Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Nationwide and Chile, England, Ecuador,Greece, Italy, India, Kuwait, Netherlands, Portugal, Puerto Rico, Saudi Arabia, Spain, Sweden, and Switzerland
OASIS Medical Vidaurri LASIK Flap Irrigator, Product Specification 4036V. The Vidaurri LASIK Flap Irrigator is a 16g x 1/2'' stainless steel cannula with two 25g x 9/16'' tip extensions. There are eight .25mm ports (four per tip).
Product Specification 4036V Lot D1201AD Lot D0702A Y  Lot D0802J  Lot D09028 Lot D0103V Lot D0303S Lot D1203AH Lot D0104AC Lot D0304AQ Lot D0504AG Lot D0105AV Lot D0205J  Lot D0305AH Lot D03058D Lot D0605AE Lot D0705Y  Lot D0805A8
''Please be aware that this is not a new recall. The firm has taken action; but, due to administrative issues additional products are now being classified by the agency''.Foreign deposit present on the surface of the Vidaurri LASIK Flap Irrigators
OASIS Medical Vidaurri LASIK Flap Irrigator, Sterilized, Product Specification 8065403604 Dual Tip Irrigator 8 Ports The Dual tip Irrigator 8 Ports is placed into a vacuum formed plastic tray and a Tyvek lid is heat-sealed onto the tray. The heat-sealed tray is placed into a Tyvek pouch, heat-sealed and sterilized. After sterilization, 10 pouches are loaded into a carton, the carton is labeled and heat-shrink wrapped.
Product Specification 8065403604 Lot D0304S Lot D0405A Y  Lot D05058H
''Please be aware that this is not a new recall. This recall was initially classified in 2005 (Z-1595-05).  The firm has taken action; but, due to administrative issues this product is now being classified by the Agency''.Foreign deposit present on the surface of the Vidaurri LASIK Flap Irrigators.
OASIS Medical Vidaurri LASIK Flap Irrigator, Non-sterilized Bulk, Product Specification MK-036V, LASIK Flap Irrigator (Vidaurri) The MK-03V cannula is placed into a vacuum formed plastic tray and a blank Tyvek lid is heat-sealed onto the tray. The heat-sealed tray is placed into a Tyvek pouch, heat-sealed and placed into a polybag. The polybag is sealed and labeled. Typically there are 100 pouches per polybag.
Product Specification MK-036V Lot D0305Y
OASIS Medical Vidaurri LASIK Flap Irrigator, Non-sterilized Bulk, Product Specification B-4036V-NS, LASIK Flap Irrigator (Vidaurri) The -B4036V-NS cannula is placed into a vacuum formed plastic tray and a Tyvek lid is heat-sealed onto the tray. The heat-sealed tray is placed into a polybag. The polybag is sealed and labeled. Typically there are 100 trays per polybag.
Product Specification 8-4036V-NS Lot D060488 Lot D0804T  Lot D0904A  Lot D1004AV  Lot D12048X
Blood product,which was out of controlled storage for an indeterminable length of time, was distributed.
Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
Blood and Blood Products for Reprocessing
Blood product, collected from a donor who reported travel to a malarial endemic area, was distributed.
Blood products, collected using trip scales for which the daily QC was not documented, were distributed.
Platelets Pheresis Leukocytes Reduced Irradiated
Blood product, which was possibly contaminated with Propionibacterium acnes, was distributed.
Blood products, collected from donors whose physical exams  were not adequately performed, were distributed.
USA Nationwide Distribution in the states of TN, MA, CA, IL, OH, FL, UT, WA, GA, IA, NY, MO, IN, and CO.
Siemens Artis Q and Artis Q biplane systems     Product Usage:  Interventional Fluoroscopic X-ray
There exists the possibility that during clinical operation, a breakdown of the x-ray tube could result in loss of x-ray imaging for the Artis Q and Artis Q biplane systems with a flat detector as 40 HDR (large 30x40).
Nationwide Distribution-including the states of AR, AK, VA, IN, PA, OH, CT, TX, MI, WI, NC, CO, IL, and MA.
Drill Template and the Saw Guide for the Ulna Osteotomy System.   Intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragments, including osteopenic bone in the ulna.
