Blood products, collected from a donor whose scheduled physical examination was incomplete, were distributed.
Community Blood Bank of Lancaster County Medical Society
Blood products, which were collected from a donor with a history of multiple high risk behaviors, were distributed.
Blood and Blood Products for Reprocessing
Community Blood Center of Greater Kansas City
Blood product, for which viral marker testing was incomplete, were distributed.
Platelets Pheresis Leukocytes Reduced Irradiated
Blood products, collected using expired control materials, were distributed.
Blood products, collected from a donor who received a tatoo within 12 months of donation, were distributed.
Blood product, manufactured without additive solution, was distributed.
Blood product, which tested negative for hepatitis, but was collected from a donor who previously tested positive for the antibody to hepatitis B core antigen (anti-HBcore) on two separate occasions, was distributed.
Blood product which did not meet Quality Control  specifications was distributed.
Red Blood Cells Leukocytes Reduced Washed
Blood product, with an unacceptable low red cell recovery rate, was distributed.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Blood product, which was exposed to unacceptable temperature during storage, was distributed.
Blood products, for which no documentation of shipment or storage at appropriate temperatures were distributed.
Blood products, collected from a donor who was previously deferred, were distributed
Blood products, which did not meet the acceptable product specifications for release, were distributed.
In this situation, blood product was stored where the temperature was not continuously monitored, was distributed.
Blood products, which Viral Testing performed, interpreted, or documented incorrectly, were distributed.
Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed.
Blood products, for which storage conditions and shipment information were undocumented, were distributed.
Mississippi Valley Regional Blood Center
Blood products, which component preparation were not prepared in accordance with specifications, were distributed.
Blood products, collected from a donor in whom donor suitability were not adequately determined, were distributed.
US States CA and NY. Nationwide to: Canada, United Kingdom, Germany, Israel, Spain, Japan, Singapore, and vietnam.
Micro SSPTM Allele Specific HLA Class I DNA Typing Tray - B*35   510(K) Number 8K 960062    Product number SSPR1-35  Product Insert Number SSP_DNAT_PIEN Rev 16
Product Name: Micro SSPTM Allele Specific HLA Class I DNA Typing Tray - B*35 Product Number: SSPR1-35  Lot Number: 002, batch 004 Expiration Date: 10/2013  Product Insert Number: SSP- DNAT-P-I EN Rev 16    510(K) Number BK 960062  Product Code MZI
HLA typing assay, associated with false negative results, was distributed.
Nationwide in the US: OR and IL, and worldwide to Canada, Saudi Arabia/USA, United Kingdom, Germany, Italy, Jordon, Sweden, and Peru.
Micro SSP Allele Specific HLA Class I DNA Typing Tray-AB, Product Number: SSP1-AB, Lot 003, batch 007
Micro SSP Allele Specific HLA Class I DNA Typing Tray-AB, Product Number: SSP1-AB, Lot Number 003, batch 007 Expiration August 2013.  Product insert Number SSP_DNAT_PI-EN Rev 16; 510(K) Number BK960062; Product Code MZI
Blood products, collected from a donor, whose suitability to donate was not adequately determined, was distributed.
Blood products, collected from a donor, for whom donor suitability was not adequately determined, were distributed.
Blood products, which were collected in a manner that may have compromised the sterility of the collection system, were distributed.
Red Blood Cells Leukocytes Reduced Irradiated
Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
Blood product, collected from a donor whose arm preparation was not documented, was distributed.
Blood product, which was collected from a donor who had traveled to a malarial endemic area, was distributed.
Product was distributed to retail outlets in DE, MD, NJ and PA within the US.
McClure's Pies & Salads, Inc. Walnut Cinnamon Streusel Cake
All product distributed prior to 11/15/2011
Undeclared allergens.  Ingredient statement lists ''nuts'' but is not specific for walnuts.  Label does say, ''Walnut Cinnamon Streusel Cake.''
McClure's Pies & Salads, Inc. Apple Cinnamon Streusel Cake
Undeclared allergens.  Ingredient statement lists ''nuts'' but is not specific for walnuts.
McClure's Pies & Salads, Inc. Marble Cake
Undeclared allergens.  Ingredient statement lists ''flour'' but is not specific for wheat flour.
McClure's Pies & Salads, Inc. German Chocolate Cake
McClure's Pies & Salads, Inc. Chocolate Cake
McClure's Pies & Salads, Inc. Red Velvet Cake
McClure's Pies & Salads, Inc. Black Walnut Cake
McClure's Pies & Salads, Inc. Yellow Cake
Undeclared allergens.  Ingredient statement lists ''flour'' but is not specific for wheat flour.  Also, coloring (yellow #5) is not listed.
McClure's Pies & Salads, Inc. Lemon Crunch Cake
Undeclared allergens.  Ingredient statement lists ''nuts'' but is not specific for walnuts.  Also, coloring is not listed - Yellow #5
McClure's Pies & Salads, Inc. Lemon Glazed Cake
Undeclared allergens.  Ingredient statement does not list coloring - Yellow #5.
McClure's Pies & Salads, Inc. Orange Cake
Undeclared allergens.  Ingredient statement lists ''flour'' but is not specific for wheat flour
McClure's Pies & Salads, Inc. Apple Dumplings
McClure's Pies & Salads, Inc. French Apple Pie
McClure's Pies & Salads, Inc. Blueberry Pie
McClure's Pies & Salads, Inc. Cherry Pie
McClure's Pies & Salads, Inc. Pumpkin Pie
McClure's Pies & Salads, Inc. Banana Cream Pie
McClure's Pies & Salads, Inc. Cherry Custard Pie
McClure's Pies & Salads, Inc. Coconut Custard Pie
McClure's Pies & Salads, Inc. Egg Custard Pie
McClure's Pies & Salads, Inc. Chocolate Cream Pie
McClure's Pies & Salads, Inc. Coconut Cream Pie
McClure's Pies & Salads, Inc. Shoo Fly Pie
McClure's Pies & Salads, Inc. Chocolate Shoo Fly Pie
Undeclared allergens.  Ingredient statement lists ''mayonnaise'' but sub-ingredients are not listed for the mayonnaise
McClure's Pies & Salads, Inc. Macaroni Salad
Undeclared allergens.  Ingredient statement lists ''macaroni'' but sub-ingredients for macaroni are not listed
McClure's Pies & Salads, Inc. Broccoli & Cauliflower Salad
Undeclared allergens.  Ingredient statement lists ''mayonnaise'' but sub-ingredients for mayonnaise are not listed.  In addition, product label lists cheese but does not list sub-ingredients from the cheese label.
McClure's Pies & Salads, Inc. Chicken Salad
Undeclared allergens.  Ingredient statement lists ''mayonnaise'' but sub-ingredients for mayonnaise are not listed
McClure's Pies & Salads, Inc. Potato Salad
Undeclared allergens.  Ingredient statement lists ''salad dressing'' but sub-ingredients for salad dressing are not listed
Hard Ten Days Capsule, 4500 mg, boxes of 6 packets, OTC, Developed by:  American Federal International Living Creature Group and Tibet Gold Source Living Creature Engineering Limited Company, Unit 18, 55 Beijing Road Central, Lhasa, Tibet
Marketed Without an Approved ANDA/NDA:  presence of sildenafil
Man King Capsules, 2800 mg, boxes of 5 packets, OTC, Developed by:  American Wanbao Pharmaceutical International Group and Hainan Wanbao Biological Engineering Co., Ltd., 27 Heping Road, Haikou, Henan Province, UPC 9 009900 0032328
Marketed Without an Approved ANDA/NDA: presence of sildenafil.
