Community Blood Centers of South Florida, Inc.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Platelet, with an unacceptable pH, was distributed.
Blood products, collected from a donor who received a tattoo within 12 months of donation, were distributed.
Blood  product was not frozen in required time, was distributed.
Blood products, which were labeled as leukoreduced, but were not tested to verify the White Blood Cell count, were distributed.
Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed.
Platelets Pheresis Leukocytes Reduced Irradiated
Blood products, possibly contaminated with bacteria, were distributed.
Blood products, which was identified as being contaminated by the BacT/ALERT system, was distributed.
Blood products, which were identified as being contaminated by the BacT/ALERT system, were distributed.
Blood product, whose integrity was compromised during component preparation (e.g., leaking at sterile connection site), was distributed.
Blood products, which gave a positive result by the BacT system, were distributed.
Blood products, with positive bacterial detection testing, were distributed.
Blood product, with positive bacterial detection testing, was distributed.
Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
Red Blood Cells (Apheresis) Leukocytes Reduced
Blood and Blood Products for Reprocessing
Distributed nationwide, including the states of: CA, IL, IN, MD, MI, MN, NC, ND, NJ, NM, NY, OH, OK, PA, SC, TN, TX, VA, VT, and VI.
Trophy Nut Brand 1.5 oz. tube; Trophy Nut Brand 1.25 oz. tube; Nut Barrel Brand 5 oz. Fundraising bag; and Nut Barrel Brand 1.25 oz. tube.
Trophy Nut Brand 1.5 oz. tube UPC 74249-50778 Code Date 8/9/2009 thru 11/3/2009; Trophy Nut Brand 1.25 oz. tube UPC 74249-89778 Code Date 8/16/2009 thru 10/13/2009; Nut Barrel Brand 5 oz. Fundraising bag UPC 74249-44267 Code Date 0449, 0709, and 0139; Nut Barrel Brand 1.25 oz. tube UPC 74249-27778 Code Date 8/16/2009 thru 10/13/2009.
The product is being recalled because it was manufactured using pistachios recalled by Setton Pistachios of Terra Bella, CA because it has the potential to be contaminated with Salmonella.
Trophy Nut Brand 1.5 oz. Red Pistachio Tube and Nut Barrel Brand 1.25 oz. Red Pistachio Tube.
Trophy Nut Brand 1.5 oz. Red Pistachio Tube UPC 74249-50779 Code Date 08/16/2009 thru 10/27/2009 and Nut Barrel Brand 1.25 oz. Red Pistachio Tube UPC 74249-27779 Code Date 8/16/2009 thru 10/6/2009.
Trophy Nut Brand 6 oz. natural pistachios
Trophy Nut Brand 6 oz. natural pistachios UPC 74249-19167 Code Date 0269
America's Choice 9 oz. Giant Pistachios UPC 54807-51371 Code Date 1/19/2010 thru 1/23/2010
Wa Wa brand 6 oz. Pistachio Gusset UPC 26191-07724 Code Date 11/15/2010 and 2/1/2010
Blood products, collected from a donor with a history of Hepatitis A, were distributed.
Blood products, collected from donors whose donor suitability was not adequately determined, were distributed.
Illinois, North Carolina, California, Germany, Switzerland
Blood products, which were collected from a donor with a history of high risk behaviors, were distributed.
Blood products, collected from a donor who was previously deferred, were distributed.
Blood product, collected from a donor based on travel to an area considered endemic for malaria, was distributed.
The product was originally distributed in a bulk container of 12/1 Dry Pints in boxes labeled ''Karol'' with the Lot No. ''01W45'' stamped in the upper, right-hand corner on the face of the box. The box states ''Distributed by Interstate Fruit & Vegetable'', which is an affiliated business of Rio Queen Citrus, Inc. These packages were distributed at the retail level between November 10th & November 19th, 2012. At the retail level, the tomatoes may have been packaged in an alternative container depending on the area and retailer.
Rio Queen Citrus, Inc. of Mission, TX is recalling 840 cartons of 12/1 Dry Pints of Mexican cherry tomatoes in ''Karol'' brand boxes, because they have the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis.
Human tissue allografts, processed in a manner that could cause contamination or cross-contamination during processing, as well as the introduction, transmission, or spread of communicable disease through the use of the HCT/P, were distributed.
Domestically, nationwide, and to Canada and the United Kingdom.
Natures Path Hemp Plus Granola sold in bulk bins at Whole Foods PLU 8106
The product has the potential to contain undeclared almond slices.
Rugby NATURAL IRON SUPPLEMENT Ferrous Sulfate, 5 gr (325 mg), 100 TABLETS,  Mfd for: RUGBY LABORATORIES, INC. DULUTH, GEORGIA 30097 UPC 0 0536-5890-013
Labeling; Label Mixup; bottles of Ferrous Sulfate actually contains Meclizine HCl (indicated for motion sickness)
Product was distributed in the following states:  Arkansas, Arizona, Colorado, Kansas, Oklahoma, New Mexico and Texas.
''Shurfine CREAMERY SELECT PREMIUM ICE CREAM Dulce de Leche Caramel Swirled in Caramel Ice Cream KEEP FROZEN 1.75 QUARTS (1.66L)'' is displayed on the carton's label in error.  The lid bears the label ''Shurfine CREAMERY SELECT PREMIUM ICE CREAM Praline Pecan KEEP FROZEN 1.75 QUARTS (1.661L)''.  The product bears UPC 015400224840, a Best Buy date of NOV 8, 2014, and a Plant Code of 48-3202-F.
