Recalling Firm
Philips Electronics North America Corporation
American National Red Cross, Greater Ozark-Arkansas Region
American National Red Cross, Biomedical Headquarters
American Red Cross Blood Services Tennessee Valley Region
Lifesouth Community Blood Centers - Montgomery Region
Vintage Pharmaceuticals LLC dba Qualitest Pharmaceuticals

Initial Firm Notification of Consignee or Public
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Distribution Pattern
AL AZ CA CO CT DC FL IA IL IN LA MA MD MI MN MO MS NJ NY OH PA Puerto Rico TN TX UT WI
Worldwide Distribution - US Nationwide and the countries of Algeria, Australia, Austria, Belgium, Brazil, Canada, Chile, China, China, Columbia, Ecuador, Egypt, Finland, France, Germany, Great Britain, Greece, Guatemala, Hong Kong, Ireland, Italy, Kuwait, Lebanon, Libya, Mexico, Netherlands, New Zealand, Pakistan, Panama, Peru, Poland, Portugal, Puerto Rico, Saudi Arabia, South Korea, Spain, Sweden, Thailand, Tunisia, and Venezuela,
Nationwide Distribution including CA, LA, NE, PR, SC, TX, VA, and WV
Nationwide Distribution including AL, AZ, CA, CT, FL, GA, KS, MA, MO, NJ, NY, PA, and WA.
Worldwide Distribution - US including DE, KS, FL, TX, CA, MI, TN, MA, ID, NJ, RI, IL and Internationally to Austria, Mexico, Canada, India, South Korea, China, Spain, South Korea, and Sri Lanka
US: WA OUS: China, Spain, Korea, Republic of, Germany
US Distribution to the states of : CA, CO, DC, FL, GA, HI, IA, IL, IN, MI, MN, NC, NJ, NM, NY, OH, PA, and TX
Worldwide Distribution - US including n FL, OH, TN, MN, NW, MI, CA. and Internationally to Canada, France, UK, Spain, Germany, Czech Republic, Belgium, Italy, Australia, Brazil, Chile, China, Costa Rica, Kuwait, New Zealand, Oman, Pakistan, Portugal, Sweded, Taiwan, and Turkey.
Worldwide Distribution - US Nationwide Distribution in the states of AL, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NH, NJ, NV, NY, OH, OK, OR, PA, RI, TN, TX, VA, WA, WI, WV, and the countries of Hawaii and Puerto Rico Canada & Jamaica
Worldwide Distribution - US Distribution to the states of : AR, CA, CT, FL, GA, ID, IL, IN, MD, ME, MI, NC, ND, NY, OH, OR, TX, TN, UT, VA, WI. and to the countries of : CANADA, UK, ISRAEL, MEXICO, AUSTRALIA, COLOMBIA, TAIWAN, BRAZIL, CHILE and INDONESIA.
USA (nationwide) distribution. The product was distributed to the following states: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NH, NJ, NM, NY, OH, OK, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, and WY. There are three (3) government accounts for this recall: VA Medical Center/Lyster Army Health Clinic, Parma VA Medical Center, Outpatient Clinic. There are no Canada accounts for this recall. There are no Mexico accounts for this recall.
Worldwide including govt/VA/military and foreign consignees.
Worldwide Distribution - US Distribution to the states of : AK CA CO FL GA KY NC NE NH NJ NY OH PA SC TN TX VA WA and WV., and to the countries of : Canada, Germany, Japan, New Zealand, Poland and United Kingdom
US: AL, CA, DC, IL,GA, KS, MD, MO, NC, NY, OH, PA, RI, SC, TX, WA OUS: Brazil, Bulgaria, Costa Rica, France, Germany, Israel, Italy, Japan, Korea, Republic of, Mexico, Russian Federation, Singapore, Spain, Sweden, Switzerland Switzerland, Turkey, United Kingdom
Worldwide Distribution-US (nationwide) and countries of: Albania, Australia, Belgium, Brazil, Bulgaria, Canada, Chile, Croatia, Denmark, Ecuador, Egypt, Finland, France, Germany, Hong Kong, India, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Oman, Philippines, Portugal, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Taiwan, Thailand, Trinidad, Turkey, United Arab Emirates, and United Kingdom.
Product was distributed to: AL, AR, CA, FL, IA, MO, NE, NC, NY, OH, and WA. The product was also distributed internationally, including Mexico and Canada. There was no goverment or military distribution.
Worldwide Distribution - USA (nationwide) and to the countries of : Chile, Peru, El Salvador and Taiwan.
Product was not distributed in the US. Unit was distributed in Australia.
