GE Healthcare Revolution XR/d; GE Healthcare, 3000 North Grandview , Waukesha, WI, 53188 Model numbers: 2259988-2 & 2351505.    The Revolution XR/d Digital Radiographic Imaging System is indicated for use in generating radiographic images of human anatomy. It is intended to replace radiographic film/screen system in all general-purpose diagnostic procedures. This device is not intended for mammographic applications.
An incident was reported that an operator's finger was pinched between the fixed roller and the gliding tabletop of a Proteus XR/a Table while moving the tabletop with the thumb placed over its edge and fingers underneath
GE Healthcare Definium 8000 Digital Radiographic Systems :  GE Healthcare, 3000 North Grandview , Waukesha, WI, 53188  Model Number: 5131070.    The Revolution XR/d with Tomosynthesis is intended for use in generating Tomographic images of human anatomy. It is not intended for mammographic use.
GE  Proteus XR/a Radiographic System. GE Medical Systems-Americas Milwaukee, WI. Model Number: 2259988.    Product is indicated for use in generating radiographic images of human anatomy in all general-purpose diagnostic procedures. This device is not intended for mammographic applications.
Blood product, collected from a donor who reported travel to a malarial endemic area, was distributed.
Blood products collected from a donor who was permanently deferred for unsuitable test results, were distributed.
Blood product, collected from a donor whose hematocrit was not recorded  during donor screening, was distributed.
Blood products, lacking assurance of having been maintained at an acceptable temperature during shipping, were distributed.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
Blood and Blood Products for Reprocessing
Blood product, collected from an ineligible donor, was distributed.
Community Blood Center of Greater Kansas City
Blood products, possibly contaminated with Propionibacterium species, were distributed.
Red Blood Cells (Apheresis) Leukocytes Reduced
Blood products, which were collected from a donor in which donor suitability were not adequately determined, were distributed.
Blood product, for which the Viral testing was not performed, was distributed.
Blood products, collected from a donor who did not have a complete physical examination, were distributed.
Blood products, collected from a donor whose scheduled physical examination was incomplete, were distributed.
CA.       Name and address of consignee involved: Talecris Biotherapeutics, Inc. (TBI), 8368 US 70 Business Highway West, Clayton, NC 27520
Blood products, collected from a donor whose routine physical examination was inadequately performed, were distributed.
Blood products, collected from donors, whose suitability to donate was not adequately determined, were distributed.
Country Fresh Ovens Cheese Coffee Cake, Net Wt 5 oz (142g).  Dist. by Country Fresh Ovens, St. Paul Park, MN  55071
Recent label audits show that the Country Fresh Ovens Cheese Coffee Cake contain an undeclared allergen, milk.
CONCENTRATED SODIUM CHLORIDE INJECTION, USP, 23.4%  a) 30 mL SINGLE DOSE VIAL,  (NDC 0517-2930-25), b) 100 mL PHARMACY BULK PACKAGE (NDC 0517-2900-25), Rx Only, AMERICAN REGENT, INC. SHIRLEY, NY 11967.
Presence of Particulate Matter:  In the course of inspecting retention samples visual particles were observed.
Initial distribution to Canada with subsequent distribution throughout the US and Canada.
better batter brand Gluten Free Pancake & Biscuit Mix packaged in chip board box, in 20 oz. (UPC 8 96439 00207 0) and in 2.5 lb sizes (UPC 8 96439 00203 2).   The 20 oz. product is labeled in part, ''*** better batter PANCAKE & BISCUIT MIX *** 20 OZ *** UPC 8 96439 00207 0***''.   The 2.5 lb. product is labeled in part, ''*** better batter gluten free pancake/biscuit mix *** 2.5 lb ***.
20 oz. product:  Best Before Dates of 27 July 2012, 25 October 2012, 23 December 2012, 28 December 2012, and 28 March 2013;  2.5 lb. product: Best Before Dates of  04 December 2011, 26 February 2012, 17 March 2012, 14 June 2012, 11 August 2012, and 03 March 2013.
20 oz product: 4,837 retail packages; 2.5 lb. product: 3,517 retail packages
The product was found to contain undeclared milk, a known allergen, from a sub-ingredient in the powdered sunflower oil.
better batter brand YELLOW CAKE MIX, A GLUTEN FREE BAKING MIX, 18.25 oz. (517 g), UPC 8 96439 00210 0. The mix is packaged in a chip board box.
Best Before Dates of 26 January 2013, 28 February 2013, 01 March 2013,  29 March 2013.
better batter brand CHOCOLATE MIX, A GLUTEN FREE BAKING MIX, 18.25 oz (517 g), UPC 8 96439 00209 4.  The mix is packaged in a chip board box.
Best Before Dates of 28 January 2013, 28 February 2013, and 30 March 2013
#1 Gluten Free brand Chocolate Cake Mix, Net Wt: 5 lb., UPC 6 54367 43530 4
#1 Gluten Free brand White Cake Mix, 5 lb., UPC 6 54367 43505 2.
Distribution was made to feed dealers located in NE and WY.
Payback Kountry Buffet 14% Text, packaged in 50-lb. bags.  The firm name on the label says the product is Manufactured by CHS Nutrition, Sioux Falls, SD.
