MO, OK, TN, IL, MD, MA, CA, MI, Guam, GA, NC, American Samoa
Blood products, collected in a manner that may have compromised the sterility of the units, were distributed.
Red Blood Cells Leukocytes Reduced Irradiated
Blood products, collected from a donor who was taking a medication containing aspirin at the time of donation, were distributed.
Red Blood Cells (Apheresis) Leukocytes Reduced
Blood products, which were stored under unacceptable storage conditions, were distributed.
Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
Red Blood Cells Apheresis Leukocytes Reduced
Blood products, which were not appropriately tested for West Nile Virus (WNV), were distributed.
Blood components, processed from Whole Blood and refrigerated more than eight hours after collection, were distributed.
Blood and Blood Products for Reprocessing
Platelets Pheresis Leukocytes Reduced Irradiated
Blood products, for which the irradiation was performed incorrectly, were distributed.
Nicomex Camaron Entero Whole Shrimp Net Wt 1 oz (28.35 grams). Productos Mexicanos Distributed by Nicomex Inc. 88 First Street, Passaic, NJ 07055 Tel. (973) 815-2062. UPC 8 84678 10173 9.
Nicomex Inc. is recalling Camaron Entero for undeclared sulfites and Color Para Tamal for unapproved color based on NYSDAM Laboratory analysis.
Nicomex Color Para Tamal Net Wt 1/8  oz (3.54gms) Productos Mexicanos Distributed by Nicomex Inc. 88 First Street, Passaic, NJ 07055 Tel. (973) 815-2062.
BEST Slim, Dietary Supplement, 100% Natural Weight Loss Pill, 40 Pills per bottle, Distributed by CTV Best Group Inc., P.O. Box 956452, Duluth, GA 30095.
Marketed without an Approved NDA/ANDA: Product contains an undeclared drug, sibutramine, making it an unapproved new drug.
Worldwide Distribution - USA including AL, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV.  Internationally to Australia, Austria, Belgium, Belize, Brazil, Canada, Czech Republic, Denmark, England, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Netherlands, Norway, Poland, Scotland, Spain, and Sweden.
4040-2: Umbilical 3 mL Line Draw, Luer lock syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro device, 22g x 1 needle, and Point-Lok needle safety device   Arterial Blood Sampling Line Draw Syringes are sterile, single-use devices, in-vitro diagnostic devices used for the drawing of arterial blood via an arterial line. The product is not for injection.
issue with the plunger tip of the Portex Arterial Blood Sampling Line Draw Syringes
4042-2: 3 mL Line Draw, Luer lock syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro device    Arterial Blood Sampling Line Draw Syringes are sterile, single-use devices, in-vitro diagnostic devices used for the drawing of arterial blood via an arterial line. The product is not for injection.
4043-2: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro device    Arterial Blood Sampling Line Draw Syringes are sterile, single-use devices, in-vitro diagnostic devices used for the drawing of arterial blood via an arterial line. The product is not for injection.
4043G-2: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro device and ice bag    Arterial Blood Sampling Line Draw Syringes are sterile, single-use devices, in-vitro diagnostic devices used for the drawing of arterial blood via an arterial line. The product is not for injection.
4043W-2: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro device, syringe tip cap and 6 mL Luer slip syringe    Arterial Blood Sampling Line Draw Syringes are sterile, single-use devices, in-vitro diagnostic devices used for the drawing of arterial blood via an arterial line. The product is not for injection.
4042LH:  3 mL Line Draw, Luer lock syringe (heparin concentration: 7 I.U. per mL)with Filter-Pro device     Arterial Blood Sampling Line Draw Syringes are sterile, single-use devices, in-vitro diagnostic devices used for the drawing of arterial blood via an arterial line. The product is not for injection.
4042E:  3 mL Line Draw, Luer lock syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro device (for sale in Europe only)   Arterial Blood Sampling Line Draw Syringes are sterile, single-use devices, in-vitro diagnostic devices used for the drawing of arterial blood via an arterial line. The product is not for injection.
4043E: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro device (for sale in Europe only)   Arterial Blood Sampling Line Draw Syringes are sterile, single-use devices, in-vitro diagnostic devices used for the drawing of arterial blood via an arterial line. The product is not for injection.
G1469J: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro device (for sale in Japan only)    Arterial Blood Sampling Line Draw Syringes are sterile, single-use devices, in-vitro diagnostic devices used for the drawing of arterial blood via an arterial line. The product is not for injection.
G1725: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro device and 1 mL Line Draw Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro device    Arterial Blood Sampling Line Draw Syringes are sterile, single-use devices, in-vitro diagnostic devices used for the drawing of arterial blood via an arterial line. The product is not for injection.
G1762: 3 mL Line Draw, Luer lock syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro device, syringe tip cap, and 5 mL Luer lock syringe   Arterial Blood Sampling Line Draw Syringes are sterile, single-use devices, in-vitro diagnostic devices used for the drawing of arterial blood via an arterial line. The product is not for injection.
G1777:  Umbilical (2) 3 mL Line Draw, Luer lock syringes (heparin concentration: 23.5 I.U. per mL) with Filter-Pro devices and (2) Needle-Pro Devices with 22G x 1needles   Arterial Blood Sampling Line Draw Syringes are sterile, single-use devices, in-vitro diagnostic devices used for the drawing of arterial blood via an arterial line. The product is not for injection.
G2001: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro device, Needle-Pro Device and 23G x 1 needle   Arterial Blood Sampling Line Draw Syringes are sterile, single-use devices, in-vitro diagnostic devices used for the drawing of arterial blood via an arterial line. The product is not for injection.
Worldwide Distribution - USA (nationwide) and Internationally to AUSTRIA, BELGIUM, CZECH REPUBLIC, FINLAND, FRANCE GERMANY, GREECE, ITALY, LITHUANIA, POLAND, SPAIN, SWEDEN, SWITZERLAND,  UNITED KINGDOM.
GE Healthcare CARESCAPE Monitor B650 and CARESCAPE Monitor B850.   K102239 CARESCAPE Monitor B650 The CARESCAPE Monitor B650 is a multi-parameter patient monitor intended for use in multiple areas and intra-hospital transport within a professional healthcare facility. The CARESCAPE Monitor B650 is intended for use on adult, pediatric, and neonatal patients and on one patient at a time. The CARESCAPE Monitor B650 is indicated for monitoring and recording of, and to generate alarms for, hemodynamic (including ECG, ST segment, arrhythmia detection, ECG diagnostic analysis and measurement, invasive pressure, non-invasive blood pressure, pulse oximetry, cardiac output, temperature and mixed venous oxygen saturation), impedance respiration, airway gases (CO2, O2, N2O and anesthetic agents), spirometry, gas exchange, and neurophysiological (including electroencephalography, Entropy, Bispectral Index (BIS) and neuromuscular transmission(NMT) status. The CARESCAPE Monitor B650 can be a stand-alone monitor or interfaced to other devices. It can also be connected to other monitors for remote viewing and to data management software devices via a network. The CARESCAPE Monitor B650 is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility. The CARESCAPE Monitor B650 is not intended for use during MRI. K092027 CARESCAPE Monitor B850 The CARESCAPE Monitor B850 is a multi-parameter high acuity patient monitor intended for use in multiple areas within a professional healthcare facility. The CARESCAPE Monitor B850 is intended for use on adult, pediatric, and neonatal patients and on one patient at a time. The CARESCAPE Monitor B850 system is indicated for monitoring of Hemodynamic (including ECG, ST Segment, Arrhythmia Detection, ECG Diagnostic Analysis and Measurement, Invasive Pressure, Noninvasive Blood Pressure, Pulse Oximetry, Cardiac Output, Temperature, Impedance Respiration and SvO2 (Mixed Venous Ox
GE Healthcare has recently become aware of potential safety issues associated with the CARESCAPE Monitor B850 and CARESCAPE Monitor B650.  These issues include both NIBP (Non-Invasive Blood Pressure)  and Bed to Bed Issues.