The Drill Template and the Saw Guide for the Ulna Osteotomy System may exhibit jamming, bending, or breaking of the screw connecting the Saw Guide to the Drill Template or jamming, bending, or breaking of the K-wire during fixation of the Drill Template.
Bonduelle USA Inc (Oakfield) BEANS GREEN CUT GRADED, Net weight: 1,480 lbs (bulk form in Totes), Keep frozen.
Bonduelle North America has recalled bulk totes of  Cut and Whole Green Beans due to the presense of filth.
Bonduelle USA Inc (Oakfield) BEANS GREEN WHOLE GRADED, Net weight: 1,100 lbs (bulk form in Totes), Keep frozen.
87 totes (Total Net Wt. 95,700 lbs) (10 totes remained quarantined in stock)
Bonduelle North America has recalled bulk totes of  Cut and Whole Green Beans due to the presense of filth
DE, FL, GA, KY, MD, NC,OH, PA, SC, TN, VA, WV, OK and District of Colombia
Chicken Soup for the Soul Thai-Style Chicken Broth, 32 oz. (2 lb., 907 g. paperboard carton. Distributed by Chicken Soup For The Soul Foods, LLC, Stamford, CT 06902-7532    UPC:  8 19239 01021 2.
American Red Cross Greater Alleghenies Region
Blood products, labeled leukoreduced without the assurance that they met the criteria for leukoreduced products, were distributed.
Blood products, collected from a donor who received a tattoo within 12 months of donating, were distributed.
Blood product, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
Distribution was made to IA, IL, and MI.  There was no foreign/military/government distribution.
New Horizon Cuisine Chicken Demi-Glace Xpress, packaged in 16-oz. plastic cups (6/case) and New Horizon Cuisine Chicken Demi-Glace packaged in 16-lb. (2-gal.) buckets.  The firm name on the label is New Horizon Cuisine, Ankeny, IA.
59/16-lb. buckets and 20/6/16-oz. plastic cup cases
Product was manufactured using chicken that was reported to be spoiled by another government agency.
DermOtic Oil (fluocinolone acetonide) 0.01% Ear Drops, 20 mL bottle, Rx only  Manufactured and Distributed by: Hill Dermaceuticals, Inc. Sanford, Florida 32773 NDC 28105-160-20
Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
Derma-Smoothe/FS fluocinolone acetonide 0.01% Topical Oil (Scalp Oil), 4 fl. oz., Rx only.  Manufactured and Distributed by: Hill Dermaceuticals, Inc. Sanford, Florida 32773 NDC 28105-149-04
Derma-Smoothe/FS fluocinolone acetonide 0.01% Topical Oil (Body Oil) 4 fl. oz., Rx only  Manufactured and Distributed by: Hill Dermaceuticals, Inc. Sanford, Florida 32773 NDC 28105-150-04
ROYAL PHARMACEUTICALS Derma-Smoothe/FS fluocinolone acetonide 0.01% Topical Oil (Body Oil) 4 fl. oz., Rx only  Manufactured by: Hill Dermaceuticals, Inc. for: Royal Pharmaceuticals NDC 68791-101-04
ROYAL PHARMACEUTICALS Derma-Smoothe/FS fluocinolone acetonide 0.01% (Scalp Oil), 4 fl.oz., Rx only  Manufactured by: Hill Dermaceuticals for: Royal Pharmaceuticals NDC 68791-102-04
ROYAL PHARMACEUTICALS DermOtic Oil fluocinolone acetonide 0.01% (Ear Drops), 20 ml,  Rx only  Manufactured by: Hill Dermaceuticalsfor: Royal Pharmaceuticals NDC 68791-103-20
SETON PHARMACEUTICALS  Fluocinolone acetonide 0.01% Topical Oil (Scalp Oil), 4 fl.oz., Rx only Manufactured by: Hill Dermaceuticals, Inc. For: Seton Pharmaceuticals NDC 13925-507-04
SETON PHARMACEUTICALS Fluocinolone Acetonide 0.01% Topical Oil (Body Oil), 4 fl.oz., Rx only  Manufactured by: Hill Dermaceuticals, Inc. For: Seton Pharmaceuticals NDC 13925-506-04
SETON PHARMACEUTICALS Fluocinolone Acetonide 0.01%  Oil EAR DROPS, 20 ml, Rx only Manufactured by: Hill Dermaceuticals, Inc. For:  Seton Pharmaceuticals NDC 13925-508-20
Thickened Water Pudding Thick 32 oz. (944ml)  Phase 3  Ingredients: Pasteurized Filtered Water, Cellulose Gum Fibre, Potassium Sorbate.
