Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
Blood Bank of San Bernardino and Riverside Counties
Blood products, collected from a donor who was taking the medication Proscar, were distributed.
Blood products, manufactured from Whole Blood units which may have reached an unacceptable temperature during shipment, were distributed.
Red Blood Cells (Apheresis) Leukocytes Reduced
Hoxworth Blood Center University of Cincinnati Medical Center
Blood products, which contained less than the required minimum amount of additive solution, were distributed.
Red Blood Cells Leukocytes Reduced Irradiated
Blood product, collected from an ineligible donor, was distributed.
Blood product, which may have been contaminated with saline during collection, was distributed.
Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed.
Red Blood Cells Leukocytes Reduced Irradiated Washed
Blood product, labeled with an extended expiration date, was distributed.
Blood products, collected from a donor who received a tattoo within one year of donation, were distributed.
Surasang Chanbada Frozen Oyster I.Q.F (8oz), 40pack/case
Wang Globalnet is recalling Surasang Chanbada Frozen Oyster IQF because it has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.
The recalled peanut products were distributed to two (2) customers:  Country Oven Bakery, Bowling Green, KY and Smith's Bakery, Layton, UT.
Medium Chopped Peanut Granules,  Product Code #410016, packaged in 30 lb. vacuum packed plastic bags within cardboard shipping boxes. The total packaging size is 2100 lbs = 70 x 30 lb boxes.
The recalling firm manufactured and distributed peanut products which contained peanuts and/or peanut butter which they received from there bulk peanut supplier, Peanut Corporation of America (PCA).  Peanuts and peanut products produced by PCA have been implicated in a recent outbreak of salmonellosis and these product may be contaminated with Salmonella Typhimurium.
Light Dry Roasted Unsalted Split Peanuts, Product Code:  400260,  packaged in 30 lb. vacuum packed plastic bags placed inside cardboard shipping boxes. The total packaging size is 2100 lbs = 70 x 30 lb boxes.
IQF Oysters 3lbs, Assi Brand, Item# 20083K,10x3 lb;   Oyster Block, Assi Brand, item# 20085K, 30x1 lb;    Oysters 8 oz - Tiny, Assi Brand, item# 20086, 40x8 oz;    IQF Oysters 20 oz - Tiny, Assi Brand, item#20093, 20x20 oz.
Korean Farm is recalling Assi Brand Korean Oysters because they have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to health.
Worldwide Distribution - US (nationwide) including the states of CT, TX, CA, AZ, MO, and MD and the countries of Europe and Japan.
Edwards Lifesciences Rigid Suction Wand, sterile.  Model numbers S033 and SPC2081.     Product Usage:  These suction catheters are typically used to remove fluid on the external surface of the heart during cardiac surgery and therefore there is little risk of intravascular involvement.
Edwards is recalling Suction Wand models SPC2081 and S033 because the plastic tip attached to the metal suction wand may become detached during routine use.
Worldwide distribution: USA (nationwide) and countries including:  Argentina, Belgium, Canada, Chile, Colombia, Costa Rica, Dominican Republic, Egypt, Germany, Guatemala, Honduras, Hong Kong, India, Indonesia, Israel, Japan, Jordan, Kuwait, Malaysia, Mexico, Pakistan, Philippines, Russia, Saudi Arabia, Singapore, South Africa, South Korea, Taiwan, Thailand, Turkey, United Arab Emirates (UAE), and Vietnam.
Central Control Module for System 1: System 1 Base, 100/120V   The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.
Terumo CVS has received reports of the Central Control Monitor (CCM) for Terumo Advanced Perfusion System 1 losing partial or full functionality.    Symptoms that have been associated with a malfunctioning CCM include: full or partial loss of display, loss of control functions; inability to distinguish various status, alert, alarm conditions, the inability to operate the touch screen, or the CCM resetting itself. If the CCM lost full functionality during bypass, the user would need to operate the pumps using the pumps' redundant controls; safety systems are not compromised. However, the user may experience distraction and/or frustration by the loss of CCM function during a case.
Central Control Module for System 1: System 1 Base, 220/240V   The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.
Worldwide Distribution - USA (nationwide) and internationally to Argentina, Australia, Austria, Belgium, Brazil, Canada, Colombia, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Ireland, Israel, Italy, Japan, Mexico, Netherlands, Puerto Rico, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Turkey, and United Kingdom.
Eon Mini Neurostimulation (IPG) System (Model 3788);   The product is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs including unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable low back and leg pain.
Model Number 3788.  All lots manufactured prior to September 20, 2010.
The firm has received 112 complaints of the Eon Mini IPGs that lost the ability to communicate or recharge due to a workmanship issue resulting in loss of pain relief and subsequent explant.  The firm has determined the cause of these reports to be related to process variances in the positioning of the internal battery and printed circuit board, causing a short, and therefore, prematurely depleting battery voltage.
Worldwide Distribution-USA (nationwide) and the countries of  ARGENTINA, BELGIUM, CANADA, CHILE, COLOMBIA, Costa Rica, Dominican Republic, Egypt, Germany, Guatemala, Honduras, Hong Kong, India, Indonesia, Israel, Japan, Jordan, Kuwait, Malaysia, Mexico, Pakistan, Philippines, Russia, Saudi Arabia, Singapore, South Africa, South Korea, Taiwan, Thailand, Turkey, UNITED ARAB EMIRATES (UAE), and Vietnam.
Terumo Advanced Perfusion System 1 Electronic O2 Blender/Analyzer.    The electronic gas blender provides control and monitoring of the gas flow rate and oxygen content of the gas input to the oxygenator in the perfusion circuit. It also provides monitoring of the carbon dioxide if 95-5 (%oxygen/%carbon dioxide) is used as the blending gas.
Terumo Cardiovascular Systems (Terumo CVS) received two complaints related to the Gas System for the Terumo Advanced Perfusion System 1. Both were reported instances of users experiencing difficulty adjusting the System 1 Gas System local flow control knob.
Terumo Advanced Perfusion System 1   System 1 Base, 100/120V.    The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment. The electronic gas blender provides control and monitoring of the gas flow rate and oxygen content of the gas input to the oxygenator in the perfusion circuit. It also provides monitoring of the carbon dioxide if 95-5 (%oxygen/%carbon dioxide) is used as the blending gas.
Terumo Advanced Perfusion System 1   System 1 Base, 220/240 V.    The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment. The electronic gas blender provides control and monitoring of the gas flow rate and oxygen content of the gas input to the oxygenator in the perfusion circuit. It also provides monitoring of the carbon dioxide if 95-5 (%oxygen/%carbon dioxide) is used as the blending gas.
Worldwide Distribution - USA including AL, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI, and WV.   Internationally to:  Republic, Egypt, Germany, Guatamala, Honduras, Hong Kong, India, Indonesia, Japan, Jordan, Kuwait, Malaysia, Mexico, Pakistan, Philippines, Russia, Saudi Arabia, Singapore, South Africa, South Korea, Taiwan, Thailand, Turkey, UNITED ARAB EMIRATES (UAE), and Vietnam,
System 1 Base, 100/120V    The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours in the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.
Terumo Advanced Perfusion System 1 battery charge is being depleted faster than expected during periods of system shutdown. The System 1 may falsely indicate a longer battery life than actual battery time remaining if not subjected to regular use, such as would occur with a backup system. This may result in unexpected system shutdown. Prolonged battery depletion may cause permanent battery damage.
System 1 Base, 220/240V  The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment. The System 1 base includes an integrated backup battery in the event of power loss.
Worldwide Distribution - USA including CA, TX, GA, NY, NC, OH), and New Zealand.
AEM Disposable Electrodes, Device, Electrosurgical, Cutting and Coagulation and Accessories.  AEM Disposable Electrodes used as electrosurgical accessories intended for ablation, removal, resection and coagulation of soft tissue in open, endoscopic and laparoscopic surgical procedures channeling monopolar high-frequency electrical current from compatible electrosurgical generators. The device is model FC03XX series.   AEM Disposable Electrodes used as electrosurgical accessories intended for ablation, removal, resection and coagulation of soft tissue in open, endoscopic and laparoscopic surgical procedures channeling monopolar high-frequency electrical current from compatible electrosurgical generators.