Product may contain undeclared pecan, soy, and/or wheat allergens.
All Sizes Milo's Kitchen home style dog treats - Chicken Jerky 3.3 oz UPC 079100504718, 14 oz. UPC 079100510771, 20 oz. UPC 079100504688
On 01/07/2013, New York State's Department of Agriculture informed the U.S. Food and Drug Administration (FDA) and the Company that trace amounts of residual antibiotics had been found in several lots of MiIo's Kitchen Chicken Jerky and Chicken Grillers. After consultation with the New York Department of Agriculture and FDA, the company decided to voluntarily recall Milos Kitchen Chicken Jerky and Chicken Grillers, which are both sourced from the same chicken suppliers.
All Sizes: Milo's Kitchen brand Chicken Grillers home style dog treats; Chicken Recipe with natural smoked flavor.  3.3 oz UPC 079100513109; 14 oz. UPC 079100513123; 20 oz UPC 079100513130.
On 01/07/2013, New York State's Department of Agriculture informed the U.S. Food and Drug Administration (FDA) and the Company that trace amounts of residual antibiotics had been found in several lots of MiIo's Kitchen Chicken Jerky and Chicken Grillers. After consultation with the New York Department of Agriculture and FDA, the company decided to voluntarily recall Milo's Kitchen Chicken Jerky and Chicken Grillers, which are both sourced from the same chicken suppliers.
Cadet Gourmet Chicken Breast   a) Net Wt. 3.6 oz   UPC 768303074929      b) Net Wt. 8 oz.   UPC 768303074936      c) Net Wt. 1 Lb (454 g)   tub - UPC  768303014352   UPC 768303014703       d) Net Wt. 1.25 Lb (567 g)   UPC 768303014741      e)  Net Wt. 1.5 Lb (681 g)   UPC 768303014161      f) Net. Wt.  2.0 lb.   UPC 768303014727         Product of China Not for Human Consumption.   Distributed by: IMS Pet Industries, Inc., 34 Passaic Street, Wood-Ridge, NJ 07075
NYSDAM Analysis has revealed the presence of unapproved antibiotics in Cadet Gourmet Chicken Breast Pet Treats.
Shep Chicken Breast Fillets Net Wt. 3.5 oz (99g)    Net Wt. 3. oz (99g)     Product of China.    Not for Human Consumption.    Distributed by: ALDI Inc.   Batavia, IL 60510-1477
Home 360 Pet  Chicken Breast Fillets Oven Roasted   a) Net Wt. 3.5 oz (99g)    UPC 725439966429      b) Net Wt. 1 Lb (454 g)   UPC 725439966436          Product of China.    Not for Human Consumption.    Distributed by:  DZA Brands, LLC 2110 Executive Drive, Salisbury, NC 28147   Product of China
Companion Chicken Breast Fillet Jerky Strips Dog Treats   a) Net Wt 3.3 oz (94 g) .   UPC 688267076862      b) Net Wt 14 oz (397g)    UPC 688267077449         Distributed by Foodhold USA, LLC Landover, MD 20785   Product of China
Blood products, collected from a potentially  ineligible donor, were distributed.
Blood products, collected from a potentially ineligible donor, were distributed.
Hartz Oinkies wraps with Chicken  Made in China for the Hartz Mountain Corporation, Secaucus, NJ 07094 USA  and imported by Hartz Canada Inc., St. Thomas, Ontario N5P 3W7 , Canada       5 pig skin twists - 3.1 oz   UPC 3270003354      7 mini pig skin twists - 6 oz.
5 pack - 38,762 units; 7 pack - 42,258 units
Pet treats contain unapproved antibiotics
Hartz Oinkies Pig Skin Twists wrapped  with Chicken  Made in China for the Hartz Mountain Corporation, Secaucus, NJ 07094 USA  and imported by Hartz Canada Inc., St. Thomas, Ontario N5P 3W7 , Canada       5 pig skin twists   UPC 3270003354      7 mini pig twists    UPC 3270003330      15 mini pig skin twists - 11.4 oz   UPC 3270003331      20  pig skin twists - 4.9 oz.   UPC 32700-13472
5 pack - 38,672 units; 7 pack - 42,258 units; 15 pack -49070 units; 20 pack - 30,912 units
Hartz Chicken Chews Soft and Tender Made in China for the Hartz Mountain Corporation, Secaucus, NJ 07094 USA       Net Wt. 3.5 oz. - UPC 3270011966   Net Wt. 8 oz - UPC 3270011967   Net Wt. 16 oz. - UPC 3270011953   Net Wt. 24 oz. - UPC 3270011954
Hartz Chicken Chews Bite Size Made in China for the Hartz Mountain Corporation, Secaucus, NJ 07094 USA       Net Wt. 5.7 oz. - UPC 3270012856    Net Wt. 16 oz - UPC 3270012765
Pet Pride Chicken Breast Jerky Distributed by: The Kroger Co. Cincinnati OH, Made In China     Net Wt. 16 oz. - UPC 1111087994   Net Wt. 24 oz - UPC 1111079250
Exer-hides Rawhide Twists Distributed by Wal-Mart Stores, Inc.. Bentonville, AR 72716 Made in China 25 pack 5'' twists.     Net Wt. 6 oz.   UPC 8113143905
Pet treats contain unapproved antibiotics.
