Oyster Meat Med IQF Farm, OYS101, 10/4lbs., Oyster Meat Large IQF Farm, OYS102, 10/4lbs.,  Oyster Meat Tiny 8oz IQF Farm, OYS105, 40/8oz.,
Pacific American Fish Company (PAFCO) is recalling recalling Korean Oysters because the product 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.
Oyster Half Shell Farm, OYS107, 144ps/cs, Oyster Half Shell small Farm, OYS114, 144ps/cs,
BRD Oyster (Kaki) IQF Farm, BRD 106, 12/2lbs.
''California Girl'' Whole Boiled Oysters, 24/8 oz cans.
UPC number 52391 70080, Lot numbers SV 39 0403 and MY 39 1429.
The product has been prepared, packed, or held under insanitary conditions wherby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.
OEC 9800; OEC FluoroTrak 9800 Plus; OEC 9800 Plus; OEC 9800 MD Motorized C-arm System, 892.1650 Image-intensified fluoroscopic x-ray system.   The OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. The system includes features specifically designed for use in diagnostic and interventional cardiac imaging procedures and is also intended for cholangiography, endoscopic, urologic orthopedic, neurologic, vascular, critical care and emergency room procedures. It may be used for other imaging applications at the physician's discretion.
The vertical lift column power supply in the mainframe C-arm of the device is defective and subject to early life failure.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Meiko Foods Co. Inc. Cooked Shrimp Balls Net Wt 8 oz. Product labeling reads in part:'' TOM VIEN COOKED SHRIMP BALLS***MEIKO FOODS CO. INC South El Monte, CA***''.   The product is packaged in a plastic box liner with a knot tied at the top in a cardboard box.
The firm is recalling the seafood balls products because the products were cooked without HACCP plans to control for known hazards.
Meiko Foods Co. Inc. Tempura, 12 oz. Product labeling reads in part:'' MEIKO***TEMPURA ***MEIKO FOODS CO. INC South El Monte, CA***''.   The product is packaged in a plastic box liner with a knot tied at the top in a cardboard box.
Meiko Foods Co. Inc. Pollock Fish Ball , 2-10 lb bags. Product labeling reads in part:'' MEIKO***POLLOCK FISH BALL ***MEIKO FOODS CO. INC South El Monte, CA***''.   The product is packaged in a plastic box liner with a knot tied at the top in a cardboard box.
Meiko Foods Co. Inc. Cooked Cuttlefish Ball, 2-10 lb bags . Product labeling reads in part:'' MEIKO***Muc Vien [Vietnamese] ***MEIKO FOODS CO. INC South El Monte, CA***''.   The product is packaged in a plastic box liner with a knot tied at the top in a cardboard box.
Arctic Zero Inc. is recalling their Arctic Zero Frozen Dessert products due to undeclared milk.
Vanilla Maple, 1pt., UPC 8 52244 00306 0
Mint Chocolate Cookie, 1pt., UPC 8 52244 00304 6
Cookies and Cream, 1pt., UPC 8 52244 00303 9
Chocolate Peanut Butter, 1pt., UPC 8 52244 00301 5
Pumpkin Spice, 1pt., UPC 8 52244 00307 7
Chocolate Dipped Bars 2 Strawberry and 2 Orange Cream, 2.1 Fl oz bars, UPC 8 52244 00309 1
Chocolate Dipped Bars, 2 Chocolate & 2 Vanilla, 2.1 fl oz bars, UPC 8 52244 00308 4
Distributed solely to one customer in AZ. AZ only.
Sonoran Rice, 14 lbs (224 oz). Chonita Foods 847 E. 18th St. Tucson, AZ 85719.
The product was recalled due to undeclared-sub ingredient, hydrolyzed soy protein.
Worldwide distribution: USA (nationwide) including states of: AZ, CA, CO, GA, IL, KS, KY, LA, MD, MI, MN, MO, NC, NE, NJ, NY, OH, OR, PA, SC, TN, TX, VA, WA, WI, & WV and countries including: AUSTRALIA, BELGIUM, BRAZIL, CANADA, JAPAN & SINGAPORE.
The Handi-Fil Disposable Syringe Fill Tube is a sterile plastic tube, approximately 10 inches in length, with a ''J'' shaped curve that projects upward approximately two inches.     The Handi-Fil Disposable Syringe Fill Tube is used to transfer radiographic contrast media from a sterile vial to an injection syringe.
A report was received from a Japanese distributor regarding a complaint from a hospital customer stating that ten packages of Handi Fil were not sealed.
Worldwide Distribution - USA (nationwide) and the countries of Nationwide and worldwide: ARGENTINA, BELGIUM, CANADA, CHILE, 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, 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) received eight complaints since September 2008 of drive motor failure of the Sarns Centrifugal System of the Terumo Advanced Perfusion System 1. A failure of the drive motor for the Terumo System 1 centrifugal system triggers error messages and alarms; therefore it is easily recognizable by the user. The potential hazards are dependent on the application of the centrifugal system: arterial flow or assisted venous drainage.
