Tri-Counties Blood Bank dba UBS- Central Coast
Red Blood Cells Leukocytes Reduced Irradiated
Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed.
Blood products, collected in a manner that may have compromised the sterility of the units, were distributed.
Blood products, collected from a donor whose suitability to donate were not adequately determined, were distributed.
Presbyterian Intercommunity Hospital, Inc. Blood Bank
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
Southern California Permanente Medical Group Blood Donor Center
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Blood products, which were collected from an unsuitable donor based on risk factors for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
Blood product, collected from a donor who did not meet acceptance criteria, was distributed.
Blood product, which did not meet the minimum requirement for Red Blood Cell recovery, was distributed.
Blood product, collected from a donor whose body temperature was not documented, was distributed.
Blood products, collected from a donor who did not have a complete physical examination, were distributed.
Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
Blood products, collected from a deferred donor, were distributed.
Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
Product was distributed to retailers in DE, FL, GA, MD, MO, NH, NJ, NY, PA, VA, and WV.
Chocolate covered raisinsin 4 oz flexible bags labeled in part ''***Pennsylvania Dutch Candies***Chocolate Covered Raisins***NET WT 4 OZ (113g)***Packed for Pennsylvania Dutch Candies Camp Hill, PA***Manufactured In A Facility That Also Processes Peanuts***''.
Chocolate Covered Peanuts were mislabeled with Chocolate Covered Raisins label; therefore Peanut Allergen is not identified.  Affected consignees were contacted in November, 2012.
University Of Miami Miller School of Medicine Tissue Bank
Human tissue allografts, mislabeled with extended expiration dates, were distributed.
Worldwide Distribution - USA (nationwide) including AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IN, KY, LA, MA, MD, MI, MN, MO, NC, NE, NJ, NY, OH, OK, OR, PA, SC, TN, TX, VA, WA, WV and WY; and internationally to: Algeria, Australia, Austria, Belgium, Brazil, Canada, Colombia, Cyprus, Czech Republic, France, Germany, Hong Kong, India, Israel, Italy, Latvia, Luxembourg, Malaysia, Mexico, Netherlands, Norway, Poland, Portugal, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey, UAE and UK.
CONFIDENCE SPINAL CEMENT SYSTEM 5CC KIT, Product Code: 2839-05-000   The CONFIDENCE Spinal Cement System is intended for percutaneous delivery of CONFIDENCE Spinal Cement, which is indicated for fixation of pathological fractures of the vertebral body during vertebroplasty or kyphoplasty procedures.
3896 units (Overall quantity distributed appears greater than quantities manufactured due to the distribution pathways)
During injection of cement, the water in the hydraulic pump leaks past the piston within the pump body resulting in the loss of pressure and inability to continue to inject cement.
CONFIDENCE SPINAL CEMENT SYSTEM 11CC PLUS KIT, Product Code:  2839-10-000   The CONFIDENCE Spinal Cement System is intended for percutaneous delivery of CONFIDENCE Spinal Cement, which is indicated for fixation of pathological fractures of the vertebral body during vertebroplasty or kyphoplasty procedures
HPBB0K, HPBB3C,HPCB7J, HPDBD6, HPBB0L,HPBB3D,HPCB7W,HPDBF0, HPBB0M,HPBB3F,HPDBBC,HPDBG4, HPBB0N,HPBBWH,HPDBBD,HPDBGB, HPBB0P,HPBBWJ,HPDBBK,HPDBGC,HPBB0T,HPBBWL,HPDBBL,HPDBGJ,  HPBB19,HPBBZ8,HPDBBY,HPDBGM,HPBB27,HPBBZD,HPDBCD,HPDBGN,  HPBB29,HPBBZN,HPDBCF, HPDBGY,HPBB2B,HPCB7B,HPDBD0,HPBB2C,  HPCB7C,HPDBD3,HPBB2G,HPCB7H,HPDBD4
CONFIDENCE SPINAL CEMENT SYSTEM KIT, Product Code: 2839-13-000     The CONFIDENCE Spinal Cement System is intended for percutaneous delivery of CONFIDENCE Spinal Cement, which is indicated for fixation of pathological fractures of the vertebral body during vertebroplasty or kyphoplasty procedures.