Nationwide Distribution including AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, IL, IN, KY, KS, LA, MA, MD, MI, MN, MO, MS, NC, NJ, NY, OH, OK, PA, TX, VA, WA, WV and  WY.
BARD Biopsy Systems (A Business Unit of Bard Peripheral Vascular, Inc.), UltraClip Dual Trigger Breast Tissue Marker 17g X 10cm needle, Ultrasound Enhanced Coil Marker 5 Pack; Sterilize, Non-pyrogenic, Rx only, Single Use; Bard Peripheral Vascular, Inc., 1625 West 3rd Street, Tempe, AZ 85281 USA.  PK4320100 Rev. 0 03/10      The UltraClip Dual Trigger breast tissue marker is a sterile, single use device comprised of a disposable introducer, and a metal implantable tissue marker with polyvinyl alcohol (PVA).
Bard Peripheral Vascular (BPV) is initiating this recall because a combination of Bard UltraClip Dual Trigger Tissue Marker's and support catheters (Microsheath and Usher) were inadvertently distributed to customers without completing the sterilization process (non sterile).
BARD Biopsy Systems (A Business Unit of Bard Peripheral Vascular, Inc.), UltraClip Dual Trigger Breast Tissue Marker 17g X 10cm needle, Ultrasound Enhanced Ribbon Marker 5 Pack, Sterile, Single Use, Non-pyrogenic, Rx only; Bard Peripheral Vascular, Inc., 1625 West 3rd Street, Tempe, AZ 85281 USA. PK4313800 Rev. 1 01/11     The UltraClip Dual Trigger breast tissue marker is a sterile, single use device comprised of a disposable introducer, and a metal implantable tissue marker with polyvinyl alcohol (PVA).
MICROSHEATH - 0.066 (1.7mm) proximal, 0.064 (1.6mm); WL 123cm, RGC 8F Guide; minimum ID: 0.086''/ (2.2mm);distal, straight non-tapered tip; PK1018-03A; Bard Peripheral Vascular; Manuf: Flow Cardia, Inc., a Subsidiary of C.R. Bard, Inc. 745 North Pastoria Ave., Sunnyvale, CA 94085.           The MicroSheath and Usher Support Catheters are single lumen catheters intended to create a pathway for other devices in the peripheral vasculature. MicroSheath is a single lumen catheter that has a 123cm working length and a straight tip shape
USHER Support Catheter- Angled Tip  WL130cm, RI 7F; REF USH07AT; PK1022-01A; Rx only, Non-Pyrogenic, Sterile; Bard Peripheral Vascular; Manuf: FlowCardia, Inc., a Subsidiary of C. R. Bard, Inc., 745 North Pastoria Ave, Sunnyvale CA 95085.      The Usher Peripheral is a single lumen support catheter, with a standard luer fitting at the proximal end. The Usher Peripheral is available in a length 130 cm with an angled tip shape.
Blood product, collected from a donor who reported living in a malarial endemic area within the past three years, was distributed.
Blood product, collected from a donor whose arm inspection was not documented, was distributed.
Blood product, collected from a donor who reported travel to a malarial endemic area, was distributed.
Nationwide, Puerto Rico and  Venezuela and Bolivia
MAXILOSS Weight Advanced, 225 mg proprietary blend of herbs, supplied in 36 count capsules in Green & Blue Boxes, Formulated and distributed by Olaax Corp, Lakeland, FL
Marketed Without an Approved NDA/ANDA: product contains sibutramine, a previously approved FDA drug removed from the U.S. marketplace for safety reasons, making it an unapproved new drug.
Blood product, collected from a donor who was suspected of receiving a piercing within 12 months of donating, was distributed.
Blood products, collected from a donor who was taking Plavix, were distributed.
Blood Systems, Inc. dba United Blood Services
Blood products, collected from donors whose body temperatures were determined incorrectly, were distributed.
Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed.
Blood product, with a low platelet concentration, was distributed.
Blood products, collected from a donor who deferred for receiving a piercing, were distributed.
Diggin Your Dog Strippin Chicks; USA Chicken Charki Strips for Dogs  100% Grown, Raised, Harvested in USA. Net Wt. 5 oz.   Ingredients: Chicken, Vitamin E Supplement.   UPC: 6-09788-82324-7   Diggin Your Dog USA, Reno, NV
45 cases ( 12 x 5 oz. packages per case)
Colorado Department of Agriculture collected a sample of Diggin Your Dog Brand Strippin Chicks at retail and had a positive result for Salmonella.
Blood products, collected from a donor who had been incarcerated, were distributed.
Hoxworth Blood Center  UC Medical Center
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
Blood product, collected from a donor who visited a malarial endemic region, was distributed.
Product was shipped to the following states: CT, DE, FL, GA, IL, IN, KY, MD, ME, MI, MO, NC, NE, NJ, NY, OH, PA, SD, VA & WV.
Chicken Noodle Soup Mix, ''9 oz cello bag, Contents: All natural enriched semolina flour***PURELY AMERICAN 5991 Industrial Park Road, Athens, OH 45701 (800) 359-7873 www.purelyamerican.com'' Sold under the brand names: PURELY AMERICAN SCHOOLHOUSE ON THE PRAIRIE UPC 7 92290 00179 8 and World's Best Teacher UPC 7 92290 00196 5.