Worldwide Distribution - Nationwide Distribution The Accu-Chek Connect App for iOS is distributed directly to end users via the Apple App Store. The Accu-Chek Connect App for Android is distributed directly to end users via the Google Play App Store.
Product distributed solely to the state of Minnesota.
Domestic: MI, OH Foreign: None VA/DOD: None
Distribution in the foreign country of Sweden
AR, AZ, CA, CO, HI, ID, LA, MT, NM, NV, OK, OR, SD, TX, UT, WA, WY

Product Description
Apollo DRF: Model: 9784220831 Multi-function x-ray systems capable of routine radiograph and general fluoroscopy procedures.
Apollo EZ: Model: 9784152036 Multi-function x-ray systems capable of routine radiograph and general fluoroscopy procedures.
Juno DRF; Model: 709020 Multi-function x-ray systems capable of routine radiograph and general fluoroscopy procedures.
Apollo: Models: 9784000131, 9784000231, 9784020131, 9784020231, 9784100231, 9784120131, 9784120231, 9784130131 Multi-function x-ray systems capable of routine radiograph and general fluoroscopy procedures.
ELDER PAINTSIL'S GA KENKEY, NET WT. 1.20, UPC: 6 61799 58166 0, MANUFACTURED BY VICTORY GENERAL FOODS IN WORCESTER, MA 01603
ELDER PAINTSIL'S FANTE KENKEY, NET WT. 1.20, UPC: 6 61799 58167 7, MANUFACTURED BY VICTORY GENERAL FOODS IN WORCESTER, MA 01603
P.S.P., Pre-Workout, Physique Stimulating Pre-workout, Powder, 360 g, green apple (UPC 764779-360344). Brand: Metabolic Nutrition.
P.S.P., Pre-Workout, Physique Stimulating Pre-workout, Powder, 360 g, fruit punch (UPC 764779-360238). Brand: Metabolic Nutrition.
P.S.P., Pre-Workout, Physique Stimulating Pre-workout, Powder, 360 g, watermelon flavor (UPC 764779-360450). Brand: Metabolic Nutrition
SYNEDREX, Powerful stimulant weight loss solution, 45 capsules (UPC 764779-224592). Brand: Metabolic Nutrition.
E.S.P. Pre-Workout, Energy Stimulant Pre-workout, Powder, 300 g, Watermelon flavor (UPC 764779-4407566). Brand: Metabolic Nutrition.
E.S.P. Pre-Workout, Energy Stimulant Pre-workout, Powder, 300 g, green apple (UPC 764779-430740). Brand: Metabolic Nutrition.
E.S.P. Pre-Workout, Energy Stimulant Pre-workout, Powder, 300 g, fruit punch flavor (UPC 764779-420734), fruit punch (UPC 764779-430740). Brand: Metabolic Nutrition.
E.S.P. Pre-Workout, Energy Stimulant Pre-workout, Powder, 300 g, blue raspberry flavor (UPC 764779-410728.
P.S.P., Pre-Workout, Physique Stimulating Pre-workout, Powder, 360 g, blue raspberry (UPC 764779-360122). Brand: Metabolic Nutrition.
Atrium Medical Oasis Single Drain as follows: 3600-100 Oasis single drain with in-line connector 3600-150 Oasis single drain with in-line connector and Pre-connected 2550 ATS Bag Product Usage: To evacuate air and/or fluid from the chest cavity or mediastinum. To help re-establish lung expansion and restore breathing dynamics. To facilitate postoperative collection and reinfusion of autologous blood from the patient s pleural cavity or mediastinal area.
Atrium Medical Ocean Drains as follows: 2002-000 Ocean single drain, with in-line connectors and suction control stopcock 2002-040 Ocean single drain, in-line connector and suction control stopcock, Pedi connector in bag on back of the drain 2002-050 Ocean single drain with in-line connector and suction control stopcock, Pre-connected 2550 ATS Bag 2002-100 Ocean single drain with in-line connector, no suction control stopcock 2002-300 Ocean single drain with suction control stopcock, no in-line connector 2002-400 Ocean single drain, no in-line connector or suction control stopcock, Water ampoule Product Usage: To evacuate air and/or fluid from the chest cavity or mediastinum. To help re-establish lung expansion and restore breathing dynamics. To facilitate postoperative collection and reinfusion of autologous blood from the patient s pleural cavity or mediastinal area.
Atrium Medical Dual Chamber Ocean Drains as follows: 2020-000 Ocean dual chamber, in-line connectors and suction control stopcock (2 Patient Tubes) 2020-100 Ocean dual chamber with in-line connectors and no suction control stopcock (2 Patient Tubes) 2020-300 Ocean dual chamber with suction control stopcock, no in-line connector (2 Patient Tubes) Product Usage: To evacuate air and/or fluid from the chest cavity or mediastinum. To help re-establish lung expansion and restore breathing dynamics. To facilitate postoperative collection and reinfusion of autologous blood from the patient s pleural cavity or mediastinal area.