The nonmedicated feed is contaminated with monensin
Nationwide Distribution including PA and TX.
Columbus Tibia Plateau (component of the Columbus REVISION Knee System)   Product Usage - The Columbus Revision Knee System is indicated for use in reconstruction of the diseased knee joint caused by osteoarthritis, rheumatoid arthritis, post-traumatic arthritis, the need to revise failed arthroplastics or osteotomies where pain, deformity or dysfunction persist, and for patients suffering from correctable valgus or varus deformity and moderate flexion contracture
NR068K, TIBIA PLATEAU, FIXED, T0; NR070K, TIBIA PLATEAU, FIXED, T0+; NR072K, TIBIA PLATEAU, FIXED, T1; NR072K, TIBIA PLATEAU, FIXED, T1+; NR073K, TIBIA PLATEAU, FIXED, T2; NR074K, TIBIA PLATEAU, FIXED, T2+; NR075K, TIBIA PLATEAU, FIXED, T3; NR076K, TIBIA PLATEAU, FIXED, T3+; NR077K, TIBIA PLATEAU, FIXED, T4; NR078K, TIBIA PLATEAU, FIXED, T4+; NR079K, TIBIA PLATEAU, FIXED, T5
During an internal quality inspection, the tibia plateau was found to be out of specification.  There is a potential for misalignment between the tibia plateau and attachment of the extension stem.
Worldwide Distribution - USA Nationwide including Puerto Rico and the countries of Canada and Okinawa
Sigma Spectrum VOLUMETRIC INFUSION PUMP, with or without Master Drug Library, Part Number 35700 -- Common/Classification Name: Infusion Pump -- Class 2 medical device -- SIGMA LLC, Medina, NY 14103    Product Usage:  The Spectrum Infusion Pump is intended to be used for the controlled administration of intravenous fluids. These fluids may include blood, blood products or mixtures of pharmaceutical drugs for required patient therapy. The Spectrum is used in conjunction with legally marked intravenous administration sets and medications provided by the user.   The Master Drug Library is a software package that will add additional features to the Spectrum Infusion Pump. The Master Drug Library will permit electronic communications with the Spectrum pump and other external peripheral devices. The intended use of the Spectrum pump includes common drug error prevention, through the stand alone settings features of the pump. This includes drug parameter limits and associated drug name identification. With the Master Drug Library, the intended use is to reduce user errors associated with drug selection, drug dose rates, drug dose concentrations, and patient identification associated with the prescribed drug.
63,225 pumps total (corrected number): Domestic - 63,032 pumps; Canada - 29 pumps; Okinawa - 164 pumps
Recall expansion; the infusion pumps have the potential to fail causing inaccurate flow conditions during use. These conditions range from back flow to free flow, which could result in over-infusion.  Sigma's evaluation of subsequent complaints involving failed bearings indicated that the loss or degradation of bearing lubricant to be a more significant contributor to bearing failure than initially believed.  Based upon the results of the analysis of these additional failures, Sigma determined that any bearings prior to the latest, improved design may be at risk for failure.  Sigma decided to expand the recall of the Spectrum Infusion Pumps to include units manufactured from 1/18/2005 through 11/01/2010.
DermaZinc Spray, 0.25% zinc pyritione, topical  OTC, 4 fl oz bottle Distributed By: Dermallogix Partners, Inc. Scarborough, ME 04070
Subpotent (Single Ingredient Drug): The firm is recalling the product because the product is subpotent and does not meet the labeled 0.25% zinc pyrithione level.
Distributed to ethnic retail stores in Florida.
1) Crispy Pistachio Cookies is labeled in part:  ''***VEGETARIAN***NO EGG***CRISPY***By TWI Foods***PISTACHIO COOKIES***Just Baked!***Biscuit Pistache***Net Wt./Poids Net 200g/7oz***TWI FOODS INC***1869  Cage Court, Mississauga, ON Canada L5S 1S3. 1-866-9-CRISPY*** ; 2) Crispy Pistachio Cookies is labeled in part:  ''***VEGETARIAN***NO EGG***CRISPY***By TWI Foods***PISTACHIO COOKIES***Just Baked!***Biscuit Pistache***Net Wt./Poids Net 400g/14oz***www.CrispyJustBaked.com***Ingredients:  Wheat flour, soybean oil margarine, sugar, pista, cornstarch, (vegetable based soy lecithin and soy protein), corn syrup, baking powder, artificial flavor, salt, and ammonium carbonate.***6 27265 00161 2***''
All Lots All Codes with expiration date up to 03/27/2013.
House of Spices (India) Inc., Orlando, FL is recalling 7 oz packages of Crispy Coconut Cookies, Crispy Almond Cookies, 7oz and 14 oz Crispy Pistachio Cookies manufactured by TWI Foods Inc. Ontario Canada. The products may contain undeclared milk and almonds.