RDB, RJB, RJE, RJH, RLG, RLI, RLJ, RLK, RLO, RLP, RLR, RLQ, SBF, SBJ.
Encision is performing a field correction to their AEM Disposable Electrodes due to two consumer complaints reporting unanticipated alarms from the AEM monitor while using the device.  This issue could result delays or complications during surgical procedures.
Worldwide Distribution-USA (nationwide) including the states of CA, FL, IL, MA, NJ, NY, SC, and TX and the countries of TURKEY, TUNISIA, TAIWAN, SPAIN, SINGAPORE, SAUDI ARABIA, RUSSIAN FEDERATION, KENYA, JAPAN, ITALY, IRELAND, INDIA, GREAT BRITAIN, GERMANY, FRANCE, EGYPT, CHILE, CHINA, CANADA, BRAZIL, BELGIUM, AUSTRIA, and ARGENTINA.
GE Advantage CT/PET Fusion for Advantage Windows Workstation with Volume View CT Colonography/Navigator 2 software. (Version 4.0, 4.1,or 4.2)   The Advantage CT/PET Fusion clinical application provides easy comparison of three dimensional (3D) anatomical images from Computed Tomography (CT) and functional images from Positron Emission Tomography (PET).
GE Healthcare has become aware of a potential safety issue due to incorrect alignment of fused CT and PET images associated with the CT/PET fusion capabilities of your Volume Viewer and CT/PET Fusion application.    Volume Viewer allows two studies (one PET and one CT) that are registered in the same spatial domain to be viewed simultaneously in fused mode.  The two images should be aligned to the same precision as the scanner.  Assuming the two images are acquired with a calibrated machine and there is no patient movement between the CT and PET acquisitions, the two images should be visually aligned to a precision of less than one half PET voxel.  However, the problem associated with this version of software may introduce a shift of up to 1.5 PET voxels, which can be as much as 8mm with certain zoom factors.
Community Blood Bank of Lancaster County Medical Society
Blood product, collected from a donor who reported travel to a malarial endemic area, was distributed.
Blood products, labeled with an extended expiration date, were distributed.
Blood product, collected from a donor who reported post donation illness, was distributed.
Blood products, collected from a donor whose health history screening was not adequately performed, were distributed.
Blood and Blood Products for Reprocessing
Blood product, which was collected from a donor who traveled to malarial endemic areas, was distributed.
Blood products,  which were collected from a donor who traveled to malarial endemic areas, were distributed
Blood products, which was collected from a donor who traveled to malarial endemic areas, was distributed.
Blood product, which was collected from a donor who traveled to malarial endemic area, was distributed.
Blood products, which were not quarantined subsequent to receiving information regarding a post donation illness, were distributed.
Worldwide Distribution - USA including WI, CA, MA, IN, WA, and NJ.  Foreign distribution was made to Germany, Canada, Denmark, Hong Kong, Ukraine, Japan, Italy, Korea, and France.
CIVCO VirtuTRAX Instrument Navigator, Reusable non-sterile general purpose driveBAY, trakSTAR, electromagnetic sensor (8mm) with VirtuTRAX instrument navigator and (8.9 tapered to 1.3 x 147cm) telescopically-folded CIV-Flex sensor covers (5), Ref. 5350925.  The firm name on the label is CIVCO, Kalona, IA.  The kit contains sensor component part number 410-240.   The general purpose sensor within the kit is intended to provide physicians with tools for electromagnetic tracking of instruments with respect to image data. The sensors are designed to attach to custom reusable tracking bracket for leading transducers and other medical devices
The general purpose electromagnetic sensor was incorrectly calibrated causing potential variability in the projected position of the needle path with the ultrasound device.
CIVCO General Purpose Sensor, Non-sterile reusable general purpose electromagnetic sensor for use with 3D Guidance driveBAY, driveBAY 2, trakSTAR, or trakSTAR2 trackers, Ref. 10441627.   The firm name on the label is CIVCO, Kalona, IA.  The kit contains sensor component part number 410-240.   The general purpose sensor within the kit is intended to provide physicians with tools for electromagnetic tracking of instruments with respect to image data. The sensors are designed to attach to custom reusable tracking bracket for leading transducers and other medical devices
CIVCO General Purpose Sensor, Non-sterile reusable general purpose electromagnetic sensor for use with 3D Guidance driveBAY, driveBAY 2, trakSTAR, or trakSTAR2 trackers, Ref. 610-1066.     The firm name on the label is CIVCO, Kalona, IA.  The kit contains sensor component part number 410-240.   The general purpose sensor within the kit is intended to provide physicians with tools for electromagnetic tracking of instruments with respect to image data. The sensors are designed to attach to custom reusable tracking bracket for leading transducers and other medical devices
CIVCO General Purpose Sensor, Non-sterile reusable general purpose electromagnetic sensor, for use with 3D Guidance medSAFE trackers, Ref. 610-1067.   The firm name on the label is CIVCO, Kalona, IA.  The kit contains sensor component part number 410-240.   The general purpose sensor within the kit is intended to provide physicians with tools for electromagnetic tracking of instruments with respect to image data. The sensors are designed to attach to custom reusable tracking bracket for leading transducers and other medical devices
CIVCO VirtuTRAX Instrument Navigator, Reusable non-sterile general purpose driveBAY, trakSTAR, electromagnetic sensor (8mm) with VirtuTRAX Instrument navigator and (8.9 tapered to 1.3 x 147cm) telescopically-folded CIV-Flex sensor covers (5), Ref. 610-1080.   The firm name on the label is CIVCO, Kalona, IA.  The kit contains sensor component part number 410-240.   The general purpose sensor within the kit is intended to provide physicians with tools for electromagnetic tracking of instruments with respect to image data. The sensors are designed to attach to custom reusable tracking bracket for leading transducers and other medical devices
Worldwide Distribution - USA including PA.  Internationally  to Japan, Kuwait, Saudi Arabia, Lenanon, Italy, Spain, China, East Europe, Slovakia, Poland, Czech  Republic, Ukraine, Egypt, Russia, Algeria, Colombia, Germany, Malaysia, Switzerland, Australia, Europe, Portugal, Iran, Israel, Philippines, UAE, Korea, and Netherlands
Dual Incu i, (Atom Infant Incubator Model 100) Atom Medical Corporation 3-18-15 Hongo, Bunkyo-Ku, Tokyo, Japan 113-0033 Usage: An incubator for infants.
There is a potential for the device's canopy to move unintentionally when using the incubator mode or radiant warmer mode.
Distributed to Canada and following US States CA, IL, NY, OH, MI, WA, NV, FL, GA, NJ, PA, AZ, WI, HI, LA, OK, and TX. Canada:  1. Lucid, 5888 Trapp Ave, Burnaby  B.C. V3N 5G4  2. 11 Edvac Dr. Units 8 & 9, Brampton, Ontario L6S 5W5  No Mexico.  One Foreign: 56 Tannery Ln. Singapore 347801
Solid Gold WolfCub Large Breed Puppy Food, 4lb, 15lb, and 33lb, with a best before date of December 30, 2012 and batch code starting with SGB1201A31X.   Product labeling reads in part:''***LARGE-BREED PUPPY DOG FOOD***SOLID GOLD WOLFCUB***MANUFACTURED FOR: SOLID GOLD HEALTH PRODUCTS FOR PETS, INC. EL CAJON, CA 92020 NET WT 4 LBS./1.81 KG***''.
with a best before date of December 30, 2012 and batch code starting with SGB1201A31X.   4lb UPC 093766750005  15lb UPC 093766750012  33lb UPC 093766750029
Products were produced at the facility that has been linked to recent recalls of Diamond brand pet foods due to potential Salmonella contamination.
Solid Gold WolfKing Large Breed Adult Dog Food, 4lb, 15lb, and 28.5lb, with a best before date of December 30, 2012 and batch code starting with SGL1201A32X.   Product labeling reads in part:''***LARGE-BREED ADULT DOG FOOD***SOLID GOLD WOLFKING***MANUFACTURED FOR: SOLID GOLD HEALTH PRODUCTS FOR PETS, INC. EL CAJON, CA 92020 NET WT 15 LBS./6.8 KG***''.
Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed.
Blood product, collected from a donor, for whom donor suitability was not adequately determined, was distributed.