HPBB0B, HPBBWM, HPCB75, HPCCBN, HPBB0R, HPBBWP, HPCB7D, HPDBBV, HPBB28, HPBBZ7, HPCB7F, HPDBCG, HPBB2D, HPBBZF, HPCB7T, HPDBD1, HPBB2F, HPBCKH, HPCB7V, HPDBD5, HPBB4R, HPBDL9, HPCB8G, HPDBF9, HPBBV1, HPCB67, HPCBLC, HPDBGH, HPBBWG, HPCB68, HPCBM1, HPDBGK, HPBBWK, HPCB74, HPCCBM, HPDBGL
Blood products, which did not meet the acceptable product specifications, were distributed.
Product was sold through physicians offices and via internet sales to consumers located nationwide and in Canada.
ebA*(TM) Multivitamin Supplement, 180 tablets in plastic bottles, Distributed by Saratoga Therapeutics, LLC, North Wales, PA.
The recall was initiated due to discovery of the presence of milk components (milk protein(s) and lactose) despite labeling that incorrectly states it is free of milk components.
SexVoltz All Natural Herbal Supplement, packaged in 1 & 2 capsule blister packs and 4, 10 and 12 capsule bottles, Manufactured For: BeaMonstar Products, Queen Creek, AZ
Marketed Without an Approved NDA/ANDA; products have been found to contain tadalafil, the active ingredient in an FDA approved product used to treat erectile dysfunction, making this product an unapproved drug
Velextra All-Natural Herbal Supplement, packaged in 1 & 2 capsule blister packs and 4, 10 & 12 capsule bottles, Manufactured For: BeaMonstar Products Queen Creek, AZ
Switzerland; North Carolina; Austria; Missouri; Arkansas
Blood products, collected from an ineligible donor, were distributed.
Blood and Blood Products for Reprocessing
Community Blood Centers of Florida, Inc.
Community Blood Centers of South Florida, Inc.
Blood product, collected from a donor who traveled to a malarial endemic area, was distributed.
Butter (salted).  8oz round clear plastic tub and 5 gallon pail.  UPC Code 7 93573 09802 3.
Elevated coliform and standard plate count.
Data Innovations Instrument Manager Software Any version of Instrument Manager using the Roche Cobas e411 (rche411) driver versions 8.00.0001 or v8.00.002
Roche Cobas e411 (rche411) driver versions 8.00.0001 or v8.00.002
Laboratory software, with a defect or glitch, was distributed.
Data Innovations Instrument Manager software Model - Versions 8.12.01
Blood products, collected from an inelgible donor, were distributed.
Blood products, collected from an inelgibile donor, were distributed.
Lots of Typhim Vi (Typhoid Vi Polysaccharide Vaccine), with potentially low antigen content, were distributed.
Worldwide Distribution - USA (nationwide) and internationally to Austria, Belgium, Canada, Denmark, Egypt. Europe, Finland, France, Germany, Hong Kong, Ireland, Italy, Netherlands, Poland, Saudi Arabia, Slovena, Spain, Sweden, Switzerland, The Netherlands, Turkey, and UK.
LeGoo Endovascular Occlusion Gel-0.25 mL LeGoo with 3 Cannula Pouch Product Number: CS-25     LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel. LeGoo is indicated for temporary endovascular occlusion of blood vessels up to 4 mm in diameter below the neck.
LeGoo Endovascular Occlusion Gel-0.5 mL LeGoo with 3 Cannula Pouch   Product Number: CS-50     LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel. LeGoo is indicated for temporary endovascular occlusion of blood vessels up to 4 mm in diameter below the neck.
LeGoo Endovascular Occlusion Gel-1.0 mL LeGoo with 3 Cannula Pouch   Product Number: CS-100     LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel. LeGoo is indicated for temporary endovascular occlusion of blood vessels up to 4 mm in diameter below the neck.
LeGoo Endovascular Occlusion Gel-0.5 mL LeGoo w/ no Cannula   Product Number: PV-50     LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel. LeGoo is indicated for temporary endovascular occlusion of blood vessels up to 4 mm in diameter below the neck.