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.
Blood product, collected from a donor whose hemoglobin screening test was not performed, was distributed.
Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.
Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
Red Blood Cells (Apheresis) Leukocytes Reduced
Blood product, which did not meet the acceptable product specifications, was distributed.
Interstate Blood Bank, Inc. of Wisconsin
Blood products, collected from a donor who received a tattoo within 12 months of donation, were distributed.
Blood products, which was collected from a donor in which donor suitability was not adequately determined, were distributed.
Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.
American National Red Cross, Greater Ozark-Arkansas Region
Blood and Blood Products for Reprocessing
Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed.
Blood product, which was not quarantined after the donor provided information concerning a post-donation illness, was distributed.
Blood products, collected from a donor who was previously deferred, were distributed.
Pediatric electrolyte, Fruit Punch flavor---oral electrolyte solution---helps replace fluids & electrolytes---8 FL OZ (236 mL)---UPC Code: 31191129235 Distributed by Duane Reade/(866)375-6925---440 Ninth Ave., NY, NY 10001---Item #51070-8-4-
Duane Reade is recalling Pediatric Oral Electrolyte Solution because of deficient sodium and potassium content.
Dent's Extra Strength Toothache Gum, (benzocaine 20%), Net Wt. .035 Oz.. (1 g) box, C.S. Dent & Co., Erlanger, KY
Lot #C2501: 18150 pieces of gum (1 per package); Lot #B2111: 18129 pieces of gum (1 per package)
Blood product which did not meet the acceptable product specifications for release, was distributed.
Blood products, collected from a donor taking the medication Finasteride, were distributed.
Blood products,  collected from an unsuitable donor based on risk factors for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
Worldwide Distribution - USA (nationwide) and the countries of Australia, New Zealand, Brazil, Canada, Chile, Argentina, Paraquay, Ecuador, Colombia, India, Japan, Mexico, Panama, Singapore, Venezuela, UK, Northern Europe, France, Germany, Italy, Spain and Portugal.
VITROS 5,1 FS System Software    For use in the in-vitro quantitative, semi quantitative, and qualitative measurement of variety of analytes of clinical interest.
software automatically switches the lot when a vancomycin (VANC) or valproic acid (VALP) reagent is depleted or the operator manually changes the lot in use causing lack of verification of proper quality assessment.
VITROS 4600 Chemistry System Software    For use in the in-vitro quantitative, semi quantitative, and qualitative measurement of variety of analytes of clinical interest.
VITROS 5600 Integrated System Software    For use in the in-vitro quantitative, semi quantitative, and qualitative measurement of variety of analytes of clinical interest.
Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed.
Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
Blood product, with pH below the acceptable level, was distributed.
The American National Red Cross - Southern Region
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
Hoxworth Blood Center  UC Medical Center
Platelets Pooled Leukocytes Reduced Irradiated
Blood product, collected from a donor who reported post donation illness, was distributed.
LifeSouth Community Blood Centers Inc - Birmingham Region
Blood product, with platelet count below the specified minimum requirement, was distributed.
Blood product, collected from a donor with unacceptably low hemoglobin, was distributed.
Worldwide Distribution-USA-including the states of  CA, MA, OH, and OK,  and the countries of  Brazil, Colombia, France, Italy, Japan, Luxembourg, and Spain.
Product is labeled in part:  ''***OPTETRAK***TIBIAL TRAY***TRAPEZOID CEMENTED***Ti Alloy*** SIZE 1F/1T, 2F/1T***FOR CEMENTED USE ONLY***Exactech, Gainesville, FL 32653-1630.***REF 204-04-21***''.   The Optetrak Comprehensive Knee Systems are indicated for use in skeletally mature individuals undergoing primary surgery for total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis and/or post-traumatic degenerative problems. They are also indicated for revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present. In the USA, the Optetrak Comprehensive Knee System is indicated for cemented use only.
Exactech, Inc. Gainesville, FL is recalling their Optetrak Cemented Trapezoid Tibial Tray, Size 1F/1T, 2F/1T and the Optetrak Rotating Bearing Knee Tibial Tray, Finned, Cemented Tibial Tray, Size 2F/1T.  Both trays have the potential to be mislabeled.
Product is labeled in part:  ''***OPTETRAK RBK***TIBIAL TRAY***FINNED,  CEMENTED***CoCr Alloy***SIZE 2F/1T***REF 260-04-21***Exactech Gainesville, FL 32653-1630***.   The Exactech Optetrak RBK Total Knee System is indicated for use in skeletally mature individuals undergoing primary surgery for knee pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders and/or avascular necrosis of the femoral condyle, post-traumatic loss of the joint configuration (particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. Additionally, the Optetrak RBK Total Knee System is indicated for cases where revision of failed previous surgical attempts is necessary, if the knee can be satisfactorily balanced and stabilized at the time of surgery.