Crispy Coconut Cookies is labeled in part:  ''***VEGETARIAN***NO EGG***CRISPY***By TWI Foods***COCONUT COOKIES***Just Baked!***Biscuit noix de coco***Manufactured by:  ***www.crispyjustbaked.com***TWI FOODS INC***2600 Drew Road, Mississauga, ON Canada L4T 3M5 1-866-9-CRISPY***Ingredients:  Wheat flour, soybean oil margarine, sugar, yellow corn flour, corn starch, dessicated coconut, vegetable based soy protein, corn syrup, artificial flavor, salt, ammonium carbonate.***PRODUCT OF CANADA***6 27265 00521 4***Net Wt./Poids Net 200g/0.44 lb(7.0 oz)***''
House of Spices (India) Inc., Orlando, FL is recalling 7 oz packages of Crispy Coconut Cookies, Crispy Almond Cookies, 7oz and 14 oz Crispy Pistachio Cookies manufactured by TWI Foods Inc. Ontario Canada. The product may contain undeclared milk.
Crispy Almond Cookie product is labeled in part:  ''***VEGETARIAN***NO EGG*** CRISPY***By TWI Foods***ALMOND COOKIES***Just Baked!***BISCUIT ALMANDE***Manufactured by***www.crispyjustbaked.com***TWI FOODS INC. 2600 Drew Road, Mississauga, On Canada.  L4T 3M5 1-866-9-CRISPY***Ingredients:  Wheat flour, soybean oil margarine, sugar, yellow corn flour, cornstarch, almond, vegetable based soy protein, corn syrup, artificial flavor, salt and ammonium carbonate.***Net Wt./Poids Net 200g/0.44 lb(7 oz)***PRODUCT OF CANADA***6 27265 00522 1***''
Liquid Peanut Butter Topping under the Brand name: Superior Nut Company, Murray's, Dairy Queen packaged in 6.5 lb., 45 lb.
54,835 lbs (2732 cases/6.5lbsx3 and 36 cases(45 lb pail)
Aflatoxin test results above the established limit of 20 parts per billion
Bliss Bros. Dairy Chocolate Peanut Butter Cookie Dough Ice Cream,  3-gallon  round paperboard,: frozen
Product contained recalled liquid peanut butter due to elevated aflatoxin levels
Newport Creamery Chocolate Peanut Butter Frozen Yogurt   3-gallon containers  and 80 half gallon containers
Integra Mozaik Strip  10 cc     Product Usage:  The product is a bone graft substitute composed of collagen (Type 1) and ceramic (I3-Tricalcium phosphate) matrix in putty and strip forms. The product is intended for use as a bone void filler to fill voids or gaps of the skeletal system in the extremities, spine. and pelvis not intrinsic to the stability of the bony structure. Integra Mozaik is also indicated for use in the treatment of surgically treated osseous defects or osseous defects created from traumatic injury to the bone. Following placement in the bone void or a defect Integra Mozaik is reabsorbed and replaced with bone during the healing process.
Strip Part Number 7701513001   510 K- K063124  Device Listing Number - D001098    Integra MOZAIKTM Strip IOcc  Reference number - CCM I021OITL  Batch Number - 105BR0215955    Integra MOZAIKTM Strip 10cc  Reference Number - CCM I021OITL  Batch Number - 105BR0216149
The Instructions for Use {IFU} {Putty Part Number 7700713001 and Strip Part Number 770151300l for CE marked Mozaik Strip and Putty products contains an incorrect translation of the term ''bone marrow aspirate''. The term is incorrectly translated in Spanish and French,
Integra Mozaik Putty 2.5cc, 5 cc, 10 cc       Product Usage:  The product is a bone graft substitute composed of collagen (Type 1) and ceramic (IP3-Tricalcium phosphate) matrix in putty and strip forms. The product is intended for use as a bone void filler to fill voids or gaps of the skeletal system in the extremities, spine. and pelvis not intrinsic to the stability of the bony structure. Integra Mozaik is also indicated for use in the treatment of surgically treated osseous defects or osseous defects created from traumatic injury to the bone. Following placement in the bone void or a defect Integra Mozaik is reabsorbed and replaced with bone during the healing process.
Putty Part Number 7700713001 510 K- K062353  Device Listing Number - E604163    Integra MOZAIKTM Putty 2.5cc  Reference No. - PTY10125ITL  Batch number - 105BR02l5949    Integra MOZAIKTM Putty 5cc  Refernce No. - PTY10155ITL  Batch No. - 105BR0216024    Integra MOZAIKTM Putty lOcc  Reference No.- PTY10210ITL  Batch No. - 105BR0215956
The Instructions for Use {HIFU} {Putty Part Number 7700713001 and Strip Part Number 770151300 l for CE marked Mozaik Strip and Putty products contains an incorrect translation of the term ''bone marrow aspirate''. The term is incorrectly translated in Spanish and French,
American Red Cross Greater Alleghenies Region
Pennsylvania; Maryland; West Virginia; Kentucky
Blood products, collected in a manner that may have compromised the sterility of the collection system, were distributed.
Endocet (oxycodone and acetaminophen) tablets, USP, 10 mg/650 mg, 100-count tablets per bottle, Rx only, Manufactured for: Endo Pharmaceuticals Inc., Chadds Ford, PA, By: Novartis, Lincoln, NE  68501; NDC 60951-797-70.
Adulterated Presence of Foreign Tablets: Customer complaint that some Endocet 10 mg/325 mg tablets were found mixed in a bottle with Endocet 10 mg/650 mg tablets.
