Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Texas, Idaho, Montana, Oklahoma, California,  Florida.
Blood products, collected from an ineligible donor, were distributed.
Blood and Blood Products for Reprocessing
Blood products,  collected from an ineligible donor, were distributed.
Blood products, with unacceptable, undocumented or incomplete product QC and platelet counts were distributed.
Blood products, collected from donor's who did not have a complete physical examination, were distributed.
Provenge (sipuleucel-T), with an out-of-specification (OOS) assay result, was distributed.
Major Oral Peroxide (Carbamide Peroxide 10%), 2 fl oz (60 mL), Distributed by: Major Pharmaceuticals 31778 Enterprise Drive, Livonia, MI 48150, NDC 0904-4062-03
Stability data does not support expiration date:  Stability data indicates the Carbamide Peroxide will degrade below acceptable levels within the 24-month expiration date printed on the packaging.
Trastuzumab Kit containing 1 vial Trastuzumab (nominal content: 440 mg); 1 20 mL multiple dose vial Bacteriostatic Water for Injection, USP (1.1% benzyl alcohol), Manufactured by Hospira, Inc., for Genentech, Inc., South San Francisco, CA  94080-4990, NDC 50242-903-69; and 1 Reconstitution Instructions per kit; Investigation Use only, Genentech, Inc., 1 DNA Way, South San Francisco, CA  94080-4990.
Lot #: 454138, Exp 07/14 (containing Trastuzumab Lot #: 886618, Exp 12/14; and Bacteriostatic Water for Injection, USP Lot #: 08-368-DK-01, Exp 07/14)
Presence of Particulate Matter: One lot of Bacteriostatic Water for Injection, USP diluent vials that were packed with Trastuzumab Kits for investigational use has the potential to contain glass particulates.
Red Blood Cells Leukocytes Reduced Irradiated
Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
Blood product, which was collected from a donor who traveled to malarial endemic areas, was distributed.
Community Blood Centers of South Florida, Inc.
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
Community Blood Centers of Florida, Inc.
Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed.
Platelets Pheresis Leukocytes Reduced Irradiated
Blood product, which was not tested to verify the pH and White Blood Cell count, was distributed.
Blood products, collected from a donor who did not have a complete physical examination, were distributed.
North Carolina;  Austria;  Missouri;  Arkansas;  Indiana
Blood products, collected from a donor who was in close contact with an individual diagnosed with Hepatitis B, were distributed.
Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
Blood product, collected from a donor who did not have a complete physical examination, was distributed.
American National Red Cross, Penn-Jersey Region
Blood products, collected using equipment that had not been validated, were distributed.
Nationwide Distribution including AL, AR, AZ, CA, CT, DC, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WY and GUAYNABO, PR.
Roche COBAS INTEGRA 400 and 400 plus Analyzer   The Roche COBAS INTEGRA 400/400 plus Analyzer is a fully automated system for clinical chemistry analysis intended for the in vitro quantitative/qualitative determination of analytes in body fluids.
A software security issue with Oracles TNS-Listener component has been identified.  TNS-Listener is supplied with the Roche COBAS INTEGRA 400/400 plus Analyzers.  The Oracle TNS-Listener can be considered as an authentication and redirection component between the client and the database inside the Roche product.  This means an attacker could register their own non-Roche database via remote access over the network to the Roche product and read and write database queries without authentication and therefore modify the content of a database.
American National Red Cross SW Region - HT
Blood products, which were labeled with an incorrect volume, was distributed.
Worldwide Distribution - US (nationwide) including the states of: AZ, CA, FL, HI,  IL, MD,MI,  MO,NC, TN, TX and the country of Australia.
DePuy Spine VIPER POLY SCREW 5.5 8 X70MM Tl Product Code: 1867-15-870 Spinal Implant Component.
Polyaxial screws 8x 80 and larger may disassociate when inserting in the Ilium., VIPER large diameter long screws in high-torque circumstances, the screw shank has the potential to separate from the polyaxial head
DePuy Spine VIPER POLY SCREW 5.5 8 X80MM Tl Product Code: 1867-15-880 Spinal Implant Component.
DePuy Spine VIPER POLY SCREW 5.5 8 X100MM Tl Product Code: 1867-15-899 Spinal Implant Component.
DePuy Spine VIPER POLY SCREW 5.5 9 X70MM Tl Product Code: 1867-15-970 Spinal Implant Component.
DePuy Spine VIPER POLY SCREW 5.5 9 X 80MM Tl Product Code: 1867-15-980 Spinal Implant Component.
DePuy Spine VIPER POLY SCREW 5.5 9 X100MM Tl Product Code: 1867-15-999 Spinal Implant Component.
DePuy Spine VIPER POLY SCREW 5.5 10 X 70MM Tl Product Code: 1867-15-170 Spinal Implant Component.
Polyaxial screws 8x 8 and larger may disassociate when inserting in the Ilium., VIPER large diameter long screws in high-torque circumstances, the screw shank has the potential to separate from the polyaxial head
DePuy Spine VIPER POLY SCREW 5.5 10 X 80MM Tl Product Code: 1867-15-180 Spinal Implant Component.
