sent out to vaiours manufactures. A spreadsheet of customers is attached.
Pea protein 85% dry powder in a 20 KG bag.
Undeclared Soy on label. RFR was generated by a customer who used the Pea Protein in a blended product that claims to be soy free. The Pea Protein tested positive for soy allergen.
Triple Ginger Brew, 25.4 FL OZ (750 mL) glass bottles, SKU 51857    Bottles are sold individually; there are 9 bottles per case
Nationwide Distribution through Tuesday Morning retail stores.
Germ Terminator, Toothbrush Steam Sterilization for Oral Health.  Model GT100.  The Germ Terminator uses steam heat to sanitize two manual toothbrushes or two toothbrush heads.  Water is poured into a reservoir in the device's housing.  The steam cycle is followed by a drying cycle.
CEG Enterprises, LLC is recalling Germ Terminator Toothbrush Sanitizer GT100 due to the following issues:  UL label believed to be not genuine; discoloration of power cords (could indicate some degradation); reports of excessive heat.
Worldwide Distribution - US (Nationwide) and Internationally to Albania Austria  Belgium Bulgaria Burkina Faso Canada Croatia Cyprus Czech Republic Denmark Egypt Estonia Finland France French Polynesia Georgia Germany Great Britain Greece Guadeloupe Hungary  Iceland Italy Kazakhstan Latvia Lithuania Luxembourg Macedonia Malta Martinique Netherlands Norway Poland Portugal Romania Russian Federation Serbia Slovakia Slovenia Spain Sweden Switzerland Tunisia Turkey United Arab Emirates and Uzbekistan.
Siemens Healthcare ADVIA Centaur Tnl-Ultra Assay . In-Vitro Diagnostic for quantitative determination of cardiac troponin  For in vitro diagnostic use in the quantitative determination of cardiac troponin I (cTnl) in serum, heparinized plasma, or EDTA plasma using the ADVIA Centaur/ADVIA Centaur XP/ADVIA Centaur XPT/ADVIA Centaur CP systems  Cat No. 02789602/SMN 1031 7708 (100 test)  Cat No. 02790309/SMN 10317709 (500 test)
Exhibits a greater than 10% change in results in samples with biotin levels up to 10 ng/mL (41 nmol/L). Instructions for Use (IFU) states that specimens that have up to 10 ng/mL (41 nmol/L) of biotin
Wicker's Black Label Steak Marinade, 16 Fl. Oz. (473.28 mL), Ingredients: Soy Sauce (Water, Salt, Hydrolyzed Soy Protein, Corn Syrup, Caramel Coloring), Vinegar, Herbs and Spices
Steak marinade product contains undeclared wheat.
Alabama, Arkansas, Colorado, Delaware, Florida, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Maryland, Maine, Michigan, Minnesota, Missouri, North Carolina, New Jersey, New York, Ohio Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Vermont, Wisconsin, and West Virginia  Per Dutch Valley Distributors.
Golden Gourmet Snacks Veggie Chips;  Net Wt. 12 OZ;  Bickel's Snack Foods, Inc., York, PA 17404  Lot codes: 26SEP16 Z4D1 and 26SEP16 Z5D1
Golden Gourmet Veggie Chips are being recalled due to an undeclared milk allergen. Ranch Flavored Veggie Chips, which contain a milk ingredient, were packed in plain veggie chip bags.
Lot codes: 26SEP16 Z4D1 and 26SEP16 Z5D1
Dicloxacillin Sodium Capsules USP, 500mg, Rx Only, 100 Capsule bottle, Manufactured in Austria by Sandoz Gmbh, Distributed by Sandoz  Inc. , Princeton, NJ 08540, Product of Spain, NDC 0781-2258-01
Failed Impurities/Degradation Specifications:Out of specification result for a known impurity obtained during testing.