NUTRA Balance Pre-Thickened Water was found to contain mold.
Thickened Water Nectar Thick 32 oz. (944ml)  Phase 1  Ingredients: Pasteurized Filtered Water, Cellulose Gum Fibre, Potassium Sorbate, Citric Acid.
NUTRA Balance Thickened Water Nectar Thick was found by the FDA to contain mold. In addition, Thickened Water Pudding thick was sampled by Nutra Balance Products and it subsequently tested positive for Enterobacter sp. and Xanthomonas sp.
Worldwide Distribution - USA (nationwide) and Internationally to Canada.
i-STAT G3+ Cartridge   pH, pCO2 and pO2 measurements are used in the diagnosis, monitoring and treatment of respiratory disturbances and metabolic and respiratory based acid-based disturbances.
Abbott Point of Care has determined that some individual patient results generated with the i-STAT G3+ cartridge lot N13183 have the potential to exhibit incorrectly elevated PCO2 and  depressed pH results.
USA Nationwide Distribution in the states of WI, KY, OH, NJ, NC, FL, PA, MA, IA, TX, NY, IL, MI, AZ, CA, and LA.
AXIOM Artis Systems   Product usage:  Artis zee is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.
Certain units of the AXIOM Artis Systems are using a flat detector cooling unit with inappropriate connectors that may possibly leak, causing a system failure and possible drop out of the gantry system.
US Nationwide Distribution in the states of:  VA, WA, KY, IL, and IA.
PowerPort Slim Implantable Port, indicated for patient therapies requiring repeated access to the vascular system.  Product Codes: 1716000, 1716070
Lot Numbers: REXA1302, REXA1350, REXB1160
Bard Access Systems, Inc. has notified customers of a labeling discrepancy involving PowerPort Slim Implantable Port 1716000, 1716070 in which the label states that the implantable port contains silicone suture plugs, however approximately 23% of the units contained in the affected lots have a PowerPort Slim titanium implantable port without silicone suture plugs.
Nationwide Distribution including FL, GA, MD, CA, NC, MA, SC, WY, and TX.
AMS BUN UREA NITROGEN For the In vitro quantitative determination of Urea Nitrogen in serum   Quantitative determination of Bun in serum.
Marketing the devices outside 510(k) requirements
AMS URIC ACID For the In vitro quantitative determination of Uric Acid in serum   Quantitative determination of Uric Acid in serum.
AMS AST For the In vitro quantitative determination of AST in serum    Quantitative determination of AST in serum.
FAIRWAY brand CONDIMENT GRILLING SAUCE, NET WT 12 oz (340 g), UPC 7 58940 70609 3 -- Distributed By: Fairway Group Central Services LLC New York, New York 10027 --- The product is packaged in a glass bottle, 12 bottles per case.
Lot 340 GRSC with a ''use by'' date of 03/08/2014, and Lot 357 GRSC with a ''use by'' date 03/25/2014 (located on side of glass bottle)
The Grilling Sauce contains undeclared fish (anchovies), a a sub-ingredient in the Worcestershire Sauce ingredient used in making the product.
Kinnikinnick Original Homestyle Waffles 210 g/7.4 oz Cardboard Box UPC 620133001981
Kinnikinnick Cinnamon & Brown Sugar Homestyle Waffles 210 g/7.4 oz Cardboard Box UPC 620133001981
Kinnikinnick Panko Style Bread Crumbs-Weight: 350g/12.5oz Cardboard Box UPC 62013360015 3
Single Analyte DAU Calibrator (5 mL) Norbuprenorphine: Cutoff Calibrator;  IVD - for in vitro diagnostic use only;  Lin-Zhi International  Sunnyvale, CA    The Norbuprenorphine Drug of Abuse (DAU) cutoff Calibrator is used for qualitative and semi-qualitative calibration of the Lin-Zhi Internal, Inc. Buprenorphine (BUP) enzyme Immunoassay (REF # A53684) on the Synchron Clinical Analyzer
Product catalog number: A68827; Lots 1308006, 1308131, Expiry: March 28, 2015.