Japan Weight Loss Blue Capsules, 9 g (300 mg), 30 count box, Green algae lipotropic (fat dissolving) agent, OTC, Distributed by Vitaminbestbuy.com, Brewerton, NY
Marketed Without an Approved ANDA/NDA: presence of sibutramine
Blood Centers of the Pacific - Irwin Center
Switzerland; Austria; Armed Forces Americas, California
Blood products, collected from a donor who gave history which warranted deferral or follow up were distributed.
Walter L. Shepeard Community Blood Center, Inc.
Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed.
Worldwide and US Nationwide Distribution
Terumo Advanced Perfusion System 1 ASSEMBLY FLOW POD   Product Usage: The Terumo Advanced Perfusion System 1 is indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures only when used by a qualified perfusionist who is experienced in the operation of Sarns or similar equipment.
Terumo Cardiovascular Systems (CVS) received two reports of the false back flow alarms for the Terumo Advanced Perfusion System 1 when there was no tubing in the flow sensor. Terumo CVS' investigation found that the voltage level on a circuit board was improperly set in a population of flow modules for Terumo System 1, the sensor operates correctly if the tubing is installed and it is highly unlikely that the failure would recur. The failure only occurs when there is no tubing installed in the flow sensor, therefore  the only risk to the patient is if the false alarm somehow delays the surgical procedure.  There are no known reports of patient injury as a result of this issue.
Worldwide Distribution - USA (nationwide) and the countries of AUSTRALIA, Singapore, Jordan, Japan, Vietnam, Germany, Russia, Saudi Arabia, BELGIUM, Mexico, and CANADA.
Terumo Advanced Perfusion System 1 Flow Module   indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures only when used by a qualified perfusionist who is experienced in the operation of Sarns or similar equipment.
Terumo Cardiovascular Systems (CVS) received one report of a flow module for the Terumo Advanced Perfusion System 1 not displaying blood flow information on the Central Control Monitor or the Centrifugal Control Unit. The tricolor LED on the flow module was not illuminated. Terumo CVS' investigation found that the malfunction was caused by an improper component on a circuit board used in a population of flow modules for Terumo System 1.
Fentanyl Transdermal System, 100 mcg/h, each transdermal system contains: 10 mg fentanyl and 0.4 mL alcohol USP, Rx only, supplied in single pouches (NDC 0591-3214-54 (pouch)), 5 pouches per carton (NDC 0591-3214-72 (Carton)), Manufactured by Watson laboratories Inc., Corona, CA, Distributed by: Watson, Pharma Inc.
Lot number 455040A (carton) 455040 (pouch)
Subpotent; some patches may not contain fentanyl gel
Worldwide Distribution - USA (nationwide) and the countries of Saudi Arabia, United Kingdom, Greece, Singapore, Germany, Switzerland, Kuwait, United Arabian Emirates, and Austria.
This voluntary medical device correction is related to Alcon products that present a 23G nonvalved trocar cannula and infusion cannula together. These items are available as components within Accurus 23G TotalPLUS Pak, Accurus 23G Combined Procedure Packs (0.9mm and 1.1mm), Constellation 23G Total PLUS Pak, Constellation 23G Combined Pack (0.9 mm and 1.1 mm) and 23G Small Parts Kit.     Single use 23G non-valved trocar cannulas are used to provide internal access to the ocular cavity during ophthalmic surgery. Single use infusion cannulas are used for the infusion of fluid or air during ophthalmic surgery to maintain intraocular pressure during posterior segment surgeries.
1) 23G TotalPLUS Pak:  Accurus Standalone - 8065750828,  2) 23G Combined Pack 0.9mm:  Accurus Standalone - 8065750814,  3) 23G Combined Pack 1.1mm:  Accurus Standalone -  8065750816, 4)23G TotalPLUS Pak: Constellation Standalone - 8065751058, 5) 23G Combined Pack 0.9mm:  Constellation Standalone -8065751077, 6) 23G Combined Pack 1.1mm: Constellation Standalone - 8065751065.  7) 23G Small Parts Kit - 8065750842.  Complete list of lot numbers will be provided with recall recommendation.
30, 413 distributed domestically & 62,906 internationally
This medical device correction is related to Alcon products that present a 23G non-valved trocar cannula and infusion cannula together because of an issue regarding the loose fit between the 23G non-valved trocar cannula and infusion cannula that could potentially cause a detachment between the non-valved trocar cannula and infusion cannula during surgery.
Vecuronium Bromide for Injection, For IV use only, 20 mg per vial, 10 x 10 mg Vials, lyophilized powder per carton, Rx Only, Mfr. By: Ben Venue Laboratories, Bedford, OH 44146: Mfg for: Bedford Labs, Bedford, OH 44146, NDC 55390-039-10.
Clark Laboratories, Inc. (dba,Trinity Biotech USA)
Nationwide Distribution-including Puerto Rico and the states of AL, CA, IL, IN, MA, MD, NJ, OH, PA, TN, TX.
Trinity Biotech, Captia VZV IgG. Product code 2325600: 96 Tests; product code: 2325601: 480 tests.    For in vitro diagnostic use. Intended for the detection and quantitative determination of IgG antibody to VZV in human sera.
The Positive Control for the Captia Varicella-Zoster Virus (VZV) IgG Kit has been reported as running high out of its assigned ISR range.
Product was distributed to specific wholesale and retail outlets within the State of Pennsylvania
Bulk Foods, Inc. Yellow Corn Meal, Light Roast, 25 lb; Bulk Foods, Inc. Yellow Corn Meal, Light Roast, 50 lb
No codes; all product ''Purchase by date shown 12/29/2012''
FDA samples of product tested positive for Fumonisin
Bulk Foods, Inc. Yellow Corn Meal, Regular Roast, 25 lb; Bulk Foods, Inc. Yellow Corn Meal, Regular Roast, 50 lb
Brinser's Best Yellow Corn Meal, 5 lb; Stauffer's Corn Meal, 2 lb
Worldwide Distribution -- US (nationwide)  including the states of AZ, ID, TX and UT.,  and the countries of  Argentina, Bolivia, China, Ecuador, France, Germany Greece, India, Indonesia, Iran, Ireland, Japan, Kuwait, Lithuania, Luxembourg, Malaysia, Mexico, Morocco, Nigeria, Poland, Romania, Russia, Saudi Arabia, Singapore, South Africa, Sudan Switzerland, Turkey, United kingdom, Venezuela, and Viet Nam.
BP7561 OPTI CCA-TS B-Lac Cassette (25 per box)   Cassettes are consumables used in the OPTI CCA-TS Analyzer intended to be used for in vitro measurements of pH, PCOX2 PO2, lactate (lactic acid), total hemoglobin (tHb), and oxygen saturation (SO2), in heparinized whole blood samples (either arterial or venous) on the OPTI CCA-TS system, in either a clinical setting or point of care locations. Cassettes contain one-time use sensors that are used with the OPTI CCA-TS analyzer to perform in-vitro measurements of blood gases and metabolites. OPTI CCA-TS B-Lac Cassettes are supplied in boxes of 25 and may only used with the OPTI CCA-TS Analyzer.
The values reported for PCO2 by BP7561 B-Lac cassettes are biased at high concentrations when used at altitudes above 2800 feet (853 meters).
Synthroid (levothyroxine sodium) Tablets USP, 50 mcg, Rx Only, 90-Count Bottle, Abbott Laboratories, North Chicago, IL 60064, NDC: 0074-4552-90.
Defective Container: A number of Synthroid bottles have a localized thin wall defect on the bottom which may potentially impact the stability of the tablets.