Dicloxacillin Sodium Capsules, USP 250mg, Rx Only, 100 Capsule Bottle, Manufactured in Austria by Sandoz Gmbh, Distributed by Sandoz  Inc.,  Princeton, NJ 08540, Product of Spain, NDC 0781-2248-01
Blood and Blood Products for Reprocessing
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
U.S. distribution to the following; CA, VA, MO, AR, KY, LA, OR, OH, NY, MT, MN, CO, IL, WV, UT, SD, PA, TX, NE, FL, KS, AZ, MA, IA, MD, NJ, CT, WI, TN, MI, VA, OK, WA, HI, PR.     Foreign distribution to the following; Canada, Finland, Australia, Sweden, Hong Kong, Poland, Lebanon
Let's Talk Health  Energizer Drink Mix Citrus  0.3oz     UPC #91131180631
Undeclared whey protein which contains milk and soy lecithin.
Let's Talk Health  Aqua Vitae Multi-Vitamin  32oz.      UPC #91131181096
Let's Talk Health  Energizer Drink Mix Pomegranate  0.3oz     UPC #91131180525
Let's Talk Health  Tox Elim Liquid  32oz.      UPC #91131181119
Let's Talk Health  Energizer Drink Mix Strawberry/Banana  0.3oz     UPC #91131180624
Let's Talk Health  Agua Vitae Kids Multi-Vitamin Liquid  16 oz.      UPC #91131180280
Blood product, in which labels applied to blood unit or product incorrect or missing information, was distributed.
Nationwide Distribution to UT, MA, OH, IN, NC, NY, VA, CA, IA and KY.
Histoplasma Yeast Complement Fixation Antigen Dilute Ref# H30150  The fungal antigens and positive controls are used to detect antibodies in patient serum by the complement fixation (CF) procedure to aid in the diagnosis of four specific fungal diseases: Histoplasmosis, blastomycosis, coccidioidomycosis, and aspergillosis
The device was found to have bacterial contamination.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
AR, AZ, CA, CO, DE, FL, GA, IA, IL, IN, KS, KY, LA, MD, MI, MN, MO, NE, NH, NY, OH, OR, PA, SD, TX, UT, VA, WI.
Dakota Style Roasted & Salted Sunflower Kernels, Net Wt. 3.5 oz. plastic bag.  UPC 84872-20172
Dakota Style Foods is recalling certain Sunflower Kernel products because they may be contaminated with Listeria monocytogenes.
Lots:  8B6M02 and 8B6M09  Expiration dates:  February 1, 2017 through March 21, 2017
Savory Bacon Sunflower Kernels, Net Wt. 4 oz and 8 oz.
NUTS Sunflower Seeds Roasted & Salted Vending Nut Co. Fort Worth, Texas 76107 Net Wt. 16 oz. (1 LB.) 454g packaged in plastic bags
Product has the potential to be contaminated with Listeria monocytogenes.
NUTS Vending Nut Co. 2222 Montgomery St. Ft. Worth, TX 76107 817-737-3071 www.vendingnut.com Sunflower Seeds Roasted & No Salt Net Wt. (160 oz) 10lb UPC: 0-98301-00006-5 in cardboard container.
1% Clotrimazol cream, 30 mg tube,  UPC 501318644335
tabcin NOCHE; Capsules,12-count box, UPC 501008485033
tabcin ACTIVE M.R. Capsules, 12-count box , UPC 7501008485057
VERMOX Tablets 500 mg, 1-count box, UPC 501109900596
VERMOX Tablets 100 mg; 6-count box, UPC 7501109900619
Blood product,s which did not meet the acceptable product specifications, were distributed.
Blood products, collected in blood bags that had exceeded the manufacturer's instructions for use, were distributed.
Distributed in the states of MA, CA, and WA and the countries of Australia, Denmark, Turkey, Germany, Russia, Slovenia, Netherlands and Zambia.
SIOOA I (EP I84) Rabbit Monoclonal Antibody;  Catalogue numbers 408R-14, 408R-15, and 408R-16; Part number: 470361.  Intended for identifying by light microscopy the presence of associated antigens in sections of formalin-fixed, paraffin embedded tissue sections using IHC test methods.
Cell Marque became aware of some lots of SIOOA I (EP I84) Rabbit Monoclonal Antibody, catalogue numbers 408R-14, 408R-15, and 408R-16, that exhibited an unacceptable IHC test result.
US Distribution to the states of : OR, IL, IA, NC, TX, CA, GA, OH, WI, AR, MI, MD, IN.