Worldwide Distribution - USA Nationwide in the states of AL, AZ, CA, CO, CT, DC, DE, FL, GA, IL, KS, KY, LA, MA, MD, MI, MN, MS, MT, NC, NE, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, VA, WA, WI, WV, including Hawaii and Puerto Rico and the countries of : Argentina, Austria, Canada, China, Costa Rica, Germany, Dominican Republic, Spain, France, Great Britain, Hong Kong, Hungary, Israel, Japan, Korea, Mexico, Poland, Portugal, Paraguay, Sweden, Singapore, Taiwan, and Uruguay.
Navigator Surgical Kit   Product Usage:  Molded plastic tray used in holding various dental instruments for autoclave processing.
During recent revised sterilization validation testing, the included surgical trays did not meet the Sterility Assurance Level required.
Tapered Navigator Certain Surgical Kit   Product Usage:  Molded plastic tray used in holding various dental instruments for autoclave processing.
Contra-Angle Torque Driver Kit   Product Usage:  Molded plastic tray used in holding various dental instruments for autoclave processing.
Contra-Angle Torque Driver Kit For Certain Internal Connection   Product Usage:  Molded plastic tray used in holding various dental instruments for autoclave processing.
Contra-Angle Torque Driver Kit For Certain and External Connection   Product Usage:  Molded plastic tray used in holding various dental instruments for autoclave processing.
Specialty Medicine Compounding Pharmacy, P.C.
Hospitals, clinics, physicians, and patients in the Michigan area only.
Dextrose* Vial In Sterile Water, 50%, 50 mL Single Dose Vial, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI  48178
Non-Sterility: 50% dextrose is being recalled after particulate matter, later identified as mold, was found floating in the product.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Product is sold at onsite retail store and through the internet (5%) to customers in ID, TX, OR, MN, Washington DC, MT, PA, IA, AZ, GA
Chocolate Pecan Fudge; Label reads in part ''***The Pecan Shed***Fresh Homemade Fudge***ALLERGY INFORMATION:  ALL OUR FUDGE IS MANUFACTURED ON THE SAME EQUIPMENT THAT PROCESSES PEANUTS, TREE NUTS, MILK, CREAM, SOY, EGG, WHEAT AND ARTIFICIAL FOOD COLORING.***''
product has no lot codes or expiration dates. Per firm, fudge expires in 2 weeks unless frozen. If frozen, it expires in 2 years
Presence of undeclared allergens soy, milk, and pecans
Plain Chocolate Fudge; Label reads in part ''***The Pecan Shed***Fresh Homemade Fudge***ALLERGY INFORMATION:  ALL OUR FUDGE IS MANUFACTURED ON THE SAME EQUIPMENT THAT PROCESSES PEANUTS, TREE NUTS, MILK, CREAM, SOY, EGG, WHEAT AND ARTIFICIAL FOOD COLORING.***''
Presence of undeclared allergens soy, and milk
Butter Pecan Fudge; Label reads in part ''***The Pecan Shed***Fresh Homemade Fudge***ALLERGY INFORMATION:  ALL OUR FUDGE IS MANUFACTURED ON THE SAME EQUIPMENT THAT PROCESSES PEANUTS, TREE NUTS, MILK, CREAM, SOY, EGG, WHEAT AND ARTIFICIAL FOOD COLORING.***''
Pecan Shed Special Turtle Fudge; Label reads in part ''***The Pecan Shed***Fresh Homemade Fudge***ALLERGY INFORMATION:  ALL OUR FUDGE IS MANUFACTURED ON THE SAME EQUIPMENT THAT PROCESSES PEANUTS, TREE NUTS, MILK, CREAM, SOY, EGG, WHEAT AND ARTIFICIAL FOOD COLORING.***''
Maple Nut with Pecans Fudge; Label reads in part ''***The Pecan Shed***Fresh Homemade Fudge***ALLERGY INFORMATION:  ALL OUR FUDGE IS MANUFACTURED ON THE SAME EQUIPMENT THAT PROCESSES PEANUTS, TREE NUTS, MILK, CREAM, SOY, EGG, WHEAT AND ARTIFICIAL FOOD COLORING.***''
Dark Chocolate with Pecans Fudge; Label reads in part ''***The Pecan Shed***Fresh Homemade Fudge***ALLERGY INFORMATION: ALL OUR FUDGE IS MANUFACTURED ON THE SAME EQUIPMENT THAT PROCESSES PEANUTS, TREE NUTS, MILK, CREAM, SOY, EGG, WHEAT AND ARTIFICIAL FOOD COLORING.***''
Tiger Fudge; Label reads in part ''***The Pecan Shed***Fresh Homemade Fudge***ALLERGY INFORMATION: ALL OUR FUDGE IS MANUFACTURED ON THE SAME EQUIPMENT THAT PROCESSES PEANUTS, TREE NUTS, MILK, CREAM, SOY, EGG, WHEAT AND ARTIFICIAL FOOD COLORING.***''
Presence of undeclared allergens soy, milk, and peanuts
Sucrose Free Chocolate Plain Fudge; Label reads in part ''***The Pecan Shed***Fresh Homemade Fudge***ALLERGY INFORMATION: ALL OUR FUDGE IS MANUFACTURED ON THE SAME EQUIPMENT THAT PROCESSES PEANUTS, TREE NUTS, MILK, CREAM, SOY, EGG, WHEAT AND ARTIFICIAL FOOD COLORING.***''
Chocolate Mint Fudge; Label reads in part ''***The Pecan Shed***Fresh Homemade Fudge***ALLERGY INFORMATION: ALL OUR FUDGE IS MANUFACTURED ON THE SAME EQUIPMENT THAT PROCESSES PEANUTS, TREE NUTS, MILK, CREAM, SOY, EGG, WHEAT AND ARTIFICIAL FOOD COLORING.***''
Pumpkin Pie Fudge; Label reads in part ''***The Pecan Shed***Fresh Homemade Fudge***ALLERGY INFORMATION: ALL OUR FUDGE IS MANUFACTURED ON THE SAME EQUIPMENT THAT PROCESSES PEANUTS, TREE NUTS, MILK, CREAM, SOY, EGG, WHEAT AND ARTIFICIAL FOOD COLORING.***''
Pumpkin Pie with Pecans Fudge; Label reads in part ''***The Pecan Shed***Fresh Homemade Fudge***ALLERGY INFORMATION: ALL OUR FUDGE IS MANUFACTURED ON THE SAME EQUIPMENT THAT PROCESSES PEANUTS, TREE NUTS, MILK, CREAM, SOY, EGG, WHEAT AND ARTIFICIAL FOOD COLORING.***''
Divinity with Pecans Fudge; Label reads in part ''***The Pecan Shed***Fresh Homemade Fudge***ALLERGY INFORMATION: ALL OUR FUDGE IS MANUFACTURED ON THE SAME EQUIPMENT THAT PROCESSES PEANUTS, TREE NUTS, MILK, CREAM, SOY, EGG, WHEAT AND ARTIFICIAL FOOD COLORING.***''
Presence of undeclared allergens soy, milk & pecans
Sucrose Free Chocolate Pecan; Label reads in part ''***The Pecan Shed***Fresh Homemade Fudge***ALLERGY INFORMATION: ALL OUR FUDGE IS MANUFACTURED ON THE SAME EQUIPMENT THAT PROCESSES PEANUTS, TREE NUTS, MILK, CREAM, SOY, EGG, WHEAT AND ARTIFICIAL FOOD COLORING.***''
Presence of undeclared allergens soy, pecans & milk
Birthday Cake Fudge; Label reads in part ''***The Pecan Shed***Fresh Homemade Fudge***ALLERGY INFORMATION: ALL OUR FUDGE IS MANUFACTURED ON THE SAME EQUIPMENT THAT PROCESSES PEANUTS, TREE NUTS, MILK, CREAM, SOY, EGG, WHEAT AND ARTIFICIAL FOOD COLORING.***''
Presence of undeclared allergens soy & milk
product has no lot codes or expiration date
Worldwide Distribution - USA (nationwide) including the states of  AL, AK, AZ, AR, CA, CO, CT, FL, GA, IL, IN, KS, KY, LA, ME, MD, MA, MI, MS, MO, NV, NJ, NY, NC, ND, OH, OK OR, PA, PR, RI, SC, TN, TX, UT, VA,WA,WY and  WI., and the countries of  ARGENTINA, AUSTRALIA, CANADA, CHINA, CZECH REPUBLIC, DENMARK, EGYPT, FINLAND, FRANCE, GERMANY, HUNGARY, INDIA, IRELAND, ITALY, JAPAN, JORDAN, REPUBLIC OF KOREA, MALAYSIA, MEXICO, NEW ZEALAND, NORWAY, PHILIPPINES, POLAND, RUSSIA, SAUDI ARABIA, SPAIN, SRI LANKA, TURKEY and UNITED KINGDOM.
