Penrose-St Franc Health Services Blood Bank
Blood and Blood Products for reprocessing
Blood products, collected from a donor who was not asked follow-up questions regarding increased risk for vCJD, were distributed.
Red Blood Cells Leukocytes Reduced Plasma Frozen
Blood products, collected from donors, whose suitability to donate was not adequately determined, were distributed
Blood and Blood Products for Reprocessing
Blood product, collected from a donor who reported travel to a malarial endemic area, was distributed.
Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
Red Blood Cells (Apheresis) Leukocytes Reduced
Blood products, collected from a donor who reported travel to a malarial endemic area, were distributed.
Blood product, positive for the S-antigen but labeled as S-antigen negative, was distributed.
Blood product, with platelet yield that exceeded the manufacturer's limit for the product to be stored in one bag, was distributed.
Baylor University Medical Center - Transfusion Service Center
Red Blood Cells Leukocytes Reduced Irradiated
Blood product, labeled with an incorrect expiration date, was distributed.
Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
University of Texas Medical Branch at Galveston (The)
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
Blood product, which was possibly contaminated with Propionibacterium species, was distributed.
Blood products, which were possibly contaminated with Propionibacterium species, were distributed.
Blood products, which failed to meet the minimum specification for product volume, were distributed
Blood product, collected from a donor who reported post donation illness, was distributed.
Platelets Pheresis Leukocytes Reduced Irradiated
Blood products, labeled as leukoreduced without the assurance that they met the criteria for leukoreduced products, were distributed.
Blood products, collected from a donor who did not have a complete physical examination, were distributed.
Blood product, collected from a donor with an unacceptably low hemoglobin, was distributed.
CABERGOLINE Tablets, 0.5 mg, RX only, 8 count bottles, Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960 NDC 0093-5420-88
Impurities/Degradation Products: This lot of product will not meet the impurity specification over shelf life
Product was distributed nationwide and Canada
I-C Drops, Eye Cleansing Agent,  15 ml  ASN/Maxam P.O. Box 1277 Hood River, OR 97031
Lack of Assurance of Sterility: The product is being recalled because the product label does not state sterile in accordance with 21 CFR Part 200.50(a)(1), Ophthalmic Preparations and Dispensers, and it is not in compliance with 21 CFR Part 349, Ophthalmic Drug Products for Over-The-Counter Use.
Worldwide Distribution - USA (nationwide) and internationally to Belgium, Egypt, Ireland, Italy, Portugal, and the UK.
DePuy Spine EXPEDIUM Offset Torque Wrench Product Code 2797-29-510    The device is intended for use during the final tightening of an Expedium Offset Spinal Construct.
A component within the handle of the Expedium Offset Torque Wrench is prematurely wearing, potentially resulting in the instrument recording torque values outside of the specification.
U.S. states to include California, Georgia, Illinois, Nevada, Ohio, Virginia, and Washington.
AvoDerm Natural Lamb Meal Brown Rice Adult Dog Formula, 26 lb. Packaged in plastic bag with plastic liner.
Product Code/SKU/Material # 1000065074, UPC Code 0 5290702043 8, Best before dates of 28 Aug 2013, 29 Aug 2013, 30 Aug 2013.
The firm recalled because the product has the potential to be contaminated with Salmonella.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Worldwide Distribution - USA (Nationwide) in the states of TX, IL, NJ, FL, OH, PA and (International) in the country of Japan.
Vycor Medical ViewSite Brain Access System 17mm/ 11mm / 5cm Device***STERILE***   Product Usage:  The Vycor Viewsite Brain Access System (VBAS) has been designed to serve as a self-retaining retractor system for brain tissue. It is comprised of an introducer and a working channel port that are secured by a spring-loaded latch. Each device allows for the gentle retraction of tissue, visualization of the surgical site and for the smooth manipulation of introduced instruments. The range of device sizes (width and length) provides various working channel sizes.
Vycor Medical recalled their VBAS (Vycor Viewsite Brain Access System) because an unidentified black fiber was found on the device.