Midazolam HCl Injection, 5 mg/mL, 1 mL single use vials, packaged in 10 x 1 mL single use vials per pack, Rx only, Manufactured by: Ben Venue Laboratories, Inc., Bedford, OH  44146; Manufactured for: Bedford Laboratories, Bedford, OH  44146, NDC 55390-138-01; UPC 3 55390-138-01 8.
Short Fill: These products are being recalled because there is potential that vials with low fill volume were released into distribution.
Octreotide Acetate Injection, 50 mcg/mL (0.05 mg/mL), 1 mL single dose vials, packaged in 10 x 1 mL single dose vials per pack, Rx only, Manufactured for: Bedford Laboratories, Bedford, OH  44146; Manufactured by: Ben Venue Laboratories, Inc., Bedford, OH  44146; NDC 55390-160-10; UPC 3 55390-160-10 1.
Philips Healthcare Practix Convenio Mobile X-ray system   Worldwide Distribution -- Nationwide
When the system is switched off or when the tube arm is parked in the down position (X-ray generator switch off), a radiation pulse (50 kV, 2.5 pGy) is generated inadvertently. .When the system is switched off or when the tube arm is parked in the down position (X-ray generator switch off), a radiation pulse (50 kV, 2.5 pGy) is generated inadvertently. The failure happened when  component supplier used a different supplier for a specific integrated circuit ''IC'' (switched from Philips to  Texas Instruments). On a specific control board, called PSM1 8 ''CONTROL LOGIC BATTERY'', the IC from  Texas Instruments is showing an unwanted behavior and is issuing an incorrect Peak Signal of 2.2Vmax.  This signal is enough to trigger the X-Ray exposure.
Panera HONEY WALNUT CREAM CHEESE SPREAD, Reduced Fat, 8 0z Refrigerated
Product ingredient statement reversed for  Reduced Fat Honey Walnut Cream Cheese and reduced Fat Hazelnut Cream Cheese
Panera ,HAZELNUT CREAM CHEESE SPREAD Reduced Fat, 8 0z , Refrigerated
Product ingredient statement reversed for  Reduced Fat Honey Walnut Cream Cheese and Reduced Fat Hazelnut Cream Cheese. Product name is correct on label
Stryker Instruments Div. of Stryker Corporation
Worldwide Distribution - US (nationwide) including the states of: AK, AL, AZ, CA, CO, DE, FL, GA, IA, ID, IL, IN, KY, LA, MA, ME, MI, MN, MO, MS, MT, NC, ND, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, VA, WA, WI, WV and the country of SWITZERLAND
T5 Hytrel Zipper Toga.    Product Usage:  The togas are intended to provide a barrier between the operating room and the members of the surgical team in order to help protect against contamination and/or exposure of infectious body fluids and harmful microorganisms.
The clear tape, that is intended to aid in the prevention of patients fluids from contacting the surgeon/surgical staff through the sleeve seam of the toga, was not applied during the manufacturing process.  Stryker has received 5 complaints associated with the defective seams which allowed bleed through of bodily fluids.
T4-Hytrel Zipper Toga    Product Usage - The togas are intended to provide a barrier between the operating room and the members of the surgical team in order to help protect against contamination and/or exposure of infectious body fluids and harmful microorganisms.
US Nationwide Distribution including the states of  CA, OH and NY.
Lipofilter 3000, model ASP-CAN-2, labeled in part ***MicroAire, 1641 Edlich Drive, Charlottesville, VA 22911, USA***   Product Usage:    A fat collection canister intended for use during liposuction procedures.
Medical device was not manufactured under Good Manufacturing Procedures and a user may be unable to sterilize the device according to procedures.
Worldwide Distribution - USA including AL, CA, DC, DE, FL, GA, IA, IN, MA, MD, MN, MS, NC, NY, OH, OR, PA, TN, TX, VT, WA & WV and the countries of Argentina, Australia, Belgium, Brazil, Canada, China, Czech Republic, Denmark, EGYPT, France, Germany, Greece, Hungary, ICELAND, India, Indonesia, Israel, ISRAEL, Italy, Japan, Jordan, Lebanon, Netherlands, New Zealand, PHILIPPINES, POLAND, Portugal, Qatar, Russia, SINGAPORE, South Korea, SPAIN, SWEDEN, Switzerland, Taiwan, THAILAND, Turkey, UNITED KINGDOM & Uzbekistan.
The Brilliance iCT and iCT SP are Computed Tomography X-Ray Systems 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.   The Brilliance iCT and iCT SP are used to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes.
Brilliance iCT: Model# 728306 Brilliance iCT SP: Model# 728311
Philips is issuing a software update (version 3.2.4) to the Brilliance iCT and iCT SP systems currently running software version 3.2.0, 3.2.1 or 3.2.3, addressing a number of non-conformances.  A review was conducted of all nonconformances that are fixed by the software upgrade.  None of these nonconformances result in unacceptable hazards.   The nonconformance documented below had the highest score for severity and probability using the risk analysis process:    - Calibration ring artifacts may be present on axial head scans that are performed with rotation times of 1.0 or 1.5 seconds.
