplasty.
The affected AGC 2000 LP Patella products were over-molded leaving the outside diameter nonconforming to the print dimension.
AGC 2000 LP Patella, labeled as AGC Porous Patellar SM, Model Number 150802.    Product Usage:  For use in Total Knee Arthroplasty.
US Nationwide Distribution in the states of  AZ, CA, CO, ID, IL, IN, MA, MD, MI, NJ, NM, PA, SC, TX, WA, WI.      Distributed internationally to Belgium, France, Germany, Italy, Japan, Netherlands, Spain, Sweden, Switzerland, UK.
Persona Partial Knee System    Product Usage:  The Persona Partial Knee System instruments are used by a surgeon to facilitate the implantation of PPK implantable components into the medical knee compartment during unicondylar knee replacement.
Potential for the Persona Partial Knee Impactor Pad to fracture.
G7 DUAL MOBILITY LINER 44MM F    Product Usage:  Intended for use in hip arthroplasty cases which involves the removal of the damaged joint and tissues to be replaced with artificial prosthesis. The result of the procedure is to relieve pain and restore a sense of normal function and mobility to the damaged joint.
The affected products are labeled and etched as F-44 mm liners; however, the physical products could potentially be E-42 mm liners.
were distributed in CA, MN, MO, NC, NY, OH, OR, WA, and VA.
373/100 mL bottles and 51/250 mL bottles
Lemon Ginger Syrup is recalled because the internal fill temperature of this product is not recorded.
191/100 mL bottles and 21/250 mL bottles
Product was shipped to the following states: AL, AZ, CA, CO, GA, IA, IN, KS, KY, MI, MN, NC, NY, OH, OR, PA, SC, TX, VA & WI.
STAR WARS TIN WITH CARAMEL POPCORN NET WT 3.5 oz (99g) CONTAINS MILK AND SOY, MAY CONTAIN TREE NUTS AND PEANUTS DISTRIBUTED BY GALERIE HEBRON, KENTUCKY 41048 UPC 7 68395 51585 0
The firm was notified by a customer that the popcorn in the product contains grain beetles.
BESTBY 30SEPT2018 Packing Lot Code 76579 324 A3 HB, Product Lot Code (Tin) 30830 3455-0349/50 244,  Food Lot Code (On Bag of Popcorn) A7262
Distributed throughout the United States
Fluoxetine Tablets USP, 10 mg, 30-count bottle, Rx only, Manufactured in Israel by: Teva Pharmaceuticals IND, LTD, Jerusalem, 9777402, Israel, Manufactured for: Teva Pharmaceuticals USA, INC., North Wales, PA 19454, NDC 0093-7188-56
Failed impurities/ degradation specifications: Teva Pharmaceuticals USA, Inc. is voluntarily recalling all lots within expiry due to out of specification (OOS) test result for the lactoside impurity obtained during routine stability testing activities.
Licensed Allergenic Extracts, with a lack of assurance of sterility, were distributed.
Distributed in 8 states: CA, IL, MD, MI, ND, NH, NY, SD, and Guam.
Video Cystoscope models ECY-1570 and ECY-1570K
The video cytoscopes lack 510(k) premarket notification clearance.
Seventeen sites located in 13 states: FL, IN, KS, KY, MA, OK, NC, NE, NY, OH, PA, VA, and TX.
The swab stick collection device provided in a convenience kit expires prior to the kit expiration date.
Avid Medical Kit Lot 1235229 (expiration date 2017-08-01); Swab Stick lots: 5M03A (expiration date 2017-06-03) and 6A21A (expiration date 2017-07-21)
Human cornea, not tested adequately and appropriately to reduce the risk of transmission of relevant communicable diseases, was distributed.
Azelastine HCl Nasal Solution (Nasal Spray) 0.1% (137 mcg per spray), 30 mL, Rx only, Distributed by: Sun Pharmaceutical Ind. Inc. Cranbury, NJ 08512 Manufactured by: Sun Pharmaceutical Ind. Ltd. Halol-Baroda Highway, Halol - 389 350, Gujarat, India --- NDC 47335-779-91
Sun Pharmaceutical is recalling Azelastine HCl Nasal Solution, 0.1% (30 mL Bottle) following a failure to meet the % RSD requirement in the test for Droplet Size during the 6 month long term stability test station
JKR7706A December 2018  JKR7705A November 2018
HCG 5,000 IU/mL + Methylcobalamin 500 mc/mL Injection **5 mL Multi-Dose Vial, Sterile, Refrigerate** 6216 Highland Place Way, Ste. 101A Knoxville, TN 37919 Ph (855) 277-2488 Fax (888) 689-9892
BonaDur For Men (lidocaine) spray, 10 mg per spray, Net Contents .25 fl. oz. (7.4 mL) spray bottles, Manufactured by WebRx Pharmacy Palace, Sarasota, FL 34232; NDC 70582-999-74
CGMP Deviations: not manufactured according to current good manufacturing practices.
Weis Weis Markets, Inc., Sunbury, PA 17801-0471; Keep Refrigerated; Dried Beef Party Rye Dip; Ingredients: Hellman's Mayonaise, Sour Cream, Dried Beef (Cured with Water, Salt, Sugar, Sodium Nitrate, Sodium Nitrite), Parsley, Onion, Dill Weed; SELL BY RANGE  up to 02/16/2018.
Label does not list sub-ingredients for mayo and sour cream   The product contains undeclared egg, milk.
Klonopin (clonazepam) 0.5 mg Tablets,100-count bottle, Rx only. Made in Canada, Distributed by Genentech USA, Inc. A Member of the Roach Group, 1 DNA Way South San Francisco, CA 94080-4990. NDC 0004-0068-01
Labeling: Not Elsewhere Classified: Schedule IV controlled substance indicator of CIV being omitted  from the product carton, primary label is correct.