Worldwide Distribution-USA including the states of AZ, CA, CO, IL, IL, IN, MA, ME, MI, MO, NC, NJ, NY, OR, TN, TX, VA and  WI and the countries of Austria, Canada, China, France, India, Ireland, Italy, Japan, Netherlands, Norway, Spain, Switzerland, Thailand and United Kingdom.
Computed Tomography X-Ray System Brilliance Workspace Portal, Model #728269 Philips Medical Systems, Highland Heights, OH.   The Brilliance Workspace Portal is a component of the Computed Tomography X-Ray System that is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. The portal (together with the scanner) provides image processing and display through software applications that process, analyze, display, quantify and interpret medical images/data.
Philips was notified that when performing post processing with the Brilliance Workspace Portal platform with software versions 2.6.1.4, the coronary arteries in the rendered image are segmented automatically. However, the center line is not extracted or highlighted upon hovering and making it impossible to activate the vessel and choose the appropriate name (label) from the drop-down menu.
Blood product, collected from a donor who emigrated from an area considered endemic for malaria, was distributed.
Nature's Recipe, Oven Baked Biscuits with Real Chicken, Made with sweet potatoes, oats, flaxseed., 19 ounces; UPC: 30521 51549
Product may be contaminated with Salmonella.
Products are distributed in Oregon and Washington
No expiration dates on packages.   Product has lot code 01148 through 01241 (it is interpreted as: 11 is for manufacturing year 2011, and 48 is week 48 of 2011).
Pet bird food and small animal pet foods are recalled due to a potential to be contaminated with Salmonella.
Small Pet Animal Food is sold under Sleek and Sassy brand.  Product are packaged from 2 lb., 4 lb., 20 lb., to 40 lb in polysynth bag.     Garden Small Animal has the following UPCs:  0-1253113902-9;     0-1253113904-3;     0-1253113920-3;        0-1253113940-1;
Garden Guinea Pig/Rabbit diet is sold under Sleek and Sassy brand.  Product is packaged from 2 lb., 4 lb., 20 lb., to 40 lb in polysynth bag.     Garden Guinea Pig/Rabbit has UPC is 0-1253113502-1.
Fortified feeds are sold under Sleek and Sassy brand.   Different products with UPCs are listed below.   Fortified Large Hookbill with the UPCs:    0-1253111402-6;        0-1253111404-0;     0-1253111420-0;        0-1253111440-8;    Fortified Large Hookbill No Sunflower with the UPCs:    0-1253111502-3;        0-1253111504-7;     0-1253111520-7;        0-1253111540-5;    Fortified Parrot with the UPCs:    0-1253113003-3;        0-1253113025-5;    Fortifed Small Animal with the UPCs:    0-1253112902-0;        0-1253112904-4;     0-1253112920-4;        0-1253112940-2;
WILD WINGS, CERTIFIED ORGANIC, PREMIUM ORGANIC BLEND, PREMIUM SEED FOR BIRDS, Net wt. 80 oz (5 lbs) (2.27 kg), HBD INTERNATIONAL, 7108 CROSSROADS BLVD., SUITE 325 BRENTWOOD, TN  37027, 615.221.9890  800.346.0269
Product was manufactured with peanuts recalled by Sunland due to the potential for salmonella contamination.
CA, IL, GA, NJ, CT, KS, MN, MA, WA, ME, NY.
Charlee Bear Protein Crunch Bars, 84% Chicken Recipe with Sweet Potatoes, 5.5 oz, UPC Code 8710890001.
Charlee Bear Products, a division of Wixon, Inc., is voluntarily recalling  certain lots of its Charlee Bear Protein Crunch Treats because they have the potential to be contaminated with Salmonella.
Charlee Bear Protein Crunch Bars, 84% Chicken Recipe with Carrots, 5.5 oz, UPC Code 8710890000.
Grandma's Peanut Butter Sandwich Creme Cookies, Net WT. 3.025 oz, Frito-Lay, Inc. Plano, TX 75024
GRANDMA'S Peanut Butter Sandwich Creme cookies have a sell-by date of March 12, 2013 or earlier and UPC code of 28400-00153.
The firm is recalling GRANDMA'S Peanut Butter Sandwich Creme cookies and GRANDMA'S Peanut Butter Mini Sandwich Creme cookies because they contain undeclared milk and egg.