Polyaxial screws 8x 80and larger may disassociate when inserting in the Ilium., VIPER large diameter long screws in high-torque circumstances, the screw shank has the potential to separate from the polyaxial head
DePuy Spine VIPER POLY SCREW 5.5 10X100MM Tl Product Code: 1867-15-199 Spinal Implant Component.
Polyaxial screws 8x 80 and larger may disassociate when inserting in the Ilium. VIPER large diameter long screws in high-torque circumstances, the screw shank has the potential to separate from the polyaxial head
Blood product, which was labeled as leukoreduced, but was not tested to verify the White Blood Cell count, was distributed.
Community Blood Bank of Lancaster County Medical Society
Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.
Blood product, collected from a donor for whom a hemoglobin screening test was not performed, was distributed.
Blood product, mislabeled as to antigen phenotype, was distributed.
Magnolia Bird Farm Hookbill Supreme, 2 lbs. clear plastic; 5 lbs.; 10 lbs. in brown Kraft bag; 25; 50 lbs. in white paper bag;***PACKAGED BY MAGNOLIA BIRD FARM 8990 CERRITOS AVE. ANAHEIM, CA. 92804***12200 MAGNOLIA AVE. RIVERSIDE, CA. 92503.
No identifying codes are used by the firm for these products
Magnolia Bird Farm is recalling Bird Feed Mix that contains In-Shell Peanuts from Sunland Inc. because it may be contaminated with Salmonella.
Magnolia Bird Farm Conure Mix, 2 lbs. clear plastic; 5 lbs.; 10 lbs. in brown Kraft bag; 25 lbs; 50 lbs. in white paper bag;***PACKAGED BY MAGNOLIA BIRD FARM 8990 CERRITOS AVE. ANAHEIM, CA. 92804***12200 MAGNOLIA AVE. RIVERSIDE, CA. 92503
Magnolia Bird Farm Parrot Mix, 3 lbs. clear plastic; 5 lbs; 10 lbs. in brown Kraft bag;  25 lbs; 50 lbs. in white paper bag.;***PACKAGED BY MAGNOLIA BIRD FARM 8990 CERRITOS AVE. ANAHEIM, CA. 92804***12200 MAGNOLIA AVE. RIVERSIDE, CA. 92503
Magnolia Bird Farm Hulled Peanuts, 2 lbs. clear plastic. in ***PACKAGED BY MAGNOLIA BIRD FARM 8990 CERRITOS AVE. ANAHEIM, CA. 92804***12200 MAGNOLIA AVE. RIVERSIDE, CA. 92503.
Peanuts packaged in clear plastic bags, brown Kraft bags, or white paper bags have no identifying codes.   Peanuts in the original Sunland yellow mesh bag will have either best by dates from October 12, 2012 through October 12, 2013 on the packaging, or a Crop Year marking on the package of 2011 or 2012, up to and including October 12, 2012.
Magnolia Bird Farm is recalling Hulled Peanuts from Sunland Inc. because it may be contaminated with Salmonella.
Magnolia Bird Farm Large Hookbill, 2 lbs. clear plastic; 5 lbs.; 10 lbs. in brown Kraft bag; 25 lbs; 50 lbs. in white paper bag;***PACKAGED BY MAGNOLIA BIRD FARM 8990 CERRITOS AVE. ANAHEIM, CA. 92804***12200 MAGNOLIA AVE. RIVERSIDE, CA. 92503
No identifying codes are used by the firm for these products.
Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed.
Blood product, collected from a donor for whom there was no documentation on the donor record of an arm inspection, was distributed.
American Red Cross Blood Svs. Indiana-Ohio Region
Blood products, collected using a machine for which the monthly quality control testing for platelet products failed,  were distributed.
Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
Blood product, collected from a donor with a history of incarceration, was distributed.
Inova Health Care Services, Inova Blood Donor Services
Blood product, collected from a donor whose health history screening was inadequately performed, was distributed.
Banco de Ojos del Leonismo Puertorriqueno
Human Corneas, recovered with a donor with risk factors for relevant communicable disease agents and diseases, were distributed.
Lisinopril Tablets, USP 40 mg, packaged in a) 100-count tablets per bottle (NDC 0143-1270-01); b) 1000-count tablets per bottle (NDC 0143-1270-10); Rx only, Manufactured by: West-ward Pharmaceutical Corp., Eatontown, NJ  07724; and c) 1000-count tablets per bottle (NDC 24658-245-10); Rx only, Manufactured for: Blu Pharmaceuticals, Franklin, KY 42134; Manufactured By: West-ward Pharmaceutical Corp., Eatontown, N.J. 07724.
Presence of Foreign Substance: Uncharacteristic black spots identified as a food grade lubicant with trace amounts of foreign particulates and stainless steel inclusions have been found in the tablets.
Propylthiouracil Tablets, USP, 50 mg, packaged in a) 100-count tablets per bottle (NDC 0143-1480-01) and b) 1000-count tablets per bottle (NDC 0143-1480-10), Rx only, Manufactured by: West-ward Pharmaceuticals Corp. Eatontown, NJ 07724.
Presence of Foreign Substance: Uncharacteristic spots identified as steel corrosion, degraded tablet material and hydrocarbon oil with trace amounts of iron were found in tablets.
LifeStyles Pleasure Collection  30 Premium Lubricated Condoms    UPC 0-70907-02625-0.    A sheath which covers the penis with a closely fitting membrane. The condom is used for contraceptive and for prophylactic purposes (preventing transmission of sexually transmitted infections).