The firm was notified by the Ohio Department of Agriculture that several of their labels are missing the the allergin declaration  contains wheat.
Pasta Salad Mix, ''10 oz cello bag, Contents: All natural enriched semolina flour, spray dried tomato, spinach and beet powders, water, parsley, celery seed, garlic, paprika, and spices***PURELY AMERICAN 5991 Industrial Park Road, Athens, OH 45701 (800) 359-7873 www.purelyamerican.com'' Sold under the brand names: PICNIC AT CAPE MAY UPC 7 92290 00143 9 and PICNIC AT FAIRMOUNT PARK UPC 7 92290 00138 5.
ITEM # CA104, ITEM #146, ITEM #143, ITEM #145 and ITEM #138
Pasta Salad Mix, Contents: All natural enriched semolina flour, spray dried tomato, spinach and beet powders, water, spices, dried tomatoes, black pepper, onion powder, onion flakes and garlic***PURELY AMERICAN 5991 Industrial Park Road, Athens, OH 45701 (800) 359-7873 www.purelyamerican.com'' Sold under the brand names: LIGHTS OF LAKE ERIE 10 oz cello bag, UPC 7 92290 00188 0,  LIGHTS OF CAROLINA 10 oz cello bag, UPC 7 92290 00155 2, LIGHTS OF THE CHESAPEAKE 11 oz cello bag, UPC 7 92290 00160 6 and LIGHTS OF LAKE MICHIGAN 11 oz cello bag UPC 7 92290 00169 9
ITEM #188, ITEM #155, ITEM #160 and ITEM #169
163/10 oz cello bags & 176/11 oz cello bags
ADIRONDACK GETAWAY PASTA TOSS MIX 11oz cello bag Contents: All natural enriched semolina flour***spray dried tomato, spinach and beet powders, water, spices, dried tomatoes, black pepper, onion powder, onion flakes, and garlic.***PURELY AMERICAN 5991 Industrial Park Road, Athens, OH 45701 (800) 359-7873 www.purelyamerican.com UPC 7 92290 00164 9
GILROY GARLIC PASTA STIR FRY MIX 11oz cello bag Contents: All natural enriched semolina flour***spray dried tomato, spinach and beet powders, water, spices, black pepper, garlic powder, salt.***PURELY AMERICAN 5991 Industrial Park Road, Athens, OH 45701 (800) 359-7873 www.purelyamerican.com UPC 7 92290 00153 8
LONG ISLAND BAYMEN SEAFOOD CHOWDER MIX 15 oz cello bag Contents: All natural enriched semolina flour***spray dried tomato, spinach and beet powders, water, spices, dried carrots, garlic, black pepper, jalapeno peppers, bay leaf***PURELY AMERICAN 5991 Industrial Park Road, Athens, OH 45701 (800) 359-7873 www.purelyamerican.com UPC 7 92290 00178 1
MAMA MARINO'S MINESTRONE SOUP MIX 15 oz cello bag Contents: Assorted beans & barley, Enriched semolina flour***spray dried tomato, spinach and beet powders, water, dehydrated carrots, onions, peas, tomato flakes, celery flakes, bell peppers, parsley & spices***PURELY AMERICAN 5991 Industrial Park Road, Athens, OH 45701 (800) 359-7873 www.purelyamerican.com UPC 7 92290 00105 7
SANTA FE CORNBREAD MIX 12.25 oz coffee bag Contents: Yellow corn meal, unbleached white flour; dehydrated garlic, onion, paprika, bell peppers, celery & parsley flakes, non-aluminum baking powder, baking soda, salt***PURELY AMERICAN 5991 Industrial Park Road, Athens, OH 45701 (800) 359-7873 www.purelyamerican.com UPC 7 92290 00126 2
INDIAN RIVER ORANGE DROP COOKIES MIX 17 oz coffee bag Contents: Unbleached white flour; granulated sugar, confectioner's sugar, orange peel, baking powder, and salt***PURELY AMERICAN 5991 Industrial Park Road, Athens, OH 45701 (800) 359-7873 www.purelyamerican.com UPC 7 92290 00135 4
SHENANDOAH VALLEY APPLE AND SPICE CAKE MIX 15.5 oz coffee bag Contents: Unbleached white flour; cane sugar, spices, non-aluminum baking powder, baking soda and salt***PURELY AMERICAN 5991 Industrial Park Road, Athens, OH 45701 (800) 359-7873 www.purelyamerican.com UPC 7 92290 00121 7
MARIN COUNTY CARROT CAKE MIX 18.5 oz coffee bag Contents: Unbleached white flour; whole wheat flour, sugar, spices, non-aluminum baking powder, baking soda and salt***PURELY AMERICAN 5991 Industrial Park Road, Athens, OH 45701 (800) 359-7873 www.purelyamerican.com UPC 7 92290 00131 6
Trima Accel Automated Blood Component Collection System, catalog number 81000, all serial numbers, with software versions prior to 5.1.9 and 6.0.6.
Catalog number 81000, ALL SERIAL NUMBERS.
Terumo BCT's Trima Accel systems, with a  potential risk for an air embolism should a donor be prematurely connected to the Trima Accel system, were distributed.
Human tissue allografts, not processed in a manner that prevents the introduction, transmission, or spread of communicable disease, were distributed.
Anticoagulant Citrate Phosphate Dextrose Solution, USP (CPD) Blood Pack Unit, NDC#0942-6470-03, Rx, 4R1584
BLOOD-PACK Units in which the platelet container is incorrectly labeled as ''AS-1 Red Blood Cell Adenine-Saline added'', were distributed.