Blood products quality control that did not meet specifications were distributed.
Safedraw Venous Close Loop System, Blood Sampling Set, packaged in a tyvek bag, Model/Part Number 688695, Argon Critical Care Systems, Singapore Pte. Ltd., 198 Yishun Avenue 7, Singapore 768028.   The blood sampling set is intended to be used for closed-loop blood sampling from the patient without the system being exposed to the outside environment.
Lot Number 204889, Expiration Date March 2017
Some of the kits may exhibit a potential defect with the pouch seal.  The pouch issue may compromise the sterile barrier.
Community Blood Council of New Jersey, Inc.
Blood product, with insufficient plasma volume to support the platelet yield, was distributed.
Blood product quality control  and distribution of product that did not meet specifications was distributed.
Product Name: Eroxil bottles of 30 tablets taken orally Nokomis Research Inc #6
The products contain synthetic equivalents of spermine and/or spermidine, which are constituents or extracts of an herb or other botanical, and the that a synthetic copy of a constituent or extract of an herb or other botanical is not a dietary ingredient, and such ingredients must be approved for use in supplements.  The use has not been approved.
Erosyn bottles of 30 tablets taken orally Nokomis Research Inc  Bell Lifestyle Products #7
Fertalin bottles of 90 tablets taken orally Nokomis Research Inc  Bell Lifestyle Products #8
Middle-Age Energy Booster bottles of 60 tablets taken orally Nokomis Research Inc  Bell Lifestyle Products #65
Blood product, collected from a donor who traveled to a malaria endemic area, was distributed.
American National Red Cross Great Lakes Region
Blood product, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed.
Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed.
Direct sales to farms in Fayette and Somerset Counties in PA, 1 direct account located in MD.
19% Calf Starter Medicated  Active Ingredient Lasatocid Yachere 19% Calf Starter Medicated  50 Lb. Net Wt.  Active Drug Ingredient   Lasatocid 47.4 g/ton  Yachere Feed, Inc.  415 Somerset Ave., Rockwood, PA 15557
Feed was labeled as containing Lasalocid medication. Inspection revealed product did not contain Lasalocid.
Blood products, which were collected from a donor in which donor suitability were not adequately determined, were distributed.
Blood Systems, Inc. dba United Blood Services
Blood products, collected from a donor in which donor screening/donor records were incomplete or incorrect.
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed
Blood product, which did not meet the acceptable product specifications, was distributed.
LifeSouth Community Blood Centers Inc - Birmingham Region
Blood product, which did not meet acceptable product specifications, was distributed.
Stryker Orthopaedics, Definition PM Femoral Hip Stem Catalog Numbers 6265-3-099 through 6265-3-107.  Howmedica Osteonics Corp. 325 Corporate Drive, Mahwah, NJ 07430. A subsidiary of Stryker Corp.  Stryker France, ZAC Satorlas Green Pusignan, Av De Satolas Green 69881 Meyzeiu, Cedex France.  Made in Ireland.   The Definition PM femoral hip stem is a forged, collared, straight stem with an integral premantle (PM) design. The Poly Methyl Methacrylate (PMMA) and Barium Sulphate (BaSO4) premantle is integral to the design as it aligns, centralizes and pressurizes the stem within the femoral canal. The forged stem is first grit blasted proximally and then the premantle is applied through an infection molding process.
Stryker Orthopaedics has become aware of the potential for cracking of the PMMA coating on their PM COCR Hip Stem product.
Alere Triage CardioProfiler Panel PN 97100CP   Used for the quantitative determination of creatine kinase MB, myoglobin, troponin I and B-type natriuretic peptide in EDTA anticoagulated whole blood and plasma specimens.
Certain lots of the affected products may have significantly decreased precision relative to the package insert, which could result in an increased frequency of false positive or false negative results. These false positive and false negative results are unpredictable within lots and may not be detected by Quality Control testing.
Alere Triage Cardiac Panel PN 97000HS   Used for the quantitative determination of creatine kinase MD (CK--MB), myoglobin and troponin I in EDTA anticoagulated whole blood or plasma specimens.
Alere Triage Profiler SOB Panel PN 97300   Used for the determination of creatine kinase MB, myoglobin, troponin I, B-type natriuretic peptide, and cross-linked fibrin degradation products containing D-dimer in EDTA anticoagulated whole blood and plasma specimens.
Alere Triage BNP PN 98000XR   Intended to be used as an aid in the diagnosis and assessment of severity of congestive heart failure (also referred to as heart failure).
Triage D-dimer PN 98100   Used as an aid in the assessment and evaluation of patients suspected of having disseminated intravascular coagulation or thromboembolic events including pulmonary embolism.
Blood Bank Of San Bernardino And Riverside Counties
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
Blood product, which was not quarantined subsequent to receiving information regarding a post donation information, was distributed.
Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.
Worldwide distribution: USA (nationwide) including states of: CA, CT, FL, GA, MD, MI, NC, OR, SC, and TX and countries of: Canada and Philippines.
Bayonet Forceps 7.75'' (196.9 mm)  0.5 mm Tips Non-Stick  Electrosurgical/Bipolar Forceps/Reusable, Model #90-7004 (k) #K982705. The surgical device is package non-sterile into small plastic tubes.   Olsen Medical Biopolar Reusable Bayonet Forceps and cords are intended for use in coagulating tissue during surgical procedures.
Model/part Number:  90-7004, Lot Numbers:  017897
Firm officials reported to CIN-DO that their Bipolar Bayonet Forceps 7.75''  are misbranded in that the manufacturer symbol was replaced by the expiry symbol on the packaging.
Bayonet Forceps 8.5'' (215.9mm) Serrated 1.0 mm Tips Electrosurgical/Monopolar Forceps/Reusable, Model #41604, 510 (k) #K885199. The surgical device is package in non-sterile small plastic tubes.   Monopolar Reusable Forceps - are intended for use in cutting and coagulating tissue during surgical procedures.
Model/part Number:  41604, Lot Number:  019737, and 021578.
Firm officials reported to CIN-DO that their Electrosurgical Monopolar Reusable Bayonet Forceps  are misbranded in that the label states that the tip size is:  (0.5mm) when the tip size actually measures (1.0mm).
Bayonet Forceps 7.-1/8 (181.0mm) 0.75mm  Insulated Tips, Sterile Single Use Surgical/Bipolar Forceps, Model #20-1360I, 510 (k) #K884656. The surgical device is package one  (s) per plastic Tyvek peel pouch, 10 plastic Tyvek peel pouches per box.    Bipolar Forceps and Cords - Olsen Medical Bipolar Forceps and Cords are intended for use in coagulating tissue during surgical procedures.
Model/part Number:  20-1360I, Lot Number:  023399, Expiration Date:  02/28/2017.
Firm officials reported to CIN-DO that the outer carton label of this sterile, single use device is misbranded in that it lists an incorrect expiration date. The outer carton label lists the sterile expiration date as:  2012-02-(28) [the manufacture date] ; however the device pouch label lists the sterile date as: 2017-02-(28). The pouch label lists the correct sterile expiration date.
Bayonet Forceps 8.25 (209.6 mm) 0.5mm Tips, Sterile Single Use Surgical/Bipolar Forceps, Model #20-13420, 510 (k) #K884175. The surgical device is package one (1) per Tyvek peel pouch with ten (10) Tyvek peel pouches per box.    Bipolar Forceps and Cords - Olsen Medical Bipolar Forceps and Cords are intended for use in coagulating tissue during surgical procedures
Model/part Number:  20-11420, Lot Number:  023340, Expiration Date:  2/28/2017.
Firm officials reported to CIN-DO that  for this device, in the labeling on the inner Tyvek peel pouch, the letter 'E' in Electrosurgical was turned into an 'X' and the number '5'' of the (mm tips) was turned into a '0'. This affected the description and some of the text of the labels.  However, it did not t affect the Part Number and Lot Number on the label.
Bayonet Forceps 7.-1/8 (181.0mm) 0.75mm Non-Insulated Tips, Sterile Single Use Surgical/Bipolar Forceps, Model #20-1360K 510 (k) #K884656. The surgical device is package one  (s) per plastic Tyvek peel pouch, 10 plastic Tyvek peel pouches per box.    Bipolar Forceps and Cords - Olsen Medical Bipolar Forceps and Cords are intended for use in coagulating tissue during surgical procedures.