The Innova 3131IQ (3131-IQ) and 2121 IQ (2121-IQ) biplane systems are indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally, rotational angiography procedures. They are also indicated for generating fluoroscopic images of human anatomy for cardiology, diagnostic, and interventional procedures. They are intended to replace fluoroscopic images obtained through image intensifier technology. These devices are not intended for mammography applications. The Innova systems are indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally, rotational imaging procures. They are also indicated for generating fluoroscopic images of human anatomy for cardiology, diagnostic, and interventional procedures. They are intended to replace fluoroscopic images obtained through image intensifier technology. These devices are not intended for mammography applications.
GE Healthcare has become aware of a potential safety issue involving the innova systems. The Innova system can unexpectedly stop delivering X-rays after a power-on or a reset cycle which may result in the loss of real-time interventional imaging. No injuries have been reported due to this issue.
Meijer stores in Illinois, Indiana, Kentucky, Michigan, and Ohio  Food Banks in
Markets of Meijer Pretzel Hamburger Bun, 4 count, NT.WT. 12.0 oz (0.75 lb), 16 oz ( 1 lb) UPC 412500558-2; Ingredients:   Enriched Wheat Flour( Wheat Flour, malted barley flour, niacin.....)water, sugar, canola oil, salt, .. , dough conditioner,  whey powder, yeast, dough conditioner...  soy oil, wheat gluten  Allergens: Contains wheat, soy    Pretzel Demi Roll 6'' , 4 count,12.0 oz (0.75 lb), 16 oz (1 lb) UPC  0-4125000560-2  Ingredients:  Wheat Flour...water, sugar, canola oil, salt, dough conditioner, cultured  , whey powder, yeast, dough conditioner...soy oil, wheat gluten  Allergens: Contains wheat, soy  Meijer Distribution, Inc.  Grand Rapids, MI 49544
all products with a sell date through 1/15/2014
Source of whey powder ingredient is not identified as milk and the allergen statement does not include milk. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume these products.
Markets of Meijer Pretzel Dinner Roll,  8 count, 14.0 oz ( 0.87 lb) UPC 0-4125099036-9   Ingredients: Enriched Flour ( Wheat Flour, Malted Barley Flour, niacin, iran, thiamine mononitrate....) water, sugar, canola oil, salt, why (milk) , yeast, wheat starch soy lecithin, wheat gluten  Allergens: Contains wheat, soy  Meijer Distribution, Inc.  Grand Rapids, MI 49544
Milk  not listed as Allergen.  People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume these products.
Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
American National Red Cross, Penn Jersey Region
Blood products, with platelet yields below the specified minimum requirement, were distributed.
Worldwide Distribution: US (nationwide) including states of: IL, LA, ME, MI, NC, OH, OK, VA, WI & WV; and to the country of: Canada.   Product was also shipped to Canada.
VERIFY SixCess 270FP Challenge Pack, STERIS Corporation, 5960 Heisley Road, Mentor, OH 44060, 440-354-2600.   The VERIFY SixCess 270FP Challenge Pack is used to monitor steam sterilization loads processed at 270F using typical healthcare dynamic air removal steam sterilization cycles.
STERIS has identified that the outer shipping package for one lot (Lot #024552A) of VERIFY SixCess Challenge Packs incorrectly identifies the lot as Lot #024522A.
Triamcinolone Acetonide Cream USP, 0.1%, Net Wt 80 grams per tube, Rx only, E. Fougera & Co., A division of Fougera Pharmaceuticals Inc., Melville, New York  11747, NDC 0168-0004-80, UPC 3 0168-0004-80 8.
Labeling: Label Error on Declared Strength: There is a misprint on the end flap which read 01% rather than 0.1%.
Blood products, collected from a donor who visited a malarial endemic region, were distributed.
HUDSON VALLEY HOMESTEAD BUSHWHACKER'S SAVORY SAUCE, Mild, Net Wt. 14 oz., UPC: 7 51122 00091 0, Hudson Valley Homstead 102 Sheldon Lane Craryville, New York 12521 (518) 851-7336, www.hudsonvalleyhomstead.com
Charlemagne's Tree Farm, Ltd. dba HUDSON VALLEY HOMESTEAD recalled BUSHWHACKER'S Savory Sauce ''Mild'' and ''Hot & Spicy'' types due to Undeclared Anchovies (fish).
HUDSON VALLEY HOMESTEAD BUSHWHACKER'S SAVORY SAUCE, Hot & Spicy, Net Wt. 14 oz., UPC 7 51122 00092 1, Hudson Valley Homstead 102 Sheldon Lane Craryville, New York 12521 (518) 851-7336, www.hudsonvalleyhomstead.com
Synthes Small Notch Titanium Reconstructive Plate   Product Usage:  The Synthes Small Notch Titanium Reconstructive Plate set offers fixation for immediate stabilization to allow bone fusion. Commercially pure titanium implants are biocompatible. The wide selection of implants accommodates variable anatomy; precisely crafted instruments facilitate implant placement. Implant plate lateral slant of holes allows for angulation of screws. Elongated central holes provide flexibility in screw placement. Wide selection of length's accommodates individual case requirements.
Certain modules containing the Synthes Small Notch Titanium Reconstructive Plate set was distributed by Spine sales consultants although it was contraindicated for certain spine applications.
Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
Carisoprodol Tablets, USP, 350 mg, unit dose blister packages of 100 tablets (10 cards of 10 tablets each), Rx only, Manufactured for: Qualitest Pharmaceuticals, Huntsville, AL NDC 51079-819-20
MARY ANN'S Chocolates Signature Assortment,May Contain Sugar, Chocolate, Butter, Corn Syrup, Assorted Fruit and Nuts, Coconut, Vegetable Oil, Egg or Vegetable Albumen , Salt, Natural and Artificial Flavors and Certified Food Colors.  Fruits Contain Sulfur Dioxide,   Savory Foods, Inc. Grand Rapids, MI 49507   SIGNATURE ASSORTMENT 5PC, 3 oz  UPC 733549030336  SIGNATURE ASSORTMENT 12PC-7OZ PINK BOX UPC 733549030343  CANDY-8OZ HEART BOXED ASSORTED CHOCOLATES  14.0 0Z BOX M CHOCOLATES SIGNATURE ASSORTMENT  13.0 OZ BOX M CHOCOLATES GRAND TRUFFLE ASSORTMENT  14 oz asstd UPC 733549030350  19 oz asstd  UPC 733549030367  25 oz asstd UPC 733549030442  CANDY-CANDY-CANDY-GRAND TRUFFLE ASSTD 4 PC   CANDY-GRAND TRUFFLE ASSTD 9 PC   CANDY-ASSORTED SNAPPERS 5PC-5OZ PINK BOX    Pictured Label placard on all boxes, all varieties:  Mary Ann's Chocolates Signature Assortment:  Lemon Creme Milk; Cherry Cordial Milk Raspberry Cream Milk, Tiramisu Truffle Dark, Caramel Milk/Dark Raspberry Truffle Dark, Almond Cluster Milk/Dark Chocolate; Coconut Cluster Milk, Chocolate Insanity Truffle Dark, Peanut Cluster Milk, Coconut Creme Milk, Maple Cream Milk, Pecan Cluster Milk, Irish Creme Truffle Dark
The ingredient panel for assorted chocolates did not identify  peanuts and specific tree nuts (almond, walnut, pecan, pistachio, cashew, macadamia and coconut). The source of lecithin was not identified as soy and lakes yellow 5, lakes yellow 6, red 3, red 40 and blue lake 1 were not identified as ingredients.
***Joint Support for Dogs***SYNOVIAL-FLEX SOFT CHEWS***TRP*Advanced Soft Chew Technology***Combining Glucosamine HCl, MSM, Creatine Monohydrate, Perna Canaliculus, Omega-3 Fatty Acids and Antioxidants in a Palatable Liver Flavored Chew***SOGEVAL***Shared solutions***Net Content: Contains 120 soft chews***
Consumer complaint of the smell of their Synovial Flex Soft Chews associated with Joint Max Double Strength soft chews that were inadvertently mislabeled as Synovial Flex Soft Chews.
US Distribution including the states of  FL, WA, PA, MS, TX, MN CA, NY, NJ, NC, CO and OH.
plastic tissue. The IHC PR Image Analysis application is intended for use as an aid to the pathologist in the detection and quantitation measurement of PR (Progesterone Receptor) in formalin-fixed, paraffin-embedded normal and neoplastic tissue. It is indicated for use as an aid in the management, prognosis, and prediction of therapy outcomes of breast cancer. Note: The IHC ER and PR Image Analysis applications are an adjunctive computer-assisted methodology to assist the reproducibility of a qualified pathologist in the acquisition and measurement of images from microscope slides of breast cancer specimens stained for the presence of estrogen and progesterone receptor proteins. The accuracy of the test result depends upon the quality of the immunohistochemical staining. It is the responsibility of a qualified pathologist to employ appropriate morphological studies and controls as specified in the instructions for the ER and PR reagent/kit used to assure the validity of the IHC ER and PR Image Analysis application assisted scores. IHC PR Breast Tissue Manual Read of Digital Slides: The ScanScope System is an automated digital slide creation, management, viewing and analysis system. It is intended for in vitro diagnostic use as an aid to the pathologist in the display, detection, counting and classification of tissues and cells of clinical interest based on particular color, intensity, size, pattern and shape. The ScanScope system is intended for use as an aid to the pathologist in the detection and quantitative measurement of PR (Progesterone Receptor) by manual examination of the digital slide of formalin-fixed, paraffin-embedded normal and neoplastic tissue immunohistochemically stained for PR on a computer monitor. It is indicated for use as an aid in the management, prognosis, and prediction of therapy outcomes of breast cancer.
In an abundance of caution, Aperio (now known as Lecia Biosystems) is providing additional information to clarify that the use of Digital IHC Breast/ER/Dako Image Analysis, Digital IHC Breast/HER2 Digital Read, Digital IHC Breast/HER2/Dako Image Analysis, Digital IHC Breast/PR Digital Read and Digital IHC Breast/PR/Dako Image Analysis with the RUO products identified in that earlier notification is also for Research Use Only and not for use in diagnostic procedures. As a result, we are including with this notice updated manuals for the image analysis algorthithms listed above so that the intended use in the hardware and software manuals is consistent.
VITROS Immunodiagnostic Products 25-OH Vitamin D Total Calibrators; REF/CATALOG # 684 4055, IVD --- COMMON/USUAL NAME: VITROS Vitamin D Calibrators -- Ortho-Clinical Diagnostics High Wycombe HP12 4DP, UK  --- For use in the calibration of the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic Systems, and the VITROS 5600 Integrated System for the quantitative measurement of total 25-OH Vitamin D in human serum.
Ortho Clinical Diagnostics has determined that the VITROS Immunodiagnostic Products 25-OH Vitamin D Total Calibrators, Lots 0091 through 0235, used with VITROS Immunodiagnostic Products 25-OH Vitamin D Total Reagent Packs, may generate negatively biased results.  As a result, users must immediately discontinue using all current lots of VITROS 25-OH Vitamin D Total Calibrators and Reagent Packs.
Treatment packs used on the VisuMax Laser Keratome. Size M    Manufactured by Carl Zeiss Meditec AG,  Jena, Germany.    The VisuMax Laser Keratome is indicated for the following: In the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring lamellar resection of the cornea. Patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea. In the creation of a lamellar cut/resection of the cornea for lamellar keratoplasty. In the creation of a cut/incision for penetrating keratoplasty and corneal harvesting.
1 package containing 10 individual treatment packs
Carl Zeiss Treatment pack, lot number M 130010, size M, may actually contain size S.
CELLTRACKS ANALYZER II (Product Code 9555)   Product Usage:    The CELLTRACKS ANALYZER II is a semi-automated fluorescence microscope, consisting of the analyzer, a dedicated computer with CELLTRACKS software, monitor, keyboard, mouse and uninterruptible power supply (UPS). The system also supports an optional Remote Review Workstation (RRW), which consists of a dedicated computer with CELLTRACKS software, monitor, keyboard and mouse. Use of this product requires training and should be used under the supervision of laboratory management. The CELLTRACKS ANALYZER II is for analysis of rare cells that are isolated from biological fluids including whole blood. It is used in conjunction with the CELLTRACKS AUTOPREP System, which automates and standardizes the sample preparation with specific reagent kits. An optional Remote Review Workstation is also available to provide the capability to review images and report results remotely.
Janssen Diagnostics, LLC received complaints of camera failures on the CELLTRACKS ANALYZER II.
Blood product, which was labeled as leukoreduced, but exceeded the acceptable limit for white blood cell count for leukoreduced products, was distributed.