One lot of LifeStyles Pleasure Collection Lubricated Condoms is misbranded.
New York, Pennsylvania, New Jersey, Virginia, Maryland, and Massachusetts
Wegmans Organic Spinach & Spring Mix --- Product is packaged in clam shell in two sizes: 5oz and 11oz.
All lot codes sold between October 14, 2012 and November 1, 2012.
Wegmans has recalled 5 oz. and 11 oz. packages of Organic Spinach and Spring Mix Blend because the product may be contaminated with E. coli O157:H7.
Worldwide Distribution -- USA (nationwide)  and the countries of   Austria, Barbados, Belgium, Canada, China, Colombia, Cyprus, Czech Republic, Denmark, France, Germany, Greece, Hungary, India, Ireland, Italy, Japan, Latvia, Libya, Malaysia, Netherlands, New Zealand, Poland, Portugal, Russia, Saudi Arabia, Serbia, Slovakia, Spain, Sweden, Switzerland, Turkey and United Kingdom.
ARCHITECT 25-OH Vitamin D Reagent Kit, 03L52-25 (ROW) and 03L52-27 (U.S.) (1 x 100 tests), 03L52-35 (ROW) and 03L52-37 (U.S.) (5 x 100 tests); Abbott Laboratories, Abbott Park, IL 60064 USA, Abbott, Max-Planck-Ring 2, 65205 Wiesbaden, Germany, product of Spain;    Product Usage:The ARCHITECT 25-OH Vitamin D assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of 25-hydroxyvitamin D (25-OH vitamin D) in human serum and plasma. The ARCHITECT 25-OH Vitamin D assay is to be used as an aid in the assessment of vitamin D sufficiency.
The Architect 25-OH Vitamin D assay has the potential to generate falsely elevated or falsely depressed results when used with certain lots of Architect Reaction Vessels.
USA including CT, FL, IL, KS, MD, MI, MO, NY, PA, RI, TX and WI.  Internationally to Canada, Europe and Japan.
BD MAX (tm) (6 channel) Instruments, Catalog number 441916, labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, Maryland 21152 USA***   The BD MAX'' System, used in conjunction with appropriate extraction kits and reagents, is capable of automated extraction and purification of nucleic acids from multiple specimen types. The BD MAX System is also capable of automated amplification and detection of target nucleic acid sequences for use in clinical, industrial and research settings. The MAX reader assembly is the optics component of the instrument that translates PCR amplification into curves. The curves are evaluated by an algorithm when used with BD assays to interpret results. For open system reagent (OSR) users, the curve is evaluated manually to interpret the results based on their own validated criteria. The heater is part of an assembly that controls both the thermal cycling during the PCR reaction and the opening of the wax valves in the cartridge consumable.
Serial Numbers:   MX0001 to MX0065   CM0001 to CM0105    NOTE:  Serial numbers are assigned sequentially.  The above ranges will include all sequential numbers in between the beginning and end points.
Clinical diagnostic instrument may exhibit minor defects, which could lead to erroneous test results.
AZ, CA, DE, FL, GA, IL, MA, MO, NC, NH, NJ, NY, OH, PA, TX, VA and Puerto Rico
Cold Smoke Salmon in vacuum plastic bags, labeled in part: ***BLACK BEAR***of the BLACK FOREST*** Naturally Smoked***Smoked Salmon***Extra Fancy***1 lb.***
Potential to be contaminated with Listeria Monocytogenes
Cold Smoke Salmon in vacuum plastic bags.  Food Service Cold Smoked Salmon Trim 1 lb.
UPC # n/a Lots = 235 thru 345  Process = 7831
Cold Smoke Salmon in vacuum plastic bags, labeled in part: ***HAND-PACKED***DARN GOOD***Atlantic Smoked Salmon***KOSHER***einsteinbros.com***
Cold Smoke Salmon in vacuum plastic bags.  Food Service Whole Smoked Side. Labeled in part: ***Unsliced Cold Smoked*** Salmon Fillet Skin On***
UPC # n/a Lots = 249 thru 291  Process = 7826 & 7823
Cold Smoke Salmon in vacuum plastic bags, labeled in part: ***Silver***Source***Smoked***Salmon***Salmon Salar***
Reorders numbers= 230237 (2 Sliced Skin Off Fillets) 230251 (4-5 Sliced Skin Off Fillets) and 230254 (10 Sliced Skin Off Fillets) Process = 7843  Lots = 249 thru 291
Cold Smoke Salmon in vacuum plastic bags, labeled in part: ***Royal Fjord*** Smoked Salmon***Toppers***
Cold Smoke Salmon in vacuum plastic bags, labeled in part: ***SMOKED***SALMON***Deli Sliced***Ready to Serve***Royal Fjord***Center***Cut Loin***
Cold Smoke Salmon in vacuum plastic bags, labeled in part: ***H E B***ALL NATURAL***SMOKED***SALMON***Sliced and Ready to Serve***4 oz***
Cold Smoke Salmon in vacuum plastic bags, labeled in part: ***Royal Fjord***Smoked Salmon***Rounds***5oz***
Cold Smoke Salmon in vacuum plastic bags, labeled in part: ***Smoke***Nova***Salmon***Supreme Fine Foods*** 2lb***
Cold Smoke Salmon in vacuum plastic bags, labeled in part: ***New England Smoked Salmon***
Massachusetts, Connecticut, Maine, New Hampshire and Vermont
Diet Wild Cherry Pepsi two liter plastic bottles  UPC 1234107
Best Before Date of Feb2513 and a Manufacturing Code of PF11282
The labels on two-liter batches of Regular and Diet Wild Cherry Pepsi were mistakenly swapped during production. This is potential safety issue for individuals who are sensitive to phenylalanine (i.e., phenylketonuric) or who are diabetic.