Model/part Number:  20-1360K, Lot Number:  023420,, Expiration Date:  2/28/2017.
Irrigating Bayonet Forceps 8.25'' (209.6 mm) 1.5 mm Tips, Electrosurgical Irrigating Bipolar Forceps, Model #20-0431, 510 (k) #K072937. Each unit of this sterile surgical device is packaged in a Tyvek peel pouch in boxes which contain five (5)Tyvek peel pouches per box.    Bayonet Bipolar Irrigating Forceps are intended for use in electro-surgery for coagulation and irrigation of tissue.
Model/part Number:  20-0431I, Lot Number:  023340, Expiration Date:  02/28/2017.
Daytrana (Methylphenidate) Transdermal System Patch, Delivers 20 mg over 9 hours (2. 2 mg/hr), 1 patch per pouch (NDC 68968-5554-01) packaged in 3-count patches per box (NDC 68968-5554-3) , Rx only, Manufactured  for Shire US Inc., Wayne, PA 19087 by Noven Pharmaceuticals, Inc., Miami, FL 33816.08/04/12.
Miscalibrated/Defective Delivery System; exceeded the specification for both mechanical peel force (MPF) and/or the z-statistic value
Worldwide Distribution --  Nationwide Distribution including the states of AZ, OR, PA and TX and the countries of  Australia, Belgium, Canada, Denmark, Finland, France, Germany, India, Indonesia, Israel, Russia, South Africa, South Korea, Spain, Sweden, Switzerland, and United Kingdom.
IntelliSpace Portal software and Extended Brillance Workspace software    Intellispace Portal is a multimodality thin-client applications server that delivers full diagnostic viewing and clinical applications to the enterprise. The Philips Extended Brillance Workspace is intended for use as a diagnostic viewing and processing workstation.
The Intellispace Portal software and Extended Brillance Workspace software may have significantly different results in the colors and size of the affected area when the customer uses the ''Time Sensitive'' and ''Time Insensitive'' methods.
Worldwide Distribution-USA (nationwide) including the states of AL, AZ, CA, FL, GA, IA, IN, MI, NC, NJ, NY, OK, PA, SC, TN, TX, and WA and the countries of Australia, Austria, Canada, China, Czech Republic, Denmark, and France.
Intellispace Portal software.   Intellispace Portal is a multimodality thin client applications server that delivers full diagnostic viewing and clinical applications to the enterprise.
Philips is issuing a software update to the Intellispace Portal systems to address a number of non-conformances. The most frequent and severe non-conformance identified involves the portal setting of ''PAC Integration''. This setting has a feature that allows the user to launch images of multiple patient studies into an application, but does not display a warning message informing the user that different patients have been selected.
Worldwide Distribution - US (nationwide)
InstaTrak with Multiple Dataset Navigation, 892.2050 System, Image Processing System,   Model Number IT3500 Plus.   Product Usage:  Usage:  The system is an aid to locate anatomical structures during open or percutaneous surgical procedures. It is indicated for use in medical conditions that may benefit from the use of stereotactic surgical technique. The system provides a reference to rigid anatomical structures such as sinus, skull, long bone, or vertebra, which are visible on medical images such as CT, MR, or X-ray.
On October 11, 2006, GE Healthcare recalled GE OEC InstaTrak 3500 Plus System with Software version 5.2, the surgical Navigation and Visualization Application due to software related issues.
Worldwide Distribution-USA (nationwide) and the countries of  Australia, Austria, Belgium, Bermuda, Canada, Cyprus, Czech Republic, Denmark, Dubai, Estonia, Finland, France, Germany, Gibraltar, Great Britain, Greece, Hong Kong, Iceland, Ireland, Israel, Italy, Japan, Kenya, Korea, Luxembourg, the Netherlands, New Zealand, Northern Ireland, Norway, Poland, Portugal, Quatar, Saudi Arabia, Singapore, Slovakia, Slovenia, Spain, Sweden, Switzerland and Turkey
Encore Mobile Patient Lifter; manufactured by Arjo Ltd., St. Catherine Street, Gloucester, GL1 2SL, England, U.K.; Models KKB5022-21US and KKB5042-21US.   The Encore is designed to be used as a standing and raising aid, it is useful for short transfers from one sitting position to another, and to elevate a patient for toileting, repositioning, changing of incontinence pads or wound dressings, standing practice etc. it is not intended for long periods of suspension or transportation.
2,552 units in the U.S., 4,970 units in the rest of the world
ArjoHuntleigh has received a limited number of customer reports concerning injuries related to an exposed metal support bracket when the proactive knee pad assembly is removed.
Chorus Mobile Patient Lifter; manufactured by Arjo Ltd., St. Catherine Street, Gloucester, GL1 2SL, England, U.K.; Models KKB5060-21US, KKB5062-21US and KKB5080-21US.   The Chorus is designed to be used as a standing and raising aid, it is useful for short transfers from one sitting position to another, and to elevate a patient for toileting, repositioning, changing of incontinence pads or wound dressings, standing practice etc. it is not intended for long periods of suspension or transportation.
1,989 units in the U.S., 1,626 units in the rest of the world
Sara Plus Mobile Patient Lifter; manufactured for Arjo by Medibo Medical Products N.V., Heikant 5, B-3930 Hamont-Achel, Belgium; Models HEP0001-US and HEP1001-US.   The Sara Plus is a standing and raising aid for short transfers e.g. raising from bed and transfer to wheelchair, or from wheelchair to toilet. Sara Plus is also suitable for walking training when the footboard and kneepad are removed.
2480 units in U.S., 2,651 units in the rest of the world
Worldwide distribution: USA (nationwide) state of GA only and countries of:  Argentina, Australia, Austria, Belgium, China, Czech Republic, Ecuador, Finland, France, Germany, India, Ireland, Israel, Italy, Latvia, Netherlands, Norway, Poland, Portugal, Romania, Russia, Serbia, Singapore, South Africa, Spain, Sweden incl Maquet Critical Care, Switzerland, Thailand, United Arab Emirates, and United Kingdom.
FLOW-I Anesthesia System   The system is intended for use in administrating anesthesia while controlling the entire ventilation for patients with no ability to breathe, as well as in supporting patients with a limited ability to breathe.
Model Number :6677300 Serial Number : 1170
A technical alarm may be generated on the FLOW-i system when using the MAN/AUTO switch to change ventilation modes from manual to automatic or from automatic to manual if the switch is not fully engaged in the ''on'' or ''off'' position but remains in the ''in-between position.
Worldwide Distribution - US (nationwide) including the states of: AR, LA, MI, NC, NY, OH, OK and PA and the countries of: Australia, Canada, Denmark, France, Germany, Israel, Netherlands, Spain and Switzerland.
Intellispace Portal software   Product Usage:  Intellispace Portal is a multimodality thin-client applications server that delivers full diagnostic viewing and clinical applications to the enterprise. Intellispace Portal is a medical software system that allows multiple users to remotely access the system from compatible computers on a network.
In the Multi-Modality Tumor Tracking application, when changing the contours of the lesion using the editing mode ''edit contour'' tool, the measurements are not recalculated causing discrepancies with the lesion measurements.
Coca Cola Zero, 20 fl. oz., The Coca Cola Company.
The product may exhibit off odor and off taste due to low levels of ammonium salts that may exist in these beverages.
International Only Distribution, including the countries of Thailand and Japan.
Pudenz Flushing Valve with Integral Connectors, catalog number NL850-1330. Integra Neurosciences, Plainsboro, NJ.  Device is used for the treatment of hydrocephalic patients when shunting cerebrospinal fluid from the ventricles of the brain.
The pouch label of catalog NL850-1330 indicates an incorrect model and closing pressure of the device. The incorrect label reads: ''Model: 12 mm-Medium Pressure'' instead of ''Model: 16 mm-Low Pressure''.
F-Tara Saikyozuke (Cod Fish with miso), 3.1lb., 20pc.x ab.2.5oz.
The recall was initiated because Mutual Trading Co. has confirmed that Tara Saikyozuke (cod fish with miso) contains undeclared soy.