Worldwide distribution: US (nationwide) and to countries of: ARUBA AUSTRALIA AUSTRIA BELGIUM BRAZIL CANADA ECUADOR EGYPT FINLAND FRANCE GERMANY HONG KONG INDIA INDONESIA IRELAND ISRAEL ITALY KENYA KOREA, REPUBLIC OF KUWAIT LATVIA LIBYAN ARAB JAMAHIRIYA MALAYSIA MEXICO MOROCCO NETHERLANDS NORWAY OMAN PAKISTAN PHILIPPINES POLAND QATAR RUSSIAN FEDERATION SAUDI ARABIA SINGAPORE SOUTH AFRICA SPAIN SWEDEN SWITZERLAND TAIWAN, PROVINCE OF CHINA THAILAND TURKEY UKRAINE UNITED ARAB EMIRATES and UNITED KINGDOM.
Philips HeartStart MRx Monitor/Defibrillator Models: M3535A and M3536A with Q-CPR Meter Option B08    The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physician
MRx units with the Q-CPR Meter option B08 and with a serial number within the range: US00100253 and US00571587
When the HeartStart MRx.is used with the Q-CPR Meter in defibrillation mode, the Q-CPR Meter may incorrectly display the Do Not Touch the Patient icon.
Distribution was made to AK, CA, CO, CT, DC, FL, GA, IL, IN, KY, LA, MA, MO, NC, NJ, NY, OH, OR, PA, RI, SC, TN, TX, VA and WI.
bioMerieux PREVI Isola System (General purpose,microbiology, diagnostic Medical Device), (REF 29500/29500R), bioMerieux, Hazelwood, MO.
Serial number range: AS 180-00001 to AS 180-00476
The firm has determined the product may fail to dispense the sample to the agar plate resulting in a ''failure to dispense'' in conjunction with urine specimens. This could lead to a ''false'' negative growth result.
Worldwide Distribution-USA (nationwide) including Puerto Rico and Guam and the countries of Algeria, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, Georgia, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Korea (Republic of), Kuwait, Latvia, Lebanon, Lithuania, Malaysia, Malta, Martinique, Mexico, Morocco, Namibia, New Zealand, Norway, Pakistan, Panama, Philippines, Poland, Portugal, Russia, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, and United Kingdom.
GE Healthcare Infinia and  Infinia Hawkeye  Nuclear Medicine Systems.  For Dual-Head Variable Angle Gamma Camera, Hawkeye Option for Dual-Head Variable Angle Gamma Camera (this includes GE Quasar Nuclear Medicine Systems). Nuclear Medicine Systems Infinia devices Product Usage: The intended use of the Quasar system is to perform general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and optional imaging features designed to enhance image quality in Oncology, Cardiology, Neurology and other clinical diagnostic imaging applications.
Potential safety issue related to unintended radial detector motion, which may occur during patient setup or at the end of a patient scan.  This failure mode has been observed on a single system, in which the detector moved to the home position and then slowly starting drifting inward toward the patient.  This generated both a visual and audio alert condition on both the console and the gantry.  No injuries have been reported.
GE Healthcare Varicam/VG and VG Hawkeye devices Product Usage: The intended use of the Quasar system is to perform general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition typed and optional imaging features designed to enhance image quality in Oncology, Cardiology, Neurology and other clinical diagnostic imaging applications. The scanning modes include planar (Static, Multi-gated, Dynamic, Whole body scanning) and tomographic (SPECT, Gated SPECT, Whole body SPECT, Camera based PET). Acquisition types include single and multi-isotope/multi-peak frame/list mode single-photon and positron imaging. Optional imaging-enhancement features include assortment of collimators, gating by physiological signals, real-time automatic body contouring, and CT-based attenuation correction and functional anatomic mapping.
all serial numbers are listed in Product 1
Elscint APEX Helix, dual-head, multi-purpose, Slip-Ring, digital gamma camera Product Usage: The intended use of the Quasar system is to perform general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition typed and optional imaging features designed to enhance image quality in Oncology, Cardiology, Neurology and other clinical diagnostic imaging applications. The scanning modes include planar (Static, Multi-gated, Dynamic, Whole body scanning) and tomographic (SPECT, Gated SPECT, Whole body SPECT, Camera based PET). Acquisition types include single and multi-isotope/multi-peak frame/list mode single-photon and positron imaging. Optional imaging-enhancement features include assortment of collimators, gating by physiological signals, real-time automatic body contouring, and CT-based attenuation correction and functional anatomic mapping.
all serial numbers are listed in Product 1.
Worldwide Distribution-USA (nationwide) including DC and the states of NM, LA, CA, MI, PR, GA, MD, MT, AL, MA, NY, IL, OH, TX, VA, MI, FL, MO, KY, TN, CT, NJ, PA, UT, SD, OK, MS, and NC and the countries of Algeria, Australia, Austria, Bangladesh, Belarus, The Netherlands, Brazil, Bulgaria, Chile, China, Columbia, Czech Republic, Denmark, Ecuador, Egypt, Finland, France,India, Indonesia, Iran, United Kingdom, Israel, Italy, Kuwait, Lebanon, Malaysia, Mexico, Sweden, Pakistan, Peru, Philippines, Poland, Portugal, Saudi Arabia, Taiwan, Thailand, Turkey, UAE, Argentina, Uzbekistan, Oman, Canada, Germany, and Switzerland.
RetCam 3, RetCam Portable and RetCam Shuttle;  manufactured by Clarity Medical Systems, Inc.; Pleasanton, CA 94588.    General ophthalmic imaging including retinal, corneal and external imaging.
166 Ret Cam Shuttles, 288 RetCam 3 and 23 RetCam Portables.
Software anomaly for RetCam 3, RetCam Shuttle and RetCam Portable with software versions 6.0.x, 6.1. x and 6.2x where the patients age is calculated incorrectly.
Nationwide Foreign:  AUSTRIA  BAHRAIN  BELGIUM  BRAZIL  CANADA  CHINA  EGYPT  ESTONIA  FINLAND  FRANCE  GERMANY  GHANA  ICELAND  INDIA  INDONESIA  IRELAND  ISRAEL  ITALY  JAPAN  JORDAN  KENYA  KOREA, REPUBLIC OF  LATVIA  LEBANON  LIBYAN ARAB JAMAHIRIYA  LITHUANIA  MALAYSIA  MEXICO  MOZAMBIQUE  MYANMAR (Burma)  NETHERLANDS  NETHERLANDS ANTILLES  NEW CALEDONIA  NEW ZEALAND  NORWAY  PAKISTAN  PERU  POLAND  PORTUGAL  QATAR  RUSSIAN FEDERATION  SAUDI ARABIA  SINGAPORE  SOUTH AFRICA  SPAIN  SWEDEN  SWITZERLAND  TAIWAN, PROVINCE OF CHINA  THAILAND  TURKMENISTAN  UNITED ARAB EMIRATES  UNITED KINGDOM  VIET NAM
Philips HeartStart MRx  Monitor/Defibrillator Model numbers: M3535A, M3536A, M3536M,M3536M4,M3536M6,861288,861289,861464,861483,and 861491
Serial numbers within the range: US00100204 to  US00570921
MRx may display a Red X in the Ready For Use (RFU) indicator during automated tests informing the user that a failure has been detected that may prevent the delivery of a shock and pacing
Valued Naturals Natural Coconut Net wt. 8oz (216.80g) Imported by Philippines  International Foodsource LLC 52 Richboynton Rd, Dover, NJ 07801    Packaged in 8 oz bag 12 per case.
NYSDAM Laboratory Analysis Reports has determined that Valued Naturals Natural Coconut contains 28.1 ppm sulfites.