LeGoo Endovascular Occlusion Gel- 1.0 mL LeGoo w/ no Cannula   Product Number: PV-100    LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel. LeGoo is indicated for temporary endovascular occlusion of blood vessels up to 4 mm in diameter below the neck.
LeGoo Endovascular Occlusion Gel-2.5 mL LeGoo w/ no Cannula Product Number: PV-250     LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel. LeGoo is indicated for temporary endovascular occlusion of blood vessels up to 4 mm in diameter below the neck.
LeGoo Endovascular Occlusion Gel- 0.5 mL LeGoo with 3 Cannula Pouch   Product Number: LG50    LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel. LeGoo is indicated for temporary endovascular occlusion of blood vessels up to 4 mm in diameter below the neck.
LeGoo Endovascular Occlusion Gel- 1.0 mL LeGoo with 3 Cannula Pouch   Product Number: LG100    LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel. LeGoo is indicated for temporary endovascular occlusion of blood vessels up to 4 mm in diameter below the neck.
LeGoo Endovascular Occlusion Gel-2.5 mL LeGoo with 1 Cannula Pouch   Product Number:  LG250     LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel. LeGoo is indicated for temporary endovascular occlusion of blood vessels up to 4 mm in diameter below the neck.
LeGoo Internal Vessel Occluder .25mL    Product Number: 10-0025    LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel. LeGoo is indicated for temporary endovascular occlusion of blood vessels up to 4 mm in diameter below the neck.
LeGoo Internal Vessel Occluder .5mL  Product Number: 10-0050    LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel. LeGoo is indicated for temporary endovascular occlusion of blood vessels up to 4 mm in diameter below the neck.
LeGoo Internal Vessel Occluder 1mL  Product Number: 10-0100    LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel. LeGoo is indicated for temporary endovascular occlusion of blood vessels up to 4 mm in diameter below the neck.
LeGoo Internal Vessel Occluder 2.5mL Product Number: 10-0250    LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel. LeGoo is indicated for temporary endovascular occlusion of blood vessels up to 4 mm in diameter below the neck.
LeGoo Internal Vessel Occluder 5mL Product Number: 10-0500    LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel. LeGoo is indicated for temporary endovascular occlusion of blood vessels up to 4 mm in diameter below the neck.
LeGoo Internal Vessel Occluder 10mL Product Number: 10-1000    LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel. LeGoo is indicated for temporary endovascular occlusion of blood vessels up to 4 mm in diameter below the neck.
LeGoo Endovascular Occlusion Gel 0.5 mL  Product Number: LG50IT    LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel. LeGoo is indicated for temporary endovascular occlusion of blood vessels up to 4 mm in diameter below the neck.
LeGoo Endovascular Occlusion Gel 1.0 mL  Product Number: LG100IT    LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel. LeGoo is indicated for temporary endovascular occlusion of blood vessels up to 4 mm in diameter below the neck.
LeGoo Endovascular Occlusion Gel 2.5 mL  Product Number: LG250IT    LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel. LeGoo is indicated for temporary endovascular occlusion of blood vessels up to 4 mm in diameter below the neck.
1) terrafina Natural Roasted Salted Pistachios, Net wt. 2.25 oz(63g) UPC 847938032112, 2) terrafina Natural Roasted Salted Pistachios, Net wt. 10 oz (283g) UPC 8497938103218, 3) terrafina Natural California Salted Pistachios, Net wt. 13 oz (368g) UPC 847938063215, 4) terrafina Natural California Salted Pistachios, Net wt. 18 oz (510 g) UPC 847938032150, 5) terrafina Natural California Salted Pistachios, Net wt. 20 oz (568g) UPC 847938073214), 6) terrafina Natural Roasted Salted Pistachios, Net wt. 7 oz (198g) UPC 847938003211.
1) terrafina Natural Roasted Unsalted Pistachios, Net wt. 10 oz (283g) UPC 847938103201, 2) terrafina Natural California Unsalted Pistachios, Net wt. 13 oz (368g) UPC 847938063208, 3) terrafina Natural California Unsalted Pistachios, Net wt. 18 oz (510g) UPC 847938032051, 4) terrafina Natural California Unsalted Pistachios, Net wt. 20 oz (567 g) UPC 847938073207, 5) terrafina Natural California Unsalted Pistachios, Net wt. 7 oz (198g) UPC 847938003204.