Atrium Medical 3620-100: Oasis dual chamber drain with in-line connectors (2 Patient Tubes) Product Usage: To evacuate air and/or fluid from the chest cavity or mediastinum. To help re-establish lung expansion and restore breathing dynamics. To facilitate postoperative collection and reinfusion of autologous blood from the patient s pleural cavity or mediastinal area.
Atrium Medical Ocean Blood Recovery Drains as follows: 2050-000 Ocean Blood Recovery drain with in-line connector and suction control stopcock 2050-300 Ocean Blood Recovery drain with suction control stopcock, no in-line connector 2052-000 Ocean Double Blood Recovery drain with in-line connector and suction control stopcock - 2 patient lines connected by one Y connector 2052-300 Ocean Double Blood Recovery drain with suction control stopcock, no in-line connector - 2 patient lines connected by one Y connector Product Usage: To evacuate air and/or fluid from the chest cavity or mediastinum. To help re-establish lung expansion and restore breathing dynamics. To facilitate postoperative collection and reinfusion of autologous blood from the patient s pleural cavity or mediastinal area.
Atrium Medical 16400 Express Mini 500 dry seal drain Product Usage: To evacuate air and/or fluid from the chest cavity or mediastinum. To help re-establish lung expansion and restore breathing dynamics. To facilitate postoperative collection and reinfusion of autologous blood from the patient s pleural cavity or mediastinal area.
Atrium Medical Oasis Blood Recovery Drains as follows: 3650-100 Oasis Blood Recovery drain with in-line connector 3652-100 Oasis Double Blood Recovery drain with in-line connectors - 2 patient lines connected by one Y connector Product Usage: To evacuate air and/or fluid from the chest cavity or mediastinum. To help re-establish lung expansion and restore breathing dynamics. To facilitate postoperative collection and reinfusion of autologous blood from the patient s pleural cavity or mediastinal area.
Atrium Medical 400 Series Express Drains as follows: 4000-100N Express single collection drain with in-line connector 4000-100P Express PreFilled Chest Drain 4020-100N Express dual chamber drain with in-line connectors ( 2 Patient Tubes) 4050-100N Express Blood Recovery drain with in-line connector 4050-100P Express PreFilled Chest Drain Product Usage: To evacuate air and/or fluid from the chest cavity or mediastinum. To help re-establish lung expansion and restore breathing dynamics. To facilitate postoperative collection and reinfusion of autologous blood from the patient s pleural cavity or mediastinal area.
Cobas b 123 POC system The cobas b 123 POC system is a fully automated POC system for whole blood in vitro measurement of pH, blood gases (B3G), electrolytes Nat, K+, iCaWt (ISE), hematocrit (THct), metabolites (Glu, Lac), total hemoglobin (tHb), hemoglobin derivatives (O2Hb, HHb, COT~b, MetHb), and oxygen saturation (SO2). In addition, the cobas b 123 POC system calculates derived parameters. It is dedicated for use in a Point-of-Care environment and laboratory. The integrated AutoQC module and the oximeter module are available as an option
Tina-Quant (Latex) HS Test System (C-Reactive Protein (Latex) High Sensitive) The Tina-Quant CRP (Latex) High Sensitive Immunoturbidimetric assay is for the in-vitro quantitative determination of C-reactive protein (CRP) in human serum and plasma on Roche automated clinical chemistry analyzers. Highly sensitive measurement of CRP is of use for the detection and evaluation of inflammatory disorders, and associated diseases, infection and tissue injury. Measurement of CRP may also be used as an aid in the assessment of the risk of future coronary heart disease. When used as an adjunct to other laboratory evaluation methods of acute coronary syndromes, it may also be an additional independent indicator of recurrent event prognosis in patients with stable coronary disease or acute coronary syndrome
Allura Xper FD20 722012 is intended for: Cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placement and atherectomies), pacemaker implantations and Electro Physiology(EP).
Allura Xper FD10 722026 is intended for: Cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placement and atherectomies), pacemaker implantations and Electro Physiology(EP).
Allura Xper FD20/15 R8.2 722058 is intended for: Cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placement and atherectomies), pacemaker implantations and Electro Physiology(EP).
Allura Xper FD20 R8.2 722028 is intended for: Cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placement and atherectomies), pacemaker implantations and Electrophysiology(EP).