Worldwide Distribution-USA (nationwide) including Puerto Rico and the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, ID, IL, KY, LA, MA, MS, MT, NC, NJ, NV, NY, OH, OR, PA, TN, TX, VA, WA, WI, WV, HI and the countries  Dubai, Curacao, Argentina, Australia, Chile, Germany, France, England, Hong Kong, Kuwait, Lebanon, Libya, Sri Lanka, Malaysia, New Zealand, Manila, Saudi Arabia, South Africa, Singapore, Turkey, Taipei and Vietnam.
Smith & Nephew  RENASYS Soft Port  REF: 66800799 (The RENASYS Soft Port Dressing Kits are used in conjunction with negative pressure wound therapy pumps)
Reports of wound fluid and /or blood that were not evacuated from beneath the wound dressing and the pump blockage alarm did not activate has been associated with inadequate Soft Port sealing at the wound site or improper positioning of the Soft Port orifice over the wound contact dressing drape.  Inadequate sealing can result in air leaks and contribute to inefficient fluid evacuation from the wound contact dressing and may adversely affect the performance of the blockage alarm.
Smith & Nephew  RENASYS-F Foam Dressing Kit with Soft Port  REF #'s: 66800794, 66800795, and 66800796 (The RENASYS Soft Port Dressing Kits are used in conjunction with negative pressure wound therapy pumps)
ALL LOT #'s: 2013011828 and lower- Small, 2013010125 and lower- Medium, and 2013011692 and lower - Large
Smith & Nephew  RENASYS-F XL with Soft Port  REF #: 66800797  (The RENASYS Soft Port Dressing Kits are used in conjunction with negative pressure wound therapy pumps)
Smith & Nephew  RENASYS-Gauze with Soft Port Kit  REF #'s: 66800933, 66800934, 66800935, and 66800936  (The RENASYS Soft Port Dressing Kits are used in conjunction with negative pressure wound therapy pumps)
ALL LOT #'s: 2013020417 and lower - Small, 2013020209 and lower- Medium, 2013020382 and lower - Large, and 2013020501 and lower- X-Large
Smith & Nephew  RENASYS-G Sterile, Gauze Dressing Kit with Soft Port REF #'s: 66800961  (The RENASYS Soft Port Dressing Kits are used in conjunction with negative pressure wound therapy pumps)
Smith & Nephew  RENASYS-AB Abdominal Dressing Kit with Soft Port REF #'s: 66800980  (The RENASYS Soft Port Dressing Kits are used in conjunction with negative pressure wound therapy pumps)
Roasting Cinnamon Butternut Squash Net Wt. 2 lbs (907 g) Foam Tray with 3 per case.  Keep Refrigerated  Distributed by Renaissance Food Group LLC   UPC 825786790333
Roasting cinnamon butternut squash is mislabeled.
Global Vitality, Inc. dba Enzyme Process International
Colon Rebuild I (90 capsules), 2boxes x 240 bottles, 1box x 200 bottles.
Global Vitality is recalling dietary supplements because they may be contaminated with chloramphenicol.
Fat Sugar (bulk), 3 boxes x 12 kg, 1 box x 8.76 kg.
Adrenal Support (bulk), 4 boxes x 12 kg, 1 box x 11.48 kg.
Energy Clarity (bulk), 6 boxes x 15 kg, 1 box x 10.55 kg.
Multi Vitamin (bulk), 6 boxes x 12 kg, 1 box x 5.5kg.
Total Digestion, Lot 1635, 4 boxes x 9.92 kg.   Lot 1841, 4 boxes x 12 kg, 1 box x 11.24 kg.  Lot 2017, 3 boxes x 10 kg, 1 box x 9.32 kg.
Pain Power, 100 vegetarian capsules, 55 boxes x 72 bottles, 1 box x 7 bottles.
Super Digestayme, 200 count, 2 boxes x 72 bottles, 1 box x 55 bottles. 300 count, 4 boxes x 72 bottles, 1 box x 12 bottles.
Colon Rebuild II, 210 capsules, 6 boxes x 72 bottles, 1 box x 70 bottles.
Mindray DS USA, Inc. dba Mindray North America
Worldwide Distribution - USA Nationwide Distribution
Panaroma Central Station     Product Usage:  This device can view real time, store, print, graph, and trend patient clinical and demographic data. The device can also set independent alarm limits for data send by the bedside monitor.
Mindray has identified two issues with the Panorama Central Station. Full Disclosure data may lag behind the Panorama system time clock when the Panorama Central Station is in use with Mindrays V-Series Monitor.  Additionally, event indicators lag behind the Panorama system time clock when the Panorama Central Station is in use with a Panorama Telepack.
Classic Sysco Custom Ready to Use Cherry Pie Filling; with other Natural Flavors #10 can - Net wt 7 lbs (3.18kg)   UPC 1 00 74865 38257 8    Manufactured for Sysco by  Lyons Magnus, Fresno, CA
Item 1846; Cherry Pie code 8004 SUPC 6346134
Precautionary withdrawal after inspection found metal on metal contact on an augur used in production. No metal has been discovered in any of the product.
Classic Sysco Custom Ready to Use Blueberry Pie Filling; Artificial Flavor #10 can - Net wt 7 lbs 1 oz  (2kg)   UPC 1 00 74865 38258 5    Manufactured for Sysco by  Lyons Magnus, Fresno, CA
Item 1847; Cherry Pie code 9204 SUPC 6346167
Product was shipped to distributors located in Texas, Louisiana, and Oklahoma.
MORRISON'S BROWN GRAVY MIX, NET WT 13 OZ (369 g) mislabeled as MORRISON'S PANCAKE MIX, NET WT 5 LB (2.27 kg)
brown gravy mix product mislabeled as pancake mix, resulting in undeclared soy (as hydrolyzed vegetable protein)
VerifyNow IIb/IIIa Test, Catalog No. 85310, 10-Test Kit and Catalog No. 85011, 25-Test kit.   Product  Usage:  The VerifyNow System is a turbidimetric based optical detection system which measures platelet-induced aggregation. The system consists of an instrument, a disposable test device and quality control materials. The VerifyNow IIb/IIIa Test is a semi-quantitative, whole blood platelet function test used to measure glycoprotein (GP) IIb/IIIa receptor blockade in patients treated with abciximab or eptifibatide. VerifyNow Ilb/Illa Test results should be interpreted in conjunction with other clinical and laboratory data available to the clinician.
Accumetrics is recalling the VerifyNow IIb/IIIa test because it may result in the reporting of an erroneous low platelet aggregation unit (PAU) result.   An erroneous low PAU result may cause a low percent inhibition calculation or low baseline PAU.
Product was distributed to AL, AR, CO, IN, GA, LA, NY, TX, VA and WI.
Jalapeno Ground 40, Elite Spice Code #JP9520, 50 lb poly-lined cartons labeled in part ***Elite Spice Inc. 7151 Montevideo Road, Jessup MD. 20794***
Bulk spice for futher manufacturing may be contaminated with Salmonella.