Blood products, labeled leukoreduced without the assurance that they met the criteria for leukoreducted products, were distributed
Worldwide Distribution - USA including Maryland, Indiana, New Mexico, Massachuesetts, Texas, Kansas and the country of Canada
Getinge brand --- large capacity, floor loading jet spray, washers for mechanical washing, intermediate level, thermal disinfection and drying of moisture and temperature stable Hospital case carts, sterilization containers, material handling carts, stands and utensils. --- Model numbers Getinge 9120, 9122, 9125, and 9128
Getinge Disinfection AB is voluntarily correcting Washer Disinfectors, Getinge Electrically Heated 9100-Series manufactured between 2009-05-04 through 09-26-2011. This action is based on a report from the ground fault breaker manufacturer of a production error.
Alaris PC unit model 8015   Product Usage:  The device is labeled for prescription use only.
112,912 units total (106,888 units in US)
The recall was initiated because the Alaris PC unit model 8015 has a component on the PC unit power supply board that is causing an error code(120.4630) ''System Error'' or ''Missing Battery Error'' at start up.  The error code is accompanied by both an audible alarm and visual error messages on the PC unit screen.
Products were directly distributed in Alaska, Oregon and Washington.
Frozen Oysters are packaged in 8 oz. 40 oz, and 3 lbs. The item numbers are 06413, 03777, FO/HS-OT8; 136300-20110430.  The brand names are Z.Shell Sanggul and Z.Shell HS.
Korean Oysters are recalled 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.
Blood product, collected from a donor in whom donor suitability was not adequately determined, was distributed.
Blood products,  collected from a donor in whom donor suitability was not adequately determined, were distributed.
Blood products, collected from a donor,  whose suitability to donate was not adequately determined, was distributed.
Blood products, collected from donors,  whose suitability to donate was not adequately determined, were distributed.
Blood product, collected from a donor,  whose suitability to donate was not adequately determined, was distributed.
Source plasma, collected from a donor who did not have a complete medical history interview, were distributed.
Source plasma, collected from a donor who did not have a complete medical history interview, was distributed.
Blood product, collected from a donor, whose suitability to donate was not adequately determined, was distributed.
Blood products, collected from donors who did not have a complete medical history interview, were distributed.
Blood products, collected from a donor, whose suitability to donate was not adequately determined, were distributed.
Tri-state area of New Jersey, New York and Pennsylvania.
Eden Quality Product Pasteurized Apple Juice from concentrate vitamin C added in a 46 fluid ounce can.  Service Size 8 fl oz. Dist. by S. Bertram Inc., Linden, NJ 07036.  Concentrate from China.
169 cases each containing (12) 46 ounce cans
Laboratory test results found the product has arsenic at a level of 36.4 parts per billion (ppb).
Worldwide Distribution - US (nationwide) in the states of: California, Colorado, Florida, Georgia, Illinois,  Indiana, Massachusetts, Michigan, Minnesota, New York, Oklahoma, Oregon, Pennsylvania, Texas, Utah, West Virginia, including Puerto Rico, and the countriy of Canada.
Leica  M525 F50 Surgical Microscope; Article No. 10338422;      Product Usage:  The intended use of this device is for improving visibility of objects through magnification and illumination. It can be applied for observation and documentation and for human and veterinary medical treatment.
Leica Microsystems evaluated data showing that a malfunction resulting in an illumination reduction can be observed when Leica M525 F50 surgical microscope is used in combination with a remote control connected to a remote video adapter or motorized dual video adapter.
Worldwide Distribution-USA (nationwide) including Puerto Rico and the states  AL, AK, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, ME, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WY, and WV and  the countries of  Belgium, Brazil, Canada, China, Columbia, Hong Kong, India, Japan, Korea, Peru, Singapore, Taiwan and Victoria (Australia).
PrepStain Kit: 1.2 DiTi Cone.   The PrepStain System is a liquid-based thin layer cell preparation process. The PrepStain System produces SurePath Slides that are intended for use in the screening and detection of cervical cancer, pre-cancerous lesions, atypical cells and all other cytologic categories as defined by The Bethesda System for Reporting Cervical/Vaginal Cytology Diagnoses. The 1.2 DiTi is the tip on the PrepStain to which a pipette tip attaches and dispenses patient samples onto a glass microscope slide.
Catalog # 490670: These items are not serially tracked.
Some Prep Stain Kit, 1.2 DiTi Cones have been found to be leaking and the PrepStain Preparation kits contain incorrect preventive maintenance (PM) instructions.
PrepStain Upgrade Kit: 1.3.0.3/1.2 DiTi Cone.   The PrepStain System is a liquid-based thin layer cell preparation process. The PrepStain System produces SurePath Slides that are intended for use in the screening and detection of cervical cancer, pre-cancerous lesions, atypical cells and all other cytologic categories as defined by The Bethesda System for Reporting Cervical/Vaginal Cytology Diagnoses. The 1.2 DiTi is the tip on the PrepStain to which a pipette tip attaches and dispenses patient samples onto a glass microscope slide.