Kerry Ingredients & Flavours Research & Developement Center
Bourbon Seasoning 30458458, item number 30458458.01. Distributed by Kerry Ingredients & Flavours 3330 Millington Road, Beloit, WI 53511 Ingredients: brown sugar, maltodextrin, molasses, yeast extract, spices, dried tomato, worcestershire sauce (distilled vinegar, molasses, corn syrup, salt, caramel color, garlic powder, sugar, spices, tamarind, natural flavor, {contains Sulfiting Agents}), natural flavor, dried onion, gumacacia, malted barley flour, salt, sugar, corn syrup solids, citric acid, bourbon, and less than 2% of calcium stearate to prevent caking.
Ingredients used to manufacture seasonings were found to be positive for Salmonella.
Spicy Chicken Marinade, item number 724435.01. Distributed by Kerry Ingredients & Flavours 3330 Millington Road, Beloit, WI 53511 Ingredients: salt, modified corn starch, yeast extract, garlic powder, spice, onion powder, chicken fat, natural flavor, soybean oil, maltodextrin, citric acid, vinegar, and less than 2% silicon dioxide (to prevent caking).
Prime Rib Rub, item number B18527.01. Distributed by Kerry Ingredients & Flavours 3330 Millington Road, Beloit, WI 53511 Ingredients: salt, dextrose, yeast extract, malted barley extract, onion powder, garlic powder, spice, maltodextrin, spice extract,  and less than 2% silicon dioxide (to prevent caking).
Spicy Chicken Marinade - Bake, item number 724444.01 Distributed by Kerry Ingredients & Flavours 3330 Millington Road, Beloit, WI 53511 Ingredients: salt, yeast extract, modified corn starch, dried chicken broth, onion powder, garlic powder, natural flavor, dried red pepper sauce (aged red peppers, vinegar, salt, garlic) maltodextrin, soybean oil, citric acid, paprika extract (color),  and less than 2% of calcium stearate to prevent caking.
Italian Marinade, item number 725450.01 Distributed by Kerry Ingredients & Flavours 3330 Millington Road, Beloit, WI 53511 Ingredients: salt, dried garlic, sugar, corn syrup solids, maltodextrin, yeast extract, spices, dried onion, dried chicken stock, dried red bell pepper, paprika, lemon juice solids, chicken fat, garlic extract, citric acid, lemon oil, spice extracts, dried parsley, natural flavor, and less than 2% silicon dioxide and soybean oil (processing aids).
Thai Seasoning, item number 30502993.01 Distributed by Kerry Ingredients & Flavours 3330 Millington Road, Beloit, WI 53511 Ingredients: sugar, yeast extract, fructose, garlic powder, salt, maltodextrin, corn starch, modified corn starch, spices, dried red bell pepper, citric acid, vinegar, dextrose, dried red pepper sauce (aged red peppers, vinegar, salt, garlic) sodium deacetate, natural flavor, paprika extract (color), annatto extract (color), and less than 2% silicon dioxide to prevent caking.
Sliced Beef Gravy Seasoning, item number B17806.02 Distributed by Kerry Ingredients & Flavours 3330 Millington Road, Beloit, WI 53511 This product contains milk, soy, wheat (contains sulfiting agents) Ingredients: modified corn starch, hydrolyzed soy protein, autolyzed yeast extract, whey wheat flour,  modified tapioca starch, onion powder, maltodextrin, guar gum, salt, caramel color, xanthan gum, natural flavor, disodium inosinate and disodium guanylate, spice.
Beef Patty Seasoning, item number B17187.01 Distributed by Kerry Ingredients & Flavours 3330 Millington Road, Beloit, WI 53511 contains soy Ingredients: hydrolyzed soy protein, salt, partially hydrogenated soybean and cottonseed oils, onion powder, dextrose, sugar, tomato powder, autolyzed yeast extract, disodium inosinate and disodium guanylate, vinegar, corn syrup solids, and less than 2% silicon dioxide (anti-caking agent).
Daytrana (methylphenidate) transdermal system patch, Delivers 20 mg over 9 hours (2.2 mg/hr), 1 patch per pouch, packaged in 30-count patches per box, Rx only, labeled as a) Manufactured for Shire US Inc., Wayne, PA 19087 by Noven Pharmaceuticals, Inc., Miami, FL 33186; NDC 54092-554-30; b) Manufactured for Noven Therapeutics, LLC, Miami, FL 33186, By Noven Pharmaceuticals, Inc., Miami, FL 33186; NDC 68968-5554-3.
Miscalibrated and/or Defective Delivery System: Out of Specification results for mechanical peel force and/or the z-statistic value which relates to the patient's ability to remove the release liner from the patch adhesive prior to administration.
Daytrana (methylphenidate) transdermal system patch, Delivers 30 mg over 9 hours (3.3 mg/hr), 1 patch per pouch (NDC 54092-555-01), packaged in 30-count patches per box (NDC 54092-555-30), Rx only, Manufactured for Shire US Inc., Wayne, PA 19087 by Noven Pharmaceuticals, Inc., Miami, FL 33186.