AZ, CO, MT, UT, CA, NV, OR, MO, WI, IL, MN, TX, AR, FL, PA, NY, VA
MannaPro Chick Stick, Net Wt 15-oz (0.43 kg).  Each Stick is individually packaged in a plastic wrapper.  Each case contains 8/15oz-Stix. The firm name on the label is Manna Pro Products, LLC, St. Louis, MO.
Routine sampling of product tested positive for Salmonella.
Worldwide Distribution -- USA, including the states of VA, CT, GA, NJ and NY and the countries of Belgium, Denmark, France, and the United Kingdom.
MOSAIQ Oncology Information Systems interfaced to Elekta Treatment machines.   An image enabled electronic medical record system used for oncology workflow management.    Manufactured by:  Impac Medical Systems  100 Mathilda Place, 5th floor  Sunnyvale, Ca 94086
Version 2.10 - all builds and version 2.20 - builds up to and including 2.20.07A7.
Impac Medical became aware of a problem with the recording of the Wedge Motor Units in MOSAIQ when it resumes after a machine terminates/faults, the remaining Wedge MU was being erroneously set to zero.
AL, AR, AZ, FL, GA, IL, IN, KY, LA, MD, ME, MI, MO, MS, NC, NM, PA, SC, TN, TX, VA and WV.
Tom's Bacon Cheddar Fries, Flavored Corn and Potato Snacks, Net Wt., 2.75 oz (78.0g),
Product contains undeclared certified colors (Yellow #6, Red #40, Yellow#6 Lake, and Blue #1).
Ocean Manna Korean IQF Oysters, sizes: Tiny, Medium, Large. Packed: 40x8oz, 10x2lbs, 2lbs, 6x4lbs, 10x4lbs, 30x1lb, 6x5lbs.  Item Code:  FO/HMART-2LB, FO/HMART-1LB, FO/HMART-8OZ, FO/HMART-5LB,  FO/HS-OHS144, FO/LP-OL6X4, FO/HS-0L4, FO/KO-OM4, FO/HS-OM4, FO/LP-OS8, FO/HS-OT8, HS-0B2.
Pacific Giant is recalling all frozen (IQF) oyster meat and 1/2 shell oysters from South Korea because the products have been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.
Maryland Style Crab Soup 2340  Net Weight 4-4LBS.  Winter Garden Quality Foods, Inc.  304 Commerce St.  New Oxford, PA 17350
Lot #872, expiration 06/29/12 Lot #879 expiration date 07/06/12  lot #888 expiration date 07/15/12
approx. 202 cases, 4 - 4lb bags per case
Possible processing temperature issue that occurred during the production of Seafood Soups
FF Cream of Crab Soup 3109  Net Weight 4-4 LB.  Keep Refrigerated  Winter Garden Quality Foods, Inc.  304 Commerce St.  New Oxford, PA  17350
Lobster Bisque 3107  Net Weight 4-4 LBS.  Keep Refrigerated  Packed By Winter Garden Quality Foods, Inc.  304 Commerce St.,  New Oxford, PA  17350
New England Clam Chowder 2338  Net Weight 4-4LBS.  KEEP REFRIGERATED  Packed by Winter Garden Quality Foods, Inc.  304 Commerce St, New Oxford, PA  New Oxford, PA  17350
Worldwide Distribution - USA (nationwide)
iStat1 Analyzer   Abbott Point of Care, Princeton, NJ 08540  Model 200. The 37 degree tests for sodium, potassium, ionized calcium, hematocrit, pH, PCO2, PO2, and the i-Stat 200 analyzer as port of the i-Stat System, are intended for use in the in vitro quantitization of arterial, venous, or capillary whole blood Model 300. The i-Stat Model 300 Portable Clinical Analyzer is intended to be used by trained medical professional for use with i-Stat test cartridges and MediSense blood glucose test strips. i-State cartridges comprise a variety of clinical chemistry tests and test panels.
Some i-Stat Analyzers become uncomfortably hot to touch in the are of the battery. This is a recall extension.
i-Stat Portable Clinical Analyzer; Abbott Point of Care, Princeton, NJ 08540   Model 200. The 37 degree tests for sodium, potassium, ionized calcium, hematocrit, pH, PCO2, PO2, and the i-Stat 200 analyzer as port of the i-Stat System, are intended for use in the in vitro quantitization of arterial, venous, or capillary whole blood 510 K940918 Model 300. The i-Stat Model 300 Portable Clinical Analyzer is intended to be used by trained medical professional for use with i-Stat test cartridges and MediSense blood glucose test strips. i-State cartridges comprise a variety of clinical chemistry tests and test panels. 510K 001387
i-Stat Portable Clinical Analyzer   06F16-02  210000  210001  210002  210003    All lots
Fuso Analyzer 300F; Abbott Point of Care, Princeton, NJ 08540   Model 200. The 37 degree tests for sodium, potassium, ionized calcium, hematocrit, pH, PCO2, PO2, and the i-Stat 200 analyzer as port of the i-Stat System, are intended for use in the in vitro quantitization of arterial, venous, or capillary whole blood 510 K940918 Model 300. The i-Stat Model 300 Portable Clinical Analyzer is intended to be used by trained medical professional for use with i-Stat test cartridges and MediSense blood glucose test strips. i-State cartridges comprise a variety of clinical chemistry tests and test panels. 510K 001387
i-STAT1 Abaxis Analyzer; Abbott Point of Care, Princeton, NJ 08540
i-Stat1 Abaxis Analyzer   6000-0000    All lots
i-STAT1 Abaxis Analyzer; Abbott Point of Care, Princeton, NJ 08540   Model 200. The 37 degree tests for sodium, potassium, ionized calcium, hematocrit, pH, PCO2, PO2, and the i-Stat 200 analyzer as port of the i-Stat System, are intended for use in the in vitro quantitization of arterial, venous, or capillary whole blood 510 K940918 Model 300. The i-Stat Model 300 Portable Clinical Analyzer is intended to be used by trained medical professional for use with i-Stat test cartridges and MediSense blood glucose test strips. i-State cartridges comprise a variety of clinical chemistry tests and test panels. 510K 001387
Military Kit  iStat1   04J48-201  215001    All lots
Military Kit  Portable Clinical Analyzer ; Abbott Point of Care, Princeton, NJ 08540   Model 200. The 37 degree tests for sodium, potassium, ionized calcium, hematocrit, pH, PCO2, PO2, and the i-Stat 200 analyzer as port of the i-Stat System, are intended for use in the in vitro quantitization of arterial, venous, or capillary whole blood 510 K940918 Model 300. The i-Stat Model 300 Portable Clinical Analyzer is intended to be used by trained medical professional for use with i-Stat test cartridges and MediSense blood glucose test strips. i-State cartridges comprise a variety of clinical chemistry tests and test panels. 510K 001387
Military Kit Portable Clinical Analyzer   04J48-01  215000    All lots
Worldwide Distribution - USA (nationwide) and the countries of:  Austria, Australia, Belgium, France, Gelmany, Italy, Spain, Switzerland and the United Kingdom.
Pathfinder NXT Fixed Percutaneous Rod Holder, Part numbers 3573-1 (angle handle) , Stainless Steel / Silicone Rubber, Rx only, non sterile.   Product Usage:  The rod is held by the instrument for inserting and guiding into the screw heads via percutaneous delivery during minimally invasive surgery to fuse the spine. Per the surgical technique (Ll554 Pathfinder NXT Surgical Technique);
Part numbers 3573-1 (angle handle) all lots including  64PY, 67YA,  69FF, 71GB, 72JL,  73GY
249 ( angle handle and straight) in total
Zimmer is recalling Pathfinder NXT Fixed Percutaneous Rod Holder,  because complaints  have been received that the rod holder tip may crack or break when the rod is manipulated during surgery.
Pathfinder NXT Fixed Percutaneous Rod Holder, Part numbers 3573-2 (straight handle) Stainless Steel / Silicone Rubber, Rx only, non sterile.   Product Usage:  PathFinder NXT is a minimally invasive pedicle screw system. The PathFinder NXT System consists of various screws and rods intended to provide temporary stabilization following surgery to fuse the spine. The intended use of the Fixed Angled Percutaneous Rod Inserter is to insert a rod percutaneously through the extender sieeves to position into the implanted screw heads for securing with closure tops forming a construct that provides temporary stabilization following MIS or mini-open surgery to fuse the spine.