Jalapeno Nut Seasoning, Elite Code # 35076A2, 50 lb poly-lined cartons labeled in part ***Elite Spice Inc. 7151 Montevideo Road, Jessup MD. 20794***
Chipotle Nut Seasoning, Elite Code # 38113A2, 50 lb poly-lined cartons labeled in part ***Elite Spice Inc. 7151 Montevideo Road, Jessup MD. 20794***
Ole Hot Chorizo Seasoning, Elite Spice # 32581A9, 32 lb poly-lined carton, labeled in part ***Elite Spice Inc. 7151 Montevideo Road, Jessup MD. 20794***
Mexican Style Mild Chorizo, Elite Spice # 32582A9, 24 lb poly-lined carton, labeled in part ***Elite Spice Inc. 7151 Montevideo Road, Jessup MD. 20794***
Jalapeno Burger Seasoning, Elite Spice # 32680B2, 50 lb poly-lined carton, labeled in part ***Elite Spice Inc. 7151 Montevideo Road, Jessup MD. 20794***
Worldwide Distribution - USA (nationwide) and the countries of Brazil, Germany and Turkey
MAQUET PLEGIOX Cardioplegia Heat Exchanger   The PLEGIOX Cardioplegia Heat Exchanger is used as part of a cardioplegia system to set and maintain temperature for given flow rates and within the given temperature range of blood cardioplegic and crystalloid cardioplegic solutions during extracorporeal circulation. The product is designed for single use only, for an application period of no longer than 6 hours.
The MAQUET post-marketing vigilance program has identified a discrepancy that the desired cardioplegia temperature may not be obtained when the PLEGIOX Cardioplegia  Heat Exchanger (PLEGIOX) is used in conjunction with a heater/cooler unit.
nationwide.  No distribution outside the US.
Mar Cor Purification CWP Reverse Osmosis System.  Models 101, 102, 104, and 106.
There exists a potential situation with the crimp connection at the pump head assembly.  The potential exists that the reverse osmosis pump head wiring could build resistance resulting in resistive heating of the surrounding components.  If this occurs, the pump head assembly may experience melting of the plastic components and potentially create smoke/fire and shut down of the unit.
Alprazolam 1 mg Tablets, USP, 500 count Bottle, Rx Only , C IV, Manufactured by: Actavis Elizabeth LLC 200 Elmora Avenue Elizabeth, NJ 07207 USA, NDC 0228-2031-50
Failed Tablet/Capsule Specifications: Complaints were received for significant tablet erosion for Alprazolam 1 mg.
US Distribution including the states of SC, NC, LA, FL, TX,, AL and GA and Internationally to Germany.
Cannabinoids DAU Calibrator Control Level 1  (37.5 ng/mL)  This solution is prepared from non-sterile urine and should be handled as potentially infectious.  IVD;    The Cannabinoids (cTHC also known as THC version c) DAU negative and positive controls are human urine-based liquids and ready to use. The constituent is a processed drug-free human urine matrix, containing buffers, stabilizers, and less than 0.09 % of sodium azide. The controls are prepared by spiking known concentrations of 11-nor-9-THC-9-COOH into the drug-free  matrix. cTHC is referenced as an abbreviation for 11-nor-9-THC-9-COOH and it may be referred to simply as THC in the text of this report. The controls contain 37.5 ng/mL and 62.5 ng/mL of cTHC, 10% by GC/MS or LC/MS analysis.    Lin Zhi International inc.  Sunnyvale, CA 94085    The Cannabinoid Drug of Abuse (DAU) negative and positive controls are used as assay quality control material to monitor the precision of the Lin-Zhi International, Inc. (LZI) Cannabinoid Enzyme Immunoassay (Ref # 0070c) on a number of automated clinical chemistry analyzers.
Catalog number 0007Cm; lot number 1211158R; Expiration May 14, 2014.
Product catalog #s 0007c Cannabinoid 37.5 ng/mL Control Level 1 and 0008c Cannabinoid 62.5 Control Level 2 of the lots mentioned may give decreased concentration readings towards  the end of their shelf life due to use of dated but unexpired secondary stock used to create the  products.
Cannabinoids DAU Calibrator Control Level 1  (62.5 ng/mL)  This solution is prepared from non-sterile urine and should be handled as potentially infectious.  IVD;    The Cannabinoids (cTHC also known as THC version c) DAU negative and positive controls are human urine-based liquids and ready to use. The constituent is a processed drug-free human urine matrix, containing buffers, stabilizers, and less than 0.09 % of sodium azide. The controls are prepared by spiking known concentrations of 11-nor-9-THC-9-COOH into the drug-free  matrix. cTHC is referenced as an abbreviation for 11-nor-9-THC-9-COOH and it may be referred to simply as THC in the text of this report. The controls contain 37.5 ng/mL and 62.5 ng/mL of cTHC, 10% by GC/MS or LC/MS analysis.    Lin Zhi International inc.  Sunnyvale, CA 94085    The Cannabinoid Drug of Abuse (DAU) negative and positive controls are used as assay quality control material to monitor the precision of the Lin-Zhi International, Inc. (LZI) Cannabinoid Enzyme Immunoassay (Ref # 0070c) on a number of automated clinical chemistry analyzers.
Catalog number 0008c; lot number 1211160R; Expiration May 14, 2014.
Horiba Instruments, Inc dba Horiba Medical
Device Name: ABX PENTRA ML Model/Part #(s): A11A01652  Lot/Serial #(s): N/A  Software Version(s): All versions are subject to this correction.      Product Usage:  The ABX PENTRA ML is a software data management system intended for use on ABX Hematology Analyzers.
Model/Part #(s): A11A01652 Lot/Serial #(s): N/A  Software Version(s): All versions are subject to this correction.  Shelf Life: N/A
HORIBA Medical initiated this recall of all software versions of ABX PENTRA ML (Model A11A06152) due to a software bug with the potential of transmitting incorrect results to the Laboratory Information System.
STONEWALL KITCHEN brand Chocolate Coconut Cupcake Mix, Net Wt. 22.5 oz. (637.9 g), UPC 7 11381 31535 4 -- DISTRIBUTED BY STONEWALL KITCHEN, STONEWALL LANE, YORK, ME 03909
Labeling error.  The cupcake mix is made with coconut milk powder which contains the sub-ingredients coconut milk and sodium caseinate (milk).  These are listed in the ingredient statement.  The ''Contains'' allergen statement lists Soy, Tree Nuts (coconut), and Wheat, but Milk is not listed.
PENTARAY NAV High-Density Mapping Catheter, Catalog No. D128201, D128202, D128204, D128205.   The Biosense Webster PENTARAY NAV High-Density Mapping Catheter is indicated for multiple electrode electrophysiological mapping of cardiac structures in the heart, i.e., recording or stimulation only. This catheter is intended to obtain electrograms in the atrial and ventricular regions of the heart.
Biosense Webster is recalling the PentaRay Nav Catheter because it has the potential to have partial tip separation from the catheter shaft.
Blood product, for which the additive solution was not added during manufacturing, was distributed.
Gyrus ACMI Disposable Falope-Ring Band Applicator Kits.  REF 006889-901 and REF 005280-901 (with 8 mm Disposable Trocan).  Sterile EO.  Single Use Only.   The disposable Falope-Ring Band Applicator is a sterile, two-band, dual-incision instrument.  The two-band applicator enables the physician to occlude both Fallopian tubes without removing the applicator from the abdominal cavity.  The Falope-Ring Band and Applicator Kits are indicated for use for female sterilization (permanent contraception).
Due to an anomaly in the packaging process for specific lots of Disposable Falope-Ring Band Kit, it is possible that a defective seal could be present that may allow a breach of the package's sterile barrier and may compromise the sterility of the product.  The breach may or may not be easily seen.
Terasaki HLA Tissue Typing Trays (HLA Class II Tissue Typing Trays only).   Terasaki HLA Tissue Typing Trays are for use in determining HLA cell surface antigens  with a complement dependent microlymphocytotoxic technique.    BK840023
Catalog ID - DR72; Lot Number - 030; Batch 087
HLA typing assay, associated with false positive results, was distributed.