Worldwide Distribution: USA Nationwide and Internationally to Europe.
BARD Biopsy Systems UltraClip Dual Trigger breast tissue marker.      Intended for use to attach to soft breast tissue at the surgical site during an open surgical breast biopsy.
Affected Product Lots with the following Product Code and Lot Number combinations.        Product Code    864017D    864017D    864017D    864017D    864017D    864017D    864017D    864017DL       Lot Number                                                                    HUWI1522                                                                    HUWI1941                                                                    HUWI1942                                                                    HUWI1943                                                                    HUWJ1851                                                                    HUWJ1852                                                                    HUWK0350                                                                    HUWJ1610
Bard Peripheral Vascular (BPV) has confirmed that some devices with the recalled product code / lot number  combination may have the metal tissue marker separated from the needle prior to use.
Amoxicillin for Oral Suspension, USP 400mg/5mL, NDC 0093-4161-78 (75ml) and 0093-4161-73 (100mL)
Discoloration: This recall is being carried out due to a yellow to brown discolored Amoxicillin powder on the inner foil seal of the bottles.
The Pure Herbs products are sold to a network of independent distributors/consumers.
Pure Herbs, Ltd. Natural Herbal Extracts Protein Dietary Supplement.120mL/4 fl. oz. bottle; 30mL/1 fl.oz bottle.
Lot codes being recalled are lots 243 and 050812, 012712A.. All Protein products manufactured prior to lot 243 are being recalled.  Unfortunately the firm does not have records to indicate the lot numbers prior to lot 243.
Pure Herbs, Ltd. Protein Extract contains undeclared milk and soy allergens.  People who have an allergy or severe sensitivity to milk or soy run the risk of serious or life-threatening allergic reaction if they consume this product.
Worldwide Distribution - USA Nationwide and countries of: Australia, Canada, Czech Republic, England, Germany, Switzerland and Turkey.
DePuy Glenosphere orientation guide            Product Usage:  The glenosphere orientation guide is an instrument used in reverse shoulder arthroplasty. The orientation guide is used to properly align the glenosphere.
Part Number 230795000/Lot Number 5120443
The Glenosphere Orientation Guide Instrument Used with the Delta XTEND Reverse Shoulder is being recalled because an arrow that is etched on the instrument was incorrectly placed on the opposite side of the instrument. Using the improperly etched arrow as a guide could potentially lead to incorrect orientation of the glenosphere implant.
90 Degree Cannulated Infant Blade Plate 25mm x 5mm x 3 Hole     Product Usage:      The OrthoPediatrics Locking Cannulated Blade Plate System is intended for fixation of long bone fractures and osteotomies in all pediatric subgroups (except neonates) and in small stature adults. Specific indications include: intertrochanteric derotation and varus osteotomies, femoral neck and pertrochanteric fractures, intertrochanteric valgus osteotomies, proximal and distal tibial osteotomies and humeral fractures and osteotomies.
All lot numbers are affected.  Catalog No. 00-1200-1000
Post Market Surveillance of the 90 degree Cannulated Infant Blade Plate indicated that there have been five reports concerning bending of the plate intra-operatively.
90 Degree Cannulated Infant Blade Plate 30mm x 5mm x 3 Hole     Product Usage:      The OrthoPediatrics Locking Cannulated Blade Plate System is intended for fixation of long bone fractures and osteotomies in all pediatric subgroups (except neonates) and in small stature adults. Specific indications include: intertrochanteric derotation and varus osteotomies, femoral neck and pertrochanteric fractures, intertrochanteric valgus osteotomies, proximal and distal tibial osteotomies and humeral fractures and osteotomies.
All lot numbers are affected.  Catalog No. 00-1200-1001
90 Degree Cannulated Infant Blade Plate 35mm x 5mm x 3 Hole     Product Usage:      The OrthoPediatrics Locking Cannulated Blade Plate System is intended for fixation of long bone fractures and osteotomies in all pediatric subgroups (except neonates) and in small stature adults. Specific indications include: intertrochanteric derotation and varus osteotomies, femoral neck and pertrochanteric fractures, intertrochanteric valgus osteotomies, proximal and distal tibial osteotomies and humeral fractures and osteotomies.
All lot numbers are affected.  Catalog No. 00-1200-1002
Jumbo Barcelona in-shell hazelnuts and Large Barcelona in-shell hazelnuts, raw,  Hazelnut Growers of Oregon Brand, package in bulk 50 pound screen-printed fabric sack.        The product is labeled in parts: ''***IN SHELL HAZELNUTS***HAZELNUT GROWERS OF OREGON***OREGON U.S. NO. 1***Hazelnut Growers of Oregon***401 N. 26 Avenue, Cornelius,  Oregon  97113***''.
Lot A102112.  This code represents day shift, date of production is October 21, 2012.       There is no expiration date on the product.
5000 lbs. Jumbo Barcelona and 5000 lbs. Large Barcelona in-shell hazelnuts
Large and Jumbo in-shell Barcelona Hazelnuts (50 lbs. bulk bags) are recalled due to a potential contamination with Salmonella.
Worldwide Disitribution - USA Nationwide in the states of Alabama, Arkansas, Arizona, California, Colorado, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia, Wyoming and the countries of Quezon City, Philippines, Singapore, and Panama City, Panama.