Mallinckrodt Pharmaceuticals INOmax DSIR Plus delivery system. Model 10007. Delivers INOMAX (nitric oxide for inhalation). The INOmax DSIR uses a dual-channel design to ensure the safe delivery of INOMAX. The first channel has the delivery CPU, the flow controller and the injector module to ensure the accurate delivery of NO. The second channel is the monitoring system, which includes a separate monitor CPU, the gas cells (NO, NO2, and 02 cells) and the user interface including the display and alarms. The dual-channel approach to delivery and monitoring permits INOMAX delivery independent of monitoring but also allows the monitoring system to shutdown INOMAX delivery if it detects a fault in the delivery system such that the NO concentration could become greater than 100 ppm. The delivery system can also shut down delivery if it detects certain serious problems with the monitoring system.
Gonsalves Sugar Coated Almonds, Net Wt. 12 oz. Distributed by The Gonsalves Company, Smithfield, RI 02917 UPC number 20539-64550
Chord-X Chordal Sizer is designed to assist in determining the proper length of chordal replacement prostheses to repair the mitral valve and help the surgeon select a preconfigured prosthesis, or configure the correct size using straight suture material, during mitral valve repair.
Blueberry Donut , ST8300-50, NET WT. 50 LBS
Gourmet Cocoa Supreme, CP302141-12, NET WT. 12 LBS
Texas Sheet Cake Icing Base, Kosher Dairy, Net Wt. 10 lbs, PB9663-10
Natural Ranch Seasoning, NET Wt. 50 lbs (22.73kg)
CCF Butter Popcorn Seasoning, NET Wt. 1000 lbs, Gluten Free
2-Step White Chocolate Mousse, NET WEIGHT: 1 BAG: 35 oz/ 1 kg
1-Step White Chocolate Mousse, NET WEIGHT: 1 BAG: 35 oz/ 1 kg
Creamy Ranch, Net Wt. 50 lbs (22.73 kg), Item Number 16131505
French Vanilla Cappuccino, CP302140-12, NET WT. 12 LBS
Smoky Bacon Blue Cheese, Net Wt. 50 lbs (22.73 kg), Item Number 16168803
Blood and Blood Products for Reprocessing
Azelastine Hydrochloride Nasal Solution (Nasal Spray), 0.1% (137 mcg per spray), packaged in 30 mL bottles, Rx only, Distributed by: West-Ward Pharmaceuticals Corp., Eatontown, NJ 07724, NDC 0054-0293-99
Temozolomide Capsules, 250 mg, 5-count bottles, Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 USA, NDC 0378-5265-98.
Temozolomide Capsules, 100 mg, packaged in a) 5-count bottles (NDC 0378-5262-98), b) 14-count bottles (NDC 0378-5262-14), Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 USA.
Temozolomide Capsules, 140 mg, packaged in a) 5-count bottles (NDC 0378-5263-98), b) 14-count bottles (NDC 0378-5263-14), Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 USA.
Temozolomide Capsules, 180 mg, packaged in a) 5-count bottles (NDC 0378-5264-98), b) 14-count bottles (NDC 0378-5264-14), Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 USA.
series This kit is intended for qualifying human IgG subclasses 1,2,3 and 4 immunoglobulins in serum on the Beckman Coulter AU series. Meaurement of these immunoglobulins ais in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents Product Code LK009.AU
II Analyser Product Code: NK009.T This kit is intended for qualifying human IgG subclasses 1,2,3 and 4 immunoglobulins in serum on the Beckman Coulter AU series. Meaurement of these immunoglobulins ais in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents
800 Analyser Product Code LK009.IM This kit is intended for qualifying human IgG subclasses 1,2,3 and 4 immunoglobulins in serum on the Beckman Coulter AU series. Meaurement of these immunoglobulins ais in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents
MininephThl Human lgG4 Kit Product Code: ZK009.LR This kit is intended for qualifying human IgG subclasses 1,2,3 and 4 immunoglobulins in serum on the Beckman Coulter AU series. Meaurement of these immunoglobulins ais in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents
Human lgG4 Subclass Liquid Reagent Kits Human lgG1& lgG2 Antisera, lgG3 & 4 Latex reagent and lgG Antisera for use on Hitachi 911/912/917 and Hitachi Modular P Product Code LK009.H/LK001.H This kit is intended for qualifying human IgG subclasses 1,2,3 and 4 immunoglobulins in serum on the Beckman Coulter AU series. Meaurement of these immunoglobulins ais in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents
6000 This kit is intended for qualifying human IgG subclasses 1,2,3 and 4 immunoglobulins in serum on the Beckman Coulter AU series. Meaurement of these immunoglobulins ais in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents Product Code LK009.CB
IJ Analyser Product Code: NK001.T This kit is intended for qualifying human IgG subclasses 1,2,3 and 4 immunoglobulins in serum on the Beckman Coulter AU series. Meaurement of these immunoglobulins ais in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents
Softbank software Product Usage: Decision support software for transfusion service. It keeps track of inventory from outside sources, multi-site inventory control, records of testing of units, and allows for record keeping for transfusion preparation.