Daytrana (methylphenidate) transdermal system patch, Delivers 15 mg over 9 hours (1.6 mg/hr), 1 patch per pouch (NDC 54092-553-01), packaged in 30-count patches per box (NDC 54092-553-30), Rx only, Manufactured for Shire US Inc., Wayne, PA  19087; by Noven Pharmaceuticals, Inc., Miami, FL  33186.
Daytrana (methylphenidate) transdermal system patch, Delivers 10 mg over 9 hours (1.1 mg/hr), 1 patch per pouch (NDC 54092-552-01), packaged in 30-count patches per box (NDC 54092-552-30), Rx only, Manufactured for Shire US Inc., Wayne, PA  19087; by Noven Pharmaceuticals, Inc., Miami, FL  33186.
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.
AK, AR, AZ, CA, CO, ID, KS, LA, MO, MT,  NM, NV, OK, OR, TX, UT, WA, WY.
Private Selections Organic Baby Spinach, 5 oz plastic clamshell,  UPC 0-11110-91128-5;    Marketside Baby Spinach Organic,  10 oz plastic clamshell,  UPC: 6-8113132900-2
Private Selections: Lot TFRS 130B 1503 KT34, Best By 5-25-2012;  Lot TFRS 130B 1803 KT34, Best By 5-25-2012.    Marketside:  Lot TFRS130B16, Best by 5-25-2012.
USDA collected a sample and performed random sample on Marketside Organic Baby Spinach lot code TFRS 130B16 Best of Used By 5-25-12. This product tested positive for Salmonella.
AlsoSalt Sodium Free Butter flavored Salt Substitute, 2.5 oz. bottle
undeclared milk present in butter flavoring
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.
GB Select Roast Meat Type Flavor Net Wt. 55 lbs.(25 kg) Product of the Netherlands further processed in China and the US
Batch #20389-EPP Plant #55-8822  Code 1742  Date produced 07 FEB 2012  Best Before 07 FEB 2014
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.
Nationwide Distribution including AZ, CA, DE, FL, IL, IN, IA, KS, KY, MD, MA, MI, MN, MO, NJ, NY, OH, PA, UT, VA, WA, WV, and WI.
Vygon VY(TM)Flush Heparin Lock Flush Syringes, 1 Unit per mL, 3mL in a 10mL Flush Syringe, 30 syringes per box    Prefilled syringes are used to maintain the patency of indwelling catheter lumens
Manufacturer issued a voluntary recall on multiple lots of VY(TM)Flush Heparin Lock Flush Syringes therefore Vygon has subsequently initiated a recall on Vygon branded Heparin Lock Flush Syringes and kits containing the syringes.
Vygon VY(TM)Flush Heparin Lock Flush Syringes, 10 Units per mL, 3mL in a 10mL Flush Syringe, 30 syringes per box, Rx only    Prefilled syringes are used to maintain the patency of indwelling catheter lumens
Vygon VY(TM)Flush Heparin Lock Flush Syringes, 10 Units per mL, 5mL in a 10mL Flush Syringe, 30 syringes per box, Rx only    Prefilled syringes are used to maintain the patency of indwelling catheter lumens
Vygon VY(TM)Flush Heparin Lock Flush Syringes, 100 Units per mL, 3mL in a 10mL Flush Syringe, 30 syringes per box, Rx only    Prefilled syringes are used to maintain the patency of indwelling catheter lumens
Vygon VY(TM)Flush Heparin Lock Flush Syringes, 100 Units per mL, 5mL in a 10mL Flush Syringe, 30 syringes per box, Rx only    Prefilled syringes are used to maintain the patency of indwelling catheter lumens
Churchill Medical Systems, Inc. A VYGON Company PICC LINE TRAY Kit   Prefilled syringes included in the tray kit are used to maintain the patency of indwelling catheter lumens
Product Code AMS-9848CP-11  -- lots 10J80 and 10K62.
Churchill Medical Systems, Inc. PORT-A-CATH Tray Kit   Prefilled syringes included in the kit are used to maintain the patency of indwelling catheter lumens
Product Code AMS-9889CP-7  -- lot 10I86.
Churchill Medical Systems, Inc. A VYGON Company PICC INSERTION TRAY Kit   Prefilled syringes included in the kit are used to maintain the patency of indwelling catheter lumens
Churchill Medical Systems, Inc. VAD ACCESS TRAY Kit   Prefilled syringes included in the kit are used to maintain the patency of indwelling catheter lumens
Churchill Medical Systems, Inc. DRESSING CHANGE KIT   Prefilled syringes included in the kit are used to maintain the patency of indwelling catheter lumens
Churchill Medical Systems, Inc. A VYGON COMPANY PICC INSERTION TRAY   Prefilled syringes included in the kit are used to maintain the patency of indwelling catheter lumens
Carbon Dioxide, USP, Medical Gas, packaged in a) size EA aluminum, CGA940 (CDUSPEA), b) size E CGA 940 (CDUSPE),  c) 50 lb CGA320 (CDUSP50, CD USP50S), d) size 160 liter (CD USP160LT350) cylinders, Rx only, Airgas, Puritan Medical, Distributed By: Airgas USA, LLC, Radnor, PA.
Impurities/Degradation Products: Out Of Specification levels of nitrogen dioxide.