Human Corneas, recovered from a donor whose plasma dilution was not properly evaluated, were distributed.
Egypt; Lebanon; Argentina; Mexico; Romania; South Africa; Iraq
Human corneas, recovered from donors 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.
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.
Capture-R Ready plates, with higher rates of equivocal and unexpected positive reactions, were distributed.
American National Red Cross, Penn-Jersey Region
Blood product, mislabeled as leukoreduced, was distributed.
Blood Systems, Inc. dba United Blood Services Texas
Measles, Mumps and Rubella Virus Vaccine Live
M-M-R II (Measles, Mumps and Rubella Virus Vaccine Live)was inadvertently distributed.
Mississippi; Puerto Rico; Maryland; Florida; Guatemala; New York
Human tissue allografts, associated with positive culture results, were distributed.
Tortillas Lupita Flour Tortillas, Net Wt. 23oz, Manufactured By Tortilleria Lupita, 235 SW 25th St., Oklahoma City, OK 73109
All product still on the retail store shelf.
The product is being recalled for undeclared soy lecithin and soybean oil.
Nationwide Distribution including TX, VA, OK,  and PA
SC2316, Distal Femoral Augment with Screw   Total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis and/or post-traumatic degenerative problems and revision of failed previous reconstructions.
Part number SC2316-3-5 with lot number 22389-111609. Part number SC2316-4-5 with lot number 22587-111609. Part number SC2316-5-5 with lot number 23214-111609.
The firm became aware of an incident relating to a breach of sterility in the sterility barrier packaging of SC2316, Distal Femoral Augment with Screw.
Worldwide Distribution - USA (nationwide) Puerto Rico and internationally to Argentina, Austria, Brazil, Bulgaria, Canada, Chile, China, Columbia, Croatia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Great Britain, Greece, Guatemala, Hungary, Indonesia, Italy, Kazakhstan, Lithuania, Norway, Poland, Portugal, Romania, Russian Federation, Serbia, Singapore, Slovakia, Slovenia, Spain, Sweden, Switzerland, South Africa, South Korea, Thailand, Turkey, Uruguay, Vatican City, and  Vietnam.
ADVIA Chemistry A1c_3 Calibrators, Catalog Number 10491408, IVD --- COMMON/USUAL NAME: ADVIA Chemistry A1c_3 Calibrators Shipping or unit package:  Level 1: 2 x 0.5 g; Level 2: 2 x 0.5 g; Level 3: 2 x 0.5 g; Level 4: 2 x 0.5 g -- Siemens Healthcare Diagnostics, Inc. Tarrytown, NY 10591 --- System Information: The ADVIA Chemistry systems are automated, clinical chemistry analyzers that can run tests on human serum, plasma, or urine in random access and batch modes for in vitro diagnostic use.    For in vitro diagnostic use in the calibration of A1c_3 (A1c_3 and A1c_3M) and Total Hemoglobin_3 (tHb_3 and tHb_3M) methods on ADVIA Chemistry systems.
Siemens confirmed that the ADVIA Chemistry Systems HbA1c method exhibits a positive bias of up to 12% for patient and CAP survey samples due to over-recovery when using A1c_3 Calibrator lots 1MD014, 1BD063, and 2GD014. The established ranges of CAP Survey Samples GH2-04, GH2-05 and GH2-06 and IFCC sample recoveries use  7% from the established mean as their acceptance criteria. This is the criterion that was used during testing to confirm the customer complaints.  Depending upon quality control limits this issue may not have been detected..
Chunky Spinach Artichoke and Parmesan Dip: Gluten Free, Trans Fat Free.  Net WT. 10 oz., (.625 lb,284g  Made with real cream cheese.  Plastic square tub    La Terra Fina  Union City, CA 94587
One lot Spinach Artichoke & Parmesan dip contains the ingredient and nutrition information for Caramelized onion dip. Both dips have the same allergens statement - Milk, Soy and Egg.
Baltic Sprats in  Spicy Brine Net Wt. 15.8 oz. Prod. of Latvia Distributed by Zip International Group LLC 160 Raritan Center Parkway Unit #6 Edison NJ 08837 T 732-225-3600   UPC 4750217602547
Baltic Sprats in Spicy Brine may be contaminated with Listeria monocytogenes.