SCC Soft Computer Softbank II software Product Usage: Supports single and multi-site transfusion services in healthcare facilities. Used by healthcare personal to document, query, and view the integrated information regarding patients and products. Quality control testing, test and transfusion history, transfusion management, inventory management, product distribution, and final disposition are all monitored using the software.
Tryptic Soy Agar, Acumedia PN 7100 500g, 2Kg, 10Kg, and 50Kg sizes
OEC 9900 Elite. MDL Numbers: D148942, D155043
cobas p 612 pre-analytical system; Pre-analytical sample handling that includes de-capping, Aliquotting and sorting of samples for analysis.
Philips Cisco 3850 layer 3 switch, 865339 model WS-C3850-12S-E in use with IntelliVue Information Center iX or Classic Information Center
Velara Generator with an old Firmware version used with the Philips Integris BH5000
Velara Generator with an old Firmware version used with Philips Allura Xper Systems (Allura 15 & 12 (monoplane), Allura FD10C, Allura FD10F, Allura FD 10 F/C, Allura FD20, Allura XPER FD10/10, Allura XPER FD20 Biplane)
Rigid Laryngostroboscopes The Rigid Laryngostroboscopes, Models 9106 and 9108 are intended to observe glottic action with the use of a stroboscopic light source. The instrument is inserted per-orally when indications consistent with the need for observation are observed.
ProSpore 4 mL Ampoule Biological indicator for steam sterilization, contains Geobacillus stearothermophilus, Catalog Number: PS-6-50, contains 50 Ampoules/Box. Product Usage: Biological indicator for steam sterilization at 121 deg C intended for use by a health care provider to accompany products being sterilized through steam sterilization procedure and to monitor adequacy of sterilization.
Alaska Salmon Bites (jerky), Spicy Fireweed Honey flavor, Dear North brand, Item # 2001, net wt. per pouch: 2 oz. UPC 8 15036 02001 0
Alaska Salmon Bites (jerky), Rhubarb & Raspberries flavor, Dear North brand, Item # 2002, net wt. per pouch: 2 oz. UPC 8 15036 02002 7.
Farm to Market Foods Smoked Turkey #1975 Holiday Ingredients: Smoked Turkey, Cornbread Dressing, Orange Cranberry Relish, Turkey Giblet Gravy, Green Bean Casserole, Mashed Potatoes. Keep Refrigerated at 38 Deg F or Less UPC: 617037959067
Farm to Market Foods Green Bean Casserole Code #1958 Net Wt. 6/1.95 lb. Trays with 6/.05 oz. Frenchs Fried Onions; Farm to Market Foods Green Bean Casserole Code #1971 Net Wt. 4/3.85 lb. Bags with 4/.15 oz. Frenchs Fried Onions UPC: 617037959029
Farm to Market Foods Smoked Ham Dinner #1977 Holiday Ingredients: Smoked Spiral Diced Ham, Mashed Potatoes, Orange Cranberry Relish, Broccoli Rice Casserole, Green Bean Casserole. Keep Refrigerated at 38 Deg F or Less UPC: 617037959081
Pittsburgh Spice Co; Buffalo Wing Sausage, 20.25 OZ for 25 #; 1235 Clairhaven St, Pittsburgh, PA 15205
Unna-Z, Unna Boot with Zinc and Calamine, Compression Wrap, 1 Per Box, 3-4in x 10yds
Earth Balance Vegan Cheddar flavored Mac and Cheese, 6oz package, Cardboard box/carton, 12 packages per distributed case, Ambient storage.
Earth Balance Vegan White Cheddar flavored Mac and Cheese, 6oz package, Cardboard box/carton, 12 packages per distributed case, Ambient storage.
Blood Bank Control System (BBCS) Primary Application, V 5.4.3, 5.5 is intended to address all phases of donor and transfusion services. The software is also capable of operating with or without ABO QuickPass (BK14130) to allow donors to complete Computer Assisted Self Interviews (CASI) and computer assisted blood donor registrations.
Furosemide Tablets USP, 20 mg, 1000 count bottles, Rx only, Roxane Laboratories, Inc., Columbus, Ohio 43216, NDC 0054-4297-31.
Cashew Curry Tahini, Jem brand, 16 oz glass jar has UPC 8 61437 00036 6. Cashew Curry Tahini, Jem brand, 6 oz glass jar has UPC 8 61437 00035 9.