PrepStain Slide Processor.   The PrepStain System is a liquid-based thin layer cell preparation process. The PrepStain System produces SurePath Slides that are intended for use in the screening and detection of cervical cancer, pre-cancerous lesions, atypical cells and all other cytologic categories as defined by The Bethesda System for Reporting Cervical/Vaginal Cytology Diagnoses. The 1.2 DiTi is the tip on the PrepStain to which a pipette tip attaches and dispenses patient samples onto a glass microscope slide.
PrepStain PM Kit, T-AG (Catalog 490588); PrepStain PM Kit Europe (Catalog 490671); PrepStain Prep Only PM Kit, T-AG (Catalog 490954); PrepStain PM Kit XLP, T-US-II (Catalog 490424); PrepStain Prep PM Kit XLP T-US-II (Catalog 491118); PrepStain Prep Only PM Kit XLP, T-US-II (490423); PrepStain Prep Only PM Kit, T-US (Catalog 490429); PrepStain PM Kit, T-US (Catalog 490626); PrepStain PM Kit Europe, T-US (Catalog 490428).   The PrepStain System is a liquid-based thin layer cell preparation process. The PrepStain System produces SurePath Slides that are intended for use in the screening and detection of cervical cancer, pre-cancerous lesions, atypical cells and all other cytologic categories as defined by The Bethesda System for Reporting Cervical/Vaginal Cytology Diagnoses. The 1.2 DiTi is the tip on the PrepStain to which a pipette tip attaches and dispenses patient samples onto a glass microscope slide.
Erythromycin Topical Solution USP, 2%, 60 mL bottle with applicator, Rx only. E. FOUGERA & CO., A division of Fougera Pharmaceuticals, Inc., Melville, New York 11747, NDC 0168-0215-60, UPC 3 0168-0215-60 0.
Chemical Contamination: This product is being recalled because trace amounts of a plasticizer (Di-Octyl Phthalate) may be present in the product.
Source Plasma, collected from a donor who did not have a complete medical history interview, was distributed.
Blood Products, collected from a donor, whose suitability to donate was not adequately determined, were distributed.
Blood Product, collected from a donor, whose suitability to donate was not adequately determined, was distributed.
Blood products, collected from a donor,  whose suitability to donate was not adequately determined, were distributed.
Blood products, collected from donors, whose suitability to donate was not adequately determined, were distributed.
Hidden Valley Salad Crispins Original Ranch; crisp mini-croutons, crunchy carrot bits and a blend of buttermilk and spices; Net Wt. 2.5 Oz. canister, 12 canisters per case;  UPC 10071100 008347
Canister lot code: CBG1 NOV27 2012 and DBG1 NOV27 2012; Case lot code: G12152
The cultured nonfat buttermilk ingredient used in production of the Salad Crispins was recalled by the supplier due to potential metal fragment contamination associated with the lactic acid used in production of the ingredient.
Kettle Brand Potato Chips, Sour Cream and Onion, 12/8.5oz, item # 0711387001, UPC 0 84114 11393 1
Metal fragments in raw material (lactic acid) of flavorings, recalled by manufacturing firm, were used in the product.
Best Before 15Nov12 for all plus 1Nov12 for 15/5 oz;   Line 2 of package code and case code:  1) 0914438;  2) 0914218, 0914328, and 0914438;  3) 0914544, plus 0914322A and  0914322B for package and 0914322 for case;  4 and 5) 0914212A and 0914212B for package and 0914212 for case;  6) 0914322A no case code.  7) no bag or case code
Kettle Brand Potato Chips, Cheddar Beer, item #0712374000, UPC 0 84114 12375 6.
Best before 15Nov12 0914325 and case code 0914325.
Korean Molluscan Shellfish (Seasoned Oysters) 250kg, 1000kg
The recall was initiated because Hamchorom dba Golden USA Trading, Inc. has Korean Molluscan Shellfish 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.
Nationwide Distribution-including the states of AZ, CA, FL, GA, IL, LA, MD, MN, NJ, NY, OH, PA, TN, TX, and VA.
4.5mm TI Multiloc Screw Length 38MM-Sterile Expiration: 04/29/2012  REF 04.019.038S    Manufactured or Distributed by Synthes (USA) 1101 Synthes Avenue, Monument CO 80132    4.5MM TI Multiloc Screw Length 38MM-Sterile  Ref 04.019,038S.     The Multiloc Screw 4.5 is used with a Multiloc PHN for treatment of proximal humerus fractures and is intended to be inserted through the Multiloc PHN until it engages the subchondral bone below the relative distal cortex (cortex closest to the humeral head, below the articular surface).
Two lots of 4.5mm multi-loc screws were recalled due to incorrect labeling of screw size.