Worldwide Distribution - USA including AL, AZ, AR, CA, CO, CT, DE, DC, FL, GA, ID, IL, IN, IA, KY, LA, MD, MA, MI, MN, MS, MO, MT, NE, NV,NH,NJ, NY, NC, ND, OH, OK, OR, PA, RI, SC,SC, TN, TX, UT, VA, WA, WV, and WI.  Internationally to Algeria, Finland,  Japan, Spain, Australia, France, Latvia, Sweden, Austria, Germany, Netherlands, Switzerland, Belgium, Great Britain, Norway, Taiwan, Brazil, Greece, Panama, Turkey, Canada, Hong Kong, Poland, Unit.Arab Emir., China, India, Russian Fed., Colombia, Ireland, Saudi Arabia, Czech Republic, Israel, South Africa, Denmark, Italy, and South Korea.
Boston Scientific, Small Peripheral Cutting BalloonTM, Sterilized using irradiation:    The Peripheral Cutting Balloon Catheters are indicated for Percutaneous Transluminal Angioplasty (PTA) of obstructive lesions of synthetic or native arteriovenous dialysis fistulae.    1) 4.00mm x 15mm Small Peripheral Cutting BalloonTM MonorailTM Microsurgical Dilatation Device, UPN #001BPM4015140F0, Catalogue # BPM4015140F & UPN # M001PCBM4015140F0, Catalogue # PCBM4015140F.    2) 4.00mm x 15mm Small Peripheral Cutting BalloonTM Over-the-Wire Microsurgical Dilatation Device, UPN #  M001PCBO4015140F0, Catalogue # PCBO4015140F.
Boston Scientific is initiating a recall removal of the 4.0mm x 15mm size of Small Peripheral Cutting Balloon (Monorail and Over-the-Wire) Microsurgical Dilatation Devices and Flextome Cutting Balloon (Monorail and Over-the-Wire) Microsurgical Dilation Devices.  Boston Scientific has determined that users may experience significant difficulty or inability to remove the protector cap from the device which may result in damage to the device.
Boston Scientific, FlextomeTM Cutting BalloonTM,  Sterilized using irradiation:    1) 4.00mm x 15mm FlextomeTM Cutting BalloonTM MonorailTM Microsurgical Dilatation Device, UPN #H749CBM3400150 Catalogue # CBM340015 & UPN# H749RB4400150 Catalogue # RB440015     2) 4.00mm x 15mm FlextomeTM Cutting BalloonTM Over-the-Wire Microsurgical Dilatation Device, UPN # H749CBO3400150, Catalogue # CBO340015    The Flextome Cutting Balloon Device is indicated for dilatation of stenoses in coronary arteries for the purpose of improving myocardial perfusion in those circumstances where a high pressure balloon resistant lesion is encountered. In addition, the target lesion should possess the following characteristics: '' Discrete (< 15 mm in length), or tubular (10 to 20 mm in length) '' Reference vessel diameter (RVD) of 2.00 mm - 4.00 mm '' Readily accessible to the device '' Light to moderate tortuosity of proximal vessel segment '' Nonangulated lesion segment (< 45) '' Smooth angiographic contour '' Absence of angiographically visible thrombus and/or calcification.
Worldwide Distribution - USA (nationwide) including Oregon and California, and internationally to: France, Belgium, Italy, Denmark, Norway, Switzerland, Romania, Finland, Germany, South Africa, Canada, Ireland, UK, Sweden and Japan.
WASP (Walk Away Specimen Process). Automatic Planting and Streaking Instrument   Catalog number: W086    WASP is a fully automated system used to process microbiological specimens in liquid phase for the investigation of infectious microbes.
The recall of the WASP (Walk Away Specimen Process) instrument was initiated because Copan Italia SpA has upgraded the software concerning the broth inoculation table feature.  The upgrade has been considered necessary from the manufacturer in order to eliminate the very low risk of rotation of the broth table when the door is open.