TX1 Tissue Removal System disposable handpieces.     Product Usage:  The TX1 Tissue Removal System is indicated for use in surgical procedures where fragmentation, emulsification and aspiration of soft tissue are desirable, including General Surgery, Orthopedic Surgery, Laparoscopic Surgery and Plastic and Reconstructive Surgery.
American Optisurgical, Inc. is recalling certain lots of TX1 Tissue Removal System disposable handpiece due to inventory being released into distribution without a cleared FDA 510(k) to cover recent product changes. Use of this product may lead to an underperformance of the device.
Atlantic Pro Nutrients, Inc. dba  XYMOGEN
AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NJ, NM, NY, OH, OK, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV, WY, District of Columbia and Hawaii
XYMOGEN EP Exclusive Patented Dietary Supplement Artriphen Clinically Tested to Support Healthy Joint Function, 90 and 180 capsule bottles
IGA Brand Vanilla & Chocolate Ice Cream, 1.75 Quart
Undeclared allergens: Almonds, Coconut, Soy Lecithin
Worldwide distribution: US Nationwide and country of Canada.
QuickDraw Venous Cannula with Insertion Kit. ThruPort Systmes. Models QD22 (22 Fr) and QD25 (25 Fr). The product is packaged sterile and non-pyrogenic in a sealed, peel-type pouch.  Two pouches (cannula and accessories) go into one shelf carton.  One shelf carton goes in one shipper carton.     Use of the QuickDraw venous cannula is indicated for patients undergoing cardiopulmonary bypass. The QuickDraw venous cannula serves to drain non-oxygenated blood from the venae cavae or right atrium during cardiopulmonary bypass. The product is packaged sterile and nona pyrogenic in a sealed, peel-type pouch.
Edwards is recalling the QuickDraw Venous Cannula due to complaints of cannula separation  during withdrawal of the device when the Percutaneous insertion method is used.
Worldwide distribution: US (nationwide) including states of: CO, AK, WA, CA, WI, MI, MA OH, DE, FL CA, CT, TX, IL, GA, PA, AZ, DC, VA, MD, UT, IN, MO, NY, NC, OR, NV, NJ, NH, DE, and country of: Canada.
519 units were calibrated at the service center
Calibration error for Embla Embletta Gold units calibrated through service center between June 15, 2012 to February 27, 2013.  This calibration error could cause a clinician to over titrate the patient and prescribe a therapy pressure higher than is necessary.
Siemens brand MicroScan Dried Negative Breakpoint Combo 47 panels (B1017-417), SMN #: 10483099),      For use in determining quantitative and/or qualitative antimicrobial agent susceptibility.
The product has the potential for false negative or delayed reaction for Arginine (ARG) results. In addition, 42 hour identification panel holds may occur due to a weak ARG reaction.
Berkshire Blue Cheese, Made from Whole Unpasteurized Cow's' Milk. Aged 60 days  Unit size: 2-3 Lb. wheels   Wrapped in wax paper then  plastic
Worldwide Distribution: USA Nationwide and countries of: Argentina, Austria, Australia, Bahrain, Belgium, Canada, Chile, Columbia, Denmark, Ecuador, Finland, France, Germany, Greece, India, Ireland, Israel, Italy, Jordan, Kuwait, Malaysia, Lebanon, Lybia, Mexico, Netherlands, New Zealand, Pakistan, Peru, Poland, Portugal, Qatar, Saudi Arabia, Serbia, Singapore, Spain, South Africa, Switzerland, Taiwan-Province of China,Turkey, United Arabs Emirates United Kingdom, Uruguay, and Venezula-Bolivarian Republic.
Applied Medicals Epix and Direct Drive Laparoscopic Graspers, Model Numbers C4130 and C4140.     Used for grasping and manipulating tissue during general or laparoscopic surgery.
Applied Medical is conducting a voluntary recall on specific lot numbers of its Epix and Direct Drive Laparoscopic  Graspers. When the ratchet trigger is activated, if a great enough force is applied, there is a potential for the trigger   to fracture and the jaws to remain in the closed position. The likelihood of this situation to occur and result in   permanent patient injury is highly unlikely; however, out of an abundance of caution for patient safety and a   commitment to provide only the highest quality products, Applied has decided to recall all potentially affected units.
Worldwide Distribution - USA Nationwide in the states of: NY, NH, IN, MI, FL and NJ and in the countries of: Europe and Latin America.
Brand Name: AFX'' Introducer System, Model Number S17-45.  Lot Numbers: 1079840, 1079843, 1079844, 1079845.      Product Usage:   The AFX Introducer System is intended for use to facilitate the introduction of catheters and other medical devices into the vasculature and to minimize blood loss associated with such introduction.
Endologix, Inc. initiated this voluntary recall of certain lots of Endologix, Inc. due to reports of dilator breakage during clinical procedures.
Worldwide Distribution-USA (nationwide) including the states of CA, FL, IA, IN, NJ, NV, NY, PA, TN, TX, and WI, and the country of Japan.
StarDental Classique(TM) Diamond Dental Bur.      Used for specific applications in dental procedures.
Recall was initiated because a manufacturing issue was found that prevented the diamond coating from adhering properly to the shank of the diamond bur for these lots.