Part numbers 3573-2 (straight handle) all lots.
Inventure Foods Inc. is recalling mozzarella sticks and onion rings because there may be a chance that there are tiny metal particles in their seasoning.
Kit item #30699-76, includes Mozzarella Sticks, 2.25 oz, 12bags/kit; Cheddar Bacon Skins, 3oz, 24 bags/kit; and Sour Cream & Onion Skins 3oz, 12bags/kit.   kit item#30679-11, 30679-12, and 30679-13, includes Mozzarella Sticks 2.25oz, 12bags/kit, Cheddar bacon skins 3oz, 24 bags/kit, and Sour Cream & Onion skins 3oz, 12bags/kit.    Kit Item#30845-A- Onion Ring Clip Strip, 2oz, 24 bag/clip strip.
Nationwide Distribution-including DC and the states of CA, GA, IN, KY, LA, MT, TX, UT, and WI.
Button Switchpens, w/Extendable Needle Electrode 2 mm Exposure Single Use Electrosurgical./Extendable Pencils, 510(k) #K936304, Model Number: 75820.  The device is packaged in a sterile Tyvek peel pouch within a cardboard box which contains 24 pouches per box.    Pens/Pencils and Handles -- Olsen Medical Pens/Pencils and handles are designed to hold active electrodes Single Use device intended for coagulating and cutting tissue during surgical procedures.
Model Number: 75820, Lot Number:  019632
The carton label for this device has the manufacturer symbol where the expiration date symbol should be.  Firm officials met with FDA on 5/17/2012. At which time, they reported various labeling errors for their Button Switch Pen Electrode Electrosurgical /Extendable Pencils.
Button Switchpens, w/Extendable Needle Electrode 10 mm Exposure, Single Use  device,  Electrosurgical./Extendable Pencils, 510(k)#K936304, Model Number: 75800.  The device is packaged in a sterile Tyvek peel pouch within a cardboard box.  The cartons contain 25 pouches per box.   Pens/Pencils and Handles -- Olsen Medical Pens/Pencils and handles are designed to hold active electrodes Single Use device intended for coagulating and cutting tissue during surgical procedures.
Model Number: 75800, Lot Numbers: 023392 and 022438
The Tyvek pouch label for this device states:  'with holster'; however, this product does not come with a holster. Firm officials met with FDA on 5/17/2012. At which time, they reported various labeling errors  with their Button Switch Pen Electrode Electrosurgical /Extendable Pencils.
Product were distributed to NY, SC, KS, PA, DE, TN, NC, FL, NJ, AL, and VA.
Oysters, IQF Standard, packed in 5 lb polyethlene bags, further packaged as 2 bags/box and 6 bags/box, and labeled in part ***Wanchese Fish Company  2000 Northgate Commerce Parkway, Suffolk, VA 23435*** Product of S Korea***
Distributed oysters were harvested from waters in South Korea, from which products had been prepared, packed, or held under insanitary conditions or where it may have become contaminated with filth, or where it may have been rendered injurious to health.
Oysters, IQF Select, packed in 5 lb polyethlene bags, further packaged as 2 bags/box and 6 bags/box, and labeled in part ***Wanchese Fish Company 2000 Northgate Commerce Parkway, Suffolk, VA 23435***Product of S Korea***
Oysters, Breaded IQF, 20-25 count, packed in 2 lb polyethylene bags, 5 bags/carton, and labeled in part ***Wanchese Fish Company, 2000 Northgate Commerce Parkway Suffolk, VA  23435***Product of S Korea***
Worldwide Distribution - USA including FL, IN, MA, M, NY, OH, TN, TX, and VA.  Internationally to AUSTRALIA, HONG KONG, and INDIA
Philips HeartStart MRx M3536A Defibrillator/Monitor with Software R.03.03   The Heartstart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physician
Defibrillator/monitor cannot analyze an ECG report during acquisition of 12 lead ECG
Sienna Bakery White Chocolate Macadamia Nut Gourmet Cookies, UPC 093901201706, NET WT /PESO NETO 54 OZ (3.38 LB) 1.52 kg, 40 Count Thaw & Serve, INGREDIENTS: ENRICHED WHEAT FLOUR, CHOCOLATE FLAKES (SUGAR, COCOA, BUTTER, WHOLE MILK POWDER, SKIM MILK POWDER, MILK FAT, SOY LECITHIN ADDED AS EMULSIFIER, VANILLA EXTRACT), BROWN SUGAR, WHITE SUGAR, WHITE CHUNK ( SUGAR, PARTIALLY HYDROGENATED PALM KERNEL AND PALM OILS, NONFAT DRY MILK, BUTTERFAT, SOY LECITHIN, ADDED AS EMULSIFIER, SALT AND ARTIFICIAL FLAVORING ADDED) BUTTER, WHOLE EGGS, MARGARINE(PARTIALLY HYDROGENATED SOYBEAN AND COTTONSEED OILS, WATER, SALT, BUTTERMILK, LECITHIN, VEGETABLE MONO AND DIGLYCERIDES, SORBIC ACID & SODIUM BENZOATE ADDED AS PRESERVATIVE ARTIFICIALLY FLAVORED, ARTIFICIALLY COLORED WITH BETA CAROTENE, VITAMIN A PALMITATE ADDED), M ACADEMIA NUTS, INVERT SUGAR, VANILLA (WATER, ETHYL ALCOHOL, CARMEL COLOR) , SALT, SODA BICARBONATE, CARMEL COLOR.), CONTAINS: WHEAT, MILK, EGG TREE NUT (MACADAMIA), SOY, Distributed by / Distribuido por Gordon Food Services, Grand Rapids, MI 49548
77 master cases, each containing 6 retail boxes
Best Maid Cookie Company is voluntarily recalling Sienna Bakery Oatmeal Walnut Raisin and Sienna Bakery White Chocolate Macadamia Nut cookies due to a potential mis-pack, resulting in an undeclared allergen. Oatmeal Walnut Raisin cookies may have been inadvertently packed in White Chocolate Macadamia Nut retail boxes. Oatmeal Walnut Raisin cookies contain walnuts which are NOT declared on the White Chocolate Macadamia Nut packaging.
Sienna Bakery Oatmeal Walnut Raisin Gourmet Cookies, UPC 093901165992, NET WT /PESO NETO 54 OZ (3.38 LB) 1.52 kg, 40 Count Thaw & Serve, INGREDIENTS: ENRICHED WHEAT FLOUR, RAISINS, BROWN SUGAR, OATS, WALNUTS, BUTTER, WHOLE EGGS, MARGARINE(PARTIALLY HYDROGENATED SOYBEAN AND COTTONSEED OILS, WATER, SALT, BUTTERMILK, LECITHIN, VEGETABLE MONO AND DIGLYCERIDES, SORBIC ACID & SODIUM BENZOATE ADDED AS PRESERVATIVE ARTIFICIALLY FLAVORED, ARTIFICIALLY COLORED WITH BETA CAROTENE, VITAMIN A PALMITATE ADDED), INVERT SUGAR, VANILLA (WATER, ETHYL ALCOHOL, CARMEL COLOR) CINNAMON, SODA BICARBONATE, SALT, CARMEL COLOR.), CONTAINS: MILK, EGG TREE NUT (WALNUT), SOY, Distributed by / Distribuido por Gordon Food Services, Grand Rapids, MI 49548
121222011525001 on the master case, 12122201 on the retail box.
40 master cases, each containing 6 retail boxes
Stryker brand Arthroscope and Hardware Set Tray (sterilization tray); Model/Part Number: 233-032-116; Product is manufactured and distributed by Stryker Endoscopy, San Jose, CA     The Arthroscope and Hardware Set Tray is used to hold and protect surgical devices during the sterilization process. Specifically this tray is used for arthroscopes and arthroscopic hardware devices. The tray consists of an interlocking tray and lid which are perforated to allow for the passage of sterilizing agent from outside the tray to the inside of the tray where the devices are held.
The gravity steam, Ethylene Oxide (EO) and STERRAD 100S sterilization methods are being removed from the ''Instructions for Use''; due to the firm's evaluation that identified original validation was not done at worst case conditions.