Regular Wild Cherry Pepsi two liter plastic bottles UPC 1231100
Product was shipped to the following states: NJ & NY
Dairy Aid Lactase Enzyme Supplement, Caplet, 3,000 FCC Units, 60 caplets, OTC, Repackaged by: Cardinal Health, Zanesville, OH 43701, NDC 55154-1335-4
The firm discovered that the labeling bears an incorrect strength of 9,000 FCC Units per caplet instead of 3,000 FCC units per caplet.
Tzatziki; Greek yogurt with cucumber and dill. sold in 8 oz retail and 5 lb bulk food service containers.  Undeclared milk.  Manufactured by Haigs Delicacies, Hayward, CA.
State of CA inspection found four products that do not declare allergy statements which reflect the use of milk, wheat and eggs.
Falafel with Tahini Sauce; nuggets of ground garbanzo beans with a rich, tangy tahini sauce.  Sold in 5 oz retail rectangular deli containers and 5 lb bulk foodservice.  Undeclared wheat  Manufactured by Haigs Delicacies, Hayward, CA.
State of CA inspection found four products do not declare allergy statements which reflect the use of milk, wheat and eggs.
Spanakopita; a triangular phyllo dough pastry with spinach and cheese filling. sold in 5 lb. bulk Foodservice cases.  Undeclared wheat, milk and eggs  Manufactured by Haig's Delicacies, Hayward, CA.
Tyropita; a triangular phyllo dough pastry with cheese filling.  sold in 5 lb.  bulk Foodservice cases  .  Undeclared wheat, milk and eggs.  Manufactured by Haig s Delicacies, Hayward, CA.
Worldwide Distribution-USA including the states of MA, TN, KY, IN, GA, NC, TX, NY, FL, AZ, WA, NJ, MI, and CA, and the countries of Uruguay, Taiwan, Singapore, Australia, South Korea, Mexico, Hong Kong, Guatemala, Columbia, Chile, Canada, India, Japan, Brazil, China and Belgium.
BBL Crystal Enteric/Nonfermenter ID Kit, Catalog # 24500, cartons of 20 kits, labeled in part ***Becton, Dickinson and Company, Sparks MD 21152***   The BBL Crystal Enteric/Nonfermentor (E/NF) identification (ID) System is for the identification of aerobic gram-negative bacteria that belong to the family Enterobacteriaceae as well as some of the more frequently isolated glucose fermenting and nonfermenting gram-negative bacilli.
In-vitro diagnostic reagents for microbiological testing may be reversed in well positions in the test kit and when utilized may lead to bacteria misidentification.
US Nationwide Distribution in the states of NY, PA and TN.
Medisystems 15 Gauge x 3/5 inch Buttonhole Needle Set Product Code: BH-2035PE    Product Usage:  Medisystems Buttonhole Needle Sets are indicated for use as an access device for dialysis and pheresis procedures using a constant site orbuttonhole method of needle insertion.
A total of 5 (ea) single needle pouches are mislabeled as 15 Ga x1'' instead of 15 Ga x 3/5''.
Medisystems 17 Gauge x 1'' inch AV Fistula Needle Product Code: D9-2007MGLB    Product Usage:  Medisystems AVF with MasterGuard anti-stick needle protector is indicated for use as a vascular access device in hemodialysis or other extracorporeal procedures. It is intended for use in conjunction with a blood tubing set equipped with a standard medical male luer-locking connector
Single needle packs in each case ( 10 needles per case) are mislabeled on the pouch as 15 Gauge needles instead of 17 Gauge
Lisinopril and Hydrochlorothiazide Tablets, 20 mg/25 mg, packaged in a) 100-count tablets per bottle (NDC 0143-1264-01) and b) 1000-count tablets per bottle (NDC 0143-1264-10), Rx only, Manufactured by: West-ward Pharmaceutical Corp., Eatontown, NJ 07724.
Presence of Foreign Substance: Reports of gray smudges identified as minute stainless steel particulates were found in the recalled tablets.
PredniSONE Tablets, USP, 20 mg, packaged in a) 100-count tablets per bottle (NDC 0143-1477-01), b) 500-count tablets per bottle (NDC 0143-1477-05), and c) 1000-count tablets per bottle (NDC 0143-1477-10), Rx only, Manufactured by: West-ward Pharmaceutical Corp., Eatowntown, NJ 07724.
Presence of Foreign Substance: A complaint was received for black specks identified as stainless steel inclusions and cellulose with trace amounts of aluminum and iron-rich inclusions.