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.
Worldwide distribution: USA (nationwide) including states of: CA and NY; and country of: United Kingdom.
PlasmaJet Open Surgery Handpiece (Part of the PlasmaJet Neutral Plasma Surgery System)   The PlasmaJet system is a neutral plasma surgery system that is designed for cutting and coagulation in open surgery and laparoscopic surgery.
Lot Number 40041, exp. date February 2015 and Lot Number 40043, exp. date February 2015
Potential failure in the glued seal between the stem and the tip of the handpiece leading to the possible leakage of a very small drop of distilled water coolant from the handpiece in use.
LifeSouth Community Blood Centers Inc - Birmingham Region
Blood product, with platelet count below the specified minimum requirement, was distributed.
Murocel (methylcellulose) Lubricant Opthalmic Solution (USP, 1%), 15 mL bottle, OTC, Manufactured by Bausch & Lomb Incorporated, Tampa, FL 33637, NDC 24208-280-15
Lack of Assurance of Sterility: Bausch & Lomb, Inc. is recalling 7 Lots of Murocel Methylcellulose Lubricant Opthalmic Solution 1% (15 mL).  Product was found to be OOS for Antimicrobial Effectiveness testing (AET) at the 12 month stability time point.
Blood product, collected from a donor with unacceptably low hemoglobin, was distributed.
Florentine Lasagna Rolls; Perishable, keep frozen;  Net weight 15 pounds, 60 x 4 oz.  For HRI Use Only. Cook Thoroughly per state food code standards.  West Best Foods, inc.  3425 Wynn Road,   Las Vegas, NV 89102
Boxes have manufacturing dated on 04-23-2012 through 5/21/2012.
1800 lbs (120 cases total, both varieties)
Soy was not included in the ingredient statement or allergen information on the label of Cheese Lasagna Rolls or Florentine Lasagna Rolls.
Cheese Lasagna Rolls; Perishable, keep frozen;  Net weight 15 pounds, 60 x 4 oz.  For HRI Use Only. Cook Thoroughly per state food code standards.  West Best Foods, inc.  3425 Wynn Road,   Las Vegas, NV 89102
1800 pounds (120 total cases, both varieties)
Quality Control and Distribution/Distribution of product that did not meet specifications
AL, FL, TX, TN, NH, SC, GA, DE to grocery distribution centers.
Daufuski Brand boiled Oysters, 8 oz;   Distributed by Liberty Gold Fruit, Inc.
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.
Stahl's Famous Original Bakery CUTOUT COOKIES 14oz. INGREDIENTS: Pastry Flour, Sugar, Shortening...Contains Wheat, Eggs, Milk and Soy.
Fresh by date: 6-1. UPC: 740174035155  Production date 4-25-12
The finished product labels do not declare sub-ingredients of Wheat (flour), Yellow #6, Red 40, Red 3, Blue 2 and Blue 1.
White brick oven WHITE BREAD INGREDIENTS: Spring Flour (unbleached), water vegetable shortning... Stahl's Bakery (586) 716-8500
The finished product labels do not declare sub-ingredients of Wheat (flour).
Cinnamon Rolls A Pastry Ingredients: Spring Flour (unbleached), water, powdered sugar sugar, vegetable shortening Net Wt 8oz Stahl's Bakery (586) 716-8500
Bear Paws MICROWAVEABLE A Pastry Ingredients: Flour (unbleached), powdered sugar, sugar, walnuts, water, vegetable shortening Net Wt 8oz Stahl's Bakery (586) 716-8500
Tri-Union Seafoods, L.L.C dba Chicken of the Sea.
1) Chicken of the Sea Whole Oysters, 12 units per case, 8oz., UPC 4800000267; 2) Ace of Diamonds Whole Oysters 24 units per case, UPC 7760015508
Chicken of the Sea is recalling Oysters supplied by Chicken of the Sea under the Chicken of the Sea, Pacific Pearl, and Ace of Diamonds brands 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.
1) Chicken of the Sea Whole Oysters Pieces 24 units per case, UPC 4800000069; 2) Pacific Pearl Whole Oysters Pieces 12 units per case, UPC 7175902112
Pacific Pearl Smoked Oyster Water 12 units per case
Nationwide in the US: CT, IL, TN, NC, MI, OH, and AR.
Polar Whole Boiled Oysters, 8 oz. net weight, 12 cans/carton.
MW Polar is recalling Polar Whole Boiled Oysters from Korea 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.
Products were distributed in California, Oregon, and Washington.
Napoleon canned, Smoked Oysters, Medium.  Item no. 48-312.  Net WT. per can is 3.66 oz (106 g). The UPC is 0 41253 00312 7.   The product is labeled in parts:  ''***NAPOLEON***Medium***SMOKED OYSTERS***NET WT. 3.66 OZ (106 g)***INGREDIENTS: SMOKED OYSTERS, SOYA OIL, SALT***PRODUCT OF KOREA***FARM RAISED***''.
BEST BEFORE: MAY 2015; Can Code: OYSO M LY-39 1505;    Can Code interpretation:  OYSO = Smoked Oyters;  M = Medium size;  LY-39 = Packer Code;  1 = Year;  5 = Month;  04 = Date;
Korean canned Medium Smoked Oysters, Napoleon brand, are recalled 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.