AZ, AR, TN, GA, TX, WI, IL, NC, SC, VA, WV, OH, KY, AL, NJ, MD, CO, WY, MI, IN, UT, ID, FL, KS, MO, NE, NV, MN, SD, OK, OR, WA, MO, PA,
Jimmy Peppers Hot Cherry Sliced Peppers, 1 gallon plastic jars
Lots: CH 2350, Best By Date 9/10/12;  CH 2550, Best By Date 9/12/12
Product was distributed to MD, VA and Washington, D.C.
Sprouts, Soybean, packed in clear plastic 1.0 lb and 1.5 lb. bags, labeled in part *** Henry's Farm Inc. 5500 Fair Oak Lane, Woodward, VA 22580*** and also bulk packaged in unlabeled 10 lb black plastic bags.
Soybean sprouts may be contaminated with Listeria monocytogenes.
Sprouts, Natto Soybean, packed in clear plastic 1.0 lb bags, labeled in part *** Henry's Farm Inc. 5500 Fair Oak Lane, Woodward, VA 22580***
Worldwide distribution: USA (nationwide) and countries including: Germany, Honduras, Hong Kong, India, Indonesia, Israel, Japan, Jordan, Kuwait, Malaysia, Mexico, Pakistan, Philippines, Russia, Saudi Arabia, Singapore, South Africa, South Korea, Taiwan, Thailand, Turkey, UNITED ARAB EMIRATES (UAE), and Vietnam.
System 1 Base 100/120V   The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.
Terumo Cardiovascular Systems (Terumo CVS) has received reports of various roller pump occlusion malfunctions that could result in the inability to use the pump and would then require replacement with back-up equipment. Occlusion malfunctions include stiff/difficult to adjust occlusion, loss of occlusion setting, unequal roller-to-roller occlusion and inability to adjust the occlusion.  If it is necessary to replace a roller pump during cardiopulmonary bypass, the user must temporarily suspend cardiopulmonary bypass to replace the equipment or reassign a pump. In this situation, the potential for patient injury depends on the patient condition, the user's response to the malfunction, the criticality of the pump that is impacted (arterial,  cardioplegia, sucker, vent) and the timing of the event (before, during, or after cardiopulmonary bypass)  The potential patient injuries range from no injury to cellular death resulting in neurologic dysfunction, cardiac dysfunction due to inadequate myocardial protection, end organ dysfunction, or death in the case of an extended period of no flow.
System 1 Base 220/240V   The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.
Worldwide Distribution-USA (nationwide) and the countries of  ARGENTINA, AUSTRALIA, BELGIUM, CANADA, CHILE, COLOMBIA, COLOMBIA, Costa Rica, Dominican Republic, Egypt, Germany, Guatamala, Honduras, Hong Kong, India, Indonesia, Israel, Japan, Jordan, Kuwait, Malaysia, Mexico, Pakistan, Philippines, Russia, Saudi Arabia, Singapore, South Africa, South Korea, Taiwan, Thailand, Turkey, UNITED ARAB EMIRATES (UAE), and Vietnam.
Terumo Cardiovascular Systems (Terumo CVS) has received reports of various roller pump malfunctions of the Terumo Advanced Perfusion System 1 that could result in the inability to use the pump and would then require replacement with back-up equipment. Description of malfunctions: '' Unplanned pump stop or pause  '' Changes in pump speed    If it is necessary to replace a roller pump during cardiopulmonary bypass, the user must temporarily suspend cardiopulmonary bypass to replace the equipment or reassign a pump.    The potential patient injuries range from no injury to cellular death resulting in neurologic dysfunction, cardiac dysfunction due to inadequate myocardial protection, end organ dysfunction, or death in the case of an extended period of no flow.
System 1 Base 220/240V.   The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.
Distributed to retail wholesalers and distributors in Florida.
Product is labeled in part:  ''***LEASA Living Alfalfa Sprouts***CHOLESTEROL FREE***PRESERVATIVE FREE***KEEP REFRIGERATED***NET WT. 6 OZ. (168 g)***''        Product is packaged in 6 oz clear plastic containers with UPC 75465-55912.  UPC Code and expiration date are located on the side of the container.
LEASA Industries Co., Inc. initiated a recall of 6 OZ containers of LEASA Living Alfalfa Sprouts with Use By Date 07/02/2012, UPC 75465-55912 after being informed by the Florida Department of Agriculture and Consumer Safety that a product sample had tested positive for Salmonella.
Coca Cola Cherry Zero, 20 fl. oz. (1.25 pt), The Coca Cola Company.
UPC 49000 04754, Optimum Taste Code: SEP0312LWC
Product is misbranded. Label indicates sugar free, however the product is actually sugar sweetened Coca Cola Cherry.
Worldwide Distribution-USA (nationwide) including Puerto Rico and the states of Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, Florida, Georgia, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Vermont, Virginia, Washington, West Virginia, and Wisconsin and the countries of  Canada, Australia, Austria, Belgium, Czech Republic, Denmark, France, Germany, Hungary, Italy, Netherlands, South Africa, Spain, Switzerland, Turkey, and United Kingdom.
superDimension Systems AAS00016-xx with Software Version 4.0-4.9.   Indicated for use for displaying images of the tracheobronchial tree to aid the physician in guiding endoscopic tools or catheters in the pulmonary tract and to enable marker placement within soft lung tissue. It does not make a diagnosis and is not an endoscopic tool. Not for pediatric use.
superDimension, Inc., is conducting a recall of certain superDimension Systems operating Software Version  4.0 - 4.9. The affected systems are sold under the product code AAS00016-xx.   The products being recalled have been found to malfunction when connected to the superDimension Locatable Guide (LG). Specifically, the Systems using Software Version 4.0-4.9 will not recognize the Locatable Guide,  and then generates an error message.
Smiths Medical HOTLINE 3 Blood and Fluid Warmer, Reorder Numbers: HL-390    Product Usage:  The Micro-switch is used on the HOTLINE 3 Blood and Fluid Warmer. This product, for use in conjunction with HOTLINE 3 L-370 Fluid Warming Set are intended for the delivery of warmed blood and intravenous fluids at normothermic temperatures. These products are intended for use by appropriately trained healthcare professionals in clinical environments
HOTLINE 3 Blood and Fluid Warmer( Reorder No. HL-390 )  disposable is not correctly installed , the microswitch may become damaged and unusable
Trizivir (abacavir sulfate 300mg, lamivudine 150 mg and zidovudine 300 mg), 60 Tablets, Rx only, Manufactured for: ViiV Healthcare, Research Triangle Park, NC 27709 by: GlaxoSmithKline, Research Triangle Park, NC 27709, NDC 49702-217-18
Adulterated Presence of Foreign Tablets: Trizivir 300/150/300 mg tables, Lot 0ZP5128 may incorrectly contain Lexiva 700 mg tablets.
Kroger Fresh Selections Greener Supreme; Iceberg lettuce, Romaine lettuce, Carrots and Red Cabbage;  12 oz plastic bag.  Best if used by date: June 19, 2012:  UPC 0 11110 91039 4    Distributed by the Kroger Co., Cincinnati, OH 45202
Positive MDP sample for Listeria Monocytogenes collected b USDA for Marketside Leafy Romaine Salad with Best By date of June 19, 2012.
Leafy Romaine; Romaine Lettuce & Leaf Lettuces; 10 oz plastic bag.  Best if used by date: June 19, 2012.    Packaged under brand names of:  Kroger Fresh Selections,  UPC 0 11110 91046 2,  Distributed by the Kroger Co., Cincinnati, OH 45202    and  Marketside  UPC: 6 81131 02781 6  Distributed by Wal-Mart Stores, Inc.  Bentonville, AR 72716
Kroger code: N158 111B KR11; Marketside code: N158111B
Distributed in Washington, D.C., the states of  AL, CA, FL, NY, OR, and VA
The Axcess Cranial Screw (sometimes referred to as the Axcess Cranial Pin) is a self-tapping, self-drilling screw and is an accessory used in conjunction with the Axcess Cranial Tri-Pin Kit.   The Axcess Bone (Cranial) Pin is intended to be used when rigid fixation of a tracking device to bone is required.
GE Healthcare is aware of a few instances where the Axcess Cranial Screw has broken during insertion.  There is a possibility that breaking of the screws could lead to a health hazard.