GreenLight HPS (High Performance System) GreenLight XPS ( Xcelerated Performance System)    Manufactured by AMS, Solutions for Life  Innovation Center - Silicon Valley,  3070 Orchard Drive, San Jose, CA 95134.    GreenLight HPS and XPS Surgical Lasers Systems and accessories are intended for use in endoscopic 532 nm laser resection of the prostate for the treatment of benign prostatic hyperplasis. The entire laser unit and controls are contained in a single console that is connected to external electricity and are required to meet IEC 60601.
During electrical recertification testing it was found that the Voltage Scaling Board was non-conforming to the IEC 60601-1-2 standard.
Worldwide Distribution - USA (nationwide) Puerto Rico and internationally to Belgium, Colombia, Czech Republic, Dubai, Guatamala, Hong Kong, India, Israel, Italy, Japan, Kenya, Kuwait, Malaysia, Mexico, New Zealand, Norway, Oman, Pakistan, Portugal, Saudi Arabia, Thailand, and Uruguay.
ELECTROLASE(R) HYFRECATOR(R) ELECTRODES - SHARP, Disposable Hyfrecator(R) Tips, REF/Catalog No. 7-100-8CS, Sterile, Rx ONLY -- CONMED CORPORATION 525 FRENCH RD., UTICA, NY 13502-5994 --- Product Name: Electrosurgery Active Electrodes and Accessories; Common First Name: Electrosurgical, Cutting and Coagulation and Accessories. MDL D092250.   The Electrolase Sterile Disposable Electrodes are intended to be used as active RF electrodes for desiccation, fulguration and coagulation. The ESP Electrode blades are components for electrosurgical pencils. The electrodes provide specific shapes and lengths to allow the clinician to utilize these different configurations for various clinical applications. The UltraClean version differs from the Universal as it has a ''non-stick'' finish. The Single Use ABC Nozzle is intended for use in the operating room for any procedure in which an electrosurgical generator would be used, i.e. for the surgical removal of tissue and for the control of bleeding.
Beginning Lot Code 120628X, Ending Lot Code 120917X. [Lot codes on boxes and packaging contain a lot code in the following format: 120917X  where 12 represents the year (2012), 09 represents the month (September), 17 represents the day of the month, and X represents the manufacturing shift code (1, 2, 3, 4,5,6 or 9)].
ConMed received complaints of some devices which had broken through the seal of the sterile pouch.  ConMed confirmed instances where the pouch seal was compromised on the affected products.  In no instance has it been reported to ConMed that a compromise in the sterile barrier has resulted in illness or injury.  The compromised seals were discovered prior to use.
ELECTROLASE(R) HYFRECATOR(R) ELECTRODES - BLUNT, Disposable Hyfrecator(R) Tips, REF/Catalog No. 7-101-8CS, Sterile, Rx ONLY -- CONMED CORPORATION 525 FRENCH RD., UTICA, NY 13502-5994 --- Product Name: Electrosurgery Active Electrodes and Accessories; Common First Name: Electrosurgical, Cutting and Coagulation and Accessories.  MDL 092250.   The Electrolase Sterile Disposable Electrodes are intended to be used as active RF electrodes for desiccation, fulguration and coagulation. The ESP Electrode blades are components for electrosurgical pencils. The electrodes provide specific shapes and lengths to allow the clinician to utilize these different configurations for various clinical applications. The UltraClean version differs from the Universal as it has a ''non-stick'' finish. The Single Use ABC Nozzle is intended for use in the operating room for any procedure in which an electrosurgical generator would be used, i.e. for the surgical removal of tissue and for the control of bleeding.
Goldvac(TM) UltraClean(R) Accessory Electrode 1 inch Coated Blade with Extended Insulation, REF/Catalog No. 60-7521-001, Sterile, Rx ONLY -- CONMED CORPORATION 525 FRENCH ROAD, UTICA, NY 13502-5994 --- Product  Name: Electrosurgery Active Electrodes and Accessories; Common First Name: Electrosurgical, Cutting and Coagulation and Accessories. MDL  D085930.   The ESP Electrode blades are components for electrosurgical pencils. The electrodes provide specific shapes and lengths to allow the clinician to utilize these different configurations for various clinical applications. The UltraClean version differs from the Universal as it has a ''non-stick'' finish. The Single Use ABC Nozzle is intended for use in the operating room for any procedure in which an electrosurgical generator would be used, i.e. for the surgical removal of tissue and for the control of bleeding.
Goldvac(TM) UltraClean(R) Accessory Electrode 6 inch Coated Blade with Extended Insulation, REF/Catalog No. 60-7523-001, Sterile, Rx ONLY -- CONMED CORPORATION, 525 FRENCH ROAD, UTICA, NY 13502-5994 --- Product  Name: Electrosurgery Active Electrodes and Accessories; Common First Name: Electrosurgical, Cutting and Coagulation and Accessories.  MDL D085930.   The ESP Electrode blades are components for electrosurgical pencils. The electrodes provide specific shapes and lengths to allow the clinician to utilize these different configurations for various clinical applications. The UltraClean version differs from the Universal as it has a ''non-stick'' finish. The Single Use ABC Nozzle is intended for use in the operating room for any procedure in which an electrosurgical generator would be used, i.e. for the surgical removal of tissue and for the control of bleeding.