This recall has been initiated due to a defective component within the handpiece which will  cause the handpiece to fail. The failure will result in the inability to cut tissue with the  handpiece, rendering it non-functional. Should this failure occur, a replacement Myriad  handpiece will be required. If a replacement handpiece is not available, alternate instrumentation for tissue removal will be necessary.
13ga, 13cm Myriad Handpiece  Part number: NN-8004  Lots 1444664 and 1508994
SYS IVK, Bio mCT-X 3R->4R Upgrade, MATERIAL NUMBER 10250745    The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.
Biograph 16 TruePoint, MATERIAL NUMBER 10249555    The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
BIOGRAPH 64-4R TruePoint w/TrueV, MATERIAL NUMBER 10097302    The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
BIOGRAPH mCT Flow 20-3R, MATERIAL NUMBER 10528956    The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
BIOGRAPH mCT Flow 20-4R, MATERIAL NUMBER 10528958    The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
BIOGRAPH mCT Flow 40-4R, MATERIAL NUMBER 10529159    The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
BIOGRAPH 40 TruePoint, Material Number 10097303	  The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
Biograph mCT-S(40) 4R, MATERIAL NUMBER 10248671    The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
Biograph mCT-S(40) 3R, MATERIAL NUMBER 10248668    The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
BIOGRAPH 40 - 3 Ring, Material Number 10097233  The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
BIOGRAPH Sys 40-3R to 40-4R, MATERIAL NUMBER 10246388    The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
Biograph mCT-X 3R, MATERIAL NUMBER 10248673    The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
Biograph 6 TP 3R to 4R Upgrade, Material Number 10246387    The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
BIOGRAPH mCT Flow Edge-3R, MATERIAL NUMBER 10528954    The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
BIOGRAPH mCT S(20)-4R, MATERIAL NUMBER 10534160    The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
Biograph mCT-X 4R, MATERIAL NUMBER 10248670    The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
SYS IVK, Bio mCT-S(40) 3R->4R Upgrade, MATERIAL NUMBER 10250743    The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
BIOGRAPH 6 TruePoint, Material Number 10097289    The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
BIOGRAPH 64 - 3 Ring, Material Number 08727450    The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
BIOGRAPH 40-3R to 64-3R Upgrade, Material Number 10246390    The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
BIOGRAPH mCT Flow 40-3R, MATERIAL NUMBER 10529158    The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
BIOGRAPH mCT Flow 64-3R, MATERIAL NUMBER 10529160    The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
BIOGRAPH SYS 64-3R to 64-4R, MATERIAL NUMBER 10246389  The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
BIOGRAPH 6-4R TruePoint w/TrueV, MATERIAL NUMBER 10097290    The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
Biograph mCT-S(64) 4R, MATERIAL NUMBER 10248672    The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
BIOGRAPH 40 TruePoint w/TrueV, Material Number 10097304  The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
BIOGRAPH mCT Flow Edge-4R, MATERIAL NUMBER 10528955    The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
BIOGRAPH 64-3R TruePoint, MATERIAL NUMBER 10097301    The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
Biograph mCT-S(64) 3R, MATERIAL NUMBER 10248669    The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
Biograph Sys 16-3R to 16-4R upgrade, MATERIAL NUMBER 10525581    The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
Biograph 16 TruePoint TV, Material Number 10249556  The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
BIOGRAPH mCT Flow 64-4R, MATERIAL NUMBER 10529161    The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
BIOGRAPH mCT S(20) - 3R, MATERIAL NUMBER 10507786    The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
Batesville, MS for retail products; LA, MS, TN, AL, GA, KY, AR for caramel icing.