Customer reported that the Synchron NBUP cutoff calibrator (10 ng/mL) could not be qualified through quality control testing. The cutoff calibrator was recovering at a concentration close to the NBUP Control Level 1 (7 ng/mL).
Worldwide Distribution - US (nationwide) including the states of AL, CA, CO, CT, DC, FL, GA, IL, IN, LA, MA, MD, MI, MS, NC, NY, PA, SC, TN, TX, WI, and the countries of Belarus, Italy and Switzerland.
DICOM Export Format for Sum Dose with Velocity v3.0.0.   A stand-alone software product that provides the oncology care specialists (physicians, physicists, dosimetrists, etc.) a means for comparison of medical imaging data from multiple DICOM conformant imaging modality sources. It allows the display, annotating, volume rendering, registration and fusing of medical images as an aid during use by diagnostic radiology, oncology, radiation therapy planning and other medical specialties.
An anomaly was detected such that, under certain conditions, a summed dose created by Velocity replaces the calculated dose from an approved plan in Eclipse when importing the dose from Velocity.
The recall was initiated due to an adverse event report from a consignee and the discovery of a compound other than L-Citrulline in at least one drum.
my essentials brand sour cream, NET WT. 24 OZ. (680g), UPC 7 25439 10546 0 --- Firm on label: DISTRIBUTED BY DZA BRANDS, LLC 2110 Executive Drive, Salisbury, NC 28147 --- The sour cream is packed in a plastic container.
APR 05 14 (ink jetted onto the lip of the lid on each container)
2789 cases (12 x 24 oz. containers per case)
HP Hood LLC received one complaint of a foreign object in  sour cream product with APR 05 14 code.  The object was  subsequently identified to be part of a metal bolt from a filling machine.
Worldwide Distribution - USA (nationwide) and Internationally to Canada, Japan, China, India, SriLanka, Argentina, Paraguay, Uruguay, Chile, Peru ,Bolivia ,Mexico ,Panama, ,Costa Rica ,Ecuador, Venezuela, Colombia, Brazil, Jamaica, Austria, Switzerland, France, Germany, Greece, Portugal, Spain, Italy, UK, Belgium, Sweden Norway, Finland ,Israel/Palestine, Tunisia, Algeria, Egypt, ,Morocco, Jordan, Yemen, Iraq, Kuwait, Qatar, Oman, Lybia, Lebanon ,UAE, Saudi Arabia, Pakistan, Afghanistan, Turkey, South Africa, Chad, Kenya, Benin, Burkina Faso, Cameroon, Gabon, Senegal, Ghana, Mali, Ivory Coast, Nigeria, Djibouti, Czech Republic, Slovakia, Slovenia, Serbia, Hungary, Romania, Poland, Russia, Ukraine, Kazakhstan, Bulgaria, Belarus, Georgia, Mauritius, Maldives, Vietnam, Philippines, Korea, Thailand, Hong Kong , Indonesia, Taiwan, Malaysia, Singapore, New Zealand, and Australia.
D-10'' Hemoglobin Testing System, Model number: 220-0220     Manufactured by:  Bio-Rad Laboratories, Inc.  4000 Alfred Nobel Drive  Hercules, CA 94545    The D-10 Hemoglobin Testing System is a single module designed for hemoglobin analysis in mid-volume laboratories. The D-10 is a fully integrated system for sample dilution, processing and analysis of hemoglobin, designed for use with specific Bio-Rad reagent kits. The D-10 incorporates the use of a dedicated software system for instrument control, data collection and analysis.
483 instruments in US. OUS to be determined.
On a rare occasion the D-10 software might generate an extra result by duplicating the result form the previous sample and the Sample ID/Injection number from the next sample.
Frozen Ice Cake (Watermelon), 17.98 oz, 6 retail units/carton, UPC 8 801062 443055
Lot codes: 13.05.01F2 and 13.07.17F2   13.05.01F2 - This code date was printed on the retail units contained within Entry #EJA-5046135-1 (November)  13.07.17F2 -  This code date was printed on the retail units contained within Entry #EJA-5045319-2 (October)
Jin Sun Mi International is recalling watermelon ice bar product because it contains undeclared peanuts.