Cashew Masala Tahini, Jem brand, 16 oz glass jar has UPC 8 61437 00037 3. Cashew Masala Tahini, Jem brand, 6 oz glass jar has UPC 8 61437 00034 2. Cashew Masala Tahini, Jem brand, 1.27 oz glass jar has UPC 8 61437 00033 5.
Accu-Chek Connect Diabetes Management App
Creamy Alfredo, Pasta Sauce; NET WT. 15 OZ, CONT. NET 425g; Glass jar, metal lid; UPC 41220845941, 70038626695 or 041498172855
Roasted Garlic Alfredo, Pasta Sauce; NET WT. 15 OZ, CONT. NET 425g; Glass jar, metal lid; UPC 36800334779
Lite Creamy Alfredo, gluten free, Pasta Sauce; Glass jar, metal lid; NET WT. 15 OZ, CONT. NET 425g; UPC 41220898732
Our Family Alfredo, Pasta Sauce; NET WT. 15 OZ, CONT. NET 425g; Glass jar, metal lid; UPC 70253266867
Four Cheese Alfredo, Pasta Sauce; NET WT. 15 OZ, CONT. NET 425g; Glass jar, metal lid; UPC 70038627838, 36800334793 or 041498198084
Ambrosia Quality Foods Brand 4/1 gallon Worcestershire Sauce Net 128 Fl. Oz.
Mesalamine, U.S.P. [CAS 89-57-6] Cambrex Charles City, Inc. Charles City, IA packaged in double lined PE liners inside Poly-lined cardboard drums. Net weight 40 kg
Maintenance Kit PH2, Cod. 6997274 The Phoenix Hemodialysis delivery system is intended to be used to provide high flux and low flux hemodialysis, hemofiltration and ultrafiltration on patients weighing 15 Kilograms or more. The Phoenix system is to be used with either high or low permeability dialyzers. The device is intended to be used by trained operators when prescribed by a physician, in a chronic care dialysis facility or acute care unit
Maintenance Kit PH1, Cod. 6997266 The Phoenix Hemodialysis delivery system is intended to be used to provide high flux and low flux hemodialysis, hemofiltration and ultrafiltration on patients weighing 15 Kilograms or more. The Phoenix system is to be used with either high or low permeability dialyzers. The device is intended to be used by trained operators when prescribed by a physician, in a chronic care dialysis facility or acute care unit
Tortilla Enchilada, 16 Oz. /16 units per case, packed in plastic bags
Corn Tortillas, 18 Count-16 Oz./453 g 16 units per case, 10 Count- 8 Oz./283 g 20 units per case, Mini- 12 Oz. 18 units per case, packed in plastic bags
Everroast Chicken Caesar Wrap, UPC: 72036-95828, in clear flexible plastic.
Merge Hemo software. Merge Hemo monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure
Apheresis Platelets, Leukocytes Reduced, Irradiated
Albuterol Sulfate Inhalation Solution, USP, 0.021% (0.63 mg / 3 mL), 3mL Vials, Rx only, Mfd. for Watson Laboratories Inc., Corona, CA 92880 USA, Mfd. by Cipla Ltd. Verna, Goa India, NDC 0591-3467-53
Dr. Pepper, 2 Liters (2.1 qt) plastic bottles, Bottled under the authority of Dr. Pepper Company, 5301 Legacy Drive, Plano, TX 75024.
DEXAMETHASONE ELIXIR, USP, 0.5 mg/5 mL, 8 fl.oz., Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL, NDC 0603-1147-56
FRONT: Stauffer's Animal Crackers Original; Net Wt. 32 OZ.; BACK: (best by date): 07SEP17; (bag lot numbers) LC120716 or LD120716; Stauffer Biscuit Co., York, PA 17403.
buPROPion Hydrochloride Extended-release Tablets, USP (SR), 150 mg, a) 60 (NDC 47335-737-86), b) 100 (NDC 47335-737-88) and c) 500 (NDC 47335-737-13) count bottles, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India
buPROPion Hydrochloride Extended-release Tablets, USP (SR), 200 mg, 60 count bottles, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India NDC 47335-0738-86

Product Quantity
964,463 cases (US) 521,975 cases (OUS) in total
59 devices (this number represents all products listed in recall)
328/ 50-count/ boxes; 16,400 individual units
2/1.27 oz. jars; 2/6 oz. jars; and 2 /16 oz. jars
242 sites potentially have the affected versions
a) 141,068 bottles b) 56,834 bottles c) 61,692 bottles

Reason for Recall
The analysis showed that the incident was caused by a chain of four faults: 1.) The injured person overcame a physical barrier (the tabletop support arm. height ca. 60 em) to access a prohibited area not intended as a working position. 2) The directions for use (device labeling and instructions for use) did not contain an explicit exclusion of the prohibited area. 3.) The movement was activated inadvertently and continuously. and it was not released (the movement requires continuous activation). 4.) Delayed activation of the emergency stop.