white and dark chocolate peanut clusters
Candy, baked goods, and Caramel icing contain undeclared allergens. Undeclared milk and soy (soybean oil and/or soy lecithin)
Candy, baked goods, and Caramel icing contain undeclared allergens. Undeclared eggs, milk, wheat, and soy (soybean oil and/or soy lecithin)
Candy, baked goods, and Caramel icing contain undeclared allergens. Undeclared milk and eggs
white and dark chocolate pecan krispie clusters
Candy, baked goods, and Caramel icing contain undeclared allergens. Undeclared eggs, milk, wheat, tree nuts, and soy (soybean oil and/or soy lecithin)
white and dark chocolate pecan turtles and tortoises
Candy, baked goods, and Caramel icing contain undeclared allergens. Undeclared tree nuts, milk, wheat, and soy (soybean oil and/or soy lecithin)
The Caramel Factory (TM) Caramel Icing, NET WT. 22OZ, 1 LB. 6OZ. (622 grams) and 2.5 GAL bucket
Candy, baked goods, and Caramel icing contain undeclared allergens. Undeclared soy (soybean oil and/or soy lecithin)
white and dark chocolate cashew turtles and tortoises
sugar free milk chocolate cashew cluster
white and dark chocolate cashew clusters
Candy, baked goods, and Caramel icing contain undeclared allergens. undeclared milk and soy (soybean oil and/or soy lecithin)
sugar free milk chocolate peanut cluster
Candy, baked goods, and Caramel icing contain undeclared allergens. Undeclared tree nuts, milk and soy (soybean oil and/or soy lecithin)
Implant Direct Sybron Manufacturing, LLC
Worldwide Distribution - U.S. Nationwide in the states of OR, NE, VA, FL, MO, WA, TX and the countries of CZ, GB, NL, MF, DK, IT, IE, DE
The incorrect sized product, InterActive Implant Open-Tray Transfer Wide, 6534-08W, was packaged instead of the InterActive Implant Open-tray Transfer Narrow, 6534-08N, causing a possible issue with the impression.  This discrepancy may lead to the possibility of an oversized crown fabrication.
(Albertsons/Safeway/Basha Hometown Grocers) Oriental Salad with Sesame Ginger Dressing, Net Wt.10 oz.(284g), 24 pieces per case, UPC 78279602691; (Food 4 Less) Oriental Salad with Sesame Ginger Dressing, Net Wt. 13 oz. (369 g), UPC 78277602840
Papa John's Salad and Produce is voluntarily recalling Oriental Salad with Sesame Ginger Dressing due to possible Listeria monocytogenes contamination.
Blood products, which did not meet the acceptable product specifications, were distributed.
Blood product, possibly contaminated with air, was distributed.
/15cm 9-0 USP because it may contain Black Nylon 9-0 suture.
Fresenius Medical Care Renal Therapies Group, LLC
Crit Line in a Clip (CLiC). CliC P/N: CL 10041001  CLiC is a continuous real-time monitor for non-invasive hematocrit oxygen saturation and percent change in blood volume measurement during hemodialysis treatment.  Used in conjunction with the Fresenius 2008T Hemodialysis Machines as follows:  Model:   190895  2008T GEN 2 BIBAG w/o CDX  190713  2008T Hemodialysis SYS with CDX  190858  2008T Hemodialysis System w/o CDX  190766  2008T Hemodialysis System  w/o CDX
Use of the Blood Pressure Graph located on the Crit-Line screen of the 2008T Hemodialysis Machine may result in a frozen screen, possibly causing the blood pump to stop.
Worldwide distribution. US nationwide; Portugal, Spain, Thailand,  Italy, China, Romania, Egypt,  India, France,  Hungary, Mexico, Germany, Norway,  Turkey,  Pakistan, Malaysia, UK, Luxembourg, Israel, Canada, Switzerland, Taiwan, South Africa, Saudi Arabia, Korea, Singapore and Japan.
CytoVision Image Analysis and Capture System, an automated cell-locating device. The Cytovision is a rapid metaphase finder, image acquisition and computer aided chromosome analysis system which assists the operator in viewing chromosomes and looking for cellular anomalies. CytoVision enables a qualified Cytogeneticist to rapidly and accurately analyze the chromosome banding pattern.
Systems have an improperly activated Windows 7 OS, even though a valid Windows 7 license was associated with each manufactured system. The system appears to be unlicensed.   These systems cannot be re-activated using standard Windows licensing procedures and are requiring checks of each potentially affected system to confirm Windows 7 OS is properly activated.