Napoleon canned, Smoked Oysters, Large.  Item no. 48-313.  Net WT. per can is 3.66 oz (106 g). The UPC is 0 41253 00313 4.   The product is labeled in parts:  ''***NAPOLEON***Large***SMOKED OYSTERS***NET WT. 3.66 OZ (106 g)***INGREDIENTS: SMOKED OYSTERS, SOYA OIL, SALT***PRODUCT OF KOREA***FARM RAISED***''.
BEST BEFORE: MAY 2015; Can Code: OYSO L LY-39 1506    Can Code interpretation:  OYSO = Smoked Oyters;  L = Large size;  LY-39 = Packer Code;  1 = Year;  5 = Month;  06 = Date;
Korean canned Large Smoked Oysters, Napoleon brand, are recalled 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.
Bumble Bee Fancy Whole Oysters 12/8 oz can.
Distributed nationwide to distributors and retail.
Canned oysters. Crown Prince Whole Boiled Oysters, 8 oz. Each case is 8oz/12.
Canned oysters. Crown Prince Natural Whole Boiled Oysters, 8 oz. Each case is 8oz/12.
Canned oysters. Crown Prince Natural Smoked Oysters in Olive Oil, 3 oz. Each case is 3oz/18.
Canned oysters. Crown Prince Natural Smoked Oysters with Chili Pepper, 3 oz. Each case is 3oz/18.
Propofol Injectable Emulsion, 1%, (10mg/mL), packaged in a) 200 mg/20 mL, 5 Units x 20 mL Single patient infusion vials per carton (NDC 0409-4699-30); b) 1 g/100 mL, 10 Units x 100 mL Single patient infusion vials per carton (NDC 0409-4699-24); Rx only, Hospira, Inc., Lake Forest, IL 60045, USA.
Lot #: a) 03440DJ*, Exp 1MAR2013; b) 07947DJ, Exp 1JUL2013; 10134DJ, Exp 1OCT2013; Note: * the lot may be followed by 01.
Presence of Particulate Matter: A single visible particulate was observed in a retention sample bottles.
CA, FL, ID, IL, IN, MD, MT, NE, NJ, NV, OR, TN, WA and Canada
1) Mrs.Friday's brand, Gourmet Breaded Oysters, Medium 18-25 CT, Ready to Fry, Net Wt 2.5 lbs (1.13 kg). 2) Mrs.Friday's brand, (Canada) Gourmet Breaded Oysters, Medium, Ready to Fry, Net Wt 2.5 lbs (1.13 kg), Distributed by King & Prince Corp., Brunswick, GA 31521. Product is packed in unlabeled, clear plastic bags.
Mrs.Friday's brand, Gourmet Breaded Oysters, Small 26-34 CT, Ready to Fry, Net Wt 2.5 lbs (1.13 kg).
Mrs.Friday's Chef Dusted Pacific Oysters, 6/1 lb, Net Wt 6 lb (2.72 kg), Distributed By: King & Prince Seafood Corp., Brunswick, GA 31521. Product is packed in clear plastic bags with no individual labeling.
Meridian Medical Technologies a Pfizer Company
Nationwide, Italy, Singapore, Sweden, and Canada.
Diazepam Injection, USP, 10 mg Automatic, Autoinjector for Buddy Use, 5 mg/mL, 2 mL autoinjector, 15-count autoinjectors per carton, Rx only, Meridian Medical Technologies, Columbia, MD  21046; A subsidiary of King Pharmaceuticals, Inc.; NSN 6505-01-274-0951, NDC 11704-600-01.
Impurities/Degradation Products: High Out of Specification levels for carbostyril, a known degradation product of diazepam.
Orchids brand Whole Oysters, Net Wt. 8 oz (226 g)  Ingredients: oysters, salt, water.  Packed for CTC Food Int'l Inc.  South San Francisco, CA 94080  Product of Korea
Orchids brand Smoked  Oysters in cottonseed oil, salt added. Net Wt. 3 oz   Ingredients: oysters, salt, water.  Packed for CTC Food Int'l Inc.  South San Francisco, CA 94080  Product of Korea
Campbell's Oyster Stew, Net Wt 10.5 oz (298g), Campbell Soup Company, Camden, NJ 08103-1701
Fresh Baby Clam Meat Labels on outer styrofoam container;  200 g packages, 30 or 40 packages/case, refrigerated.  Refrigerate after opening.  Product arrived via Korean Air Cargo directly to consignees.
No code information available at this time
The shellfish was harvested from waters that may have been exposed to inadequate sanitation controls.
Arthrotec 75 (diclofenac sodium and misoprostol) tablets, 75 mg/200 mcg, a) 30-count tablets per bottle (NDC 54868-4165-1); b) 60-count tablets per bottle (NDC 54868-4165-0); Rx only, Mfg. By: G.D. searle LLC Div Pfizer, New York, NY  10017; Repacked & distributed by: Physicians total Care, Inc., Tulsa, OK  74146.
Tablet Separation: The manufacturer of Arthrotec had recalled the lots that were used to re-package this product because they may contain broken tablets.