Synthroid (levothyroxine sodium) Tablets USP, 75 mcg, Rx Only, 90-Count Bottle, Abbott Laboratories, North Chicago, IL 60064, NDC: 0074-5182-90.
Synthroid (levothyroxine sodium) Tablets USP, 112 mcg, Rx Only, 90-Count Bottle, Abbott Laboratories, North Chicago, IL 60064, NDC: 0074-9296-90
AZ, CT, MO, MS, PA, FL, WA, NC, CA, TX, OK
Thallous Chloride Tl 201 Injection, Diagnostic Sterile, Non-Pyrogenic Solution, a) 2.8 mL (NDC 0019N12028) b) 6.3ml (NDC 0019N12063) For Intravenous Administration, each milliliter contains 37 MBq (1 mCi) Thallous Chloride Tl 201 (no carrier added) at date and time of calibration, 9 mg sodium chloride and 0.9% (v/v) benzyl alcohol as a preservative, RX, Mallinckrodt Inc., St. Louis, MO 63134
Labeling: Correct Labeled Product Miscart/Mispack: labels on outer containers do not match labels on vials (the correct label)
''Derby City Vending ''Infielder's Breakfast'' Biscuit and Gravy, Daybreak Selections, Ingredients: PILLSBURY buttermilk biscuit, PIONEER biscuit gravy mix, PURNELLS sausage***Fresh Thru***Derby City Vending Louisville, KY 40206''
Product is stamped: Fresh Thru 4/21/12 - 6/17/12
During an FDA inspection of the firm on 6/12/2012, the firm was notified that they were missing the following allergen declarations from their labels: soy, milk, eggs and wheat.
Derby City Vending ''Finish Line'' Hand Made Chicken Salad Ingredients: 100% whole wheat bread, Fresh hand cut chicken breast, miracle whip, salt, pepper, celery, pickle relish  Fresh Thru***Derby City Vending Louisville, KY 40206
Derby City Vending ''Heckuva'' Grilled Ham And Swiss Deli Selections Ingredients: Classic Pit-Style Ham, KLOSTERMAN sub bun, Swiss Cheese, mayonaise packet, SYSCO Clasic Redskin Potato Salad  Fresh Thru***Derby City Vending Louisville, KY 40206
Worldwide Distribution - USA including Washington, DC, AL, AZ, AR, CA, CO, CT, DE, FL, GA, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MO, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI and the country of Canada.
DEXIS Imaging Suite - catalog number 1.008.7932, version numbers 10.0.0 through 10.0.3   Radiological Image Processing System
Catalog number 1.008.7932, version numbers 10.0.0 through 10.0.3
A condition can occur during renumbering of the patient database using the DEXCopy feature.  When renumbering is being performed using the DEXCopy feature and multiple patients with an identical name are present, the software will assign all subsequent records to the first patient record, resulting in mixed patient records.  In order for this problem to occur several conditions need to be met: 1) DEXIS Imaging Suite versions 10.0.0 - 10.0.3 must be installed, 2) The DEXCopy feature Mus thave been used to renumber the patient database, and 3) Two or more patients with identical names must be present within the database.
CARDIOGEN-82 (Rubidium Rb 82 Generator), 140 millicurie, Rx Only, For Elution of sterile nonpyrogenic Rubidium Chloride Rb 82, Manufactured for: Bracco Diagnostics Inc. Princeton, NJ 08543 by Medi-Physics, Inc. South Plainfield, NJ 07080, NDC 0270-0091-01
GMP deviation; Sr-82 levels exceeded alert limit specification
Levetiracetam Tablets, USP 500 mg, 500 count bottle, Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 USA, NDC 0378-5615-05
Adulterated Presence of Foreign Tablets: Pharmaceutical manufacturer may have distributed foreign tablets in bottles of Levetiracetam Tablets, USP 500 mg.
Product was distributed throughout the state of Florida and Texas.
Approximately 5 lb bag of Pre-cooked Conch Fritters labeled in part: ''***NEPTUNE'S CONCH FRITTERS PRECOOKED***Ingredients: Conch, Flour, Onions, Milk, Bell Peppers, Eggs, Garlic, Salt, Black Pepper, Lime Juice & Hot Pepper Sauce.***Packed by Triton Seafood Co. Miami, FL 33166***Pack: 125 Units Net Wt. 5# (approx.)***
Triton Seafood Co recalled their Neptune brand frozen Pre-cooked Conch Fritters and Conch Fritter Batter because the allergen, ''Wheat'' was not identified on the product label.
Approximately 5 lb plastic bucket of  Conch Fritter Batter labeled in part: ''***NEPTUNE'S CONCH FRITTERS ALL NATURAL***Ingredients: Conch, Flour, Onions, Milk, Bell Peppers, Eggs, Garlic, Salt, Black Pepper, Lime Juice, Hot Pepper Sauce.***Packed by Triton Seafood Co. Miami, FL 33166*** Net Weight 5 lbs.***
Worldwide Distribution - USA and Germany
Sleek OTW***REF 426-1201X***Inflated Balloon Dia/mm***1.25***Inflated Balloon Length/mm***15***Usable Catheter Length/cm***150*** Lot 50027149***2013-09***Cordis*** Sleek***OTW***REF Cat. No. 426-1201X***PTA Dilatation Catheter***Cordis***Johnson Johnson Company***LOT Lot No. 50027149***Use by 2013-09***Sterile***EO***Method of Sterilization: ETO***ClearStream***Clearstream Technologies, Ltd.***Moyne Upper, Enniscorthy Co Wexford, Ireland***Phone: +353-53-92-37111***Fax: +353-53-92-37-100***Made in Ireland***Distributed by: Cordis Cashel***Cahir Road, Cashel, Co. Tipperary, Ireland***Tel: +353--(0)62-70000.       The SLEEK OTW Percutaneous Transluminal Angioplasty (PTA) Peripheral Catheter Family is a non-reusable semi-compliant coaxial design catheter with a balloon mounted on its distal tip.  The hub/''Y'' connector consists of a through lumen, allowing the catheter to track over a guidewire, and a balloon port, used to inflate the balloon.  The catheter shaft is small beneath the balloon achieve low profile.  The distal tip is further tapered to accept the appropriate guidewire.  Platinum iridium bands serve to locate the balloon under fluoroscopy.  A 0.014'' (0.356 mm) guidewire is recommended for use with the SLEEK OTW Catheter.
On 1/20/2011 Cordis Corporation , Miami Lakes, FL initiated a recall of their Sleek OTW PTA Dilatation Catheter Model #4261201X Lot #50027149 and Model #4261501X Lot #50026688.  Product is incorrectly labeled.
Sleek ***OTW ***Ref ***426-1501X***Inflated Balloon Dia/mm 1.5 Inflated Balloon Length/mm 15 Usable Catheter Length/cm 150***Lot 50026688***2013-09***Cordis***PTA Dilatation Catheter***Cordis***Johnson Johnson Company***Sterile***EO***Method of Sterilization: ETO***ClearStream***Clearstream Technologies, Ltd.***Moyne Upper, Enniscorthy Co Wexford, Ireland***Phone: +353-53-92-37111***Fax: +353-53-92-37-100***Made in Ireland***Distributed by: Cordis Cashel***Cahir Road, Cashel, Co. Tipperary, Ireland***''.     The SLEEK OTW Percutaneous Transluminal Angioplasty (PTA) Peripheral Catheter Family is a non-reusable semi-compliant coaxial design catheter with a balloon mounted on its distal tip.  The hub/''Y'' connector consists of a through lumen, allowing the catheter to track over a guidewire, and a balloon port, used to inflate the balloon.  The catheter shaft is small beneath the balloon achieve low profile.  The distal tip is further tapered to accept the appropriate guidewire.  Platinum iridium bands serve to locate the balloon under fluoroscopy.  A 0.014'' (0.356 mm) guidewire is recommended for use with the SLEEK OTW Catheter.