System	23CAP001KXX001 with Serial Number 201021, System 23CAP001KXX001 with Serial Number 201020, System 23CAP001KXX001 with Serial Number	200994, System 23CAP001KFX001 with Serial Number	200752, System 23GSLXXXKFXUPG with Serial Number 201013, System 23GSLXXXKFXUPG with Serial Number 201050, System	23CAP007FXX001 with Serial Number	200930, System	 23CAP002KFX001 with Serial Number	201000, System 23CAP001KXX001	  with Serial Number	200969, System 23CAP001KFX001	with Serial Number 200942, System	23GSL120KFX001 with Serial Number	200910, System 23CAP001FXX001	  with Serial Number	200710, System	23GSLXXXKFXUPG		 with Serial Number	200890, System 23GSL120KFX001		 with Serial Number	201001System	 23CAP002FXX001		 with Serial Number	200889, System	23GSLXXXKFXUPG with Serial Number	201087, System	23CUP003CVX720		 with Serial Number 201086, System	23GSL10XKXX001		 with Serial Number	201085, System 23REV001XXX001	  with Serial Number	201084, System	23REV001XXX001		 with Serial Number	201083, System	23REV001XXX001		 with Serial Number 201082, System	23REV001XXX001		 with Serial Number	201081, System	23REV001XXX001		 with Serial Number	201080, System 23REV001XXX001	  with Serial Number	201079, System	23REV001XXX001		 with Serial Number	201078, System	23REV001XXX001		 with Serial Number 201077, System	23REV001XXX001		 with Serial Number	201076, System	23CUP001CVX720		 with Serial Number	201056  System 	23CUP001CVMV4		 with Serial Number	200921, System	23CUP001CVX720	 with Serial Number	200920, System	23CAP001FXX001		 with Serial Number	201004, System	23CUP001CVX720		 with Serial Number	200922, System	23CUP003CVX720		 with Serial Number	200749, System	23CUP001CVX720		 with Serial Number	200748, System	23CUP001CVX720	 with Serial Number	200747, System	23CUP001CVX720		 with Serial Number	200996, System	23CUP003CVX720		 with Serial Number	200980, System	23REV000KXX001		 with Serial Number	200973, System	23REV000KXX001		 with Serial Number	200972, System	23REV000KXX001	 with Serial Number	200971, System	23CW4000UP002		 with S
Hyoscyamine Sulfate Sublingual Tablets, 0.125 mg, packaged in 100-count bottles, Rx only, Manufactured for: Virtus Pharmaceuticals OPCO II, LLC. Nashville, TN 37217. NDC 76439-0309-10
Chemical Contamination: Bottles may contain broken dessicants
Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.
Blood product, which did not meet the acceptable product specification, was distributed.
Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
Blood products, in which quality control and distribution of products did not meet specifications, were distributed.
over-the-wire delivery system. The stent is cut from a Nitinol tube in an open lattice design, and has tantalum radiopaque markers at the proximal and distal ends of the stent. Upon deployment, the stent achieves its predetermined diameter and exerts a constant, gentle outward force to establish patency
Self-expanding Peripheral Stent Systems, model PRB35-08-040-  080, from lot A164580. The size on the outer box is labeled as 8x40x80mm while potentially containing a  6x40x120mm device as indicated by both the inner pouch and device labels. This potential issue is limited to  two EverFiex stent system devices from lot A164580 that were repackaged by Medtronic and distributed.  This does not affect any other Medtronic product or implantable devices.
Big Sur Breakfast Burrito;  A delicious blend of roasted potatoes & red peppers, smoked  seitan and seasoned tofu.  Net Wt. 7.0 oz. (198 g).    Ingredients: Filling: Russet Potatoes, tofu (water, soybeans, Calcium sulfate, Calcium chloride, Sweet Earth Traditional Seitan (water, wheat gluten, soy sauce (water soybeans,  wheat,  salt, alcohol), ginger, garlic, lemon, roasted red peppers, yellow onions, canola oil,  nutritional yeast, sea salt,  natural hickory smoke,  turmeric and spices.  Wrap - ,water. unbleached white flour , Non GMO expeller, pressed canola oil, salt, baking powder (sodium bicarbonate, sodium acid  pyrophosphate, potato starch), yeast, citric acid.    Contains, Soy, wheat.    UPC - 7 oz. unit: #016741111127;  UPC - 12-pack case: #016741111134    Sweet Earth Natural Foods, Moss Landing, CA 95039.
Packaging error where a small quantity of Sana Cruz Burritos were packaged in Big Sur Burrito pouches and do not properly declare milk as an ingredient or allergen.