Product manufactured under insanitary conditions and firm did not follow the Food Code-mandated scheduled process
Products contain Picamilon and/or methylpentane citrate (DMBA), which are not recognized as a dietary ingredients
under specific settings, an issue may occur during simultaneous Sensor Cartridge and Fluid Pack change on the cobas b 123 <2> POC system and cobas b 123 <4> POC system. The issue occurs when the software function [AutoQC as follow-up] is configured to run all three levels of AutoQC only after a Fluid Pack change, but not after a Sensor Cartridge change. When both are changed simultaneously, starting with the Sensor Cartridge and followed by the Fluid Pack, the analyzer carries out only the follow-up actions associated with the Sensor Cartridge change after completing the change workflow. As a result, no follow-up AutoQC is performed and the three expected AutoQC measurements for the Fluid Pack change are not carried out. Without running quality control, there is a remote possibility that system issues would not be detected and wrong results would not be excluded on all parameters: pH, PO2, PCO2, Na+, K+, Ca++, Cl-, Glu, Lac, Hct, SO2, O2Hb, COHb, MetHb, HHb, and Bili.
Tina-quant Cardiac C-reactive Protein (Latex) High Sensitive (CRPHS) lot number 604450 (catalog number 11972855216) shows an under-recovery of up to -25% at concentrations below 5 mg/L on the MODULAR ANALYTICS P module. this issue can lead to erroneous low CRPHS results. CRPHS is used as a marker for the prediction of cardiovascular risk. An erroneous low result could lead to an incorrect cardiovascular risk assessment and subsequent delay of further examination.
Certain lots are showing an atypical decrease in optical density (OD) over time, which may result in an impact to performance at the high end of the linear range.
Due to a production error, screws were not tightened to specified torque. These screws may come loose from the C-arm shaft causing the C-arm to rotate uncontrolled.
Mallinckrodt discovered that some devices may have been manufactured with an out-of-tolerance manometer which can result in in an inaccurate proportional valve calibration table in an affected device.
Product contains undeclared wheat, Red #3, Red #40, Blue #1, Yellow # 6
Four issues were uncovered by the recalling firm's CAPA: 1) Burrs were found to be present on Left Housing, Right Housing and Barrel components, 2) Loose plastic particulate was found within sealed primary packages, 3) Loose hair was discovered within four sealed primary packages and 4) Assembly error, wherein Left and Right Housing components were acceptably press-fit together, was discovered within one sealed primary package. One of the Left Housing press-fit pins was not pressed into the associated hole of the Right Housing, resulting in a small gap in the housing assembly.
Dutch-American foods is recalling various seasoning products and baking bases due to potential contamination of product with Salmonella.
Blood products, collected from ineligible donors, were distributed.
Defective Delivery System: out of specification result for droplet size distribution at the d90 measurement testing during the 6 month time point..
Failed Tablet/Capsule Specifications: customer complaints of broken or crushed capsules, resulting in loose powder in the bottle.
Customer complaints identified that samples containing extremely high IgG4 levels exhibit antigen excess and will yield spuriously low IgG4 results.
Software error. Potential for incorrect results
light precipitate may form in prepared plates of Acumedia Tryptic Soy Agar (7100) Lot# 108166. While there is no change in growth performance of this medium, the formation of particulate matter may be misinterpreted as growth in poured plates thereby leading to inaccurate counts.
The customer indicated that the coil balun was hot to the touch when removing the coil from the patient table after an exam.
GE Healthcare Surgery announces a voluntary field action for the OEC 9800 and OEC 9900 Elite due to additional supplementation to the user documentation to include areas for enhanced planned maintenance and component replacement frequencies.
May experience a loss of centralized monitoring.
Pentax is initiating a Field Correction to revise the Instructions for Use of the Rigid Laryngostroboscopes Model 9106 and 9108.
Blood products, collected from a donor for which donor suitability was inadequately determined, were distributed.
Blood product, collected from a donor for whom donor suitability was inadequately determined, was distributed.
Blood product, collected from a donor whose eligibility to donate was inadequately determined for malarial travel, was distributed.
Product resistance has fallen outside of label claim within expiry.
Alaska Salmon Bites (jerky), Spicy Fireweed Honey flavor is recalled due to undeclared soy. Product contains undeclared soy sauce from the ingredient Tamari sauce.