4.5mm TI Multiloc Screw Length 28MM-Sterile Expiration: 04/29/2012  REF 04.019.028S    Manufactured or Distributed by Synthes (USA) 1101 Synthes Avenue, Monument CO 80132    4.5MM TI Multiloc Screw Length 28MM-Sterile  Ref 04.019,038S.     The Multiloc Screw 4.5 is used with a Multiloc PHN for treatment of proximal humerus fractures and is intended to be inserted through the Multiloc PHN until it engages the subchondral bone below the relative distal cortex (cortex closest to the humeral head, below the articular surface).
Nationwide Distribution including GA, PA, SC, TX, and UT.
Universal Spinal System Lamina Hooks Synthes Medium TI Lamina Hook - Right   498.320  Non sterile  LOT 6876785    Noncervical spinal fixation devices intended for posterior pedicle screw fixation, posterior hook fixation, or anterolateral fixation. Limited to skeletally mature patients with the exception of the small stature USS, which includes small stature and pediatric patients. These devices are indicated as an adjunct to fusion for all of these indications: degenerative disc disease, spondylolisthesis, trauma, deformities or curvatures, tumor, stenosis and failed previous fusion.
Catalog number 498.321, lot/serial #6876785
USS Lamina Hooks, Medium, Right are being recalled because the hooks are etched with the wrong part number - 498.321 (Lamina Hook, Medium, Left). The Lamina Hooks should be etched with part number 498.320 (Lamina Hook, Medium, right).
US Nationwide Distribution including the states of: Arizona. and California.
.***ANSPACH***Sterile. REF SHD-4820DS***QTY: 1, 4.8 mm x 2mm Twist Drill with Depth Stop.  Use with SHORT-HD Attachment ***RX Only     Product Usage:  Cutting and shaping bone including bones of the spine and cranium.
Anspach Effort, Inc.  Palm Beach Gardens, FL is recalling their Single Use Sterile Bone Cutting Burrs used with XMax, microMax, microMax Plus, eMax, eMax2 and eMax2 Plus High Speed Drill Systems.  It is possible for the cutter to come apart.
Worldwide Distribution -- USA, including states of IN, GA, MI, FL, MO, OH, and SC and country of Australia.
OrthoPediatrics PediLoc Locking Plate System, 4.5mm Contour Locking Compression Femur 8 Hole Plate Right.   Used for pediatric patients as indicated for pelvic, small and long bone fractures.
Lot number: 7736703 and part number: 00-1050-4308
The device is a Left 8 hole plate but is incorrectly labeled and etched as a Right device.
Tibial Punch Tower Assembly.  Non-Sterile.  CAT NO. 8000-1089.  Howmedica Osteonics Corp., 59 Route 17, Allendale, NJ  07401.     During primary Scorpio TKA procedures, the Scorpio Tibial Punch Tower (8000-1089) is used in conjunction with Scorpio Tibial Keel Punches (3760-0305/-0709/-1113 and 3761-0305/-0709/-1113) and Tibial Templates (3750-0003/-0005/-0007/-0009/-0013) to prepare the tibia for baseplate implantation. Per the surgical protocol for Duracon and Scorpio Total Knee Systems with Xcelerate Instrumentation (LSPK31 03/03), tibial templates are used to determine the appropriate coverage of the tibial plateau. Once a template size is selected, the device is secured to the plateau with fixation pins, and the tibial punch tower is assembled by placing the tower onto the two small locating pins on the tibial template. A keel punch is then selected, assembled into the channel of the tower, and impacted with a mallet. Depending on the intended implant size, several keel punches of increasing size may be utilized to incrementally enlarge the cavity. Each keel punch is advanced until it fully seats on the tibial template. Tibial preparation is considered complete when the final keel punch fully seats on the tibial template.
Stryker Orthopaedics received a report indicating that a Tibial Keel Punch could not be inserted into the slot of the Tibial Punch Tower.  The slot that guides the stem of the keel punch into the channel of the tower was later determined to be undersized.
OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures.   Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.
The OEC 6800 Miniview was recalled in November 2006 due to several intermittent potential safety issues including navigation tracking inaccuracy, system Lock-up, incorrect image display, incorrect dose area calculated air kerma in ''film mode'' and ''digital spot mode'', and the system does not reboot.
OEC 8800 Flexview, 892.1650 Image-intensified fluoroscopic x-ray system      Product Usage:  The 8800 Flexview is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical, and interventional procedures. Clinical applications may include cholangiography, urologic, endoscopic, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures. The system may be used for other imaging applications at the physicians discretion.
The OEC 8800 Flexview was recalled in November 2006 due to several intermittent potential safety issues including navigation tracking inaccuracy, system lok-up, incorrect image display, incorrect dose area calculated air kerma in ''film mode'' and ''digital spot mode'', and the system does not reboot.