On 1//20/2011 Cordis Corporation , Miami Lakes, FL initiated a recall of their Sleek OTW PTA Dilatation Catheter Model #4261201X Lot #50027149 and Model #4261501X Lot #50026688.  Product is incorrectly labeled.
KY LIQUIBEADS Vaginal Moisturizer; Distributed By: McNeil-PPC, Inc. Skillman, NJ 08558-9418; UPC 380041087704; 380040087958.   Personal lubricant
Johnson & Johnson Healthcare Products (JJHP) is voluntarily recalling this product to address FDA concerns that the product should have been cleared under a separate medical device application.  This voluntary recall is not being conducted on the basis of any consumer safety or product performance issues related to K-Y LIQUIBEADS.  JJHP received a Warning Letter on May 23, 2012 indicating that this device, KY Liquibeads Vaginal Moisturizer, is misbranded under the section 502(o) the Act, 21 U.S.C. 352(o), because we did not notify the agency of our intent to introduce the device into commercial distribution, as required by 510(k) of the Act, U.S.C. 360(k).  The Warning Letter indicated that changes were made to the predicate device that would require submission of a new 510(k).
Worldwide Distribution-USA (nationwide) including DC and the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY and the countries of AUSTRALIA, CANADA, GUAM, ISRAEL, NEW ZEALAND, THAILAND, TRINIDAD AND TOBAGO.
Invacare I-Fit'' Shower Chair (Models 9780, 9781, 9781-1), Invacare Corporation, Elyria, OH 44035.   These shower chairs are designed for individuals who require seating support when bathing or showering and provide comfort and safety in the bathtub.
On August 6, 2012, Invacare voluntarily recalled the Invacare I-Fit'' Shower Chair (Models 9780, 9781, 9781-1) based on the return, quality and adverse event data received.
Worldwide Distribution - USA (nationwide) and the countries of Saudi Arabia, United Kingdom, Singapore, Germany, Switzerland, Kuwait, United Arabian Emirates, and Austria.
BariAir Therapy System   The BariAir Therapy System is a risk management treatment system designed for large and / or difficult-to-manage patients. The BariAir Therapy System provides low air-loss pressure management therapy, pulsation, percussion, Turn Assist. flexible patient positioning capabilities and built-in scales for patients weighing 300 Ib* to 850 Ib ([136*-386 kg] including accessories). The BariAir Therapy System is indicated to aid in: '' Patients whose body weight and size pose a significant risk or care management issue to the patient or staff during the performance of routine nursing care. '' Large patients weighing between 300 Ib* and 850 Ib (136*-386 kg) including accessories. '' Large patients who are difficult to turn. '' Preventing and treating pressure ulcers. '' Large patients requiring percussion therapy.
Multiple Serial Numbers with Model Numbers: 404000,405500, 405500RF
KCI has issued a medical device correction for the BariAir Therapy System Hand Pendent.  The BariAir Therapy System is not designed to allow the patient to place the bed into the patient exit position.  KCI has received complaints indicating that patients used the hand pendent to inadvertently place the BariAir Therapy System into a pseudo-exit position.  In a small number of instances, this allowed the patient to unintentionally exit the therapy system, resulting in some patients receiving minor injuries.
Wildwood Emerald Valley Kitchen Organic Medium Salsa, 30 oz. Pack size 6/30 oz per case, 14 oz  Pack size 6/14oz per case,    Packaged in plastic cup, sealed with film and capped with plastic cap. Product labeling reads in part:'' WILDWOOD Emerald Valley KITCHEN ORGANIC MEDIUM SALSA***MANUFACTURED BY PULMUONE FOODS USA, Inc. Fullerton, CA 92833***''
The firm recalled due to a potential non-safety quality concern related to a particular ingredient that was causing premature spoilage.
Wildwood Emerald Valley Kitchen Organic Mild Salsa, 14 oz. Pack size 6/14 oz per case. Packaged in plastic cup, sealed with film and capped with plastic cap. Product labeling reads in part:'' WILDWOOD Emerald Valley KITCHEN ORGANIC MILD SALSA***NET WT. 14 OZ (850g)***MANUFACTURED BY PULMUONE FOODS USA, Inc. Fullerton, CA 92833***''
Wildwood Emerald Valley Kitchen Organic Hot Salsa, 14 oz. Pack size 6/14 oz per case. Packaged in plastic cup, sealed with film and capped with plastic cap. Product labeling reads in part:'' WILDWOOD Emerald Valley KITCHEN ORGANIC HOT SALSA***NET WT. 14 OZ (850g)***MANUFACTURED BY PULMUONE FOODS USA, Inc. Fullerton, CA 92833***''
Wildwood Emerald Valley Kitchen Organic Medium Salsa - Canada (containing French in labeling), 397 mL. Pack size 6/14 oz per case. Packaged in plastic cup, sealed with film and capped with plastic cap. Product labeling reads in part:'' WILDWOOD Emerald Valley KITCHEN ORGANIC MEDIUM SALSA***NET WT. 397mL, MANUFACTURED BY PULMUONE FOODS USA, Inc. Fullerton, CA 92833***''.
Wildwood Emerald Valley Kitchen Organic Mild Salsa - Canada (containing French in labeling), 397 mL. Pack size 6/14 oz per case. Packaged in plastic cup, sealed with film and capped with plastic cap. Product labeling reads in part:'' WILDWOOD Emerald Valley KITCHEN ORGANIC MILD SALSA***NET WT. 397mL, MANUFACTURED BY PULMUONE FOODS USA, Inc. Fullerton, CA 92833***''.
Wildwood Organic Mild Salsa , 14 oz, Pack size 6/14 oz per case. Packaged in plastic cup, sealed with film and capped with plastic cap. Product labeling reads in part:'' WILDWOOD ORGANIC salsa MILD ***NET WT. 14OZ, MANUFACTURED BY PULMUONE FOODS USA, Inc. Fullerton, CA 92833***''.
Wildwood Organic Medium Salsa , 14 oz, Pack size 6/14 oz per case. Packaged in plastic cup, sealed with film and capped with plastic cap. Product labeling reads in part:'' WILDWOOD ORGANIC salsa MILD ***NET WT. 14OZ, MANUFACTURED BY PULMUONE FOODS USA, Inc. Fullerton, CA 92833***''.
nationwide in the US and worldwide to Canada and United Kingdom.
Whey Protein Concentrate, Net Weight: 1lb (454g)
True Nutrition is recalling Whey Protein Isolate, Whey Protein Concentrate, and Hydrolyzed Whey Protein because they contain undeclared milk.
Whey Protein Isolate Cold-Filtration, Net Weight: 1lb (454g)
Whey Protein Isolate MicroFiltration, Net Weight: 1lb (454g)
Whey Protein Isolate Cross-Flow Microfiltration, Net Weight: 1lb (454g)
Hydrolyzed Whey Protein High Grade, Net Weight: 1lb (454g)
Worldwide Distribution - US Nationwide and the countries of Canada, DK, HK, IN, IT, KR, MY, RU, CO, VN, ZA.
***REF LS7600***Qty 1*** EC REP*** ConMed Linvatec Xenon Light Source
Linvatec Corporation dba ConMed Linvatec, Largo, FL initiated a recall of their products LS7700 Xenon Universal Light Source and LS7600 Xenon Light Source are intended to be used with an endoscope to provide illumination during endoscopic procedures.