Goldvac(TM) UltraClean(R) Accessory Electrode 4 inch Coated Blade, REF/Catalog No. 60-7524-001, Sterile, Rx ONLY -- CONMED CORPORATION 525 FRENCH ROAD, UTICA, NY 13502-5994 --- Product Name: Electrosurgery Active Electrodes and Accessories; Common First Name: Electrosurgical, Cutting and Coagulation and Accessories.  MDL D085930.   The ESP Electrode blades are components for electrosurgical pencils. The electrodes provide specific shapes and lengths to allow the clinician to utilize these different configurations for various clinical applications. The UltraClean version differs from the Universal as it has a ''non-stick'' finish. The Single Use ABC Nozzle is intended for use in the operating room for any procedure in which an electrosurgical generator would be used, i.e. for the surgical removal of tissue and for the control of bleeding.
Goldvac(TM) UltraClean(R) Accessory Electrode 6 inch Coated Blade, REF/Catalog No. 60-7526-001, Sterile, Rx ONLY -- CONMED CORPORATION 525 FRENCH RD., UTICA, NY 13502-5994 --- Product Name: Electrosurgery Active Electrodes and Accessories; Common First Name: Electrosurgical, Cutting and Coagulation and Accessories.  MDL D085930.   The ESP Electrode blades are components for electrosurgical pencils. The electrodes provide specific shapes and lengths to allow the clinician to utilize these different configurations for various clinical applications. The UltraClean version differs from the Universal as it has a ''non-stick'' finish. The Single Use ABC Nozzle is intended for use in the operating room for any procedure in which an electrosurgical generator would be used, i.e. for the surgical removal of tissue and for the control of bleeding.
ABC(R) NOZZLE, Single Patient Use Nozzle, (For use with 130500 Reusable ABC(R) Handpiece), REF/Catalog No. 130343, Sterile, Rx ONLY -- CONMED CORPORATION 525 FRENCH RD., UTICA, NY 13502-5994 --- Product Name: Electrosurgery Active Electrodes and Accessories; Common First Name: Electrosurgical, Cutting and Coagulation and Accessories.  MDL E323246.   The ESP Electrode blades are components for electrosurgical pencils. The electrodes provide specific shapes and lengths to allow the clinician to utilize these different configurations for various clinical applications. The UltraClean version differs from the Universal as it has a ''non-stick'' finish. The Single Use ABC Nozzle is intended for use in the operating room for any procedure in which an electrosurgical generator would be used, i.e. for the surgical removal of tissue and for the control of bleeding.
TUR/Endoscopic Cable, 10 feet (3.05 mm), REF/Catalog No. 135171, Disposable, Sterile, Rx ONLY -- CONMED CORPORATION 525 FRENCH RD., UTICA, NY 13502-5994 --- Product Name: Electrosurgery Active Electrodes and Accessories; Common First Name: Electrosurgical, Cutting and Coagulation and Accessories.  MDL D092258.   The ESP Electrode blades are components for electrosurgical pencils. The electrodes provide specific shapes and lengths to allow the clinician to utilize these different configurations for various clinical applications. The UltraClean version differs from the Universal as it has a ''non-stick'' finish. The Single Use ABC Nozzle is intended for use in the operating room for any procedure in which an electrosurgical generator would be used, i.e. for the surgical removal of tissue and for the control of bleeding.
CONMED(R) ELECTROSURGICAL SAFETY HOLSTER, Disposable Safety Holster, REF/Catalog No. 137668, Sterile, Rx ONLY -- CONMED CORPORATION 525 FRENCH RD., UTICA, NY 13502-5994 --- Product Name: Electrosurgery Active Electrodes and Accessories; Common First Name: Electrosurgical, Cutting and Coagulation and Accessories.  MDL D092249.   The ESP Electrode blades are components for electrosurgical pencils. The electrodes provide specific shapes and lengths to allow the clinician to utilize these different configurations for various clinical applications. The UltraClean version differs from the Universal as it has a ''non-stick'' finish. The Single Use ABC Nozzle is intended for use in the operating room for any procedure in which an electrosurgical generator would be used, i.e. for the surgical removal of tissue and for the control of bleeding.
ELECTROSURGICAL ENT NEEDLE ELECTRODE, 6 inch with Extended Insulation, REF/Catalog No. 138025, Single Use, Sterile, Rx ONLY -- CONMED CORPORATION 525 FRENCH RD., UTICA, NY 13502-5994 --- Product Name: Electrosurgery Active Electrodes and Accessories; Common First Name: Electrosurgical, Cutting and Coagulation and Accessories.  MDL D092258.   The ESP Electrode blades are components for electrosurgical pencils. The electrodes provide specific shapes and lengths to allow the clinician to utilize these different configurations for various clinical applications. The UltraClean version differs from the Universal as it has a ''non-stick'' finish. The Single Use ABC Nozzle is intended for use in the operating room for any procedure in which an electrosurgical generator would be used, i.e. for the surgical removal of tissue and for the control of bleeding.
Beginning Lot Code 120628X, Ending Lot Code 120917X. [Lot codes on boxes and packaging contain a lot code in the following format: 120917 X  where 12 represents the year (2012), 09 represents the month (September), 17 represents the day of the month, and X represents the manufacturing shift code (1, 2, 3, 4,5,6 or 9)].