Dove Chocolate  Discoveries Fruit Collection Dark Chocolate - Covered Cranberries, Blueberries, Cherries Net Wt. 18 oz. Distributed by Dove Chocolate Discoveries, LLC A subsidiary of Mars, Incorporated Hackettstown, NJ 07840-1503 USA  Item #3265D    Each 18 oz box of mislabeled Fruit  Collection contains two clear 8 oz polypropylene bags, labeled DK  CINN ALMOND .
lot code 317DAIDS01   Each 18 oz box of mislabeled Fruit  Collection contains two clear 8 oz polypropylene bags, labeled DK  CINN ALMOND .     The interior polypropylene bags are stamped with lot  code 308 BC4CP02 which reflects the co-packer of the 8 oz bags (Cano  acquired by Coregistics, Wheeling, IL 60090).
Cinnamon Dusted Dark Chocolate Almonds (Item Number: 3059D) were packaged in boxes labeled Fruit Collection  (Item Number: 3265D), a mix of Dark Chocolate-Covered Cranberries,  Blueberries, and Cherries.
CARBOplatin Injection, 600 mg/60ml, MultiDose, Rx only, Teva Parenteral Medicines, Inc., Irvine, CA 92618 NDC 0703-3249-11
Lack of Assurance of Sterility: The required reduction of endotoxin was not met during the annual revalidation of the vial washer.
The product was distributed nationwide, in all U.S. states, and in Canada (Wade & Sandy Pierson  Company Name: In Case Of , #102 127 Commercial Drive , Calgary AB T3Z 2A7 Canada, Tel. 403-381-0005).   The product was not distributed to the U.S. Defense Supply Center, VA or other Federal Government Agency Sales/distribution center.
THRIVE 6 Grain Pancake Mix; There are two unit sizes: (1) 4 lb. #10/gallon can (6.03x 7.02) (the ''Gallon Cans''); and  (2)  1.17 lb. Pull-Top Pantry Cans (4.01x 5.08) (the ''Pantry Cans'').    Both units are packaged in metal cans. The Pantry Can has a metal pull-top lid and the Gallon Can has a metal lid that must be opened by a can opener. (1) The Gallon Cans may be ordered as single units or in six (6) can cases. (2)  The Pantry Cans may be ordered as single units or in ten (10) can  cases.
Gallon Cans - 100,116 cans; Pantry Cans -  4,219 cans
Thrive Foods is recalling certain lots of its 64 and 72 ounce cans of THRIVE 6 Grain Pancake Mix because this product contains ingredients that react over time and increase the pressure inside the can, which may cause cans to expand or bulge and increase the risk of sudden release of the pancake mix when the can is opened and could pose the risk of injury.
Nationwide.  No foreign, military, gov't, VA distribution.
Maple Almond Butter 16 oz Jar (Unit USPC 894455000322,   Case USPC 894455002135)
Lot Code 188 (Best By Date 07/07/14)  Lot Code 190 (Best By Date 07/09/14)  Lot Code 191 (Best By Date 07/10/14)
5,649 master cases (6 jars per master case)
Justi's has initiated a voluntary recall of certain lots of its Maple Almond Butter 16oz jars and its Chocolate Hazelnut Butter 16oz jars due to the presence of foreign metallic fragments in unpackaged nut butter.
Chocolate Hazelnut Butter 16oz Jar (Unit UPC 894455000490, Case UPC 894455000612)
Lot Code 191 (Best By Date 07/10/14) Lot Code 192 (Best By Date 07/11/14)
1,512 master cases (6 jars per master case)
Justin's has initiated a voluntary recall of certain lots of its Maple Almond Butter 16oz jars and its Chocolate Hazelnut Butter 16oz jars due to the presence of foreign metallic fragments in unpackaged nut butter.
Potter's Crackers, Classic White, Net Wt 5 ounces, UPC 6 80569 15877 2, Potters Fine Foods LLC, 100 S. Baldwin, Madison WI 53703., Ingredients, Wheat Flour, Milk, Butter, Cracked Wheat, Sugar, Crystal Salt, Baking Powder, Black Pepper.  Allergen Information: wheat, dairy & tree nuts.
Potters Fine Foods LLC are recalling Potter's Crackers Classic White because of cross contamination with a Basil Walnut Presto Cracker dough.  Even though there is an allergen statement on the Classic White tag for tree nuts, we initiated a voluntary recall.  All 109 packages were accounted for.