Worldwide Distribution - USA including AZ, CA, IL, IN, LA, MI, MN, MO, NJ, NY, NC, PA, SC, TN, TX, and WI and the countries of Canada, Denmark, Estonia, Finland, France, Great Britian, India, Italy, Japan, Korea, Saudi Arabia, and Spain.
Respironics Trilogy 100, 200, and 202 Ventilators   The Respironics Trilogy systems provides continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. Trilogy 100 is intended for pediatric through adult patients weighing at least 5 kg (11 lbs.). The devices are intended to be used in home, institution/hospital, and portable applications such as wheelchairs and gurneys, and may be used for both invasive and non-invasive ventilation. They are not intended to be used as a transport ventilator.
The specified Trilogy units are being recalled because of the potential for a faulty component in the power supply.
Frozen Yellow Fin Tuna Loins (AAA)Co Treated Skinless Frozen. 44 lbs./carton (3-4 Loins/Case)  Imported from Vietnam
Tuna tested positive for histamines over 50ppm
Connecticut, Massachusetts, Maine and Rhode Island
New England Clam Chowda,  pouch 8 lbs., refrigerated. For Institutional Use Only.   Mfd. by Plenus Group, Inc., Lowell, MA 01852  Product Number 1023  UPC #: 7 3051691023 3
MFG DATE: June 18, 2012, Use By: July 19, 2012;  MFG DATE: June 20, 2012A, Use By: July 20, 2012;   MFG DATE: June 20 2012B, Use By: July 20, 2012.
New England Clam Chowda Base,  pouch 4 lbs., refrigerated. For Institutional Use Only.   Mfd. by Plenus Group, Inc., Lowell, MA 01852  Product Number 1010  UPC #: 7 3051691010 3
International Distribution including Nationwide(USA), and the countries of Japan and Canada.
Bella Blanket Protective Coverlet, for Mammography, 18cm x 25cm or 24cm x 30cm, Product Code: 311.  The purpose of the product is to remove the cold by placing this sheet between the patients breast and the imaging receptor plate.
Imaging artifact can occurr on mammogram result.
Worldwide distribution: USA (nationwide) including: AL, AZ, CA, CO, GA, IL, KY, MD, MN, MO, NC, NY, OR, PA, WA, and WI; and countries of: Australia and Sweden.
BridgePoint Medical, Stingray  Catheter, REF M - 1000, Sterilized with Ethylene Oxide Gas, Prescription Only, Manufacturer BridgePoint Medical Inc. 13355 10th Ave N, Suite 110, Plymouth, MN 55441.   Stingray'' Catheters are intended to facilitate the intraluminal placement of conventional guidewires beyond stenotic coronary lesions (including chronic total occlusions) prior to PTCA or stent intervention. When used as part of the BridgePoint Medical System, the Stingray Catheter is intended to facilitate the intraluminal placement of conventional guidewires beyond stenotic coronary lesions (including chronic total occlusions [CTOs]) prior to PTCA or stent intervention. .
BridgePoint Medical Inc. is voluntarily recalling  Stingray Catheter, Model M1000 lots BP20121440078 and BP20121560089.    BridgePoint Medical, Inc. recently determined the potential of compromised sterility assurance of the product due to a faulty pouch seal.  In no case was there any reported adverse clinical event related to the problem.
Worldwide Distribution - US Nationwide and countries including: Argentina , Aruba, Australia, Austria, Bahamas, Bahrain, Belgium, Bermuda, Brazil, Brunei, Bulgaria, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Republic, Egypt, Finland, France, Germany, Greece, Guam, Guyana, Hong Kong, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kenya, Kuwait, Lebanon, Libya, Malaysia, Mauritius, Mexico, Netherlands, New Zealand, Nigeria, Norway, Oman, Pakistan, Palestine, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tobago, Turkey, Turks and Caicos Islands, United Arab Emirates, United Kingdom, United States, US Virgin Islands, Venezuela and Vietnam
Affinity Four Birthing Bed P3700    Product Usage:  The Affinity, Four Birthing Bed is intended to be used as birthing beds for women of child bearing age in an LDR (Labor, Delivery, Recovery ) or LDRP (Labor, Delivery, Recovery, Postpartum) setting within the acute care Labor and Delivery market. They are not intended for use as general hospital beds.
Affinity Four Birthing Beds (P3700) manufactured with Serial Numbers H331AA4785 thru N081AA7966
During review of our last braking system via that field corrective action, the system still did not meet our expectations, which is to eliminate the hazards of patient falling. Bed movement immediately prior to, or during the birthing process may still create distractions and delays, resulting in patient or caregiver falls, or contribute to a deviation in a procedure, (e.g. IV insertion, epidural placement,  episiotomy incision, vacuum extraction, forceps  delivery, suprapubic pressure).    In an effort to further improve the braking system of the Affinity Four Birthing Bed, Hill-Rom developed an enhanced brake detent assembly.