Alaska Salmon Bites (jerky), Rhubarb & Raspberries flavor is recalled due to undeclared soy. Product contains undeclared soy sauce from the ingredient Tamari sauce.
Pittsburgh Spice and Seasoning Company is voluntarily recalling Buffalo Wing And Sausage Seasoning because the milk powder ingredient was recalled by the ingredient manufacturer due to possible salmonella contamination.
Medline Industries, Inc is recalling Unna Z Unna Boot Bandage 3 X10 and Unna Z Unna Boot Bandage 4 X10 due to contamination of the products with common mold (Cladosporium sphaerospermum/cladosporioides/herbarum/phaenocomae/halotolerans and Penicillium corylophilum)..
Earth Balance Vegan White Cheddar flavored Mac and Cheese and Earth Balance Vegan Cheddar flavored Mac and Cheese with undeclared allergen, milk.
Blood Bank Control System (BBCS) with Primary Application (software version BBCS Primary Application 5.4.3, 5.5; ABO Express 1.0.0, 1.1.0, 1.2.0), with a defect or glitch, was distributed.
Failed Tablet/Capsule Specifications: An unusually thick tablet was reported through a complaint.
During a retrospective review of production documentation it was observed that the M6 Rotor Counterweight Bolt may have been improperly torqued.
Cashew Curry Tahini, Jem brand, is recalled due to a confirmed positive for Salmonella.
Cashew Masala Tahini is recalled due to a confirmed positive for Salmonella.
iOS and Android: Under certain conditions the affected app versions may disregard historical bolus data potentially leading to an incorrect bolus insulin recommendation being provided to the user. iOS only: Pairing and using multiple meters with the Accu-Chek Connect app can under rare circumstances cause the bolus advisor to fail to offer a correction bolus recommendation within the eligible time window following a blood glucose measurement (10 15 minutes). Depending on the individual metabolic situation potentially incorrect bolus advice could lead to serious health consequences such as hypoglycemia. Both software issues may also cause the amount of active insulin displayed during the bolus calculation process to be incorrect and should not be used to manually calculate a bolus.
Product contaminated with spoilage bacteria, Enterobacter cloacae and Pantoea species.
Ambrosia brand 4/1 Gallon Worcestershire Sauce may contain undeclared peanuts.
Presence of Particulate Matter: Stainless steel in a chemical reactor dissolved into the API solution and was detected in the finished product.
(Code SP00721). Installation of these connectors in machines modified with SP00721 may result in fluid leaks during dialysis treatment. These Preventive Maintenance Kits include the FILTER sub-group, which contains the silicone straight connectors that are larger than expected.
Tortillas Tita initiated a voluntary recall of all lots of their Corn Tortillas and Tortilla Enchilada produced between September 2016 and December 7, 2016, due to undeclared allergen Wheat.
There is a potential connection issue when powering up the Merge Hemo Record Station and the Hemo Monitor does not communicate with the Client PC.
Plateletpheresis product that did not meet specifications, was distributed.
Failed Impurities/Degradation Specifications: Product is out of specification for a known degradant.
Plateletphersis product that did not meet specifications, was distributed.
Source Plasma, collected from an ineligible donor, was distributed.
Blood products, tested incorrectly for communicable disease agents, were distributed.
Ortho reagent products, not meeting product specifications, were distributed.
Product labeled Dr. Pepper may instead contain Diet Dr. Pepper (containing undeclared Aspartame as a sweetener).
D. F. Stauffer Biscuit Co., Inc. is voluntarily recalling one specific best by date of 32 oz. Original Animal Crackers because they may be packaged with other cookies that contain milk powder.
Failed Dissolution Specifications; 18 month stability time point
Human corneas, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, were distributed.

Code Info
All Lot Numbers With Expiration Date Prior To October 2019
Catalog number: 11972855216, lot number 60445001
All product distributed prior to Dec 12, 2106
InfiniBand cables shipped between June 22, 2016 and October 6, 2016 in use with the Cisco 3850 switch.
Unit Numbers: NONUNNA3 & NONUNNA4 Lot Numbers: 52581 through 63599
BBCS Primary Application 5.4.3, 5.5 ABO Express 1.0.0, 1.1.0, 1.2.0
Rotor-4535-673-94382 SN 19, installed on Brilliance ICT System S/N 200203
batch number 2768. Expiration date: 11/16/2017
UPC: 0865168000039, 16 Oz. /16 units per case; All lots produced between September 2016 and December 7, 2016.
On back of bag: (best by date): 07SEP17; (bag lot numbers) LC120716 or LD120716; UPC code: 7232091022