Worldwide Distribution- USA (nationwide) including the states of Alabama, Florida, Georgia, Louisiana, Missouri, New York, South Carolina, Tennessee, Texas and Wyoming, and the countries of Australia, Canada, Czechoslovakia, China, Colombia, France, Great Britain, Italy, Netherlands, Poland, Saudi Arabia, and Turkey.
Spacelabs Healthcare G2 Clinical Access Mislabeled CDs for PN: 063-1829-11 Rev A and Update Kit, PN: 040-1565-10.   Used for installing ICS G2 Clinical Access software onto hospital personal computers.
Two G2 Clinical Access CD part numbers are affected: PN: 063-1829-11 Rev A and Update Kit, PN: 040-1565-10.   Serial numbers distributed in the US: ''040-1565-10'' and ''063-1829-11''.           Serial number distributed outside the US: ''063-1829-11''.
36 units total: 17 units were distributed in the US and 19 units distributed outside the US.
Spacelabs has voluntarily recalled G2 Clinical Access Software CD because the programs installed on the Clinical Access CD are incorrect and it will prevent the customer from installing Clinical Access.
Worldwide distribution: US (nationwide) including states of: AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, and WI; and countries of: Austria, Belgium, Czech Republic, France, Germany, Ireland, Israel, Italy, Lebanon, Lithuania, Poland, Saudi Arabia, Singapore, Slovenia, Sweden, Switzerland, The Netherlands, Turkey, and United Kingdom.
HeartMate II Implant Kit with Pocket Controller; with sealed grafts (NAm)  with sealed grafts (EU)    Product Usage:  HeartMate II is a mechanical device that circulates blood throughout the body when the heart is too weak to pump blood adequately on its own.
Catalog number 106015 (NAm) 106016 - EU  all serial numbers
1737 catalog number 106015; 609 catalog number 106016
Discovery of serious injuries and deaths associated with the process of changing from a primary System controller to their back-up System controller in patients using the Pocket System controller model.
HeartMate II System Controller   Product Usage:  HeartMate II is a mechanical device that circulates blood throughout the body when the heart is too weak to pump blood adequately on its own. It is sometimes called a a heart pump or VAD. HeartMate II is a small implantable LVAD. HeartMate II attaches to the heart and is designed to assist or take over the pumping function of the patients left ventricle, the main pumping chamber of the heart.
Catalog number 106762 (NAm) 106017 - EU  all serial numbers
Heart Mate II Pocket Controllers removed from packaging     Product Usage:  HeartMate II is a mechanical device that circulates blood throughout the body when the heart is too weak to pump blood adequately on its own.
Catalog number 105109 (found on side of unit) all serial numbers
HeartMate II LVAD Pump and Pock Controller Kit;     Product Usage:  HeartMate II is a mechanical device that circulates blood throughout the body when the heart is too weak to pump blood adequately on its own.
Catalog number 107801 all serial numbers
Worldwide Distribution - US including the states of  IL, PA, MA, VA. RI and LA., and the countries of Germany, Italy, Poland, Romania, Saudi Arabia, Kosovo, Slovakia and Spain.
FIBERNET Embolic Protection System: Recommended Vessel Diameter 3.5 0 5.0 mm, Maximum Guidewire Diameter: 0.014 in ( 0.36 mm)  Rx only, Sterile;  Manufactured in:  Invatec S.P.A., 25030 Roncadelle, Italy;  Manufacturer:  Medtronic Inc.  Minneapolis, MN 55432.    The FiberNet Embolic Protection System is indicated for use as a guidewire and emboli protection system to capture and remove embolic material (thrombus/debris) produced while performing percutaneous transluminal interventional procedures in carotid arteries in high surgical risk patients with reference vessel diameters of 3.5 mm to 7.0 mm.
US Model Number FBC350500190, lot number 1E029174; Internation Model number FBN350500190; lot 1E012912.
50 total, all sizes: 18 in US, 32 Internationally.
Medtronic is recalling a specific subset of lot numbers of the FIBERNET Embolic Protection System (EPS) where the yellow polyimide tube on the FIBERNET EPS was not removed from the FIBERNET EPS during the manufacturing process and subsequently may remain on the FIBERNET EPS.