ABG II Modular Hip Stem Stryker Howmedica Osteonics Corp. Mahwah, NJ 07430  Stryker Ireland Carrigtwohill Industrial Estate, Carrigtwohill County Cork, Ireland.    The ABG II Modular range of implants is constituted of 8 right stems and 8 left stems. The necks are made of GADS Vitallium, a proprietary Co Cr alloy that Stryker has developed. GADS stands for Gas Atomized Dispersion Strengthened. IT is a Co Cr alloy that is a corrosion resistant and demonstrates qualities of improved fatigue strength (with respect to regular Co Cr alloy). Neck Range - The ABG II modular neck range is composed of 10 reversible neck implants. There are different options in terms of length, version and neck angle. The AG II Modular necks come in two different lengths: 28 mm (short) and 36 mm (long). The necks are offered in two version angles ; 0 and 7. The 0 and 7 necks are available in 125, 130 and 135 neck angles.
510 K092406   all lots    (4845-4XXX and NLS/NLV)
Stryker has updated the instruction for use (IFU) (product correction)for the ABGII Modular and Rejuvenate Modular Hip Systems.  This is based on a reported rate of less than one percent for revisions potentially associated with fretting and or corrosion at or about the modular neck junction. On June 29, 2012, Stryker has decided to remove the affected product from the field since there may be an increased likelihood for Adverse Local Tissue Reaction.
Rejuvenate Modular Stems  Stryker Ireland Carrigtwohill Industrial Estate  Carrigtwohill County Cork, Ireland    Rejuvenate Modular Necks Stryker Howmedica Osteonics Corp. Mahwah, NJ 07430.    Stem Bodies Rejuvenate Modular consists of 6 modular stems bodies in sizes 7-12. The Modular Stem bodies are made of TMZF alloy, developed specifically for orthopaedic applications. Rejuvenate Modular Necks The Rejuvenate Modular Necks are made of Cobalt Chrome. The necks in this system consist of 4 lengths in 4 mm increments. They are 30 mm, 34 mm, 38 mm and 42 mm. They come in multiple neck angles and versions in each length. They are 127, 130 and 132. The versions are 0, 8, 16 degrees. In total there are 16 unique neck implants in the Rejuvenate Modular System.
510 K092561 all lots  Rejuvenate  (NLS/NLV)  Rejuvenate (SPT)  (4845-4XXX and NLS/NLV)
(NLS/NLV) - 23193 units and (SPT) - 20,743 units
(USA) nationwide including the states of CA, FL, GA, MA, MN, MO, NJ, NY, OH, WA, and WI.
Siemens syngo.plaza.    Radiological image processing system
Siemens became aware of a potential malfunction when using syngo.plaza with software version VA20C_HF01.  For datasets with distance measurements it can happen, that all images are not loaded to Viewer but no error message is displayed to user.
21st Century Foods Soy Tempeh, packaged in 12 lb plastic bags and 8 oz containers
Product tested positive for the presence of coliforms
Philips And Neusoft Medical Systems Co., Ltd.
Nationwide Distribution -- North Carolina, Ohio, and Texas.
NeuViz 16 Multi-Slice CT Scanner System is a computed Tomography X-ray system, and has a Part number 989605858501.   The device is labeled in part: ''***Neusoft***NeuViz16 MULTI-SLICE CT SCANNER SYSTEM***MANUFACTURED FOR NEUSOFT MEDICAL SYSTEMS CO., LTD***MANUFACTURED BY PHILIPS AND NEUSOFT MEDICAL SYSTEMS CO., LTD***ADDRESS: NEUSOFT PARK, HUNNAN INDUSTRIAL AREA, SHENYANG***CHINA***''.
One of the four screws that secure the Oil-accumulator to the X-Ray Tube pulled out in the NeuViz 16 CT scanner, which caused the Oil-accumulator to detach.
Peppermint Bon Bon Light Ice Cream under the following three brands:   Hornbachers,   Peppermint Bon Bon Light Ice Cream,  Half Gallon (1.89 L),   UPC 41130-21663, Distributed by Supervalu Inc, Eden Prairie, MN 55344.    SunnyBrook, Peppermint Bon Bon Light Ice Cream,  Half Gallon (1.89 L),    UPC 70422-24919, Distributed by Mason Brothers Co., Wadena, MN 56482.    Schroeder, Peppermint Bon Bon Ice cream,  56 oz  or 1.75 Qt (1.65 L)   3 ,   UPC 72340-00193, Schroeder Company, Maplewood, MN 55113
Brand                 code   Hornbachers -  138M, 051M,     Sunnybrook   -   138M    Schroeders    -   060M
The ice cream products may contain undeclared eggs.  A flavoring containing egg yolks was used as an ingredient in the products, and the ingredient statement on the product package did not reveal the presence of eggs.
Worldwide Distribution, including the state of Florida (USA) and the countries of Germany, India, Poland, Thailand, and the Republic of Korea.