Worldwide Distribution - USA (nationwide) and Internationally to Australia, Belgium, Canada, China, Denmark, Finland, France, Germany, Great Britian, Greece, India, Ireland, Italy, Netherlands, New Zealand, Norway, Poland, Puerto Rico, Singapore, Sweden, Turkey, Japan, Spain, Chile, Argentina, Colombia, Brazil, Taiwan, Mexico, South Korea, Venezuela, Paraquay, South Korea, Russian Federation, Costa Rico, Portugal, Uruquay, Martinique, Israel, Bolivia, Ecuador, Lebanon, Thailand, Saudi Arabia, Egypt, Dominican Republic, United Arab Emirates, Czech Republic, Indonesia, Kuwait, Ukraine, Guatemala, Phillipines, Trinidad, Tobago, Mongolia, Jordan, Malaysia, Hong Kong, Bulgaria, Oman, Kazakhstan, Bulgaria, Peru, Bolivia, Croatia, Romania, Yemen, Vietnam, Uzbekistan, Libyia, Slovakia, Algeria, El Salvador, and Cyprus.     .
STAR S3 ActiveTrack  Excimer System (STAR S3)     Mfg by AMO Manufacturing USA, LLC   510 cottonwood Drive   Milpitas, CA 95035      The STAR Excimer Laser System, a class Ill device, is indicated for laser assisted in situ keratomileusis (LASIK) eye surgery in certain patient populations.
Model 0030-4864 - all serial numbers of STAR Excimer Laser Systems that were manufactured prior to 26-Jul-2011.
Under specific conditions, there is an unlikely potential to result in inadvertent laser firing of the laser.
STAR S4  with Variable Spot Scanning Excimer System (STAR S4)     Mfg by AMO Manufacturing USA, LLC   510 Cottonwood Drive   Milpitas, CA 95035      The STAR Excimer Laser System, a class Ill device, is indicated for laser assisted in situ keratomileusis (LASIK) eye surgery in certain patient populations.
Model 0030-4077 - all serial numbers of STAR Excimer Laser Systems that were manufactured prior to 26-Jul-2011.
STAR S4 IR Excimer System (STAR S4 IR)     Mfg by AMO Manufacturing USA, LLC   510 Cottonwood Drive   Milpitas, CA 95035      The STAR Excimer Laser System, a class Ill device, is indicated for laser assisted in situ keratomileusis (LASIK) eye surgery in certain patient populations.
Model 0030-2450 - all serial numbers of STAR Excimer Laser Systems that were manufactured prior to 26-Jul-2011.
The 16-20 EZ Peel Shrimp was distributed by Perishable Distributors of Iowa (PDI) and sold from February 12 to May 23, 2013 at the seafood display counters in the retail markets seafood section of Hy-Vee stores located in eight states: Iowa, Nebraska, Kansas, Illinois, Missouri, South Dakota, Minnesota, and Wisconsin, and at Cedar Valley Fish Market in Waterloo, Iowa.
Blessing Brand Wild White EZ Peel Shrimp, 16/20 CT.     4 x 5 lbs cartons. The product is bagged in 5 lbs clear plastic bags, the only label iss on the master carton.  The product is sold in a seafood retail case.      Product labeled as:''WILD WHITE EZ PEEL SHRIMP 16/20 CT WILD CAUGHT PRODUCT OF USA CHEM FREE INGREDIENTS: Shrimp, Salt***PACKED BY: BLESSINGS, INC.***.
Blessing Seafood, Inc. is voluntarily recalling one lot of Blessing Inc. Wild White EZ Peel Shrimp due to undeclared sulfites.
AMICUS Exchange Kit;      Product Usage:   This kit is designed for use with the AMICUS separator for the Therapeutic Plasma Exchange (TPE) procedure. Sterilized by irradiation. Sterile fluid path. Non-pyrogenic fluid path.
Model No.: R4R2339;   Lot No.: FA12C07070;    Expiration Date: 03/2014
Fenwal has initiated a voluntary Urgent Product Recall for lot FA12C07070 of product code R4R2339, Amicus  Exchange Kits. Fenwal identified a labeling issue with this batch of Product Code R4R2339 (which was cleared for European use only) in which this batch was distributed within the United States market. The problem is identified as labeling that did not include the written description for the symbols used on the label.
Fresh Thai chili peppers.     Loose fresh Thai chili peppers packaged with inner plastic mesh bag into paper carton cardboard boxes. Imported bulk. Outer carton labeling reads in part: ''***PRODUCE OF MEXICO***JAMMIN PEPPERS***THAI CHILI***DISTRIBUTED BY: JT BROKERAGE 651 KOHLER ST. LOS ANGELES, CA 90021***WWW.JAMMINPEPPERS.COM***''.
Bulk outer carton labelets with Lot # 162.  Sold to retail with no coding or marks.
The firm recalled the Thai chili peppers because FDA analytical results revealed the presence of Salmonella.
Cefazolin, injection, 1 gram per vial, 25 vials per box, sterile, Rx only, single-use vial, Manufactured in Austria by Sandoz GmbH for Sandoz, Inc. Princeton, NJ 08540, NDC 00781-3451-70 (vial), NDC 00781-3451-96 (box)
Lack of Assurance of Sterility: Sandoz Inc is recalling Cefazolin for Injection, USP 1 gm vials, lot DB2208, due to a customer complaint for broken/cracked vials which was confirmed through review of retained samples.