FIBERNET Embolic Protection System: Recommended Vessel Diameter 5.0 -6.0 mm, Maximum Guidewire Diameter:  0.014 in (0.36mm)  Rx only, Sterile;  Manufactured in:  Invatec S.P.A., 25030 Roncadelle, Italy;  Manufacturer:  Medtronic Inc.  Minneapolis, MN 55432.    The FiberNet Embolic Protection System is indicated for use as a guidewire and emboli protection system to capture and remove embolic material (thrombus/debris) produced while performing percutaneous transluminal interventional procedures in carotid arteries in high surgical risk patients with reference vessel diameters of 3.5 mm to 7.0 mm.
US Model Number FBC 500600190, lot number 1E029176; International Model Number FBN500600190, lot number 1E012914.
FIBERNET Embolic Protection System: Recommended Vessel Diameter 6.0 -7.0 mm, Maximum Guidewire Diameter:  0.014 in (0.36mm)  Rx only, Sterile;  Manufactured in:  Invatec S.P.A., 25030 Roncadelle, Italy;  Manufacturer:  Medtronic Inc.  Minneapolis, MN 55432.    The FiberNet Embolic Protection System is indicated for use as a guidewire and emboli protection system to capture and remove embolic material (thrombus/debris) produced while performing percutaneous transluminal interventional procedures in carotid arteries in high surgical risk patients with reference vessel diameters of 3.5 mm to 7.0 mm.
US Model Number FBC 600700190, lot number 1E029750; International Model Number: FBN600700190: lot numbers 1E012916, 1E017817.
USA Nationwide Distribution in the state of MO
MEVION S250, System, Radiation Therapy, Charged-Particle, Medical used for Proton Radiation Therapy   Product Usage:  Proton Radiation Therapy
Geometric positioning error can occur after a rotational correction has been applied to one or more treatment fields
US and small quantities exported to Hong Kong, Singapore and Malaysia.
Stage 2 World Baby Thailand; Roasted Pumpkin & Coconut Rice, 3.5 oz. pouch.  Product of USA  distributed by Plum Inc., Emeryville, CA
11,595 total cases, both varieties. 12 x 3.5 oz  pouches per case.
Intermittent damage to the plastic spouts during manufacturing of two varieties of Plum products on two production dates may cause plastic fragments  to break loose and cause a potential choking hazard.
Stage 2 World Baby ; Zucchini & Spinach with Pasta Marinara; 3.5 oz. pouch.  Product of USA  distributed by Plum Inc., Emeryville, CA
11,595 cases total, both varieties (12 x 3.5 oz pouches per cast)
Intermittent damage to the plastic spouts during manufacturing of two varieties of Plum products on two product dates may cause plastic fragments  to break loose and cause a potential choking hazard.
AL, DE, FL, GA, IA, IL, IN, KS, ME, MI, MN, MO, NC, NH, NY, OH, PA, SD, TN, WI
UNCLE BEN's(R) READY RICE(R) Original Enriched Long Grain White Rice, 8.8 oz. (250g), UPC  054800 031764
Best Before Date 12/14 MADE IN CANADA 351GBBFP [1L, 2L, 3L, 1R, 2R, 3R]
Voluntary recall was initiated after identifying a number of packages with punctures on the back of the package that led to spoilage (off odors and appearance).
Golden Natural Fruit Island Net Wt. 25.00 oz Product of Crown Food North Bergen, NJ 07047 Packed by: Crown Food/North Bergen 07047 USA   UPC 098346021032
NYSDAM analysis has revealed the presence of undeclared sulfites and undeclared FD&C Yellow #6 in Golden Natural Brand ''Fruit Island''.
Worldwide Distribution including Austria, Belgium, Czech Republic, France, Germany, Greece, Hungary, Italy, Luxembourg, Norway, Poland, Spain, and Sweden.
Ovation Prime Abdominal Stent Graft System; Manufacturer:  TriVascular, Inc. 3910 Brickway Blvd. Santa Rosa, CA 95403    The TriVascular Ovation Prime Abdominal Stent Graft System is an endovascular device delivered via a small diameter catheter to treat abdominal aortic aneurysms (AAAs). The stent graft is designed to reline the diseased vasculature, providing an endovascular blood conduit for isolating the aneurysm from the high pressure flow of blood, thereby reducing the risk of rupture. The stent graft is a modular configuration comprised of an aortic body section, iliac limbs, and iliac extensions as required.