Grandma's Peanut Butter Mini Sandwich Creme Cookies, Net WT. 1.71 oz, Frito-Lay, Inc. Plano, TX 75024
GRANDMA'S Peanut Butter Mini Sandwich Creme cookies have a sell-by date of May 21, 2013 or earlier and UPC code of 28400-00901.  The sell-by date is located on the front of the package.
Worldwide distribution: USA including DC and PR; and countries of: Canada and Mexico accounts not available at this time.
Bausch and Lomb 27G sterile cannula packed in the Bausch and Lomb Amvisc 1.2% Sodium Hyaluronate ( Model 59051, 59081, 59051L, 59081L) and Amvisc Plus 1.6% Sodium Hyaluronate (Model 60081, 60051, 60051L, 60081L)  ophthalmic viscosurgical device.   The 27G disposable cannula is attached to the syringe standard luer fitting to deliver the Amvis or Amvis Plus during use as a surgical aid in opthalmic anterior or posterior segment procedures.
Some disposable cannulas (with 4-digit lot numbers) provided with the Amvisc or Amvisc Plus OVD are not properly engaging to the Luer-Lock on the Amvisc and Amvisc Plus sterile glass syringes.  The cannulas may leak viscoelastic material or detach from the syringe during injection.  In rare incidents, detachment has resulted in serious patient injury.
Fresenius GranuFlo Dry Acid Concentrate For Bicarbonate Dialysis 2.0 K 2.5 Ca 1 Mg 16.5 GAL Catalog Number: OFD2251-3B    Product Usage:  GranuFlo is indicated in the treatment of acute and chronic renal failure during the hemodialysis treatment.
GranuFlo Dry Acid Concentrate may show discoloration
Fresenius GranuFlo Naturalyte  Dry Acid Concentrate For Bicarbonate Dialysis 2.0K  2.0 Ca 1Mg .16.5GAL Catalog Number: OFD2201-3B    Product Usage:  GranuFlo is indicated in the treatment of acute and chronic renal failure during the hemodialysis treatment.
Lot Numbers:12NXGF004,   12NXGF008, 12PXGF010, 12PXGF014
Fresenius GranuFlo Naturalyte  Dry Acid Concentrate For Bicarbonate Dialysis 3.0K  2.5 Ca 1Mg .16.5GAL Catalog Number: OFD3251-3B    Product Usage:  GranuFlo is indicated in the treatment of acute and chronic renal failure during the hemodialysis treatment.
Fresenius GranuFlo Naturalyte  Dry Acid Concentrate For Bicarbonate Dialysis 2.0K  2.25 Ca 1Mg .16.5GAL Catalog Number: OFD2231-3B    Product Usage:  GranuFlo is indicated in the treatment of acute and chronic renal failure during the hemodialysis treatment.
Fresenius GranuFlo Naturalyte  Dry Acid Concentrate For Bicarbonate Dialysis 1.0K  2.0 Ca 1Mg .16.5GAL Catalog Number: OFD1201-3B    Product Usage:  GranuFlo is indicated in the treatment of acute and chronic renal failure during the hemodialysis treatment.
Fresenius GranuFlo Naturalyte  Dry Acid Concentrate For Bicarbonate Dialysis 2.0K  2,5 Ca  0.75 Mg .16.5GAL Catalog Number: OFD2225-3B    Product Usage:  GranuFlo is indicated in the treatment of acute and chronic renal failure during the hemodialysis treatment.
Fresenius GranuFlo Naturalyte  Dry Acid Concentrate For Bicarbonate Dialysis 2.0K  2,5 Ca 0.75Mg .16.5GAL Catalog Number: OFD2223-3B    Product Usage:  GranuFlo is indicated in the treatment of acute and chronic renal failure during the hemodialysis treatment.
Fresenius GranuFlo Naturalyte  Dry Acid Concentrate For Bicarbonate Dialysis 3.0K  2,0 Ca 1.0Mg .16.5GAL Catalog Number: OFD3201-3B    Product Usage:  GranuFlo is indicated in the treatment of acute and chronic renal failure during the hemodialysis treatment.