Worldwide Distribution - USA (nationwide) and internationally to Australia, Ireland, Canada, Netherlands, Sweden, Japan, and United Kingdom.
Steinmann Pin, packed in a clear tube with end caps, tubes packed in a sterile barrier pouch, 6 pouches/sales unit. Pouches are labeled in part ***MicroAire Surgical Instruments 3590 Grand Forks Blvd Charlottesville, VA LLC 22911***   Models:  1620-109              1636-509  1620-509              1640-509  1620-609              1648-509  1620-709             1648-509T  1624-109              1648-609  1624-509             1648-609T  1624-509T  1628-509  1632-509  1632-609      A smooth or threaded wire / pin that may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.
A medical device used in surgical procedures was packaged in a pouch in which a defective seal may compromise sterility
Kirschner-Wire (K-Wire), packed in a clear tube with end caps, tubes packed in a sterile barrier pouch, 6 pouches/sales unit. Pouches are labeled in part ***MicroAire Surgical Instruments 3590 Grand Forks Blvd Charlottesville, VA LLC 22911*** Models:  1620-109              1636-509  1620-509              1640-509  1620-609              1648-509  1620-709             1648-509T  1624-109              1648-609  1624-509             1648-609T  1624-509T  1628-509  1632-509  1632-609    A smooth or threaded wire / pin that may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.
El Basham Weight 400 g  Ingredients: Natural Apricot Juice, Glucose, Sugar, Oil. Made by: For the Owner of the Trade Mark ABU Ode h Bros Co. Amok St. Aman -Jordan   Tel +962 6 4914961  Fax +962 6 4907878        Remaining information is in Arabic.
None listed in Attachment B. However, the outside markings on the label has an expiration date code 6/2012-6/2014 (Attachment #2 2 of 2 and in  Memorandum Report dated June 14, 2013.
Kamar  Deen AL Basham Apricot Dried Paste does not declare product identity in English.
Pentosan Polysulfate Sodium  (K9) 150 mg/ml aqueous solution for injection, for Veterinary Use only 10 mL Sterile amber vials Refrigerated Storage required. Item Code PENTOS-INJ007VC    This preparation is dispensed with a prescription label, so each vial would be individually labeled with specific information containing not only the drug name, strength, etc. but also the patient name, prescriber name, and directions for use.
Routine endotoxin testing of this batch indicated that the finished injection solution contained a concentration of endotoxins exceeding established endotoxin concentration limits. A second sample tested from this same lot confirmed the higher than expected endotoxin concentration.
Nationwide distribution: AL, CT, FL, GA, IA, MS, MO, NJ, NY, ND, OH, OK, PA, RI, TX, VA and Puerto Rico.
DMLC IV-ERGO - Beam shaping block for Radiation Therapy.
Clinical mistreatment may occur when there are errors in the clinical work flow.
Distribution was made to: Alabama, Alaska, Arizona, California, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Michigan, Missouri, Montana, Nebraska, Nevada, New Mexico, North Carolina, Ohio, Oregon, South Carolina, Tennessee, Utah, Virginia, Washington, West Virginia and Wyoming.
Kroger Break 'N Bake Chocolate Chip Cookie Dough, refrigerated dough, packaged in 16.0 oz. plastic package.
Peanut Butter Cup Cookie Dough (refrigerated) is packaged in Chocolate Chip Cookie Dough packaging. Peanuts or peanut butter are not listed on the ingredient list or allergen statement.
Hawaii Fresh Sweet Basil Hawaii Fresh Thai Basil   product of the USA    Crown Pacific International, Inc.  Hilo, HI
56 boxes of sweet basil (14, 15 or 16 lbs per box);  16 boxes of Thai basil  (15 or 16 lbs per box)
State of Hawaii Issued a Cease and Desist Order to grower of basil for positive sample results for pesticides not allowed on basil.
H-E-B Jumbo Butterfly Shrimp-10.5 oz Box, 20 units per case
Product marked with ''BEST BY 23APR2014''
Cartons of this product have been found to contain coconut shrimp.  Coconut is not listed as an ingredient.