Communication to European physician users of the Ovation Prime Abdominal Stent Graft system to notify them of changes to Instructions for Use.
Worldwide Distribution - USA Nationwide including Puerto Rica and the countries of: Australia, Brazil, China, Canada, Malaysia, Korea, Ireland Singapore and Vietnam.
Weck Vista'', Universal Laparoscopic Port, Size 5/10mmx100mm,    Product Usage:    An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals.
Complaints were received of leakage of insufflation gas through the device, which can cause difficulty or delay in the completion of laparoscopic surgical procedures.
10mm Weck Vista'' Cannula-only, Teleflex Medical,    Product Usage:    An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals.
5/10 mm Weck, Vista'' Optical Bladeless Laparoscopic Access Port,    Product Usage:    An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals.
5/10 mm Weck, Vista'' Universal Cannula, Teleflex Medical,    Product Usage:    An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals.
Weck Vista'' Universal Laparoscopic Port, Size 5/10/12mmx100mm,    Product Usage:    An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals.
Weck Vista'' Universal Laparoscopic Port, Size 5/10/12mmx125mm,    Product Usage:    An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals.
12mm Weck Vista'' Cannula-only, Teleflex Medical,    Product Usage:    An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals.
5/10/12 mm Weck Vista'' Optical Bladeless Laparoscopic Access Port,    Product Usage:    An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals.
5/10/12 mm Weck Vista'' Universal Cannula,   Product Usage:    An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals.
5/10/12MM X 100MM Weck Vista'' UNIVERSAL CONE OPEN ACCESS,    Product Usage:    An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals.
5/10 Weck Vista'' Universal Balloon Open Access Port - Standard Length (70mm),    Product Usage:    An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals.
5/10 Weck Vista'' Universal Balloon Open Access Port - Long Length (100mm),    Product Usage:    An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals.
5/10 Weck Vista'' Universal Balloon Open Access Port  Short Length (53mm),    Product Usage:    An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals.
5/10/12 Weck Vista'' Universal Balloon Open Access Port  Standard Length (70mm),    Product Usage:    An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals.
5/10/12 Weck Vista'' Universal Balloon Open Access Port  Long Length (100mm),   Product Usage:    An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals.
Worldwide Distribution: US (nationwide) and country of: Israel.
Morph AccessPro Steerable Introducer; 6F Introducer, 45 cm working length  Single use only.  BioCardia, Inc.  San Carlos, CA 94070    BioCardia Morph AccessPro is intended to provide a pathway through medical instruments cush as balloon dilation catheters, guidewires or other therapeutic devices that may be introduced into the peripheral vasculature.
Firm discovered the potential for particulates in the inner lumen of Morph Access Pro Steerable Introducer, which could result in am embolic event.
Morph AccessPro Steerable Introducer; 6F Introducer, 90 cm working length:    Single use only.  BioCardia, Inc.  San Carlos, CA 94070    BioCardia Morph AccessPro is intended to provide a pathway through medical instruments cush as balloon dilation catheters, guidewires or other therapeutic devices that may be introduced into the peripheral vasculature.
Worldwide Distribution - U.S. Nationwide and the countries of  Canada, Germany, and Ireland
Suture, Non-absorbable, Synthetic, Polyamide, Sterile, Rx only,    Product Usage:  Non-absorbable polyamide surgical suture is a non-absorbable, sterile, flexible thread prepared from long-chain aliphatic polymers Nylon 6 and Nylon 6,6 and is indicated for use in soft tissue approximation.
Product Code: 1154654, Lot number: 02K0801212
The products are being recalled because they did not meet minimum needle attachment strength requirements.
Sutures, Non-absorbable, Synthetic, Polyethylene, Sterile, Rx only,    Product Usage:  Non-absorbable poly(ethylene terephthalate) surgical suture is a multifilament, non-absorbable, sterile, flexible thread prepared from fibers of high molecular weight, long-chain, linear polyesters having recurrent aromatic rings as an integral component and is indicated for use in soft tissue approximation.