Fresenius GranuFlo Naturalyte  Dry Acid Concentrate For Bicarbonate Dialysis 3.0K  2,5 Ca 0.75Mg .16.5GAL Catalog Number: OFD2325-3B    Product Usage:  GranuFlo is indicated in the treatment of acute and chronic renal failure during the hemodialysis treatment.
NEOGRAM AMINO ACIDS AND ACYLCARNITINES TANDEM MASS SPECTROMETRY KIT   Product Number: 3026-0030.    This kit is intended for the measurement and evaluation of amino acid, free carnitine, and acylcarnitine concentrations from newborn heel prick blood samples dried on filter paper. (Table 1 of Attachment 2) details the analytes measured by the kit. Quantitative analysis of amino acids, free carnitine and acylcarnitines and their relationship with each other is intended to provide analyte concentration profiles that may aid in the screening of newborns for one or more of several metabolic disorders. This kit is to be used for in vitro diagnostic use only, by trained, qualified laboratory personnel.
Truncated V-Bottomed Microplate Wells used in assays contain defective wells.
NEOBASE NON-DERIVATIZED MSMS KIT                             Product Number:        3040-001U.   This tandem mass spectrometry (MSMS) reagent kit is intended for the measurement and evaluation of amino acids, succinylacetone, free carnitine, and acylcarnitine concentrations from newborn heel prick blood samples dried on filter paper. Quantitative analysis of these analytes ) and their relationship with each other is intended to provide analyte concentration profiles that may aid in screening newborns for metabolic disorders.
NEONATAL TOTAL GALACTOSE KIT                                    Product Numbers:    3029-0010, 3029-001B.    This kit is intended for the quantitative determination of total galactose (galactose and galactose-1-phosphate) concentrations in blood specimens dried on filter paper as an aid in screening newborns for galactosemia.
DBS MICROPLATE, TRUNCATED V-BOTTOMED Product Number:        3033-0010
Microplate, truncated V-bottomed lots included in the above listed products   Product Number:        1380 5465.    DBS Microplate is a general purpose 96 well microplate used in the preparation and examination of specimens from the human body.
Worldwide distribution: USA including IN, OH and OR; and the countries: Australia, Belgium, China, Israel, and Sweden.
Brilliance 64 and Ingenuity CT Computed Tomography X-Ray Scanning Systems:  Brilliance 64 - Model #728231; and Ingenuity CT - Model # 728326, Distributed By: Philips Healthcare, Cleveland, OH. The Brilliance 64 and Ingenuity CT 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.
Brilliance CT X-RAY System - Model/System Code #728231,  Serial Number distributed in the U.S. was:   9654. Ingenuity CT X-Ray System - Model/System Code #728326 - Serial Numbers distributed in the U.S. were:  300018, and 300003. The remaining Serial Numbers distributed overseas were:  91003, 95130, 95157, 95504, and Serial Numbers:  300010,  and 300030 .
A total of nine (9) units were distributed (3 units in the U.S & 6 units overseas)
Software anomalies. Philips Medical Systems recalled their Brilliance 64 running software v4.0.0xx516 and their Ingenuity CT running software v4.0.0xx518 due to software issues detected in these CT scanning systems.  If these  issues were to re-occur they could pose the risk of injury to patients undergoing scans; device users; or device service personnel.
Sugar Flowers Plus Inc of Glendale, CA is recalling Cake Decors Pastillage (gum paste) Flowers because of the undeclared use of egg white wash as a glue for the inner petals of flowers.
Cymbidium - W/M UPC Code: 8 38437 00010 8
Cattleya - W/P UPC code: 8 38437 00011 5
Gladiolus - A/W UPC ocde: 8 38437 00012 2
Gladiolus - P/BUR UPC code: 8 38437 00013 9
Product was shipped to the folloiwng states: AL, FL, GA, IL, IN, KY, MI, NC, NY, OH, PA, TN, VA, WI & WV.
Red Apple Slices 2.4 oz, Item #71746, 20 oz, Item # 71729 14 oz, Item # 71735. Item #71729 is sold under the brand name Sonic  UPC 95829 20000.  The other two packages are in clear plastic bags.
