IA, NC, TX, SD, CA, NE, FL, GA, TN, NJ, NY
Blood products, which were labeled as leukoreduced, but were tested incorrectly for residual White Blood Cell count, were distributed.
Red Blood Cells (Apheresis) Leukocytes Reduced Irradiated
Platelets Pooled Leukocytes Reduced Irradiated
Platelets Pheresis Leukocytes Reduced Irradiated
Red Blood Cells (Apheresis) Leukocytes Reduced
Red Blood Cells Leukocytes Reduced Irradiated
Blood products, which were not quarantined after the donor provided information concerning medical history, were distributed.
American Red Cross Blood Services Northern NewEngland Region
Blood and Blood Products for Reprocessing
Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed.
Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
Blood product, collected from a donor who warranted deferral due to travel to a malaria endemic area, was distributed.
Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed.
Worldwide Distribution - US Nationwide and the countries of: CANADA, ITALY, NETHERLANDS, CZECH REPUBLIC, AUSTRIA, GERMANY, BELGIUM, HONG KONG, SPAIN, UNITED KINGDOM (GREAT BRITAIN), UNITED KINGDOM, JAPAN, FRANCE, FINLAND, LUXEMBOURG, KOREA, SWITZERLAND, SWEDEN, MALAYSIA, ISRAEL, NORWAY, AUSTRALIA, COLOMBIA, TURKEY, THAILAND, SOUTH KOREA, SAUDI ARABIA, TAIWAN, SOUTH AFRICA, and DENMARK.
Cryogenic probe for cardiac ablation surgery, packaged individually in Tyvek pouches   Product Usage:  Cryogenic probe for cardiac ablation surgery. The CryoICE cryoablation probe is a sterile, single use device intended to use in the cryosurgical treatment of cardiac arrhythmias. The probe freezes target tissues, creating an inflammatory response (cryo-necrosis) that blocks the electrical conduction pathway.
Affected product may have compromised sterility due to packaging defects. It was determined that some mishandling of the product during the packaging process could inadvertently damage the sterile barrier.
Lifesouth Community Blood Centers - Montgomery Region
Blood product, with an unacceptable pH, was distributed.
Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed.
Penrose-St Francis Health Services Blood Bank
Blood product, in which Quality Control and Distribution of product did not meet specifications, was distributed.
Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
Blood product, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
ACCU-CHEK Tender I 13/60 10 pieces   Product Usage:  Usage:  Intended for the infusion and/or injection of fluids into the body below the surface of the skin. The indwelling catheter can be inserted independently from the infusion catheter and can be accessed for the injections through the injection port. The indwelling catheter can also be securely attached to the infusion catheter by means of a proprietary click-lock connector for the infusion of drugs subcutaneously. The infusion set can be detached from the indwelling catheter, and the catheter capped to allow freedom from the infusion set and pump for showers, athletics or other activities.
Roche Diabetes Care was informed by UnoMedical, the Manufacturer of ACCU-CHEK Tender I and ACCU-CHEK Tender II infusion sets, about potential for the the tubing of the infusion set to become detached at the connect/disconnect location on  the ACCU-CHEK Tender I and ACCU-CHEK Tender II infusion sets. If tubing detachment occurs, insulin delivery is interrupted and the pump will not alarm to notify the user. The interruption of insulin delivery can cause hyperglycemia, which if left untreated, can result in diabetic ketoacidosis (DKA).
ACCU-CHEK Tender I 13/80 10 pieces   Product Usage:  Intended for the infusion and/or injection of fluids into the body below the surface of the skin. The indwelling catheter can be inserted independently from the infusion catheter and can be accessed for the injections through the injection port. The indwelling catheter can also be securely attached to the infusion catheter by means of a proprietary click-lock connector for the infusion of drugs subcutaneously. The infusion set can be detached from the indwelling catheter, and the catheter capped to allow freedom from the infusion set and pump for showers, athletics or other activities.
ACCU-CHEK Tender I 13/110 10 pieces   Product Usage:  Intended for the infusion and/or injection of fluids into the body below the surface of the skin. The indwelling catheter can be inserted independently from the infusion catheter and can be accessed for the injections through the injection port. The indwelling catheter can also be securely attached to the infusion catheter by means of a proprietary click-lock connector for the infusion of drugs subcutaneously. The infusion set can be detached from the indwelling catheter, and the catheter capped to allow freedom from the infusion set and pump for showers, athletics or other activities.
ACCU-CHEK Tender I 17/60 10 pieces   Product Usage:  Intended for the infusion and/or injection of fluids into the body below the surface of the skin. The indwelling catheter can be inserted independently from the infusion catheter and can be accessed for the injections through the injection port. The indwelling catheter can also be securely attached to the infusion catheter by means of a proprietary click-lock connector for the infusion of drugs subcutaneously. The infusion set can be detached from the indwelling catheter, and the catheter capped to allow freedom from the infusion set and pump for showers, athletics or other activities.
ACCU-CHEK Tender I 17/80 10 pieces   Product Usage:  Intended for the infusion and/or injection of fluids into the body below the surface of the skin. The indwelling catheter can be inserted independently from the infusion catheter and can be accessed for the injections through the injection port. The indwelling catheter can also be securely attached to the infusion catheter by means of a proprietary click-lock connector for the infusion of drugs subcutaneously. The infusion set can be detached from the indwelling catheter, and the catheter capped to allow freedom from the infusion set and pump for showers, athletics or other activities.
ACCU-CHEK Tender I 17/110 10 pieces   Product Usage:  Intended for the infusion and/or injection of fluids into the body below the surface of the skin. The indwelling catheter can be inserted independently from the infusion catheter and can be accessed for the injections through the injection port. The indwelling catheter can also be securely attached to the infusion catheter by means of a proprietary click-lock connector for the infusion of drugs subcutaneously. The infusion set can be detached from the indwelling catheter, and the catheter capped to allow freedom from the infusion set and pump for showers, athletics or other activities.
ACCU-CHEK Tender II 13/60 10 + 10 pieces   Product Usage:  Intended for the infusion and/or injection of fluids into the body below the surface of the skin. The indwelling catheter can be inserted independently from the infusion catheter and can be accessed for the injections through the injection port. The indwelling catheter can also be securely attached to the infusion catheter by means of a proprietary click-lock connector for the infusion of drugs subcutaneously. The infusion set can be detached from the indwelling catheter, and the catheter capped to allow freedom from the infusion set and pump for showers, athletics or other activities.
ACCU-CHEK Tender II 13/80 10 + 10 pieces   Product Usage:  Intended for the infusion and/or injection of fluids into the body below the surface of the skin. The indwelling catheter can be inserted independently from the infusion catheter and can be accessed for the injections through the injection port. The indwelling catheter can also be securely attached to the infusion catheter by means of a proprietary click-lock connector for the infusion of drugs subcutaneously. The infusion set can be detached from the indwelling catheter, and the catheter capped to allow freedom from the infusion set and pump for showers, athletics or other activities.
ACCU-CHEK Tender II 13/110 10 + 10 pieces   Product Usage:  Intended for the infusion and/or injection of fluids into the body below the surface of the skin. The indwelling catheter can be inserted independently from the infusion catheter and can be accessed for the injections through the injection port. The indwelling catheter can also be securely attached to the infusion catheter by means of a proprietary click-lock connector for the infusion of drugs subcutaneously. The infusion set can be detached from the indwelling catheter, and the catheter capped to allow freedom from the infusion set and pump for showers, athletics or other activities.
ACCU-CHEK Tender II 17/60 10 + 10 pieces   Product Usage:  Intended for the infusion and/or injection of fluids into the body below the surface of the skin. The indwelling catheter can be inserted independently from the infusion catheter and can be accessed for the injections through the injection port. The indwelling catheter can also be securely attached to the infusion catheter by means of a proprietary click-lock connector for the infusion of drugs subcutaneously. The infusion set can be detached from the indwelling catheter, and the catheter capped to allow freedom from the infusion set and pump for showers, athletics or other activities.
ACCU-CHEK Tender II 17/80 10 + 10 pieces   Product Usage:  Intended for the infusion and/or injection of fluids into the body below the surface of the skin. The indwelling catheter can be inserted independently from the infusion catheter and can be accessed for the injections through the injection port. The indwelling catheter can also be securely attached to the infusion catheter by means of a proprietary click-lock connector for the infusion of drugs subcutaneously. The infusion set can be detached from the indwelling catheter, and the catheter capped to allow freedom from the infusion set and pump for showers, athletics or other activities.
ACCU-CHEK Tender II 17/110 10 + 10 pieces   Product Usage:  Intended for the infusion and/or injection of fluids into the body below the surface of the skin. The indwelling catheter can be inserted independently from the infusion catheter and can be accessed for the injections through the injection port. The indwelling catheter can also be securely attached to the infusion catheter by means of a proprietary click-lock connector for the infusion of drugs subcutaneously. The infusion set can be detached from the indwelling catheter, and the catheter capped to allow freedom from the infusion set and pump for showers, athletics or other activities.
Blood product, collected from a donor who had traveled to a malarial endemic area, was distributed.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Pride of the Redlands brand Florida green skin avocado, 12ct,14ct, 16ct, 18ct, and 20ct packaged in 1/2 bushel boxes
FDA random sample positive for Salmonella.
GINSENG KIANPI PIL, 60 capsules, PRODUCT OF KWEILIN DRUG MANUFACTORY
Marketed Without An Approved NDA/ANDA: FDA analysis found this product to contain undeclared dexamethasone and cyproheptadine which are FDA approved drugs making this product an unapproved drug.
US Nationwide Distribution in the states of AZ CA FL GA IL IN LA MA MN MO MS MT NC ND NJ NV NY OH OR PA RI TN TX VA WA WI WV
Hypodermic Needle Pro Edge'' Safety Device 20G x1; Reorder Number: 402010   Product Usage:  The Needle Pro Edge Safety Hypodermic Needle is intended for injection or aspiration of fluids utilizing a luer lock or luer slip syringe.
Needle is not captured in the needle safety sheath in specific lots.
Hypodermic Needle Pro Edge'' Safety Device with Syringe 20G x1 10mL Luer lock syringe; Reorder Number: 4102010   Product Usage:  The Needle Pro Edge Safety Hypodermic Needle is intended for injection or aspiration of fluids utilizing a luer lock or luer slip syringe.
Hypodermic Needle Pro Edge'' Safety Device with Syringe 20G x1 5mL Luer lock syringe; Reorder Number: 452010   Product Usage:  The Needle Pro Edge Safety Hypodermic Needle is intended for injection or aspiration of fluids utilizing a luer lock or luer slip syringe.
Worldwide Distribution - US Nationwide and the countries of Italy, Czech Republic, Russia, Spain, Singapore, France, Germany, Denmark, Netherlands and Australia.
Sensei X Robotic Catheter System, model numbers 02057 and 08257. - Set up joint (SUJ)mechanical clamp that secures the SUJ to the catheter laboratory table.   Product Usage:     The Sensei X Robotic Catheter System is an electromechanical software controlled system designed to facilitate navigation and control of Hansen Medicals robotically steerable catheters for collecting electrophysiological data within the heart atria with electro-anatomic mapping and recording systems.
Model numbers 02057 and 08257, all installed Sensei X Robotic systems are subject to this action.
The Set Up Joint subassembly of the Sensei X Robotic Catheter System may become loose relative to the operating table with the potential for the device to fall causing, uncontrolled catheter movement. cardiac tampenade, delayed procedure, or crush injury to the patient and/or user.
Inova Health Care Services, Inova Blood Donor Services
Blood products, which did not meet the acceptable product specifications, were distributed.
Blood products, possibly contaminated with air, were distributed.
MRS FRIDAY'S GOURMET BREADED MEDIUM OYSTERS 18/25 CT/LB, Net Wt. 2.5 lbs (1.13 kg), Ready to Fry, Distributed by: King and Prince Seafood Corporation, Brunswick, GA 31621
Product tested positive for Norovirus GI GII
US Nationwide Distribution in the states of AZ and CO.
Bard Caliber (CL3030)  Inflation Device   Product Usage:  Inflation Device intended for use during cardiovascular to create and maintain, monitor pressure in the balloon catheter -  balloon inflation device for angioplasty procedures
All lot numbers beginning with Numbers: 1403,1404,1405,1406,1407
Additional instructions for use due to inability to raise the pressure above 10 atm during inflation phase may result in an incomplete inflation or delay in procedure
Synthes Inflation System (03.804.4135) Product Usage: Inflation system is used during kyphoplasty or other interventional kyphoplasty or other interventional procedures, to create and monitor pressure In the balloon catheter and to deflate the balloon catheter.
US Distribution to states of: MI, KS, and CA.
Osteobond Bone Cement-- Bone cement monomer kitted with bone cement powder to create a cement mantle for orthopedic implants.
Samples of product from Supplier lot 14D0809 and 14D0808 showed little adhesive transfer between the Tyvek lid and cavity when opened for internal bone cement cure and pairing tests. Visually these samples do not meet the requirements of ZWI 43.109 and corresponding visual aid 55-0000-310-01.
CA, IA, TX, NJ, GA, OR, NH, CO, NY and one customer in Canada.
Organic Cilantro Medium Bulk - size is dependent on customer request;  Certified Organic by QAI  High Quality Organics  Reno, NV;  Product of Israel
Immediate customer received a positive result for Salmonella of Organic Cilantro, Medium.
Organic Southwest Seasoning, Item no. 12785 and Organic Southwestern Seasoning, Item no. 12835, Net Wt. 50 lbs. (22.6 kg).   The product is labeled in parts: ''***Organic Southwest Seasoning***12785 ***OREGON SPICE COMPANY***13320 NE Jarrett St. Portland, Oregon 97230***''.     The product is labeled in parts: ''***Organic Southwestern Seasoning***12835 ***OREGON SPICE COMPANY***13320 NE Jarrett St. Portland, Oregon 97230***''.
Organic Southwest Seasoning: 12785-140925; Organic Southwestern Seasoning: 12835-140925.  Use by Date: 9/25/15;
1100 lbs. of Organic Southwest Seasoning; 250 lbs. of Organic Southwestern Seasoning
Organic Southwest Seasoning and Organic Southwestern Seasoning are recalled due to potential contamination with Salmonella.
Organic Cilantro Cut & Sifted, packaged in 1 lb. or 20 lbs.   The product is labeled in parts: ''***Organic Cilantro Cut & Sifted***OREGON SPICE COMPANY***13320 NE Jarrett St. Portland, Oregon 97230***''.
Organic Cilantro Cut & Sifted is recalled due to potential contamination with Salmonella.
Product was distributed to various Safeway distribution centers located within the U.S. in the following states: CA, AZ, TX, CO, OR, WA, and MD.
Open Nature Chile Cheese Enchilada     Two enchiladas filled with a queso fundido cheese mix topped with guajillo sauce and Mexican cheeses    KEEP FROZEN  COOK THOROUGHLY  NET WT 9 OZ (255 g)    COOKING INSTRUCTIONS  FOR FOOD SAFETY, FOLLOW THESE COOKING INSTRUCTIONS.  PRODUCT NEEDS TO BE THOROUGHLY COOKED.    MICROWAVE OVEN (preferred method (Cook from frozen)  1. Remove tray from outer package and pierce film 3-4 times to vent.  2. Cook on HIGH 3 minutes.  3. Pull back film and stir sauce along enchiladas, replace film.  4. Continue cooking on HIGH for an additional 1 1/2-2 minutes.  5. Carefully remove tray from microwave and let sit 2 minutes.    CONVENTIONAL OVEN  Cook from frozen,  1. Preheat over to 350 F.  Do not exceed 350 F.  2. Remove tray from outer package and pierce film 3-4 times to vent.  3. Place tray on a baking sheet on center rack in oven.  4. Cook 35-40 minutes.  5. Remove baking sheet with tray from oven and let stand on baking sheet 2 minutes.  6. Carefully remove film.    COOK THOROUGHLY TO AN INTERNAL TEMPERATURE OF 165 F AS MEASURED BY A FOOD THERMOMETER.  SINCE COOKING APPLIANCE VARY, THESE INSTRUCTIONS ARE GUIDELINES ONLY.    Outer package of the product is a cardboard box containing all product label information, and inside contains a sealed tray with two enchiladas.
Lot code # 141006 Best Before: AUG-06-15
A recall notice from High Quality Organics (HQO) recalling their organic Cilantro, used in the product, which has the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy people infected with Salmonella should monitor themselves for some or all of the following symptoms: nausea, vomiting, diarrhea or bloody diarrhea, abdominal  cramping and fever.  Rarely, Salmonella can result in more serious ailments, including arterial infections, endocarditis, arthritis, muscle pain, eye irritation, and urinary tract symptoms. Consumers exhibiting these signs after having contact with this product should contact their healthcare providers.
Distributors in CO, AZ, OR, CA, MD, WA, TX and then to Safeway owned stores nationwide.
Safeway Select French Salted Caramel (Fleur De Sel) Premium Ice Cream; 1.5 quart round paper carton with lid.
4576 cases (24,456 1.5 qt. individual cartons)
The recipe's caramel cups ingredient was replaced with peanut butter cups due to a supply error.  Peanut butter is not listed on the ingredient list or allergen statement.
International Only Distribution -- RUSSIA, ROMANIA, UNITED KINGDOM, GERMANY, ITALY, SPAIN, FRANCE, TURKEY, POLAND, and JAPAN.
ev3 Protege Rx Tapered Carotid Stent System, SECX-10-7-40-135, Sterile EO,  Rx only.   Indicated for the treatment of patients at high risk for adverse events from carotid endarterectomy who require percutaneous carotid revascularization and meet outlined criteria.
Two production lots of the Protege Rx Tapered Carotid Stent Systems (SECX-10-7-40-135, Lot # 9922452 & SEPX-8-6-40-135, Lot # 9922795) because of a product labeling error.
ev3, Protg Rx Tapered Carotid Stent System,  SEPX-8-6-40-135, Sterile EO, Rx only.   Indicated for the treatment of patients at high risk for adverse events from carotid endarterectomy who require percutaneous carotid revascularization and meet outlined criteria.
Two production lots of the Protege Rx Tapered Carotid Stent Systems (SECX-10-7-40-135, Lot # 9922452 &amp; SEPX-8-6-40-135, Lot # 9922795) because of a product labeling error.
SenSmart,  Regional Oximetry  EQUANOX Classic Plus Adult/Pediatric Sensor > 40 kg.,  Model 8003CA (REF 9824-001, 3-Wavelength), 8004CA (REF 9705-001, 4-Wavelength), with associated materials (INT-100 cable, operator's manual; and Quick Start Guide).   Sensors are single-packed in a pouch, then multi-packed, 20 per shelf-box.
Nonin Medical is conducting a recall of certain regional oximetry sensors and associated products. They have received reports of signal loss during use of our shortcabled regional oximetry sensors with diaphoretic patients.  No injury or illness have been reported.
Entertainer's Secret Throat Relief, 2.0 FL oz (59.2 mL), Honey  Apple Flavor, KLI Corp, Carmel, IN
Microbial Contamination of Non Sterile Product; microbial assay reported unacceptable high plate counts and positive for E. Coli
J-TAN D PD Drops (bromphenirame maleate 1 mg and pseudoephedrine hcl 7.5 mg/ teaspoon), 1 fl oz (30 mL) Bottle, Over the Counter. Manufactured for JayMac Pharmaceuticals, LLC, Sunset, LA; Manufactured by Sonar Products Inc., Carlstadt, NJ, NDC: 64661-032-30.
Labeling: Not Elsewhere Classified: Product is labeled ''Dye Free'' on front panel but contains Red Dye 40.