Electrosurgical Tip Cleaner, REF/Catalog No. 138029, Single Use, Sterile, Rx ONLY -- Distributed By: CONMED CORPORATION 525 French Road, Utica, NY 13502-5944 --- Product Name: Electrosurgery Active Electrodes and Accessories; Common First Name: Electrosurgical, Cutting and Coagulation and Accessories.  MDL D092281.   The ESP Electrode blades are components for electrosurgical pencils. The electrodes provide specific shapes and lengths to allow the clinician to utilize these different configurations for various clinical applications. The UltraClean version differs from the Universal as it has a ''non-stick'' finish. The Single Use ABC Nozzle is intended for use in the operating room for any procedure in which an electrosurgical generator would be used, i.e. for the surgical removal of tissue and for the control of bleeding.
Beginning Lot Code 120628X, Ending Lot Code 120725X.  [Lot codes on boxes and packaging contain a lot code in the following form: 120725X  where 12 represents the year (2012), 07 represents the month (July), 25 represents the day of the month, and X represents the manufacturing shift code (1, 2, 3, 4,5,6 or 9)].
UltraClean(R) Accessory Electrode, 1 inch Coated Blade, REF/Catalog No. 139100, Single Use, Sterile, Rx ONLY --CONMED CORPORATION, UTICA, NY 13502 --- Product Name: Electrosurgery Active Electrodes and Accessories; Common First Name: Electrosurgical, Cutting and Coagulation and Accessories.  MDL D085930.   The ESP Electrode blades are components for electrosurgical pencils. The electrodes provide specific shapes and lengths to allow the clinician to utilize these different configurations for various clinical applications. The UltraClean version differs from the Universal as it has a ''non-stick'' finish. The Single Use ABC Nozzle is intended for use in the operating room for any procedure in which an electrosurgical generator would be used, i.e. for the surgical removal of tissue and for the control of bleeding.
Beginning Lot Code 120628X, Ending Lot Code 120917X. [Lot codes on boxes and packaging contain a lot code in the following format: 12 09 17 X  where 12 represents the year (2012), 09 represents the month (September), 17 represents the day of the month, and X represents the manufacturing shift code (1, 2, 3, 4,5,6 or 9)].
UltraClean(R) Accessory Electrode 1 inch Coated Needle,  REF/Catalog No. 139102, Single Use, Sterile, Rx ONLY -- CONMED CORPORATION 525 FRENCH ROAD, UTICA, NY 13502-5994 --- Product Name: Electrosurgery Active Electrodes and Accessories; Common First Name: Electrosurgical, Cutting and Coagulation and Accessories.  MDL D085930.   The ESP Electrode blades are components for electrosurgical pencils. The electrodes provide specific shapes and lengths to allow the clinician to utilize these different configurations for various clinical applications. The UltraClean version differs from the Universal as it has a ''non-stick'' finish. The Single Use ABC Nozzle is intended for use in the operating room for any procedure in which an electrosurgical generator would be used, i.e. for the surgical removal of tissue and for the control of bleeding.
UltraClean(R) Accessory Electrode 1 inch Coated Blade with Extended Insulation, REF/Catalog No. 139104EXT,  Single Use, Sterile, Rx ONLY -- CONMED CORPORATION 525 FRENCH ROAD, UTICA, NY 13502-5994 --- Product Name: Electrosurgery Active Electrodes and Accessories; Common First Name: Electrosurgical, Cutting and Coagulation and Accessories.  MDL D085930.   The ESP Electrode blades are components for electrosurgical pencils. The electrodes provide specific shapes and lengths to allow the clinician to utilize these different configurations for various clinical applications. The UltraClean version differs from the Universal as it has a ''non-stick'' finish. The Single Use ABC Nozzle is intended for use in the operating room for any procedure in which an electrosurgical generator would be used, i.e. for the surgical removal of tissue and for the control of bleeding.
UltraClean(R) Accessory Electrode 1 inch Coated Needle with Extended Insulation, REF/Catalog No. 139105EXT, Single Use, Sterile, Rx ONLY -- CONMED CORPORATION 525 FRENCH ROAD, UTICA, NY 13502-5994  --- Product Name: Electrosurgery Active Electrodes and Accessories; Common First Name: Electrosurgical, Cutting and Coagulation and Accessories.  MDL D085930.   The ESP Electrode blades are components for electrosurgical pencils. The electrodes provide specific shapes and lengths to allow the clinician to utilize these different configurations for various clinical applications. The UltraClean version differs from the Universal as it has a ''non-stick'' finish. The Single Use ABC Nozzle is intended for use in the operating room for any procedure in which an electrosurgical generator would be used, i.e. for the surgical removal of tissue and for the control of bleeding.
UltraClean(R) Accessory Electrode 6 inch Coated Blade,  REF/Catalog No. 139107, Single Use, Sterile, Rx ONLY --  CONMED CORPORATION, 525 FRENCH RD., UTICA, NY 13502-5994 --- Product Name: Electrosurgery Active Electrodes and Accessories; Common First Name: Electrosurgical, Cutting and Coagulation and Accessories.  MDL D085930.   The ESP Electrode blades are components for electrosurgical pencils. The electrodes provide specific shapes and lengths to allow the clinician to utilize these different configurations for various clinical applications. The UltraClean version differs from the Universal as it has a ''non-stick'' finish. The Single Use ABC Nozzle is intended for use in the operating room for any procedure in which an electrosurgical generator would be used, i.e. for the surgical removal of tissue and for the control of bleeding.