USA including AL, AK, AZ, CA, CO, CT, DE, DC, FL, GA, IL, IN, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NJ, NY, NC, ND, OH, OK, PA, RI, SC, TN, TX, VA, WA, WV, WI, WY, Puerto Rico and Internationally to  Albania, Algeria, Argentina, Australia, Austria, Bahamas, Barbados, Bermuda, British Guiana, Boliva, Brazil, British West Indies, Burundi, Canada, Chile, China, Columbia, Costa Rica, Cuba, Curacao, Cyprus, Czechoslovakia, Dominica, Equator, Estonia, Egypt, Finland, France, Gambia, Germany, Great Britain, Georgia, Greece, Guatemala, Hong Kong, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Lativa, Lithunia, Madagascar, Malaysia, Malta, Mexico, Mongolia, Myanmar, Netherlands, New Zealand, Nigeria, Pakistan, Peru, Philippines, Poland, Portugal, Romania, Russia, San Salvador, Saudia Arabia, Serbia, Singapore, Sir Lanka, South Korea, Spain, Sudan Slovenia, Suriname, Tajikistan, Thailand, Turkey, Turkmenistan, Taiwan, Ukraine, Uruguay, Venezuela, Viet Nam, Zambia.
XiO RPT System   The XiO RTP System is used to create treatment plans for any cancer patient for whom external beam radiation therapy or brachytherapy has been prescribed. The system will calculate and display, both on screen and in hard-copy, either two or three dimensional radiation dose distributions within a patient for a given treatment.
Dose and Monitor Unit values are not computed correctly when Elekta Motorized Wedges are used with Dynamic Conformal arcs.
Worldwide Distribution - USA (nationwide) and Internationally to Canada, Australia, Austria, China, Czech Republic, Denmark, Dubai / UAE, Estonia, France, Germany, Hungary, Iberia, India, Ireland, Israel, Italy, Malaysia, Netherlands, New Zealand, Norway, Pakistan, Poland, Portugal, Russia, Singapore, Slovenia, Spain, South Africa, Sweden, Switzerland, Turkey, United Kingdom, and Vietnam.
REF 623401 L S-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (with Pin), Left, medium,  Sterile R  Qty 1    The S-ROM Hinged knee femoral component is used in revision surgeries when there is significant bone loss or ligament instability and additional support is needed. S-Rom femorals and inserts are brought into nearly every revision case as backup should the MCL become compromised during the procedure. If additional constraint is required the surgeon can use the S-ROM femoral and insert. S-ROM femorals are used in less than 10% of knee revision procedures, but are present almost all the time.
DePuy Orthopaedics has identified the potential for holes to develop in the inner and outer flexible pouches that form the sterile barrier for S-ROM Noiles Rotating Hinge Femur with Pin devices. The outer carton and shrink wrap are intact. A package redesign is underway to resolve this issue. S-ROM Noiles Rotating Hinge Femur with Pin devices will remain in US Distributors inventory during the packaging redesign because all units within recalled lots may not be affected. In addition, pre-implantation inspection of the implants packaging will allow the surgeon to determine whether there are any breaches in the packaging of individual S-ROM Noiles Rotating Hinge Femur with Pin devices. Implants with intact packaging may be used as intended.
REF 623401 R, S-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (with Pin), Right, Medium,  Sterile R Qty 1    The S-ROM Hinged knee femoral component is used in revision surgeries when there is significant bone loss or ligament instability and additional support is needed. S-Rom femorals and inserts are brought into nearly every revision case as backup should the MCL become compromised during the procedure. If additional constraint is required the surgeon can use the S-ROM femoral and insert. S-ROM femorals are used in less than 10% of knee revision procedures, but are present almost all the time.
REF 623411 L, S-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (with Pin), Left, Small,  Sterile R Qty 1    The S-ROM Hinged knee femoral component is used in revision surgeries when there is significant bone loss or ligament instability and additional support is needed. S-Rom femorals and inserts are brought into nearly every revision case as backup should the MCL become compromised during the procedure. If additional constraint is required the surgeon can use the S-ROM femoral and insert. S-ROM femorals are used in less than 10% of knee revision procedures, but are present almost all the time.
REF 623411 R S-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (with Pin), Right, Small,  Sterile R Qty 1    The S-ROM Hinged knee femoral component is used in revision surgeries when there is significant bone loss or ligament instability and additional support is needed. S-Rom femorals and inserts are brought into nearly every revision case as backup should the MCL become compromised during the procedure. If additional constraint is required the surgeon can use the S-ROM femoral and insert. S-ROM femorals are used in less than 10% of knee revision procedures, but are present almost all the time.
REF 623421 L S-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (with Pin), Left , X-Small,  Sterile R Qty 1    The S-ROM Hinged knee femoral component is used in revision surgeries when there is significant bone loss or ligament instability and additional support is needed. S-Rom femorals and inserts are brought into nearly every revision case as backup should the MCL become compromised during the procedure. If additional constraint is required the surgeon can use the S-ROM femoral and insert. S-ROM femorals are used in less than 10% of knee revision procedures, but are present almost all the time.
REF 623421 RS-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (with Pin), Right , X-Small,  Sterile R Qty 1    The S-ROM Hinged knee femoral component is used in revision surgeries when there is significant bone loss or ligament instability and additional support is needed. S-Rom femorals and inserts are brought into nearly every revision case as backup should the MCL become compromised during the procedure. If additional constraint is required the surgeon can use the S-ROM femoral and insert. S-ROM femorals are used in less than 10% of knee revision procedures, but are present almost all the time.
USA including  FL, MN, LA, NJ, NM, PA, TX and Internationally to Canada.
Hand Control 12FR Suction Coagulator with 10 ft cord and holster, Sterile, Disposable, Model Number 0043-25, packaged Tyvek polyester peel pouch, 25 pouches per box.   This device is intended to conduct monopolar electrosurgical energy from an electrosurgical generator (ESU) to target tissue during ENT and general surgical procedures. It is also a suction apparatus used to remove surgical smoke and fluids from the site. The device is intended for single use; it is not intended to be cleaned or reused.
Catalog Number: 0043-25 Lot Number: 132405  Exp. Date: 07-2018
Megadyne Medical Products, Inc. is voluntarily recalling Hand Control 12Fr Suction Coagulator with 10ft cord and 132405 Holster, Sterile, Disposable, Lot 132405 due to the potential for a small number of these suction coagulators to self-activate immediately on connection to the electrosurgical generator and to remain activated until it is disconnected.
Human corneas, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, were distributed.
Boston Scientific, RunWay'' Guide Catheter, UPN H749389696640, Catalog Number 38969-664.
Boston Scientific is initiating this Recall Removal of one lot (2013040058) of the RunWay'' Guide Catheter. Boston Scientific has become aware that the sterile pouch of the devices from this lot may not be completely sealed and sterility may be compromised. To date, Boston Scientific has received one complaint for this issue. The most common adverse health consequence expected from an unsealed pouch is a transient bacteremia, which may require antibiotic therapy.
Human corneas, recovered from a donor who was not properly evaluated for hemodilution, were distributed.
Photofrin (porfimer sodium) for Injection, 75 mg Single Use Flip-Top Vial, Rx Only. Manufactured for: Pinnacle Biologics, Inc. Bannockburn, IL 60015. NDC:76128-155-75
Stability Data Does Not Support Expiry: Printed expiration date should be Nov 2013 rather than Nov 2014.
Blood products, collected from a donor whose suitability to donate was not fully evaluated, was distributed.