***REF LS7700***Qty 1*** EC REP*** ConMed Linvatec  Xenon Universal Light Source
Product was distributed to Oregon and Washington
Cucina Fresca Smoked Tomato Sauce.  Product is packaged in a glass jar, net weight 24 oz. The UPC is 8-84337 00522-4
Lot 11002A and 11002B.   Code is deciphered as:  First digit = Shift;  Second, Third, and Fourth digit = Julian date;  Fifth digit = Production year
117 cases/6 jars/ 24 oz. total (59 cases to warehouse and 58 cases to retail stores)
Smoked Tomato Sauce was recalled due to undeclared milk.  The jars actually contain Cucina Fresca Tomato Vodka Sauce, which contains milk as an ingredient, but was mis-labeled as Smoked Tomato Sauce and the label does not declare milk.
Covidien Duet TRS 45 3.5 mm Universal Straight Single Use Loading Unit. Product Code:  DUET4535.    Single Use Loading Unit (SULU) tissue reinforcement stapler. The Endo GIA Universal Staplers with Duet TRS reloads have applications in abdominal, gynecologic and pediatric surgery for resection, transection and creation of anastomoses. They may be used for transection and resection of liver substance, hepatic vasculature and biliary structures and for transection and resection of pancreas.
Duet TRS may have the potential to injure adjacent anatomical structures which may result in life threatening post-operative complications
Covidien Duet TRS 45 3.5 mm Universal Articulating Single Use Loading Unit. Product Code: DUET4535A.    Single Use Loading Unit (SULU) tissue reinforcement stapler. The Endo GIA Universal Staplers with Duet TRS reloads have applications in abdominal, gynecologic and pediatric surgery for resection, transection and creation of anastomoses. They may be used for transection and resection of liver substance, hepatic vasculature and biliary structures and for transection and resection of pancreas.
Duet TRS may have the potential to injure adjacent anatomical structures which may result in life threatening post-operative complications.
Covidien Duet TRS 45 4.8 mm Universal Straight Single Use Loading Unit. Product Code: DUET4548.    Single Use Loading Unit (SULU) tissue reinforcement stapler. The Endo GIA Universal Staplers with Duet TRS reloads have applications in abdominal, gynecologic and pediatric surgery for resection, transection and creation of anastomoses. They may be used for transection and resection of liver substance, hepatic vasculature and biliary structures and for transection and resection of pancreas.
Covidien Duet TRS 45 4.8 mm Universal Articulating Single Use Loading Unit. Product Code: DUET4548A.    Single Use Loading Unit (SULU) tissue reinforcement stapler. The Endo GIA Universal Staplers with Duet TRS reloads have applications in abdominal, gynecologic and pediatric surgery for resection, transection and creation of anastomoses. They may be used for transection and resection of liver substance, hepatic vasculature and biliary structures and for transection and resection of pancreas.
Covidien Duet TRS 60 3.5 mm Universal Straight Single Use Loading Unit Product Code: DUET6035.    Single Use Loading Unit (SULU) tissue reinforcement stapler. The Endo GIA Universal Staplers with Duet TRS reloads have applications in abdominal, gynecologic and pediatric surgery for resection, transection and creation of anastomoses. They may be used for transection and resection of liver substance, hepatic vasculature and biliary structures and for transection and resection of pancreas.
Covidien Duet TRS 60 3.5 mm Universal Articulating Single Use Loading Unit. Product Code: DUET6035A.    Single Use Loading Unit (SULU) tissue reinforcement stapler. The Endo GIA Universal Staplers with Duet TRS reloads have applications in abdominal, gynecologic and pediatric surgery for resection, transection and creation of anastomoses. They may be used for transection and resection of liver substance, hepatic vasculature and biliary structures and for transection and resection of pancreas.
Covidien Duet TRS 60 4.8 mm Universal Straight Single Use Loading Unit. Product Code: DUET6048.    Single Use Loading Unit (SULU) tissue reinforcement stapler. The Endo GIA Universal Staplers with Duet TRS reloads have applications in abdominal, gynecologic and pediatric surgery for resection, transection and creation of anastomoses. They may be used for transection and resection of liver substance, hepatic vasculature and biliary structures and for transection and resection of pancreas.
Covidien Duet TRS 60 4.8 mm Universal Articulating Single Use Loading Unit. Product Code: DUET6048A.    Single Use Loading Unit (SULU) tissue reinforcement stapler. The Endo GIA Universal Staplers with Duet TRS reloads have applications in abdominal, gynecologic and pediatric surgery for resection, transection and creation of anastomoses. They may be used for transection and resection of liver substance, hepatic vasculature and biliary structures and for transection and resection of pancreas.
Duet TRS  may have the potential to injure adjacent anatomical structures which may result in life threatening post-operative complications.
Corneas, recovered in a manner that may increase the risk of the introduction, transmission, or spread of communicable diseases, were distributed.
Human corneas, recovered from donors whose donor eligibility may have been determined with inaccurate and/or  incomplete donor records, were distributed.
Human tendon, with a swab culture positive for coagulase-negative Staphylococcus, was distributed.
Arizona; Pennsylvania; South Carolina; Oregon; Maryland; California; Florida
Human tendons, with a culture positive for coagulase negative Staphylococcus, were distributed.
Daniella Mangoes May be identified by Daniella sticker with a PLU code of   3114, 4051, 4311, 4584 or 4959.
All fruit had identifying stickers with label ''Daniella'' and one of the following PLU numbers: 3114, 4051, 4311, 4584 or 4959.
Firm is recalling  certain lots of Daniella brand mangoes because they may be contaminated with Salmonella. Mangoes have been linked to a number of recent cases of salmonellosis in Canada, and may be linked to cases in California and perhaps other states
Worldwide Distribution - USA including AL, AZ, CA, CO, FL, GA, IL, KS, KY, MI, MS, NJ, NM, NV, NY, OH, TX, WA & WI and internationally to: Australia, Belgium, Brazil, Canada, China, Denmark, France, Germany, India, Italy, Japan, Jordan, Mexico, Saudi Arabia, South Korea, Spain, Thailand, Turkey & United Kingdom.
Computed Tomography X-Ray Systems, (Brilliance 6, Brilliance 16, MX8000 Dual v. Exp, GEMINI Dual), Philips Healthcare Systems, Cleveland, OH.   The Brilliance 6, 16 and MX8000 Dual v. Exp are Computed Tomography X-Ray Systems that are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient, and equipment supports, components and accessories. GEMINI Dual is an imaging system that combines positron emission tomography (PET) and X-ray computed tomography. The GEMINI produces attenuation and non-attenuation corrected images of the distribution of PET radiopharmaceuticals in the head, body and total body as well as X-ray transmission images of these areas. The PET and CT images are registered and displayed in a fused format to provide combined PET and anatomical data at different angles for interpretation by trained health professionals. The PET and CT portions of the system can be used either as an integrated system or as a stand-alone PET or CT system. GEMINI can provide CT data suitable for use in attenuation correction.
A bolt which attaches the oil accumulator within the gantry may fail, resulting in the oil accumulator detaching from the tube housing assembly within the gantry.
Up to 199 Meijer stores located in Illinois, Indiana, Kentucky, Michigan, and Ohio may have received product from Meijer distribution centers.
Product Name: Walnuts 160z. Brand Name: Markets of Meijer  Meijer Distribution, Inc. Grand Rapids, MI49544  UPC 8-8692619782-2
The firm was notified by a produce manager at one of the store locations that some of the bags from this lot of product contain pecans in addition to walnuts. Pecans are not listed in the ingredient statement and are not called out as an allergen.