Department of Army William Beaumont Army Medical Center
Blood products, collected from ineligible donors, were distributed.
Source Plasma, collected from an ineligible donor, was distributed.
Red Blood Cells, lacking proper labeling, were distributed.
Low platelet yield pheresis product was distributed.
Blood product, with an unacceptable pH, was distributed.
Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed.
Nationwide directly to consumers through online purchase.
NatureBox Cheddar and Onion Sunflower kernels:   5 oz. (142g) customer stand up pouch.  UPC: 8 54557 00531 1    Ingredients: Non GMO Sunflower kernels, Sunflower Oil, Sweet Onion and White Cheddar Seasoning Blend (cane sugar, onion and garlic powder, cheddar cheese powder {cheddar cheese (pasteurized milk, cheese cultures, salt, enzymes), buttermilk, whey, salt, disodium phosphate}, salt, natural flavors, lactic acid, spices, silicon dioxide (to prevent caking).  Contains: Milk.      Distributed by NatureBox, San Carlos, CA 94070
Firm was notified by supplier of sunflower seeds that they are being recalled due to Listeria Monocytogenes.
SunOpta Country Ranch Sunflower Kernels- 45lbs case    6075 lbs received (35 cases)
NatureBox Country Ranch Sunflower kernels;   5 oz. (142g) customer stand up pouch.  UPC: 8 52523 00535 8    Ingredients: Sunflower kernels, Sunflower Oil, Buttermilk Powder, Salt, Rice Syrup Solids, Onion and Garlic, Sour Cream Powder (cultured milk, nonfat milk), Tomato Powder, Cheese Powder (cheddar cheese, cultures pasteurized milk, salt, enzymes), Torula Yeast, natural Flavors, Corn Flour, Citric Acid, Parsley. Green Bell Pepper Powder, Silicon Dioxide.  Contains: Milk.    Distributed by NatureBox, San Carlos, CA 94070
Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed.
Blood products, collected from an ineligible donor, were distributed.
Blood product, collected from an unsuitable donor due to a donor screening deviation, was distributed.
VP-CH-PNV Prenatal/Postnatal capsules, prenatal supplement, 30-count bottle, Rx only, Manufactured for: Virtus Pharmaceuticals, LLC, Tampa, FL 33619, NDC 69543-224-30
Defective delivery system: Softgel capsules are leaking.
Apheresis Red Blood Cells, Leukocytes Reduced
Apheresis products, which were not filtered according to specifications, were distributed.
Blood Centers of the Pacific - Irwin Center
Misbranded blood product was distributed.
Mycophenolate Mofetil, Bulk Powder, Quantity 1000 g, For prescription compounding use and medical manufacturing or processing only, Attix Pharmaceuticals, Toronto, Canada
cGMP deviation; manufacturer is Not Registered with the Food and Drug Administration
Lot Number: A3160A, Manufacturer batch number: 151201, Expiry November 2017
Blood product, collected from a donor for whom suitability to donate was inadequately determined, was distributed.
US Distribution to states of: CA, FL,  KS, NE, NY, and PA.
Fujifilm Synapse PACS software version 4.4.000,  Fujifilm Synapse PACS software version 4.4.001,  Fujifilm Synapse PACS software version 4.4.004,  Fujifilm Synapse PACS software version 4.4.010 and  Fujifilm Synapse PACS software version 4.4.020    FUJIFILM Synapse Workstation Software (a Picture Archiving And Communications System) is intended to serve as the primary user interface for the processing of medical images for presentation on displays appropriate to the medical task being performed. Also intended for installation on an  off-the-shelf PC networked with Fuji Synapse PACS.
Human cornea, recovered without verifying supplies and reagents met specifications for use, and was distributed.
Irbesartan and Hydrochlorothiazide Tablets, USP, 300/12.5 mg, Rx only, Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd, Xunqiao, Linhai, Zhejiang 317024, China; Distributed by: Solco Healthcare U.S., LLC, Cranbury, NJ  08512, NDC 43547-331-09.
Labeling: Incorrect or Missing Lot and/or Exp Date: Incorrect lot number, 327B160012, appears on the case label, the correct lot number, 327B16002 appears on the immediate container.