Possible contamination with Listeria monocytogenes.
Sliced Green Apples READY TO EAT 14 oz Innerlock Bag UPC 95829 20042 Use By: 12/3/12, Item #71736
Celery Stick 2, 80/2 oz clear plastic bag, Item #70648 USED BY: 11/21/12
Red Grapes 80/1.5 oz (3,402g) bag Item #71305 BEST USED BY: 11/21/12
Pineapple Chunks 80/2 oz (4.536g) bag Item #71607, BEST USED BY: 11/21/12 TC: 1 217 2359
Red Apples DICED 3/4 & 5/1# (4,536G) bag Item #71707 Ingredients: Apples (Apples, Calcium Ascorbate), BEST USED BY: 11/25/12 TC: 1 317 2359 15:40 PRODUCT OF: USA
Radish Sliced 80/2oz bag Item #74605 BEST USED BY: 11/21/12 TC: 1 317 2359 15:45
Holiday Fruit Delight Kit 5.1875 lbs (2,353g) INGREDIENTS: APPLES***RED GRAPES, STRAWBERRY GLAZE***MARSHMELLOW***WALNUTS, ALLERGENS: WALNUTS (TREE NUTS) BEST USED BY 11/23/12 TC: 13171319 15:42
Waldorf Salad Kit 5.19lb (2,345g) bag Item #74802 INGREDIENTS: APPLES***MAYONNAISE***CELERY, WALNUTS CONTAINS: SOYBEAN OIL, EGG, TREE NUTS (WALNUTS) BEST USED BY: 11/23/12 TC: 13171319 15:43
SHREDDED BROCCOLI FRUIT SALAD 6.19# (2,807 g) Ingredients: Broccoli, Cauliflower, Apples, Pears, Cole Slaw Dressing***Cranberry***Raisins CONTAINS: Soybean, egg BEST USED BY: 11/23/12 TC: 13171319 15:59***
Knorr Pasta Sides Cheesy Bacon Macaroni Net Wt. 3.8 oz, (107 g) Unilever Englewood Cliffs, NJ 07632 USA  Made in Canada from domestic and imported ingredients    Case SCC 10041000082488  UPC 4100008248
Knorr Pasta Sides Cheesy Bacon Macaroni may contain soy as a different product mix was inadvertently packaged in the Cheesy Bacon Macaroni pouch.
Nationwide Distribution, including the states of PA, OH, NY, CA and IL.
Hoffman LRF Wire Bolt, Catalog number 4933-1-001 through -003.
Two complaints have been filed where Hoffman LRF Wires have broken during load bearing application by patients.
Alabama, Colorado, District of Columbia, Florida, Iowa, Idaho, Illinois, Indiana, Kansas, Louisiana, Minnesota, Missouri, New York, North Carolina, Ohio, Oklahoma, Pennsylvania, Tennessee, Texas and Virginia.
Plum A+ Single Channel Infusion Pump with Module for Veterinary Use Only; Hospira, Inc., Lake Forest, IL 60045; list number 60529, module 60530-04
The volume control knob on some Plum A+  infusers (located on the back of the infuser) may not function as described in the System Operating Manual - the direction for Loud and Quiet may be reversed. The manual indicates a clockwise rotation of the knob decreases the volume; however, on some of the devices the alarm volume increases when the knob is turned clockwise.
Nationwide to distributors and retailers in AZ, CA, CO, CT, MA, NH, NJ, NY, OR, PA, RI, TX and WA.