Worldwide Distribution - US Nationwide all fifty states and including the countries of  Canada, Belgium, India, Malaysia, Saudi Arabia, Brazil, Israel, Mexico, Singapore, Jordan, New Zealand, Taiwan, Chile, Korea, Puerto Rico, Turkey, Columbia, Kuwait, Qatar, United Arab Emirates, Egypt, Lebanon and Russia.
ECHELON 60mm Endoscopic Linear Cutter Reloads Black in Flexible Blister pack with Tyvek lid.     The ECHELON and ECHELON FLEX families of Endoscopic Linear Cutters (articulating and straight) are sterile, single patient use instruments that simultaneously cut and staple tissue. There are six staggered rows of staples, three on either side of the cut line. The ECHELON 60 instruments have a staple line that is approximately 60 mm long and a cut line that is approximately 57 mm long. The shaft can rotate freely in both directions and an articulation mechanism on articulating instruments enables bending the distal portion of the shaft to facilitate lateral access of the operative site. The instruments are shipped without a reload and must be loaded prior to use. A staple retaining cap on the reload protects the staple leg points during shipping and transportation. The instruments''' lock-out feature is designed to prevent a used reload from being refired.
Ethicon Endo-Surgery is initiating a voluntary worldwide recall for ECHELON 60mm Black Reload (ECR60T) due to the potential for incomplete staple line formation from reload damage during the firing sequence.
Fentanyl Transdermal System, 50 mcg/h, 1 system per pouch (NDC 0591-3212-54), packaged in 5-count systems per box (NDC 0591-3212-72), Rx only, Manufactured by Watson Laboratories, Inc, Corona, CA, 92880 USA; Distributed by: Watson Pharma, Inc.
Uncle Eddies Vegan Oatmeal Chocolate Cookies, 12 oz.     One shipping carton/case consists of 12bags.   Product labeling reads in part:''uncle Eddies vegan oatmeal chocolate-chip cookies***net wt. 12 oz (340g)***MFG BY:INTERNATIONAL DESSERTS GLENDALE, CA 91203***(818) 549-0056***www.vegancookies.com***''.
International Desserts of Glendale, California is recalling Uncle Eddies Vegan Oatmeal Chocolate Cookies in 12 oz bags, because it may contain undeclared walnuts.
VIA Medical Collection Bag;  The collection bag is an accessory waste bag used in conjunction with the sterile LVM blood gas sensor with the LVM Monitor.  The collection bag is packaged in a tyvek pouch which is included in either replacement kit (777-3103) or LVM sensor kit (777-3102).
International Biomedical has received reports of interference between the collection bag and the extension set connectors. Evaluation of the affected components indicates that the collection bag connector can become occluded due to an over-tightening of the luer lock by the end user.  To alleviate the occurrence of this issue in the fixture, the connector on the collection bag has been improved to assure a tight seal while not allowing the component to be overtightened to the extent where an occlusion would occur.
One main customer,  Target Corporation  with 52 distribution locations.      AL, AZ, CA, CO, GA, IL, IN, IA, KS, MI, MN, NY, NC, OH, OR, PA SC, TX, VA, WI.
Market Pantry, Sweet & Salty Mix, NET WT 3 oz (85g), UPC 0 85239 08131 0, INGREDIENTS: Peanuts (peanuts...) ...Honey Roasted Peanuts...Honey Roasted Soy Nuts(soybeans...)., CONTAINS PEANUTS AND SOY,  May contain tree nuts, milk, wheat and eggs.     Distributed by Target Corporation, Minneapolis, MN 55403.
American Importing Co, Inc is recalling Market Pantry Sweet & Salty Mix because it contains Butter Toffee Peanuts instead of , Honey Roasted Peanuts listed on the label. Butter Toffee Peanuts contain a very small amount of butter (0.5% to 1.0%) which is a milk allergen.
Worldwide Distribution - United States Nationwide in the states of (MO, NE, KY, FL, OH, NY), and countries of Columbia, Brazil, Venezuela.  West Indies, Latin America, Ecuador are distributed through a US direct consignee exporter.
Deltran Disposable Pressure Transducer Kit  (DPT Kit)      Extracorporeal disposable pressure transducer and tubing set with integral stopcock and flush device,          Product Usage:  Deltran is a disposable pressure transducer that provides consistent and accurate readings during invasive blood pressure monitoring of humans and animals.
Part number DPT-248A, lot number 1122508.
Utah Medical Products, Inc. is recalling certain Deltran Disposable Pressure Transducer Kits due to complaints related to packaging integrity of the sterile packaged devices.
BARD PERIPHERAL VASCULAR VACCESS PTA Balloon Dilatation Catheters, 8mm x 4cm x 80cm.     Product Usage:  Vaccess PTA Balloon Dilatation Catheters are recommended for use in Percutaneous Transluminal Angioplasty of the femoral, iliac and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also recommended for post-dilatation of balloon expandable stents, self-expanding stents and stent grafts in the peripheral vasculature. This catheter is not for use in coronary arteries. Vaccess PTA Balloon Dilatation Catheters are supplied sterile and intended for single use.
Product Codes and Lot Numbers, respectively:   VA8084R, 93JW0056   VA8084, 937W0090
Bard Peripheral Vascular (BPV) has confirmed that some product code/lot number combination of devices may have the incorrect balloon diameter labeled on the inflation hub. Specifically, the balloon size printed on the hub may read 7mm x 4cm, when the actual balloon size is 8mm x 4cm. All other product labeling is consistent with the actual 8mm x 4cm balloon size.