Product Code: 0100019-507, Lot number: 02F1301128; Product Code: 6-511, Lot number: 02M0800561; Product Code: 6-559, Lot number: 02A0800005; Product Code: 69-403, Lot number: 02H0802530; Product Code: 7-5008M4, Lot number: 02C0900466; Product Code: 7-518, Lot number: 02E1302561; Product Code: 7-565, Lot number: 02B1100185; Product Code: 7-655A, Lot numbers: 02C0901963 & 02M0800836; Product Code: 7-740, Lot number: 02L1000536; Product Code: 833-114, Lot numbers: 02A1202112, 02C0903374 & 02D1202794; Product Code: 02F0902697, 02K1100404, 02L1202369 & 02M0802509; Product Code: E13-6351, Lot number: 02F0902446; Product Code: E13-6354, Lot number: 02F0902439; Product Code: E13-6399, Lot number: 02F0902436; Product Code: E6-545, Lot number: 02F0902443; Product Code: E7-4578,  ot number: 02D0901672; Product Code: H5300, Lot number: 1450153E13; Product Code: RN6-5106M5, Lot number: 02F1003837; Product Code: RN7-536M5, Lot number: 02A0801205; Product Code: TEV100, Lot number: 02G1101500; Product Code: V-2599, Lot number: 02F0802055; Product Code: X-5424, Lot number: 02B0900765; Product Code: X6-692W, Lot number: 02C0803135; Product Code: X7-655M6A, Lot number: 02A0900806, 02A0902742, 02C0900446 & 02H1003233 and Product Code: XF7-7011, Lot numbers: 02A0901594.
Sutures, Non-absorbable, Synthetic, Polypropylene, Sterile, Rx only,    Product Usage:  Non-absorbable polypropylene surgical suture is a monofilament, Non-absorbable, sterile, flexible thread prepared from long-chain polyolefin polymer known as polypropylene and is indicated for use in soft tissue approximation.
Sutures, Absorbable, Synthetic, Polyglycolic Acid, Sterile, Rx only,    Product Usage:  Non-absorbable polypropylene surgical suture is a monofilament, Non-absorbable, sterile, flexible thread prepared from long-chain polyolefin polymer known as polypropylene and is indicated for use in soft tissue approximation.
Sutures, Non-absorbable, Steel, Monofilament and Multifilament, Sterile, Rx only,    Product Usage:  A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or Ushaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It 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.
Product Code: X-4981M4, Lot number: 02J0800451
Sutures, Non-absorbable, Silk, Sterile, Rx only,    Product Usage:  Natural non-absorbable silk surgical suture is a non-absorbable, sterile, flexible multifilament thread composed of an organic protein called fibroin. This protein is derived from the domesticated species Bombyx mori (B. mori) of the family Bombycidae. Natural non-absorbable silk surgical suture is indicated for use in soft tissue approximation. Natural non-absorbable silk surgical suture meets the United States Pharmacopeia (U.S.P.) monograph requirements for Non-absorbable Surgical Suture (class I). Natural non-absorbable silk surgical suture may be braided or twisted; it may be provided uncoated or coated; and it may be undyed or dyed with an FDA listed color additive.
Product Code: X-6371M5, Lot numbers: 02E0801603
CT, FL, IL, IN, KY, MA, MD. MI, NC, NJ, NY, OH, PA, SC, VA and  Canada
Italian blend Salad (Romaine Lettuce and Radicchio) packaged under the following brand names: Dole Italian Blend,  (UPC 7143000819);  Fresh Selections Italian Style Blend (Kroger) (UPC 1111091045);  Little Salad Bar Italian Salad, (UPC 4149811014);  Marketside Italian Style Salad, (Wal Mart)  (UPC 8113102780)  10 oz. bags (283 g)    Dole Fresh Vegetables  Monterey, CA 93942
Canadian Food Inspection Agency tested a random sample of bagged Italian Blend which tested positive for Listeria Monocytogenes.
Cookin' Cajun (TM) Acadiana Style Etouffee Seasoning Blend, UPC 898851004
all product distributed 03/10/2012 - 03/10/2014
Product is labeled as containing flour, but contains wheat flour which is not declared on the label.
Product was distributed in MD, DE, and VA
Sausage & Egg English Muffin, Good and Fresh brand, 4.1 oz, packaged in clear plastic wrap. UPC 855173005204.
Ready to eat breakfast sandwich was assembled with raw suasage meat.