Umbilical cord blood stem cells, not tested in accordance with the manufacturer's instructions to adequately and appropriately reduce the risk of transmission of relevant communicable disease agents, were distributed.
Lions Eye Institute for Transplant & Research, Inc.
Human corneas, recovered from a donor whose donor eligibility may have been been determined with inaccurate and/or incomplete donor records, were distributed.
restaurants and GFS retail outlets in Florida
Pistachios, Shelled Raw, 4 /2.5 Packed by Tropical Food Nut & Fruit- Orlando, FL 32811
Gordon Food Service is recalling Tropical Food Nut & Fruit Shelled Raw Pistachios , because there is potential for the box to be mis-packed with chopped peanuts.  People who have an allergy or severe sensitivity to peanuts run the risk of serious or life-threatening allergic reaction if they consume this product.
***Dulce De Leche ''Del Campo''***Ice Cream ''Base'' (Flavor)***FB 23546***Mfg. Date***Keep Refrigerated at 40*f***Lot#***Net Wt 55 LBS***Indalco Food Corp., Miami, FLA (305) 620 1444***   Caramel milk spread is packed in white plastic pails of 55 lbs. under the firm's brand name ''Del Campo''.
On June 28, 2011, Indalco Foods, Corp., Miami, FL initiated a voluntary recall of their product caramel milk spread ice cream base (dulce de leche heladero).  Product labeling does not list Milk.
Nationwide to following US States and Canada: Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, District of Columbia, Washington D.C., Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kentucky,  Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, Nebraska,  Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio,  Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah,  Virginia, Vermont, Washington, Wisconsin, Wyoming, and Canada.
Fruit Mixes: 1) Dining In Super Fruit Medley,10.5oz, UPC 1122508396, Use by date 9/6/2012; 2) Ready Pac Super Fruit Blend, 6oz , UPC 7774523076, Use by Dates 9/8/2012 or earlier, 9/6/2012 & 9/7/2012; 3) Ready Pac Super Fruit Medley, 10.5oz, UPC 7774523746, Use by dates 9/8/2012 or earlier, 9/6/2012 & 9/7/2012. Ready Pac Super Fruit Medley, 298g , UPC 7774524023, Use by dates 9/8/2012 or earlier and 9/8/2012.
Firm is voluntarily recalling, out of an abundance of caution, packaged fruit products containing mangoes, distributed through August 30th 2012, since they contain Daniella Brand mandoes, which have been recalled by supplier Splendid Products, due to potential contamination with Salmonella Braenderup.
Mango: 1) Dining In Mango ,10.5oz , UPC 1122508640, Use by Date 9/7/2012; 2) Wawa Mango, 8oz, UPC  2619106437, Use by dates 9/6/2012 or earlier.
1) Use by Date 9/7/2012; 2) Use by dates 9/6/2012 or earlier
Ready Pac Fruit Tray Bien, 907g UPC 7774523415 and Use by date 9/8/2012. Ready Pac Fruit Tray Bien 32oz UPC 7774521606, Use by date 9/8/2012 or earlier.
Firm is voluntarily recalling, out of an abundance of caution, packaged fruit products containing mangoes, distributed through August 30th 2012, since they contain Daniella Brand mandoes, which have been recalled by supplier Splendid Products, due to potential contamination with Salmonella Braenderup
Ready Pac Fruit & Chocolate Platter, 40oz , UPC 7774523673, Use by dates 9/6/2012 & 9/7/2012
Ready Pac Sliced Mango, 10.5oz , UPC 7774523751, Use by dates 9/8/2012 or earlier, 9/6/2012 & 9/7/2012. Ready Pac Sliced Mango, 32oz, UPC 0000088356, Use by dates 9/6/2012 & 9/7/2012. Ready Pac Sliced Mango, 32 oz, UPC 7774522859, Use by dates 9/8/2012 or earlier and 9/6/2012 & 9/7/2012.
Ready Pac Mango Fandango'', 32oz, UPC 7774524099, Use by dates 9/8/2012 or earlier and 9/6/2012 & 9/7/2012.
Ready Pac Gourmet Fruit Bowl, 64oz , UPC 7774522620, Use by dates 9/9/2012 or earlier and 9/7/2012 & 9/8/2012.
Ready Pac Sweet Sunshine Platter, 37oz, UPC 7774524204, Use by dates 9/8/2012 or earlier and 9/6/2012 & 9/7/2012.
Ready Pac Seasons Choice'', 32oz, UPC 7774524276, Use by dates 9/8/2012 or earlier and 9/7/2012 & 9/8/2012.
Starbucks Seasonal Harvest Fruit Blend, 6oz, UPC 6211171390, Use by dates 8/22/2012 through 9/7/2012 and 9/4/2012 & 9/5/2012.
Walmart Super Fruit Blend, 10oz, UPC 7774523327, Use by dates 9/6/2012 & 9/7/2012.
Walmart Seasonal Blend ,16oz, UPC 7774523761, Use by dates 9/6/2012 & 9/7/2012.  Walmart Seasonal Blend, 32oz, UPC 7774523765, Use by dates 9/6/2012 & 9/7/2012.
Alere Triage TOX Drug Screen 9 Panel, P/N: 94402.   The Alere Triage TOX Drug Screen is a fluorescence immunoassay intended to be used with the Alere Triage Meters for the qualitative determination of the presence of drug and/or the major metabolites above the threshold concentrations of up to 10 distinct drug classes, including assays for acetaminophen/paracetamol, amphetamines, methamphetamines, barbiturates, benzodiazepines, cocaine, opiates, phencyclidine, THC and tricyclic antidepressants in urine. The acetaminophen/paracetamol assay will yield positive results when acetaminophen/paracetamol is ingested at or above therapeutic doses.
Alere San Diego is recalling Alere Triage TOX Drug Screen because there is a possibility that after installing the code chip provided with the affected lots: AMP, BAR, and PCP, the threshold ranges may not be consistently set correctly in all meters.
Nationwide(US) Distribution and Puerto Rico.
Armada 35/ Armada 35 LL PTA Catheters. The device is intended for dilatation of lesions in the vasculature.
Abbott Vascular is recalling the Armada 35 and Armada 35 LL PTA Catheters because they have discovered that some devices may exhibit difficulty inflating and/or deflating.
Varian Medical Systems, Inc. Oncology Systems
Worldwide Distribution - USA (nationwide) and Internationally.   .    .
Varian brand Eclipse Treatment Planning System, Model Number: H48; Eclipse 8.9 and 10.0 Reference/FSCA Identifier: CP-08922; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA     The Eclipse Treatment Planning System (Eclipse TPS) is used to plan radiotherapy treatments for patients with malignant or benign diseases. Eclipse TPS is used to plan external beam irradiation with photon, electron and proton beams, as well as for internal irradiation (brachytherapy) treatments. In addition, the Eclipse Proton Eye algorithim is specifically indicated for planning proton treatment of neoplasms of the eyes.
Varian has identified an anomaly with the Eclipse Treatment Planning where an outdated assigned Hounsfield Unit [HU] value can be used for dose calculation when the clock on the Eclipse Client Workstation is not synchronized with the Database/System Server. Treatment of the patient using these values can therefore lead to under or over-dose.