UltraClean(R) Accessory Electrode 6 inch Coated Needle with Extended Insulation, REF/Catalog No. 139108, Single Use, Sterile, Rx ONLY -- CONMED CORPORATION 525 FRENCH ROAD, UTICA, NY 13502-5994  --- Product Name: Electrosurgery Active Electrodes and Accessories; Common First Name: Electrosurgical, Cutting and Coagulation and Accessories.  MDL D085930.   The ESP Electrode blades are components for electrosurgical pencils. The electrodes provide specific shapes and lengths to allow the clinician to utilize these different configurations for various clinical applications. The UltraClean version differs from the Universal as it has a ''non-stick'' finish. The Single Use ABC Nozzle is intended for use in the operating room for any procedure in which an electrosurgical generator would be used, i.e. for the surgical removal of tissue and for the control of bleeding.
UltraClean(R) Accessory Electrode 6 inch Coated Blade with Extended Insulation, REF/Catalog No. 139110EXT,  Single Use, Sterile, Rx ONLY -- CONMED CORPORATION 525 FRENCH ROAD, UTICA, NY 13502-5944  --- Product Name: Electrosurgery Active Electrodes and Accessories; Common First Name: Electrosurgical, Cutting and Coagulation and Accessories.  MDL D085930.    The ESP Electrode blades are components for electrosurgical pencils. The electrodes provide specific shapes and lengths to allow the clinician to utilize these different configurations for various clinical applications. The UltraClean version differs from the Universal as it has a ''non-stick'' finish. The Single Use ABC Nozzle is intended for use in the operating room for any procedure in which an electrosurgical generator would be used, i.e. for the surgical removal of tissue and for the control of bleeding.
UltraClean(R) Accessory Electrode 4 inch Coated Blade, REF/Catalog No.  139112, Single Use, Sterile, Rx ONLY -- CONMED CORPORATION 525 FRENCH ROAD, UTICA, NY 13502-5994 --- Product Name: Electrosurgery Active Electrodes and Accessories; Common First Name: Electrosurgical, Cutting and Coagulation and Accessories.  MDL D085930.   The ESP Electrode blades are components for electrosurgical pencils. The electrodes provide specific shapes and lengths to allow the clinician to utilize these different configurations for various clinical applications. The UltraClean version differs from the Universal as it has a ''non-stick'' finish. The Single Use ABC Nozzle is intended for use in the operating room for any procedure in which an electrosurgical generator would be used, i.e. for the surgical removal of tissue and for the control of bleeding.
UltraClean(R) Accessory Electrode 4 inch Coated Blade with Extended Insulation,  REF/Catalog No. 139112EXT, Single Use, Sterile, Rx ONLY -- CONMED CORPORATION 525 FRENCH ROAD, UTICA, NY 13502-5994  --- Product Name: Electrosurgery Active Electrodes and Accessories; Common First Name: Electrosurgical, Cutting and Coagulation and Accessories.  MDL D085930.   The ESP Electrode blades are components for electrosurgical pencils. The electrodes provide specific shapes and lengths to allow the clinician to utilize these different configurations for various clinical applications. The UltraClean version differs from the Universal as it has a ''non-stick'' finish. The Single Use ABC Nozzle is intended for use in the operating room for any procedure in which an electrosurgical generator would be used, i.e. for the surgical removal of tissue and for the control of bleeding.
Coca-Cola, 12 fluid ounce aluminum cans in 20-packs and 32-packs, The Coca Cola Company.
UPC: 496340, Optimum Taste Code: SEP1613HWA
31,000 cases (32 cans/case and 20 cans/case)
Distribution was made to NJ, NY, PA, CT, WV, MD, DE and VA.
Andy Capp's Cheddar Cheese Fries packaged in Andy Capp's Hot Fries, 0.85-oz foil bags, snack size, Case UPC: 20-0-26200-47169-7 and Unit UPC: 00-0-26200-47168-6.
Best By: AUG 17 13 and (batch number) 5381232500
Andy Capp's Cheddar Cheese Fries snacks were packaged in Andy Capp's Hot Fries snack bags in error. The Cheddar Cheese Fries contain Soy which is not listed on the ingredients label of the Hot Fries bag.
Abbott Point of Care i-Stat cTnI cartridge.   The i-Stat cardiac troponin I (cTnI) test is an in vitro diagnostic test for the quantitive measurement of cardiac troponin I (cTnI) in whole blood or plasma. Measurements of cardiac troponin I are used in the diagnosis and treatment of myocardial infarction and as an aid in the risk stratification of patients with acute coronary syndromes with respect to the relative risk of mortality.
APOC has determined that 10 boxes of i-Stat cTnI cartridges from lot P12179 have an incorrect barcode applied to the cartridge portion pack.
Flanax (aluminum hydroxide, magnesium hydroxide, and simethicone) Fast Acting Antacid, 200 mg/200 mg/20 mg, 12 fl oz (355 mL) bottles, Distributed by: Belmora LLC, PO Box 3063, Arlington, VA 22203, UPC 8 53030 00209 0, NDC 27854.101.01.
Defective Container: Product lacks tamper evident breakaway band on cap.