Cold-smoked salmon in vacuum plastic bags that are partially clear and partially colored black, white, gold and pink, labeled in part:  front panel: ***NATHAN'S TRADITIONAL DELICATESSEN NOVA SALMON CLASSIC SMOKED***NET WT 3 OZ (85g)*** back panel: ***NATHAN'S TRADITIONAL DELICATESSEN NOVA SALMON CLASSIC SMOKED***This salmon can be frozen for up to 45 days.  Thaw under refrigeration.  Once opened, keep refrigerated and be sure to enjoy within five days.  Keep refrigerated at 38F or below.***0 73030 80368 2***INGREDIENTS: ATLANTIC SALMON (COLOR ADDED), SALT, SUGAR, PRESERVATIVES (SODIUM BENZOATE, SODIUM ERYTHORBATE, SODIUM NITRITE), FD&C YELLOW #5, YELLOW #6, RED #40, BLUE #1, AND NATURAL HARDWOOD SMOKE.  DISTRIBUTED BY OCEAN BEAUTY SEAFOODS LLC, SEATTLE, WA 98119 WWW.OCEANBEAUTY.COM  FARM RAISED PRODUCT OF CHILE  A white stick-on label, affixed to the top left hand corner of the back panel, reads: top line: M228208 middle line left to right: 07 09 285 12 14 09 and bottom line: 10632
272 cases - 12/3 ounce packages per case.  The press release had reported 275 cases had been distributed, but that was incorrect.
Ocean Beauty Seafood's sample was found positive for Listeria monocytogenes.
Cold-smoked salmon in vacuum plastic that are partially clear and partially colored blue, yellow, white, labeled in part:  front panel: ***Lascco  BRAND SLICED SMOKED NOVA SALMON NET WT 4 OZ (113g)  PERISHABLE.  KEEP REFRIGERATED AT 38F OR COLDER. back panel: ***Lascco BRAND SLICED SMOKED NOVA SALMON***0 72840 01751 7***INGREDIENTS: ATLANTIC SALMON (COLOR ADDED), SALT, SUGAR, PRESERVATIVES (SODIUM BENZOATE, SODIUM ERYTHORBATE, SODIUM NITRITE), FD&C YELLOW #5, YELLOW #6, RED #40, BLUE #1, AND NATURAL HARDWOOD SMOKE.  DISTRIBUTED BY OCEAN BEAUTY SEAFOODS LLC, SEATTLE, WA 98119 WWW.OCEANBEAUTY.COM  FARM RAISED PRODUCT OF CHILE  A white stick-on label, affixed to the top left hand corner of the back panel, reads: top line: M228208 middle line left to right: 07 09 285 12 14 09  and bottom line: 10632
95 cases - 12/4 ounce packages per case.  The press release reported 96 cases distributed, but that was incorrect.
Worldwide Distribution-USA including Puerto Rico and the states of California, Florida, Iowa, Illinois, Louisiana, Michigan, Minnesota, North Carolina, South Carolina, Texas, and Washington, and the countries of Argentina, Mexico, France, and India.
Spacelabs Smart Disclosure System, Model 92810, is an integrated component of the Intesys Clinical Suite (ICS) G2, Version 4.03.   The Smart Disclosure product collects patient waveforms, alarms, vital signs, and 12-lead reports. A 24-hour waveform acquisition is standard, with an upgrade option to 72 hours.    The product provides basic trends in both tabular and graphical format, along with a retrospective ECG analysis. The analysis may be defined by patient, and the data may be presented in multiple formats, including a rhythm, a histogram, and a summary view.    Standard reports are available from Smart Disclosure, including saved events, disclosure, trends, histogram, and summary.    The Spacelabs Smart Disclosure System, Model 92810 is indicated for use in clinical situations where there is a need for review of physiological waveform information and alarm events up to 72 hours after the fact. Smart Disclosure is also indicated in those situations where a retrospective analysis of monitoring patients' ECG waveform data, that can be annotated and edited, is desired. The intended use of the Spacelabs Smart Disclosure is to interface with the Spacelabs monitoring network, providing the user with a means of recalling waveform information and performing retrospective analysis. The most recent 72 hours of monitored patient ECG waveform data can be analyzed, with each analysis limited to 24 hours or less.
ICS G2 Smart Disclosure Model 92810, Version 4.03.   There are no serial numbers.
Displaying or printing of an incorrect waveform for the time indicated in the printout or display in the Spacelabs Healthcare Intesys Clinical Suite (ICS) G2, Version 4.03, Clinical Access portion of Smart Disclosure, Model 92810.
Marketside, Chunky Bleu Cheese Dressing, Net Wt. 14 fl. oz (414)mL, