Recalling Firm
Japanese Specialty Food Distributors Ltd, Co.
MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK
Southern California Permanente Medical Group
GF Health Products, Inc./d.b.a.Basic American Metal Products
The Dannon Company, Inc - Discovery & Innovation Center

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

Distribution Pattern
Nationwide to retailers and distributors
Worldwide Distribution - USA (nationwide) and Internationally to Australia, Bahrain, Canada, France, Germany, India, Ireland, Israel, Italy, Mexico, Netherlands, New Zealand, Poland, Romania, Saudi Arabia, South Africa, Spain, Sweden, United Kingdom, and Uruguay.
Distributed in the states of LA, OK, and TX.
Worldwide Distribution-USA (nationwide) and the countries of Algeria, Argentina, Australia, Austria, Azerbaijan, Bangladesh, Byelarus, Belgium, Bosniak, Brazil;, Bulgaria, Burma, Canada, Chile, China, Columbia, Costa Rica, Czech Republic, Denmark, Dominican Republic, Ecuador, Estonia, Finland, France, Germany, hong Kong, Hungary, Iceland, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Luxembourg, Macau, Macedonia, Malaysia, Mauritania, Mexico, Netherlands, New Zealand, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russia, Saudi Arabia,, Singapore, Slovakia, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Arab Emirates, United Kingdom, and Venezuela.
Nationwide, Puerto Rico, Singapore, and Hong Kong
Product was distributed directly to CT, NY, NJ, TX, and GA
Worldwide Distribution - USA (nationwide) and Internationally to Argentina, Austria, Brazil, Canada, China, Colombia, Croatia, Cyprus, Denmark, Estonia, Finland, France, Germany, Greece, Guatemala, India, Indonesia, Istanbul, Italy, Lithuania, Mexico, Paraguay, Peru, Poland, Romania, Russian Federation, Serbia, Singapore, Slovakia, South Korea, Spain, Switzerland, Thailand, Uruguay, Vietnam, and Zambia.
Distributed in the states of NY, FL, and TX.
Nationwide to WA, CA, MT, LA, TX. No foreign/VA/govt/military
Nationwide OUS: UK, Iceland, South Africa
Worldwide Distribution: USA (nationwide) and country of: Guam.
Worldwide Distribution: US distribution in OH and countries of: Australia, China, Belgium, Israel, and Sweden.
Worldwide Distribution - USA (nationwide) and Internationally to Korea, Thailand, Canada, Australia, Chili, Mexico, Argentina.
Nationwide Distribution incuding states of: AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KS, KY, MA, MD, MI, MN, MO, MS, NC, ND, NH, NJ, NM, NY, OH, OK, OR, PA, TN, TX, VA, WA, and WI.
Worldwide Distribution: USA (nationwide) including the states of AL, AZ, AR, CA, CO, CT, FL, GA, IL, IN, IA, KY, LA, ME, MD, MA,MI, MN, MS, MO,MT, NE, NH, NJ, NM, NY,M NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, LT, VA, WA, WV, and WI and PUERTO RICO and the country of CANADA.
Worldwide Distribution: US (Nationwide) including the states of 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, TN, TX, UT, VA, VT, WA, WI and WV., and Internationally to the countries of Belgium, Canada, Colombia, India, Mexico, Singapore and Taiwan.
Nationwide Distribution including IL VA TN PA TX IN MN NM GA MI FL CA NY ME OK MO NJ and AZ.
Worldwide Distribution: USA (nationwide) and the country of Canada.
Worldwide Distribution: US (nationwide) and countries of: Argentina, Austria, Australia, Bahrain, Bangladesh, Belgium, Belgrade, Brazil, Botswana, Canada, Chile, China, Colombia, Croatia, Czech Republic, Cyprus, Denmark, Egypt, Estonia, Finland, France, Germany, Georgia, Great Britain, Hungary, Indonesia, India, Ireland, Israel, Italy, Japan, Jordan, Korea, Kazakstan, Lebanon, Libya, Lithuania, Luxembourg, Macedonia, Malaysia, Malta, Martinique, Mexico, Myanmar, New Caledonia, Netherlands, Norway, New Zealand, Pakistan, French Polynesia, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovenia, Slovakia, South Africa, Spain, Switzerland, Thailand, Turkey, United Arab Emirates, Vatican, Venezuela, Vietnam, Yemen, and Zimbabwe.
United States including: OH, HI, NH, MS, IL, TX, CA.
US: AL AK, AZ, AR, C,A CO, CT, DC, FL, HI ID, IL IN, IA, KS, KYT,LA, MD, MA, MI, MN, NS, NO, NT,NV, NJ, NM, NY, NC, ND, OH,OK, OR, PA, PR, SC, TN, TX, UT, VA, WA, WV, WI, WY. OUS: AUSTRALIA, SWEDEN, CANADA, MEXICO, KOREA, CHILE.
Worldwide Distribution-USA (nationwide) including the District of Columbia, Virgin Islands, Puerto Rico, and Guam, and the states of AK, AL, AZ, CA, CO, CT, FL, GA, HI, IL, IN, KS, KY, LA, MA, ME, MD, MI, MT, MO, NC, NH, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WY, and WV, and the countries of Canada, England, Africa, and Australia.
Nationwide Distribution including AL, AZ, CA, CT, DC, FL, GA, IN, LA, MI, MO, NC, NH, NJ, NY, OH, OK, OR, PA, TN, TX, UT, VA, and WA.
In the US: FL, IL, WI, NC, OH, GA, MI, VA, SC. No foreign firms.
Worldwide Distribution - USA (nationwide) and Internationally to Canada, Chile, Mexico, Panama, and Thailand. .
US Distribution in states of: AR, CA, CT, DE, IA, ID, IL, IN, MI, MD, MO, NE, NY, OH, PA, TN, TX, and WA.
Worldwide Distribution - US (nationwide) including states of- AL, AZ, CA, CO, FL, GA, ID, IL, IN, LA, MA, MD, MI, MN, MO, NV, NJ, NY, NC, OH, PA, TX, UT, and VA. Internationally to Canada, France, and Switzerland
Worldwide Distribution - USA (nationwide) and Internationally to Argentina, Brazil, Canada, Chili, China, Columbia, Czech Republic, France, Georgia, Germany, hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Latvia, Lithuania, Macau, Malaysia, Mexico, Netherland,s Portugal, Qutar, Russia, Singapore, Slovenia, South Korea, Spain, Sri Lanka, Switzerland, Taiwan, Thailand, Ukraine and United Kingdom.
One distribution center in AZ and retail stores in AZ, NM and NV.
Worldwide Distribution-USA (nationwide) including Puerto Rico and the countries of Argentina, Australia, Austria, Bangladesh, Belgium, Brazil, Canada, Chile, China, Colombia, Denmark, Egypt, Finland, France, Germany, Greece, Hungary, India, Ireland, Israel, Italy, Lebanon, Lithuania, Luxemburg, Malaysia, Mexico, Netherland, New Zealand Norway, Pakistan, Portugal, Peru, Qatar, Russia, Saudi Arabia, Singapore Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand United Arab Emirates, United Kingdom, Uruguay, Zambia.
Distributed to all 50 states. No foreign countries.
Worldwide Distribution-USA (nationwide) and internationally to: Australia, Canada, and European, Latin American and Asian Pacific countries.
Worldwide Distribution - USA (nationwide) and Internationally to Australia, Canada, and Germany.
Worldwide Distribution-USA (nationwide) and the countries of Austria, Belgium, Bahrain, Belgrad, Canada, Croatia, Cypress, Czeck Republic, Denmark, Finland, Germany, Great Britain, Hungary, Ireland, Italy, Libya, Netherlands, Norway, Romania, Russia, Saudi Arabia, Slavonia, Slovakia, Spain, Switzerland, Turkey, Portugal and Zambia.

Product Description
Red Blood Cells Leukocytes Reduced Irradiated
Platelets Pheresis Leukocytes Reduced Irradiated
Goldenfeast Australian Blend packaged in 32 lb foil Bulk Bags, 13 lb. foil mini bulk bags, 64 oz super size plastic jars, and 25 oz barrier film bags.
Goldenfeast Bean Supreme in 32 lbs.Foil Bulk Bag, 10 lb. Foil Mini Bulk Bags, 64 oz. Super Size Plastic Jars, and 23 oz. Barrier Film Bag.
Goldenfeast Caribbean Bounty Foil 32 lb. Bulk Bag Foil, 11 lb. Mini Bulk 64 oz. Super Size Plastic Jar, 25 oz. Barrier Film Bag.
Goldenfeast Gardenflora Foil 12 lb. Bulk Bag, Foil 4 lb. Mini Bulk Foil Bag, Super Size 23 oz Plastic Jar, and Barrier Film 9 oz. Bag.
Goldenfeast Petite Hookbill Bulk Foil 32 lb. Bag, Foil Mini Bulk Bag 12 lb., Super Size 64 oz. Plastic Jar, and Barrier Film 25 oz. Bag.
Goldenfeast Schmitts Original Bulk Foil 32 lb. Bag, Mini Bulk Foil Bag 13 lb., Super Size 64 oz. Plastic Jar, and Barrier Film 25 oz. Bag.
Goldenfeast Basics Plus Finch Bulk Foil 40 lb. Bag, Mini Bulk Foil Bag 13 lb., Super Size 80 oz. Plastic Jar, Barrier Film 32 oz. Bag.
Goldenfeast Basics Plus Parakeet Bulk Foil 40 lb. Bag, Mini Bulk Foil Bag 13 lb., Super Size Plastic Jar 72 oz, and Barrier Film 32 oz. Bag.
34739-2, HOMESTEAD, FASTGROW AM.0125 NAP/NAB, MEDICATED Complete Chicken Starter/Grower/Finisher/Broiler Feed, Complete Turkey Grower/Finisher, Aid in prevention of coccidiosis. ACTIVE DRUG INGREDIENT AMPROLIUM 0.0125 % GUARANTEED ANALYSIS ... CALCIUM, min 0.8 % CALCIUM, max 1.3 % PHOSPHORUS, min 0.65 % ... Net Weight 50 lb (22.68 kg) or bulk invoice
Price Chopper Orange Juice; 100% Pure ORANGE JUICE FROM CONCENTRATE; DISTRIBUTED BY THE PRICE CHOPPER, INC., SCHENECTADY, NY 12306; in one gallon plastic containers
Lehigh Valley Dairy Farms Orange Juice from concentrate HALF PINT (236 mL); DISTRIBUTED BY TUSCAN/LEHIGH DAIRIES, INC., A DEAN FOODS COMPANY DALLAS, TEXAS 75204 in paper cartons
Lehigh Valley Dairy Farms Orange Juice FROM CONCENTRATE; DISTRIBUTED BY LEHIGH VALLEY DAIRY FARMS, A DEAN FOODS COMPANY DALLAS, TEXAS 75204 in both half gallon and one gallon plastic containers
Swiss PREMIUM 100% Pure Orange Juice FROM CONCENTRATE; DIST BY: SWISS PREMIUM DAIRY; A DEAN FOODS COMPANY; DALLAS, TEXAS 75204 in both half gallon and one gallon plastic containers
AFRICAN BLACK ANT, 2800 mg, 6 capsules per box, produced by: Qinghan Hongwei Bioengineering Company, No. 158, Renmin Road, Xining City.
Black Ant, 4600 mg, four capsules per box, , Manufacturer Timpo Bioengineering Co., Ltd, USA.,
XZEN GOLD,750 mg, six capsules per bottle, Distributed by: XZEN, City of Los Angeles, CA 90012
XZEN PLATINUM, 750 mg, 1 capsule per blister pack, Distributed by: XZEN, City of Los Angeles, CA 90012
Xzen 1200, 750 mg, six capsules per bottle, Distributed by: xzen, City of Los Angeles, CA 90012
Xzone 1200, 750 mg, one capsule per blister pack, Distributed by: xzone, Orlando, FL 32789
XZONE GOLD, 750 mg, one capsule blister pack, Distributed by: XZONE, Orlando, FL 32789
MOJO RISEN ,670 mg, 2 capsule per pouch, Distributed by: Mojo Risen, LLC, Springville, UT 84663
NORepinephrine 4 mg in 250 mL Sodium Chloride0.9%, For IV Use Only, Flexible Bag, Rx only, UNIQUE PHARMACEUTICALS, Inc.Temple, TX USA 76502
Avocados approximately 14-30 oz each in packed 20 units in cardboard boxes with black lettering labeled in part: in part: ''USDA/FL 2/196 LOT# 2610''.
Tenor is a mobile passive lift, intended to be used on horizontal surfaces for lifting and transfer in hospitals, nursing homes or other healthcare facilities. Transfers with the Tenor are made indoors in the patient's room, in communal areas or in a bathroom. Tenor is meant to be used with the patient type who: sits in a wheelchair, has no capability to support themselves at all, cannot stand unsupported and is not able to bear weight (not even partially), is dependent on caregiver in most situations, is a passive resident, might be almost completely bed ridden, is often stiff and has contracted joints, and/or is totally dependent. The Tenor has a safe working load of 320 KG (705 lbs).
COUMADIN FOR INJECTION (Warfarin Sodium for Injection, USP 5 mg Single-Use Vial Rx Only Distributed by Bristol Meyers Squibb Company, Princeton, NJ 08543 USA NDC 0590-0324-96
THINOGENICS, WEIGHT LOSS MADE EASY! DIETARY SUPPLEMENT, 30 CAPSULES, 30 Count Bottles, THINOGENICS LLC, Nashville, TN 37203 USA.
BD Vacutainer Serum Tubes (RED TOP PLAIN TUBE 6.0 ML)Part Number: BD 367815 FMC Part Number: 87-7815-4 Single use tube used to collect, separate, transport or process blood specimens for laboratory determinations for in vitro diagnostic use.
BD Vacutainer EDTA Tubes (LAVENDER TOP TUBE 2.0ML) Part Number: BD 367841 Part Number: FMC 87-7841-7 Single use tube used to collect, separate, transport or process blood specimens for laboratory determinations for in vitro diagnostic use.
BD Vacutainer SST Tubes (RED/GREY TOP SST TUBE 3.5ML) Part Number: BD 367981 Part Number: 87-7981-5 Single use tube used to collect, separate, transport or process blood specimens for laboratory determinations for in vitro diagnostic use. serum determination in chemistry.
BD Vacutainer Trace Element Tubes (ROYAL BLUE TOP TUBE 6.0ML) Part Number: 363083 Part Number: FMC 87-8380-1 Single use tube used to collect, separate, transport or process blood specimens for laboratory determinations for in vitro diagnostic use. Trace elements, aluminum and zinc determination.
BD Vacutainer Citrate Tubes (LIGHT BLUE TOP TUBE 2.7ML)Part number: BD 363083 Part Number: FMC 87-3083-8 Single use tube used to collect, separate, transport or process blood specimens for laboratory determinations for in vitro diagnostic use. Coagulation studies.
BD Vacutainer PST Tubes (GOLD TOP PST TUBE 3ml) Part Number: BD 367960 FMC part Number: 87-4544-4 Single use tube used to collect, separate, transport or process blood specimens for laboratory determinations for in vitro diagnostic use. The concentrate is formulated to be used with a three steam hemodialysis machine which is calibrated for acid and bicarbonate concentrates.
C-Series High Energy Linear Accelerator - Models: Novalis Tx, Trilogy, Trilogy Tx, Clinac iX, Clinac 2100 C/D, Clinac 2300C/D, Clinac 21EX, Clinac 23EX with versions 7, 8, 9 and 6 MV configuration and maximum dose rate of at least 6000 MU/min only. Varian High Energy Linear Accelerator is intended to provide sterotactic radiosurgery and precision radio-therapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.
0.9% Sodium Chloride Injection USP, packaged in a) 50 mL VIAFLEX Container bags, NDC 0338-0049-41, Product Code 2B1306; and b) 100 mL VIAFLEX Container bags, NDC 0338-0049-18, Product Code 2B1302, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA.
0.9% Sodium Chloride Injection USP MINI-BAG Plus Container, 100 mL VIAFLEX Single Dose Container bags, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 0338-0553-18, Product Code 2B0043.
Potassium Chloride Injection, 20 mEq per 50 mL, 50 mL Sterile Single Dose Container bag, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, NDC 0338-0703-41, Product Code 2B0822.
Ibuprofen Tablets, USP, 600 mg, 100 tablets per carton (10 x 10), Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, OH 43217, NDC 68084-0703-01
Oxcarbazepine Tablets, 300 mg, 100 tablets per carton (10 x 10), Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, OH 43217, NDC 62584-143-01
AbSorber XM-ONE Transplantation Cross Match, ABX100-03
JSF Ground Tuna - IQF - Origin: Indonesia - 2/11LB, frozen
ADVIA Chemistry A1c_3 CAL (Calibrator) for use on the ADVIA Chemistry Systems, REF/Catalog Number/Siemens Material Number (SMN) 10491408, IVD --- Siemens Healthcare Diagnostics, Inc. Tarrytown, NY 10591-5097 USA --- ADVIA Chemistry A1c_3 Calibrator Information: For in vitro diagnostic use in the calibration of A1c_3 (A1c_3 and A1c_3M) and Total Hemoglobin_3 (tHb_3 and tHb_3M) methods on ADVIA Chemistry systems. The ADVIA Chemistry systems are automated, clinical chemistry analyzers that can run tests on human serum, plasma, or urine in random access and batch modes for in vitro diagnostic use.
Pedi-Pak Pedi-Syringe Filter 30 mL Becton Dickinson Syringe Rx Only Genesis BPS, LLC The intended use is to prepare and deliver small aliquots of filtered whole blood, red blood cells, platelets, plasma, and cryoprecipitate for pediatric and or neonatal transfusion
Pedi-Pak Pedi-Syringe Filter 60 mL Becton Dickinson Syringe Rx Only Genesis BPS, LLC The intended use is to prepare and deliver small aliquots of filtered whole blood, red blood cells, platelets, plasma, and cryoprecipitate for pediatric and or neonatal transfusion
Pedi-Pak Pedi-Syringe Filter 35 mL Becton Dickinson Syringe Rx Only Genesis BPS, LLC The intended use is to prepare and deliver small aliquots of filtered whole blood, red blood cells, platelets, plasma, and cryoprecipitate for pediatric and or neonatal transfusion.
VERO (TM) Linear Accelerator System, Model Number MHI-TM2000; Common Name: Medical Linear Accelerator. MHI-TM2000 Linear Accelerator System is intended for radiation therapy of lesions, tumors and conditions anywhere in the body where radiation treatment is indicated.
Raw Milk Mild Cheddar Cheese, in 8 oz, (UPC 79004-10002) and 5 lb. (no UPC) size packages.
Lean Cuisine Culinary Collection Chicken with Peanut Sauce. Packaged in 9 oz (255g) Plastic Tray in Fiberboard Carton 12 cartons per case by Nestle USA, INC, Solon, OH 44139 USA.
Green Vibrance- A Comprehensive Restorative Advanced Daily Superfood (Dietary Supplement) packaged as follows: A. 15-day, 181.5g, 6.4 oz. powder- Product Code GV15; B. 30-day, 363g, 12.8 oz. powder; Product Code GV 30; C.60-day, 726g, 25.61 oz. family size powder, -Product Code GV60; D. Bulk Supply Kilo Canister, 1 kg (35.27 oz.) powder,-Product Code GVKG
Green Vibrance 15 single serve pkts, 181.5g, 6.4oz. Product Code: GVSD
Green Vibrance, 240 Vegicaps/bottle Product Code: GVC
Rainbow Vibrance Hi ORAC Superfood, 177g, 6.24 oz. Product Code: RV
Vac-Assist Suction Units (SUA01 Suction Aspirator Unit w/800 cc Canister). The suction unit is intended for professional use to remove fluids from a patient's airway or respiratory support unit. The intended population for this device is s both adult and pediatric.
Red Blood Cells (Apheresis) Leukoreduced
JBAIDS Instrument System Software version 3.5.0.72. The JBAIDS instrument is a portable thermocycler and real-time fluorimeter capable of simultaneous and rapid identification of multiple biological warfare and clinical pathogens from a variety of biological specimens. The software and instrument provides an integrated environment for performing the required functions to control JBAIDS instruments and to perform PCR tests and analysis.
SUN DASH RADIUS 252 PN 8000809705. The device is intended to be used for the tanning of human skin.
The Brilliance 64 and Ingenuity CT are Computed Tomography X-Ray Systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient, and equipment supports, components and accessories.
Volcano TrakBack II Disposable Pullback Device; Sterile and nonpyrogenic; Single Use. TrakBack II is used to move the catheter steadily and precisely, allowing uniform collection of imaging data.
The Brilliance CT Big Bore is a whole-body Computed Tomography X-ray system intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data from the same axial plane taken at different angles. Model Numbers 728244 and 728243.
B.Braun ''Accuflo 100ML/H 100ML'' Elastomeric Infusion Device. AccuFlo devices are intended for patients requiring intravenous, percutaneous, subcutaneous, intra-operative sites or epidural administration of medications.
Zenith Slide W-I-D-E Long Term Care Bed, Model(s) APS98674, APS9867406, APS986741, APS986742, ZG58674, ZG78674, ZZ78674, ZZ98674, and ZZ98774. Designed for use within an institutional healthcare environment (i.e. assisted living, skilled nursing, transitional care, rehabilitation centers, etc.).
BD BBLTM Vancomycin Screen Agar Vancomycin Screen Agar is used to test enterococci for resistance to vancomycin and to predict the synergistic activity of this antimicrobial with an aminoglycoside antimicrobial.
AXIOM Luminos dRF system with SW VD10 or on Luminos dRF Max The Axiom Luminos dRF is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic studies. Using a digital flat detector, it can perform a range of applications including general R/F, angiography and pediatric examinations. The Axiom Luminos dRF is a device intended to visualize anatomical structures by converting a pattern of X-ray into a visible image.
Stago IVD, Liquid Anti-Xa, NDC 3607450003116. The STA - Liquid Anti-Xa kits are intended for use with STA-R, STA Compact and STA Satellite Analyzers for the quantitative determination of the plasma levels of unfractionated (UFH) and low molecular weight (LMWH) heparins by measuring their anti-Xa activity on antithrombin in a competitive assay using a synthetic chromogenic substrate.
ADVIA Centaur XP Immunoassay System, Catalog Numbers/Siemens Material Numbers (SMN) 10285219, 10316507, 10317207, 10317284, 10319668, 10320757, 10323213, 10324519, 10327135, 10327836, 10328940, 10329339, 10336292, 10338631, 10364455, 10388696, 10471899 --- For in vitro diagnostic use This immunoassay system is intended for professional use in a laboratory environment only. Tests performed using this system are intended for in vitro diagnostic use.
Warfarin Sodium Tablets, USP Crystalline, 2 mg, 100 and 1000 Tablet Bottles, Rx Only. Mfd. by: Taro Pharmaceutical Industries, Ltd., Haifa Bay, Israel 26110. Dist. by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532. 100 Tablet Bottle NDC: 51672-4028-1, 1000 Tablet Bottle NDC: 51672-4028-3.
Swanson 100% Certified Organic, Carob Powder, Raw Chocolate Substitute, Net wt 1 lb (454 grams), in round 1000 cc High Density Poly-ethylene plastic containers, Product of Italy, Distributed by Swanson Health Products, PO Box 2803, Fargo ND 58108 USA, SWF115.
Amerigel Wound Dressing Maximum Strength CAT# A2001. Wound management.
Amerigel Hydrogel Saturated Gauze Dressing; 10 Individually Packaged pads size 2x2 4 Ply Pads; CAT # A5002. Wound management.
Amerigel Post-Op Surgical Kits . Kit includes: Amerigel Wound Dressing, Amerigel Wound Wash, 22x2 Gauze Pads, and 1x3 Fabric Bandages CAT # A2002. Wound management.
Amerigel Daily Dressing Advanced 3-in-1 Hydrogel; 30 single used foil packets 1g. each; CAT # A2003. Wound management.
ProVue Instrument Driver for JResultNet (ProVue.jrm) v. 1.5.3 and below JResultNet is a stand-alone software package that provides connectivity between in-vitro diagnostic instruments (IVDs) and Laboratory Information Systems (LIS) aiding the flow of laboratory information, including test orders and results, specimen information, and patient information.
PEDIGREE Adult Complete Nutrition Dry Dog Food sold under the Pedigree brand in 15 and 55 lbs. bags.
Thien Minh Cashew Kernels, Net Wt. 50 lb. Product of Vietnam
Activia Lowfat Yogurt Blueberry 4 x 4oz, Form Fill Seal plastic cups.
Coulter DxH Diluent, Catalog No. 628017 Blood cell analysis comprises diluting a whole-blood sample with a solution that functions as a diluent. The diluent provides the ability to analyze portions of the diluted blood sample for different blood cell types and the measurement of hemoglobin.
TRx Vertical Positioner, Classification Name: Wheelchair Component - Power Positioning System.
Ultraslim. These include all products labeled as UltraSlim, Luxurian, BioSlim Lipo, Cellulize, Slim 'n Trim, UltraRed, UltraBlue, Slim-PRO, Dazzle Light, UltraSlim Cold Light, SlenderRay, and U-Slim It, as well as those products with private labelling branding. Company claims that the program combines detoxification, red light exposure, hydration, full body vibration, massage, Niacin, Milk Thistle, and the use of compression garments. Sensible diet and exercise are recommended, but not required.
Luxurian. These include all products labeled as UltraSlim, Luxurian, BioSlim Lipo, Cellulize, Slim 'n Trim, UltraRed, UltraBlue, Slim-PRO, Dazzle Light, UltraSlim Cold Light, SlenderRay, and U-Slim It, as well as those products with private labelling branding. Company claims that the product provide non-invasive solutions to improve the appearance of fat accumulations, cellulite, fine lines, wrinkles, skin tone, and blemishes.
Photonica Light Modulator. These include all products labeled as UltraSlim, Luxurian, BioSlim Lipo, Cellulize, Slim 'n Trim, UltraRed, UltraBlue, Slim-PRO, Dazzle Light, UltraSlim Cold Light, SlenderRay, and U-Slim It, as well as those products with private labelling branding. Company claims that the product provide non-invasive solutions to improve the appearance of fat accumulations, cellulite, fine lines, wrinkles, skin tone, and blemishes.
4D Integrated Treatment Console (4DITC), versions 10 and 11. 4DITC provided assistance for accurate treatment delivery by monitoring linear accelerator parameters and preventing the radiation therapy device from commencing irradiation when any parameter is out of conformance with the treatment plan.
Dole Spinach: Thoroughly Washed, Preservative Free Net Wt. 8 oz. bag; Perishable, keep refrigerated. UPC 071430009765 SKU 320 Dole Fresh Vegetables Monterey, CA 93940
Dole Baby Spinach: Thoroughly Washed, Preservative Free, All natural Net W.t6 oz. bag; SKU 323 Perishable, keep refrigerated. UPC 071430009642; Dole Fresh Vegetables Monterey, CA 93940
Siemens CentraLink Data Management System, software version 14. The CentraLink system software is a network solution provider and multi-system data manager for the instruments and lab automation systems (LAS) within the lab.
Apple Cider Sorbet- possible pints/possible half gallon. Flavor of frozen dessert on the immediate package. No ingredients listed.
Backyard Mint Straciatella- possible pints/possible half gallon. Flavor of frozen dessert on the immediate package. No ingredients listed.
Berries and Burgundy- possible pints/possible half gallon. Flavor of frozen dessert on the immediate package. No ingredients listed.
Bourbon Egg Nog- possible pints/possible half gallon. Flavor of frozen dessert on the immediate package. No ingredients listed.
Cassis Sorbet- possible pints/possible half gallon. Flavor of frozen dessert on the immediate package. No ingredients listed.
Cocoa Zin- possible pints/possible half gallon. Flavor of frozen dessert on the immediate package. No ingredients listed.
Cranberry Royale- possible pints/possible half gallon. Flavor of frozen dessert on the immediate package. No ingredients listed.
Violet- possible pints/possible half gallon. Flavor of frozen dessert on the immediate package. No ingredients listed.
Creme Fraiche- possible pints/possible half gallon. Flavor of frozen dessert on the immediate package. No ingredients listed.
Cucumber Granita- possible pints/possible half gallon. Flavor of frozen dessert on the immediate package. No ingredients listed.
Dark Cocoa Peppermint- possible pints/possible half gallon. Flavor of frozen dessert on the immediate package. No ingredients listed.
Dark Cocoa Smoked Almond- possible pints/possible half gallon. Flavor of frozen dessert on the immediate package. No ingredients listed.
Forest Berry Sorbet- possible pints/possible half gallon. Flavor of frozen dessert on the immediate package. No ingredients listed.
Goat cheese with Fig Cognac- possible pints/possible half gallon. Flavor of frozen dessert on the immediate package. No ingredients listed.
Heirloom Melon Sorbet- possible pints/possible half gallon. Flavor of frozen dessert on the immediate package. No ingredients listed.
Lapsang Souchong with Armagnac Prumes- possible pints/possible half gallon. Flavor of frozen dessert on the immediate package. No ingredients listed.
Lime Cardamom with Lingonberries- possible pints/possible half gallon. Flavor of frozen dessert on the immediate package. No ingredients listed.
Pineapple Yogurt- possible pints/possible half gallon. Flavor of frozen dessert on the immediate package. No ingredients listed.
Pumpkin 5 spice- possible pints/possible half gallon. Flavor of frozen dessert on the immediate package. No ingredients listed.
Root Beer- possible pints/possible half gallon. Flavor of frozen dessert on the immediate package. No ingredients listed.
Belgian Milk Chocolate- possible pints/possible half gallon. Flavor of frozen dessert on the immediate package. No ingredients listed.
Saigon Cinnamon- possible pints/possible half gallon. Flavor of frozen dessert on the immediate package. No ingredients listed.
Savannah Buttermint- possible pints/possible half gallon. Flavor of frozen dessert on the immediate package. No ingredients listed.
Spiced Pecan Praline- possible pints/possible half gallon. Flavor of frozen dessert on the immediate package. No ingredients listed.
Star Anise with Candied Fennel- possible pints/possible half gallon. Flavor of frozen dessert on the immediate package. No ingredients listed.
Strawberry Rose Petal- possible pints/possible half gallon. Flavor of frozen dessert on the immediate package. No ingredients listed.
Strawberry Sorbet- possible pints/possible half gallon. Flavor of frozen dessert on the immediate package. No ingredients listed.
Sweet Basil with Honey- possible pints/possible half gallon. Flavor of frozen dessert on the immediate package. No ingredients listed.
Torrone- possible pints/possible half gallon. Flavor of frozen dessert on the immediate package. No ingredients listed.
Sweet Corn with Blackberry- possible pints/possible half gallon. Flavor of frozen dessert on the immediate package. No ingredients listed.
Winter Squash- possible pints/possible half gallon. Flavor of frozen dessert on the immediate package. No ingredients listed.
Winter Squash with Pecan Pralines- possible pints/possible half gallon. Flavor of frozen dessert on the immediate package. No ingredients listed.
Dermatend Original, mole, wart and skin tag remover, For external use only, Ingredient: Distilled Water, Sanguinaria Canadensis, Vegetable Glycerin, Butter of Zinc, Germall Plus, 0.17 OZ (5g) container, Solace International, Inc., Reno, NV 89509, USA
Dermatend Ultra, mole, wart and skin tag remover, For external use only, Ingredient: Distilled Water, Sanguinaria Canadensis, Vegetable Glycerin, Butter of Zinc, Germall Plus, 0.34 OZ (10g) container, Solace International, Inc., Reno, NV 89509, USA
Bard DuaLok Breast Lesion Localization Wire, Product Code (Gauge x Length) LW0037 (20gx37mm); LW0057 (20gx57mm), LW0077(20gx77mm), LW0107(20gx107mm), LW0137(20gx137mm). The Bard DuaLok Breast Lesion Localization Wire is intended for use as a guide for directing surgical biopsies.
ZOLL Pro-padz Sterile Adult Multi-Function Electrodes Part number: 8900-4012 These MFE Electrodes are used in connection with ZOLL Defibrillators for Adult patients. These disposable single use MFE's are processed through Gamma Radiation to a SAL of 1 o.e per International/ National Standards, EN ISO 11137- 2:2012 and ANSI/AAMI/ISO 11137-2:2013, Method 1, for use in a sterile environment by trained medical professionals. The indications for use include defibrillation, cardioversion, external non-invasive pacing and monitoring. These MFE electrodes have a 12 month shelf life from time of manufacture.
ZOLL Pro-padz Sterile Adult Multi-Function Electrodes ((singles) Part number: 8900-4013 These MFE Electrodes are used in connection with ZOLL Defibrillators for Adult patients. These disposable single use MFE's are processed through Gamma Radiation to a SAL of 1 o.e per International/ National Standards, EN ISO 11137- 2:2012 and ANSI/AAMI/ISO 11137-2:2013, Method 1, for use in a sterile environment by trained medical professionals. The indications for use include defibrillation, cardioversion, external non-invasive pacing and monitoring. These MFE electrodes have a 12 month shelf life from time of manufacture.
ZOLL Pro-padz Sterile Adult Multi-Function Electrodes with 10-ft (3 m) leadwires Part number: 8900-4052 These MFE Electrodes are used in connection with ZOLL Defibrillators for Adult patients. These disposable single use MFE's are processed through Gamma Radiation The indications for use include defibrillation, cardioversion, external non-invasive pacing and monitoring.
Candesartan Cilexetil and Hydrochlorothiazide Tablets 32 mg/12.5 mg, 90 count bottles, Rx only, Manufactured by: Apotex Research Pvt. Ltd. Bangalore - 560 099, India NDC 60505-3759-9
Rusch, Soft Rubber (Nelaton and Nelaton Robinson), Bladder Catheter, Sterile. These catheters are indicated for the routine drainage of urine from the bladder. These catheters are not intended or designed for indwelling use.
Avocados, PLU#4770, size 32, 32 pcs/case. Packed in boxes with green, yellow, and red print with a black and white label.
Red blood cells leukocytes reduced irradiated
Bupivacaine HCl Inj., USP, 0.5% (5 mg/mL), 30 mL Single-dose Preservative-Free, For Nerve Block, Caudal, and Epidural Anesthesia, Not for Spinal Anesthesia, Rx Only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-1162-02

Code Info
Goldenfeast Australian Blend Bulk Bag, UPC741919167629, 32 lb. best if used by May 31, 2013 through October 31, 2013 Australian Blend Mini Bulk Bag UPC 741919165625, 13 lb. bag best if used by May 31, 2013 through October 31, 2013 Australian Blend Super Size Plastic Jar, UPC 741919163621, 64 oz. best if used by May 31, 2013 through October 31, 2013 Australian Blend Barrier Bag, UPC 741919164628, 25 oz. best if used by May 31, 2013 through October 31, 2013
Bean Supreme Bulk Bag, UPC 741919167759, 32 lb., best if used by July 31, 2013 through December 31, 2013 Bean Supreme Mini Bulk UPC 741919165755, 10 lb., best if used by July 31, 2013 through December 31, 2013 Bean Supreme Super Size UPC 741919163751, 64 oz., best if used by July 31, 2013 through December 31, 2013 Bean Supreme Barrier Bag, UPC 741919164758, 23 oz., best if used by July 31, 2013 through December 31, 2013
Caribbean Bounty Bulk Bag, UPC 741919167728, 32 lb., best if used by July 31, 2013 through September 30, 2013 Caribbean Bounty Mini Bulk UPC 741919165724, 11 lb., best if used by July 31,2013 through September 30, 2013 Caribbean Bounty Super Size UPC 741919163720, 64 oz., best if used by July 31, 2013 through September 30,2013 Caribbean Bounty Barrier Bag UPC 741919164727, 25 oz., best if used by July 31,2013 through September 30, 2013
Goldenfeast Gardenflora Bulk Bag UPC 741919167681, 12 lb., best if used by July 31, 2013 through February 28, 2014 Gardenflora Mini Bulk Bag UPC 741919165687, 4 lb., best if used by July 31, 2013 through February 28, 2014 Gardenflora Super Size UPC 741919163683, 23 oz., best if used by July 31, 2013 through February 28, 2014 Gardenflora Barrier Bag UPC 741919164680, 9 oz., best if used by July 31, 2013 through February 28, 2014
Goldenfeast Petite Hookbill Bulk Bag UPC 741919167605, 32 lb., best if used by June 30, 2013 through October 31, 2013 Goldenfeast Petite Hookbill Mini Bulk Bag UPC 741919165601, 12 lb., best if used by June 30, 2013 through October 31, 2013 Goldenfeast Petite Hookbill Super Size Jar, UPC 741919163607, 64 oz., best if used by June 30, 2013 through October 31, 2013 Goldenfeast Petite Hookbill Barrier Bag UPC 741919164604, 25 oz., best if used by June 30, 2013 through October 31, 2013
Goldenfeast Schmitts Original Bulk Bag UPC 741919167865, 32 lb., best if used by July 31, 2013 through August 31, 2013 Goldenfeast Schmitts Original Mini Bulk Bag UPC 741919165861, 13 lb. best if used by July 31, 2013 through August 31, 2013 Goldenfeast Schmitts Original Super Size UPC 741919163867, 64 oz, best if used by July 31, 2013 through August 31, 2013 Goldenfeast Schmitts Original Barrier Bag UPC 741919164864, 25 oz., best if used by July 31, 2013 through August 31, 2013
Goldenfeast Basics Plus Finch Bulk Bag, UPC 741919167926, 40 lb., best if used by August 31, 2013 through February 28, 2014 Goldenfeast Basics Plus Finch Mini Bulk Bag 741919165922, 13 lb., best if used by August 31,2013 through February 28, 2014 Goldenfeast Basics Plus Finch Super Size Jar UPC 741919163928, 80 oz., best if used by August 31, 2013 through February 28, 2014 Goldenfeast Basics Plus Finch Barrier Bag UPC 741919164925, 32 oz., best if used by August 31, 2013 through February 28, 2014
Goldenfeast Basics Plus Parakeet Bulk Bag UPC 741919167933, 40 lb., best if used by August 31, 2013 through February 28, 2014 Goldenfeast Basics Plus Parakeet Mini Bulk Bag UPC 741919165939, 13 lb., best if used by August 31, 2013 through February 28, 2014 Goldenfeast Basics Plus Parakeet Super Size Jar UPC 741919163935, 72 oz., best if used by August 31, 2013 through February 28, 2014 Goldenfeast Basics Plus Parakeet Barrier Bag UPC 741919164932, 32 oz., best if used by August 31, 2013 through February 28, 2014
None Available. All lots distributed prior to 02/06/2014 are being recalled.
Software Version 3.0.0 and after. Serial Numbers 201902, 203901, and 203919
UPC code 13800 10154, production code of 4165595911U and has a best before date of JULY 2015
''Product Model No: SUAOI ''SeriaJ No: SUI4B01391-SU14B02117. SU14C00556-SU14C01280
model # 10094200, see distribution list for individual device serial numbers
Lot #: 149400, Expiry: January 2016; Lot #: 149649, Expiry: January 2016.
Lot codes: 3WD02, 3WD03, 3WD04, and 3WD05
No codes: product distributed/purchased 1/1/2006-6/27/2008

Product Quantity
450 cases shipped with 12 cartons in each case.
10,515 (Domestic: 2771; Foreign: 7744) in total
1) 15 lbs. bags: 72 bags; 2) 55 lbs. bags: 1,685 bags

Reason for Recall
Blood products, incorrectly tested for cytomegalovirus (CMV), were distributed.
Goldenfeast Inc. is recalling several bird seed blends due to possible contamination with Salmonella from parsley flake ingredients supplied by Specialty Commodities, Inc.
Goldenfeast Inc. is recalling several bird food blends due to possible contamination with Salmonella from parsley flake ingredients supplied by Specialty Commodities, Inc.
Hubbard Feeds has initiated a voluntary recall of three additional lots of Hubbard Life Homestead FASTGROW AM.0.0125 NAB/NAB MEDICATED because of elevated calcium levels that may be harmful to chickens and turkeys. This voluntary recall is the result of identification of additional lot numbers through assays by the FDA related to a voluntary recall of the same product on July 2, 2013. Although no adverse events or complaints have been reported to date for the three additional lots, chickens and turkeys exposed to these lots may exhibit decreased feed intake, decreased growth rate or death
Nova Products, Inc. of Aston, Pennsylvania is voluntarily recalling AFRICAN BLACK ANT because FDA laboratory analysis determined they contain undeclared amounts of sildenafil an active ingredient of FDA-approved drugs used to treat erectile dysfunction.
Nova Products, Inc. of Aston, Pennsylvania is voluntarily recalling Black Ant because FDA laboratory analysis determined they contain undeclared amounts of sildenafil an active ingredient of FDA-approved drugs used to treat erectile dysfunction.
Nova Products, Inc. of Aston, Pennsylvania is voluntarily recalling XZEN GOLD because FDA laboratory analysis determined they contain undeclared amounts of sildenafil and tadalafil, active ingredients of FDA-approved drugs used to treat erectile dysfunction.
Nova Products, Inc. of Aston, Pennsylvania is voluntarily recalling XZEN PLATINUM because FDA laboratory analysis determined they contain undeclared amounts of sildenafil and tadalafil, active ingredients of FDA-approved drugs used to treat erectile dysfunction.
Nova Products, Inc. of Aston, Pennsylvania is voluntarily recalling Xzen 1200 because FDA laboratory analysis determined they contain undeclared amounts of sildenafil and tadalafil, active ingredients of FDA-approved drugs used to treat erectile dysfunction.
Nova Products, Inc. of Aston, Pennsylvania is voluntarily recalling XZone 1200because FDA laboratory analysis determined that they contain undeclared amounts of sildenafil and tadalafil, active ingredients of FDA-approved drugs used to treat erectile dysfunction.
Nova Products, Inc. of Aston, Pennsylvania is voluntarily recalling XZONE GOLD because FDA laboratory analysis determined that they contain undeclared amounts of sildenafil and tadalafil, active ingredients of FDA-approved drugs used to treat erectile dysfunction.
Nova Products, Inc. of Aston, Pennsylvania is voluntarily recalling MOJO RISEN, because FDA laboratory analysis determined that they contain undeclared amounts of sildenafil an active ingredient of FDA-approved drugs used to treat erectile dysfunction.
Lack of Assurance of Sterility: A mold like substance was discovered on the surface of an unopened bag of Sodium Chloride 0.9% while prepping the bag for production.
ArjoHuntleigh received reports where the Tenor Lift without Scale (spreader bar) bolt broke during use. There is a remote risk concerning the breakage of the spreader bar bolt connection, part # TEN.018. During use, the bolt is subjected to mechanical forces, which may lead to breakage.
Presence of Particulate Matter: particulate matter identified as metallic-like and non-metallic cellulose fiber particles found in retain vials
Marketed Without an Approved NDA/ANDA: Product contains undeclared sibutramine.
Products were held at improper storage temperature
Trend in reports of unexpected decrease in beam output in C-series High Energy Linear Accelerators for 6MV photon treatment mode.
Presence of Particulate Matter: particulate matter identified as fibers and/or plastics.
Labeling: Label Mix-Up: Some cartons of AHP Ibuprofen Tablets, USP, 600mg, lot #142588 that contain blister cards filled with Ibuprofen tablets, 600mg drug product, were found to be mis-labeled with blister card print identifying the product as AHP Oxcarbazepine Tablets, 300mg, lot #142544
Labeling: Label Mix-Up: Some cartons of AHP Ibuprofen Tablets, USP, 600mg, lot #142588 that contain blister cards filled with Ibuprofen tablets, 600mg drug product, were found to be mis-labeled with blister card print identifying the product as AHP Oxcarbazepine Tablets, 300mg, lot #142544.
AbSorber XM-ONE Transplantation Cross Match (ABX100-03), containing a certain lot of BD Vacutainer Cell Preparation Tubes (CPT) which has the potential for poor separation resulting in a reduced number of recovered mononuclear cells, was distributed.
Product associated with scombroid illness.
ADVIA Chemistry A1c_3 CAL (Calibrator) for use on the ADVIA Chemistry Systems, REF/Catalog Number/Siemens Material Number (SMN) 10491408, IVD --- ADVIA Chemistry A1c_3 Calibrator Information: For in vitro diagnostic use in the calibration of A1c_3 (A1c_3 and A1c_3M) and Total Hemoglobin_3 (tHb_3 and tHb_3M) methods on ADVIA Chemistry systems. The ADVIA Chemistry systems are automated, clinical chemistry analyzers that can run tests on human serum, plasma, or urine in random access and batch modes for in vitro diagnostic use.
Genesis BPS is recalling numerous devices since they did not notify the agency of its intent to introduce material changes.
Software Anomaly: Due to certain software bug, if a user changes the calendar setting from ''workday'' to ''holiday'' or vice versa, that would erroneously change the status of treatment/fractions, which are completed and to become ''treated (completed)'' status on the exact day when such change is made, to ''untreated'' status. Furthermore, such treatment would be cloned and mistakenly added to the schedule as ''untreated'' treatment.
Mt. Sterling Coop Creamery is recalling one lot of Raw Goat Milk Cheddar Style Cheese in 5 lb and 8 oz sizes because it may be contaminated with Shiga toxin producing Escherichia coli (STEC) O111:H8 bacteria.
Nestl Prepared Foods Company Announces Allergy Alert and Voluntary Recall of LEAN CUISINE Culinary Collection Chicken with Peanut Sauce Recall Due to Package Mislabeling
A raw material used in the manufacture of the dietary supplements was found to contain Salmonella bacteria.
EMG Technology Co., Ltd. Is voluntarily recalling Vac-Assist Suction Units (SUA01 Suction Aspirator Unit w/800 cc Canister) with serial number ranges: SU14B01391-SU14B02117 and SU14C00556-SU14C01280 which contain suction canister lids that may have occluded ports.
Blood products, in which donor gave history which warranted deferral or follow up and was not deferred or follow up questions were not asked, were distributed.
Blood product, collected from a donor in which donor suitability was not adequately determined, was distributed.
Blood product, in which donor testing was not performed or incomplete, was distributed.
Blood product, collected from a donor with no documentation of an arm inspection or general appearance, was distributed.
Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.
Platelets, with insufficient plasma volume to support the platelet yield, were distributed.
Blood product, which was collected from a donor who had traveled to a malarial endemic area, was distributed.