Atrovent HFA Inhalation Aerosol, (ipratropium bromide) 12.9 grams, 200 metered actuations, Rx only, Packaged Exclusively by: Dispensing Solutions, Inc., Santa Ana, CA --- NDC 68258-8952-01, DSI product #8A0947
Label Mix up; side panel of sticker label applied by Dispensing Solutions Inc. incorrectly indicates product name as Ventolin HFA 90 mcg instead of correctly as Atrovent HFA 12.9 grams Inhalation Aerosol
Worldwide Distribution-USA (nationwide) and the countries of  United Arab Emirates, Austria, Australia, Belgium, Canada, Germany, Ecuador, Estonia, Spain, France, United Kingdom, Hong Kong, Ireland, Israel, Italy, Republic of Korea, Libyan Arab Jamahiriya, Malaysia, Netherlands, New Zealand, Pakistan, Poland, Portugal, Qatar, Serbia, Saudi Arabia, Taiwan, and South Africa.
Embolectomy Catheters (Models A44XX, A4FXX, CE0XXXST, and CE0XXX): Model Numbers & Description:    A4402, 3F-40CM, SYNTEL RT-EMB;  A4403, 3F-80CM, SYNTEL RT-EMB;  A4404, 4F-40CM, SYNTEL RT-EMB;  A4405, 4F-80CM, SYNTEL RT-EMB;  A4406, 5F-80CM, SYNTEL RT-EMB;  A4407, 6F-80CM, SYNTEL RT-EMB;  A4408, 7F-80CM, SYNTEL RT-EMB;  A4F00, 2F-60CM (PREM) SYNTEL CATHETER;  A4F01, 2F-80CM, (PREM) SYNTEL CATHETER;  A4F02, 3F-40CM, (PREM) SYNTEL CATHETER;  A4F03, 3F-80CM, (PREM) SYNTEL CATHETER;  A4F04, 4F-40CM, (PREM) SYNTEL CATHETER;  A4F05, 4F-80CM, (PREM) SYNTEL CATHETER;  A4F06, 5F-80CM, (PREM) SYNTEL CATHETER;  A4F07, 6F-80CM, (PREM) SYNTEL CATHETER;  A4F08, 7F-80CM, (PREM) SYNTEL CATHETER;  CE0260ST, L2F-60CM PREM SYNTEL CATH;  CE0280ST, L2F-80CM PREM SYNTEL CATH;  CE0340ST, 3F-40cm (PREM) SYNTEL CATHETER;  CE0380ST, 3F-80CM PREM SYNTEL CATH;  CE0440ST, 4F-40CM PREM SYNTEL CATH;  CE0480ST, 4F-80CM PREM SYNTEL CATH;  CE0580ST, 5F-80CM PREM SYNTEL CATH;  CE0680ST, 6F-80cm (PREM) SYNTEL CATHETER;  CE0780ST, 7F-80CM PREM SYNTEL CATH;  CE0340, 3F-40cm, SYNTEL RT-EMB;  CE0380, 3F-80cm, SYNTEL RT-EMB;  CE0440, 4F-40cm, SYNTEL RT-EMB;  CE0480, 4F-80cm, SYNTEL RT-EMB;  CE0580, 5F-80cm, SYNTEL RT-EMB;  CE0680, 6F-80cm, SYNTEL RT-EMB;  CE0780, 7F-80cm SYNTEL RT-EMB.    BARD Embolectomy Catheters are indicated for the removal of emboli and thrombi from the peripheral arterial system. These devices consist of a catheter body with a latex-free balloon on the distal end and an inflation hub on the proximal end.
40,238 units for all products in Recall Event
Applied Medical is recalling specific lot numbers of its Vascular Catheters because they may have a potential for packaging particulate matter to reside on the product.
Biliary Catheters (Models A47XX and CB0XXXXX): Model Numbers & Description:    A4752, SYNTEL BILIARY 5F-23CM CATHETER;  A4754, SYNTEL BILIARY 5F-40CM CATHETER;  A4762, SYNTEL BILIARY 6F-23CM CATHETER;  CB052308, SYNTEL BILIARY 5F-23CM CATH;  CB054008, SYNTEL BILIARY 5F-40CM CATH;  CB062313, SYNTEL BILIARY 6F-23CM CATH.    Biliary Catheters are indicated for the removal of stones and ductal debris from the biliary system.
Irrigation Catheters (Models IRR-XXX-XX): Model Numbers & Description:    IRR-023-10F,CATHETER IRRIGATION 10F 23CM;  IRR-080-4F, CATHETER, IRRIGATION 4F 80CM;  IRR-080-6F, CATHETER, IRRIGATION 6F 80CM.    Irrigation Catheters are indicated for irrigation in the peripheral vascular system and biliary tree.
Worldwide Distribution--USA (nationwide) including the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, LA, MA, MD, MI, MN, MO, NC, NE, NJ, NV, NY, OH, OR, PA, SC, TN, TX, UT, WA ,WI and Hawaii., and the countries of  Australia Canada, China, Switzerland, Germany, Czech Republic, Denmark, Egypt, Spain, France, South Africa, United Kingdom, Israel, Italy, Netherlands, New Zealand, Poland, Portugal, Russia and Saudi Arabia.
Catheter Irrigation Set labeled in part: ***24K Arthroscopy Outflow/Suction Tubing Set***   This Arthroscopy Tubing Set is intended for use, in conjunction with the ConMed Linvatec 24k Pump, for pump-induced outflow and/or suction of fluid from the joint during arthroscopic procedures.
ConMed Linvatec recalled their 24k Arthroscopy Outflow/Suction Tubing Set (Product Number 24k100)because there is a possibility that the product may have a breach in the Tyvek seal that could potentially compromise the sterility of the contents.
Worldwide Distribution--USA (nationwide) and the countries of Australia, Austria, Canada, Chile, Finland, France, Germany, Hungary. Italy, Japan, Latvia, Netherlands, New Zealand. Oman, South Korea, Switzerland and United Kingdom.
Philips Digital Diagnost-Mobile Detector Holder for Digital Diagnost (Single Detector, Dual Detector, Release 3) System codes: 712020, 712022, 712025    This system is used for making X-ray exposures for diagnostics.
The Wireless Portable Detector (WPD) is not fixed securely inside the Mobile Detector Holder and may fall down
Boston Scientific, Z Flex 270,  Steerable Sheath, Sterile EO, Rx only, Distributed by Boston Scientific Corporation, One Boston Scientific Place, Natick, MA 01760-1537, Manufactured by Greathbatch Medical, 2300 Berkshire Lane North, Minneapolis, MN 55441.    To facilitate transvenous introduction of diagnostic / therapeutic catheters into the vasculature and into the chambers of the heart.
During the investigation of four returned Z Flex 270 Steerable Sheaths that were used with cardiac cryoablation balloon catheters, the internal PTFE sheath liners were found to display varying degrees of damage that could pose an embolic risk to a patient.
M & K Trading is recalling Korean Molluscan Shellfish 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.
To Sam's Club locations in UT, OK, TX CA, MO, and WY, USA.
Sam's Club Chunky Cinnamon Streusel, Net Wt 25 lb, in white plastic pails, Manufactured for Sam's Club, Bentonville, AR 72716, Best if stored in a cool, dry location between 65 - 75 degrees Farenheit.
Dawn Foods is recalling 251, 25 lb pails of Chunky Cinnamon Streusel due to the omission of the major allergens milk and soy from the finished product label.
Progel Pleural Air Leak Sealant, Model #: PGPS002 Lot #: 111202-002    Product Usage:  The Progel Pleural Air Leak Sealant is indicated for application to visceral pleura during an open thoracotomy after standard visceral pleural closure with, for example, sutures or staples, of visible air leaks (;::2mm) incurred during open resection of lung parenchyma.
Product was distributed with an incorrect expiration date. Product was labeled with an expiration date of 2013-04 and should have been labeled with 2012-09.