Hydrocodone Bitartrate & Acetaminophen Oral Solution 7.5 mg/325 mg per 15 mL, a) 15 mL Unit Dose Cups (50 unit dose cups per case), b) 473 mL Bottles, C III, Rx Only, Warning May be habit forming, Manufactured by VistaPharm, Largo, FL 33771, NDC a) 66689-023-50, b) NDC 66689-023-16.
Impurities/Degradation Products: exceeded specification at 3 month stability testing
Nationwide distribution including CA, FL, IL,  MI, MN, PA, and TX.
CSI Stealth 360-degree Orbital Atherectomy Device (OAD), Part Number 70056-11, Model Number PRD-SC30-125S.  Sterilized with Ethylene Oxide.  The Stealth 360-degree Orbital Atherectomy Device (OAD) is part of the Stealth 360-degree Orbital PAD system.   The Stealth 360-degree Orbital PAD system is a percutaneous orbital atherectomy system indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries and who are acceptable candidates for percutaneous transluminal atherectomy.
CSI has initiated a recall on specific lot numbers of Stealth 360-degree Orbital Atherectomy devices which  have the potential for an insufficient crown solder bond that may result in the crown becoming detached from the driveshaft.
Giusto's Wheat Germ, Raw, Net Wt. 25 lb, (11.34 Kg) paper bag;   Item number: 154205  Giusto's  344 Littlefield Ave.  South Francisco, CA 94080
Firm was notified by supplier that Wheat germ product is contaminated with metal fragments, approximately 0.5mm in diameter and range 3-15mm in length.
Kleenex Luxury Foam Hand Sanitizer, (Benzalkonium Chloride 0.1%), in a) 1 Liter (33.8 fl oz.), b) 1.2 Liters (40.5 fl oz.) Cassettes, Distributed by Kimberly Clark, LLC, Roswell, GA 30076
SKU #12977-00 (Cassette - 1 Liter), Lot #: SA1229ANB; b) SKU #12979-00 (E-Cassette - 1.2 Liters), Lot #: SA1229ANA, Exp 08/13
Microbial Contamination of Non-Sterile Products; The affected lots were found to be contaminated with bacterium, Burkholderia cepacia complex.
Kleenex Foam Hand Sanitizer, Alcohol Free in a) 1.5 fl oz. (45mL) , b) 8 fl oz. (236mL) , and c) 16 fl oz (473mL) bottles, Distributed by Kimberly Clark, LLC, Roswell, GA 30076
Banner Mountain Sprouts;Alfalfa Sprouts; California Certified Organic Sprouts.  100% certified organic seeds used.  Sacramento, Ca 95820.    Net Wt. 4 oz; 1 lb and 2 lb packages.  Rinse and Eat; Perishable, Keep refrigerated.  UPC  4 oz size: 0- 9691172842 3;   UPC  1 lb size: 0 96911 72850 8
USDA MDP Sampling found a positive result for Salmonella in Alfalfa Sprouts grown by Banner Mountain Sprouts.
Banner Mountain Sprouts;Alfalfa Broccoli Sprouts; California Certified Organic Sprouts.  100% certified organic seeds used.  Sacramento, Ca 95820.    Net Wt. 4 oz; Rinse and Eat; Perishable, Keep refrigerated.  UPC  4 oz size: 0- 9691172840 9;
Banner Mountain Sprouts;Zesty Greens - Clover, Radish; California Certified Organic Sprouts. 100% certified organic seeds used.  Sacramento, Ca 95820.    Net Wt. 4 oz; Rinse and Eat; Perishable, Keep refrigerated.  UPC  4 oz size: 0- 96911 72845 4;
Banner Mountain Sprouts; Sprout Salad: Alfalfa, Peas, Garbanzo, Adzuki, Lentil, Clover, Radish;   California Certified Organic Sprouts.  100% certified organic seeds used.  Sacramento, Ca 95820.    Net Wt. 4 oz; Rinse and Eat; Perishable, Keep refrigerated.  UPC  4 oz size: 0- 96911 72846 1;
Banner Mountain Sprouts; Clover Sprouts: California Certified Organic Sprouts.  100% certified organic seeds used.  Sacramento, Ca 95820.    Net Wt. 4 oz and 1 lb containers; Rinse and Eat; Perishable, Keep refrigerated.  UPC  4 oz size: 0- 96911 72843 0;   UPC - 1 lb size: 0 96911 72851 5.
Nationwide Distribution including CA, CT, FL, IL, IN, KY, MI, MN, MO, NJ, NY, NC, OH, OK, OR, PA, WA, and WI.
Incorrect patient shift directions when the Setup reference dialog is printed out when the DICOM coordinates option is enabled for reports.
US Nationwide Distribution - including the states of:  CA, CT, FL, IL, IN, KY, MI, MN,  MO, NJ, NY, NC, OH, OK, OR, PA, WA, and WI
Monaco   Product Usage:  Planning of radiation therapy
Nexium (esomeprazole magnesium) Delayed-Release Capsules, 40 mg, 1000-count bottle, Rx only, Manufactured for: AstraZeneca LP, Wilmington, DE  19850; By: AstraZeneca AB, S-151 85 Sodertalje, Sweden, NDC 0186-5040-85, UPC 3 0186-5040-85 0.
Adulterated Presence of Foreign Tablets/Capsules: Some bottles may contain a small number of Nexium 20 mg capsules intended for the Japanese market in addtion to Nexium 40 mg capsules.
Vital Signs Devices, a GE Healthcare Company
enFlow IV Fluid Warmer (510k name: EFLOW IV FLUID WARMER, MODEL 100, EFLOW DISPOSABLE CARTRIDGE, MODEL 200 AND EFLOW AC POWER SUPPLY,  MODEL 120).    The Enginivity enFlow TM IV Fluid Warmer is intended for warming blood, blood products and intravenous solutions prior to administration. It is intended to be used by healthcare professionals in hospital, clinical and field environments to help prevent hypothermia.
a) 510(k): K060537 b) Medical device listing number: D071942    All enFlow Warmer Straps in the field present a potential for tissue injury.  Sold separately as Product #: 980304 and 980304EU  Included as an accessory in following enFlow products:    Military      Domestic  91000153 980100  91000154 980100EU  91000156 980105VS  91000103
The EnFlow Warmer Strap does not meet the requirements of the biocompatibility standard (ISO 10993) for products that may  have contact with skin for less than 24 hours.
Dole brand Hearts of Romaine; Net Wt. 10 oz.  UPC 71430 00956;  Dole
Product number 0540 Code number N165112A  Enjoy by 06/26/2012.
IEH sample of Dole's Hearts of Romaine was positive for  Listeria Monocytogenes.
Nationwide Distribution-USA (nationwide) and Puerto Rico.
A routine internal quality check found that the Drager PT 4000 Phototherapy System is fitted with a 16 Amp rated fuse instead of the specified 1.6 Amp rated fuse.  This may mean that the internal fuse would not trip promptly in the event of an internal short-circuit.  The possible consequence is the wall outlet circuit breaker would trip first on the device may severely overheat.  There have not been any reports received from the field of such cases occurring, or any injury or harm being suffered in connection with this issue.
Per firm, the product is distributed in Southern Califormia and are sold by push cart vendors and ice cream trucks.
Fruiti Pops Coconut Ice Bars, 4 oz. Product labeling reads in part:'' Fresh fruit bar Fruiti Pops Classic Coconut 4 FL OZ (118mL)***FRUITI POPS 15418 CORNET SANTA FE SPRINGS, CA 90670 PLANT NO. 06-4562***''.
The firm initiated the recall because the product may contain egg yolk.
Clams, Frozen Boiled Baby, in shell, 10 oz packages, 24 pkgs/carton, item #20699K. UPC 081652 206996.
Frozen clams, product of S. Korea, may be contaminated with Norovirus.
Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals
HYDROCORTISONE and ACETIC ACID OTIC SOLUTION, USP, 10 mL bottle, Rx only, Mfg. for:  QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811; NDC 0603-7039-39; UPC 3 0603-7039-39 7.
Impurities/Degradation Products: Out of specificiation results for impurities at the 18-month room temperature time point.
There are no codes on the product. Sold on July 2 or 3, 2012,
945 cases (891 returned, 35 cases destroyed)