MTS A/B/D Monoclonal and Reverse Grouping Cards, with the potential for false positive reactions with some lots, were distributed.
Blood product, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), was distributed.
Blood product, labeled 'leukoreduced', but which had not undergone leukoreduction, was distributed.
Blood product, labeled ''leukoreduced'', but which had not undergone leukoreduction, was distributed.
BioFire Defense, LLC is initiating a field action for JBAIDS Software version 3.5.0.72 because the wrong version software may have been installed.
The integrity of the wires inside main electrical chord become compromised from excessive flexing (during the door open/close process).
During a Field Test (a customer external evaluation period), the customer detected a problem in the CIRS 4.0 Beta 2 software. When using the CIRS 4.0 Beta 2 software, during the recon during ready stage of reconstruction, images may be overlapped with, or superimposed on other images. Philips has disabled this feature at all sites evaluating 4.0 Beta 2 software. Philips will issue a software update to Beta 3 to correct this issue.
Internal testing had identified a potential breach to the sterile barrier that may impact the sterility of the product.
Philips Healthcare received a complaint stating the system opens e-stop while sitting idle causing all movements and scan to stop. The problem has only occurred one time when the scan was out of Ready for Scan or scanning mode.
B. Braun Medical Inc. (USA) became aware that one (1) lot of the CT-1000-100 ''Accufix 100ML/H 100ML'' product was recalled by their German manufacturing site due to customer complaints that product was distributed to U.S. customers which contains incorrect product labeling. Specifically, the primary packaging label (inner pouch label) indicates that the package contents are Catalog Item: CT-1000-250, while the secondary packaging label (outer carton label) indicates the contents are CT-1000-100. The actual contents are CT-1000-100.
GF Health Products, Inc / Basic American Medical Products is conducting a recall on various models of Zenith Slide W-I-D-E Long Term Care Beds. The bed head deck may fail to elevate as expected during normal operation. When the non-operation occurs, the head deck remains in the lowered horizontal / flat position and will no longer function as intended.
BD has confirmed reports that the referenced lots of Vancomycin Screen Agar may have exhibited breakthrough growth of vancomycin susceptible Enterococcus species control organisms. Vancomycin Screen Agar that is allowing susceptible enterococci to grow gives the appearance of a falsely resistant culture. With the majority of laboratories performing appropriate QC testing, it is likely that QC will identify the problem and the results would not be used for patient reports. However, on the chance that a laboratory is not performing QC, falsely resistant enterococci would still go on to have further AST workup and the error would be identified. There could be a delay in the identification of false-resistance.
It was determined that a potential malfunction may occur on the Luminos dRF system with SW VD10 or on Luminos dRF Max when the table side control is exposed to fluids. Fluid may infiltrate the tableside control panel and result in malfunction. In the very unlikely case of fluid infiltration a permanent short circuit within the control panel of the Luminos dRF / Luminos dRF Max will automatically disable the affected button(s) with the start-up of the system. Pressing button on the control panel may lead to unintended system movement. The remote control panel is not affected by any malfunction of the tableside control panel and can reliably be used at any time. In case of a malfunction of the tableside control panel, users are recommended to switch to solely using the remote control panel(s).
Diagnostica Stago Inc. received some customer complaints regarding a misreading of Reagent 1 (substrate) barcode on STA analyzers.
The firm is conducting a field correction for the ADVIA Centaur and ADVIA Centaur XP Immunoassay systems, regarding manually loaded sample racks that are improperly loaded or pushed too far on the sample entry queue during normal operation of the ADVIA Centaur and ADVIA Centaur XP Immunoassay systems. Pushing the sample racks may cause misreads of Sample IDs (SID) if the sample rack loading instructions are not followed exactly as described in the ADVIA Centaur or ADVIA Centaur XP Operators Guide.
Swanson Certified Organic Carob Powder, item number SWF115 is being recalled due to a potential risk of Salmonella contamination from a raw ingredient used in this product.
Not approved labeling claims (antimicrobial and autolytic debridement)
Potential issues with the ProVue driver have been identified which may cause data to be misassociated with patient results under a given set of circumstances.
Mars Petcare US is recalling specific 15 and 55 pound bags of PEDIGREE Adult Complete Nutrition Dry Dog Food because they may contain metal fragments.
The Cashew Pieces have the potential to be contaminated with Salmonella.
The recalled product includes an ingredient (condensed skim milk) that the supplier Dairy Farmers of America has advised may have been produced from raw milk that has tested positive for the presence of sulfamethazine antibiotic.
Beckman Coulter is recalling Coulter DxH Diluent because it may be associated with elevated platelet (PLT) background counts between 3-7 x 10(3) cells/uL. This will result in failed Daily Checks on the UniCel DxH 800 and DxH 600 Coulter Cellular Analysis Systems.
Motion Concepts identified that there is a possibility of knee support failure occurring through fatigue of two attachment bolts in the Vertical Position System (TRx Vertical Positioner).
Marketing without marketing clearance or approval.
Due to user error, the 4DITC can improperly allow users to clear a safety interlock imposed by the 4DITC on behalf of Varian's Bar Code Conical Verification system from the BrainLab's ExacTract console when it is used with BCCV.
Green Walnuts from a tree dropped into spinach as it was being tractored away from the harvested field. Walnuts were discovered on the Dole spinach processing line
Siemens Healthcare Diagnostics has identified a task scheduler issue with the CentraLink'' Data Management System, software version 14. The issue may cause the software to stop executing commands, including uploading validated results to the LIS. The issue is related to an internal software timer that overflows after 24 days. Automated rules triggered by task schedulers or by actions in the CentraLink user interface may also be affected. As each customer configuration is unique, in addition to the delay in uploading of validated results, the specific consequences of discontinued command execution will vary.
Frozen desserts do not include ingredients on the labeling.
Labeling: Labeling Bears Unapproved Claims; Dermatend is not FDA approved and therefore has not been shown to be safe and effective for the uses suggested in the labeling.
Bard Peripheral is recalling the Bard DuaLok Breast Lesion Localization Wire because it may be at risk of having portions of the wire protruding from the packaging, thus representing a breach of sterile barrier.
Blood products, which were labeled as leukoreduced, but exceeded the acceptable limit for white blood cell count, were distributed.
Platelet, with an unacceptable pH, was distributed.
Failed Impurity/Degradation Specification; high out of specification for CAD II degradant
Misbranding: Although the product labeling identifies the catheters as "soft rubber," the Natural Rubber Latex caution statement was not printed on the product label.
Blood product, collected from a donor who traveled to a malarial endemic area, was distributed.
Calavo Growers is recalling Avocados because they may be contaminated with Salmonella.
Blood products, collected in a manner that may have compromised the sterility of the collection system, were distributed.
Presence of Particulate Matter: A confirmed customer complaint reported the presence of a brown, rust-colored particle embedded at the bottom of the glass vial.