Nationwide distribution: USA including states of: MA, MD, and NV.
TSX-301A/2 Aquilion One CT System.  The TSX-30IAl2 is a whole body CT scanner. This device captures cross sectional volume data sets. The device consists of a gantry, patient couch (table) and peripheral cabinets used for data processing and display.    This device is intended to produce cross sectional volume sets of the anatomy. Additionally the system, when used by a trained professional, is capable of proving data for dynamic and perfusion studies of organs and extremities.
The SureStart function may not operate in the usual manner, and you may obtain abnormal analysis results when using the cerebral blood flow analysis function.
Worldwide Distribution - USA (nationwide) and the countries of Argentina, Australia,Belgium, Canada, China, Germany, Ecuador, Spain, France, Great Britain, Greece, Hong Kong, Italy, Japan Korea, Lithuvania, Neherlands, qatar, Russia, Saudi Arabia, Sweden, Singapore, Slovenia, Thailand, Taiwan, South Africa, and Switzerland.
Hologic Fluoroscan Mini C-Arm Model with InSight2, Software version 4.0 and 4.0.1    The device is a Mini C-arm Fluoroscopic Imaging System designed to provide -physicians with general fluoroscopic visualization of a patient, including but not limited to surgical orthopedic and podiatry use, critical and emergency procedures, and light anatomy imaging situation.
InSight2, version 4.0 and 4.0.1 - DICOM images stored in PACS may be flipped 180around vertical axis. InSight FD, version 5.0.1 and 5.0.2 - DICOM images stored in PACS may be lipped 180 around vertical axis as well as 180 around a horizontal axis.
Hologic Fluoroscan Mini C-Arm Model with InSight- FD Software Version 5.0.1and 5.0.2   The device is a Mini C-arm Fluoroscopic Imaging System designed to provide -physicians with general fluoroscopic visualization of a patient, including but not limited to surgical orthopedic and podiatry use, critical and emergency procedures, and light anatomy imaging situation.
Fluoroscan Mini C-Arm models -InSight2, version 4.0 and 4.0.1 - DICOM images stored in PACS may be flipped 180around vertical axis. InSight FD, version 5.0.1 and 5.0.2 - DICOM images stored in PACS may be lipped 180 around vertical axis as well as 180 around a horizontal axis.
Worldwide Distribution - USA including CA, KY, MI, NY, OK, OR, SD, and WI.  Internationalyl to Canada, Sweden, France, Germany, Australia, Poland, Belgium, and United Kingdom.
SharePlan 1.1, aka t-RayAutoplan version 1.2.1 (build number 1.3.1.10).  Manufacturing name RayAutoplan, aka t-RayAutoplan, commercial name (TomoTherapy) SharePlan   Intended use: t-RayAutoplan is a software that, based on the planned dose distribution from a TomoPlan treatment planning system, generates a family of individually optimized IMRT plans and presents their characteristics to the user in a GUI. Among the generated plans, the user selects and clinically approves a treatment plan and exports it electronically to DICOM, for subsequent treatment of the patient. The intended users of t-RayAutoplan shall be clinically qualified staff, such as medical physicists, medical doctors or dosimetrists.
This notice concerns behavior of the SharePlan that may be unexpected and not clearly described in the user manual. This behavior has not caused patient mistreatment or other incidents. However, the described user actions must be adhered to for best agreement between treatment plan evaluation and the clinical outcome of the delivered treatment. The behavior appears, when importing RFA-files (.asc). In such cases, special notice has to be taken of the coordinate system used. The correction is to modify the labelling.
Micro Therapeutics Inc, Dba Ev3 Neurovascular
Worldwide Distribution - US Nationwide including the states: MN, FL, OR, TX and the countries of:  Brazil, Belgium, Czech Republic, Finlind, France, Germany, Netherlands, Poland, and United Kingdom.
UltraFlow HPC Flow Directed Micro Catheter, Model # 105-5065.   Product Usage:  The UltraFlow HPC Flow Directed Micro Catheter is intended to access peripheral and neuro vasculature for the controlled selective infusion of physician-specified therapeutic agents such as embolization materials and of diagnostic materials such as contrast media.
The recall was initiated because ev3 Neurovascular has identified one lot of UltraFlow Flow Directed Micro Catheters and Marathon Flow Directed Micro Catheters may have been mislabeled.
Marathon Flow Directed Micro Catheter, Model #105-5055.   Product Usage: The Marathon Flow Directed Micro Catheter is intended to access the peripheral and neuro vasculature for the controlled selective infusion of physician-specified therapeutic agents such as embolization materials and of diagnostic materials such as contrast media.
5% Dextrose Injection USP, packaged in a) 250 mL AVIVA Container, product code 6E0062, NDC 0338-6346-02; b) 500 mL AVIVA Container, product code 6E0063, NDC 0338-6346-03; Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA
Chemical Contamination: The IV solutions were packaged in AVIVA containers which may contain trace levels of cumene hydroperoxide (CHP).
10% Dextrose Injection USP, packaged in a 500 mL AVIVA Container, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA; product code 6E0163, NDC 0338-6347-03
5% Dextrose and 0.45% Sodium Chloride Injection USP, packaged in a 500 mL AVIVA Container, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA; product code 6E0173, NDC 0338-6308-03
0.9% Sodium Chloride Injection USP, packaged in a) 250 mL AVIVA Container, product code 6E1322, NDC 0338-6304-02; b) 500 mL AVIVA Container, product code 6E1323,  NDC 0338-6304-03; Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA
Lactated Ringer's Injection USP, packaged in a) 250 mL AVIVA Container, product code 6E2322B, NDC 0338-6307-02; b) 500 mL AVIVA Container, product code 6E2323, NDC 0338-6307-03; Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA
Nationwide Distribution - USA including Washington, DC and AL, AK, AZ, AR, CA, CO, CT, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WV, WI and Puerto Rico.
Siemens Magnetom Skyra, Verio, Spectra and Biograph MMR   Nuclear Magnetic Resonance Imaging System and Tomographic Imager
Model numbers: 10276755 (Verio), 10684333 (Verio Dot), 10684334 (Verio Dot upgrade), 10432915 (Skyra), 10655588 (Spectra), and 10433372 (Biograph mMR)
When positioning the Flex Large 4 Coil (part No. 8625761) off-center in left-right direction as it is used for example for hip and shoulder imaging and, in addition at an off-center position with respect to the head-foot direction, the coil can heat up in the area of the electronic housing (white plastic lids).
Propofol Injectable Emulsion, 1%, packaged in a) 20 mL Single patient infusion vial, 200 mg/20 mL (10 mg/mL), NDC 0409-4699-30; b) 50 mL Single patient infusion vial, 500 mg/50 mL (10 mg/mL), NDC 0409-4699-33; c) 100 mL Single patient infusion vial, 1 g/100 mL (10 mg/mL), NDC 0409-4699-24; Rx only, Hospira, Inc., Lake Forest, IL 60045 USA
Presence of Particulate Matter: A single visible particulate was observed and confirmed in sample bottles of the recalled lots during retain inspection.
NAPROXEN TABLETS USP, 500 mg, 100-count Tablets per bottle, Rx only, Manufactured by: Glenmark Generics Ltd., Colvale-Bardez, Goa 403513, India; Manufactured for: Glenmark Generics Inc., USA, Mahwah, NJ 07430; NDC 68462-190-01.
Labeling: Label Mix-Up: Bottles labeled as Naproxen Tablets USP, 500 mg, 100-count may contain 90-count Pravastatin Sodium Tablets, 40 mg.