ARTISTE or ONCOR Digital Linear Accelerators with syngo RT Therapist version 4.2/MOSAIQ OIS Systems and Multiple-X, Manufactured by SIEMENS AG.  The ARTISTE and ONCOR family of Linear Accelerators are used to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer.
ARTISTE, Part #: 08139789, ONCOR Avant Garde, Part #: 05863472,  ONCOR Impression Plus, Part #: 05857912,  ONCOR Expression, Part #: 07360717
Siemens became aware of a potential safety issue when using the ''IMMEDIATE RESUMPTION'' feature of the syngo RT Therapist 4.2 software after a Control Console interlock during the delivery of flattening-filter-free (Multiple-X) beams or segments; in a very rare scenario, the RT Therapist  will send again the previously completed beam or segment for delivery to the control console, thus repeating the already delivered Monitor Units of the same beam or segment.
Worlwide Distribution - US (nationwide) and to countries of: Australia, Belgium, Brazil, Canada, France, Germany, Greece,  Hong Kong, Ireland, Japan, Korea, Mexico, Panama, Philippines, Russian Federation, and Singapore, Sweden, Switzerland and Thailand and United Kingdom.
Oto Ease by Westone, labeled as a bacteria free, greaseless lubricant.  Sold in 0.5 oz consumer sized semi transparent flexible plastic bottles.     Product Usage:  The product is used as a patient lubricant which eases insertion of earmolds and hearing instruments such as hearing aids.
Individual products are not identified with lot numbers.  There may be lot numbers on the bottom of the bulk packaging of a twelve pack of individual products but the end user may not be aware of a lot number for the specific vial.  No expiry is applied to the finished products.
Westone is recalling all Oto Ease ear lubricant in all packaging configurations and sizes due to potential microbial contamination of the product.
Nationwide Distribution including IN, SC, OH, TX
IMPAX CV Reporting   The Results Management (RM)/IMPAX CV reporting component facilitates the quick, effective creating of digital structured reports for : adult catheterization and echocardiography, pediatric echocardiography, congenital heat disease, nuclear cardiology and non-invasive vascular disease management. This webb-based application allows cardiology departments to view, edit and sign the structured reports.
Software Version: RM 2.03 to 2.08, NIV 1.0
When users selected ''Left stenosis'' in the ''Graft Duplex Conclusion'' section in IMPAX CV Reporting Non-Invasive(NIV) module, ''Right stenosis'' appeared in the sentence display within the printed representation of the report.
Nature's Grain Garlic French Bread, 10 oz (284 g) packages,
Southern Bakeries, Hope, AR is recalling its Nature's Grain Garlic French Bread (10 oz) product because it contains undeclared Yellow #5 and Yellow #6.  The recalled products have a UPC code 047300109064.
Worldwide Distribution-USA (nationwide) including the states of  California, Colorado, Connecticut, Florida, Illinois, Kentucky, Maryland, Massachusetts, Minnesota, Oklahoma, Texas, Utah, Virginia, Washington, West Virginia and Wyoming, and the countries of Barbados and Canada.
Hospira LifeShield Latex-Free 100 mL Burette Set, Convertible Pin, 77 inch with 2 Prepierced Injection Sites and Option-Lok Microdrip Soluset with Calibrated Burette and Precision Drip Chamber; an Rx sterile medical device used to administer fluids; 20 individually wrapped sets per case; Made in Costa Rica, Hospira, Inc., Lake Forest, IL 60045 USA; list 12722-65.     Intended use: for the administration of fluids.
The float valve in the burette sticks to the burette wall and does not open or close properly.
The products were distributed to VA, MD, and PA
Frozen Oyster, IQF, Surasang Brand, 1) 8 oz, packed in plastic bags, 40 bags/case, Item No.: 03777; 2) 2.5 lb, packed in plastic bags, 10 bags/case, Item No.: 06413.
all codes distributed prior to May 12, 2012
Molluscan shellfish may have been exposed to human fecal waste and are potentially contaminated with norovirus.
Frozen Oyster, Blocks, Wang Brand, 1 lb, packed in plastic bags, 24 bags/case, Item No.: 01356.
Wellements Baby Move Prune Concentrate with Prebiotics, 4oz., 12 units per case, SKU# 141161, UPC 729609019878.
Wellements is recalling Wellements Baby Move Prune Concentrate, 4oz. because they have confirmed that their supplier of the ingredient galacto-oligosaccharide which is used in the Baby Move product may be contaminated Salmonella.
Tizanidine (Generic for: Zanaflex), 4 mg, 90 Tablets per Bottle, Rx only, , Mfg By: Dr Reddys Labs Ltd., Bachepally, IN 500 - 090, Packaged and distributed by STAT Rx USA, Gainesville, GA, NDC 16590-221-90.
Labeling: Label Mix-Up; Some bottles of Tizanidine 4mg Tablets, had the incorrect manufacturer (Actavis) printed on the label.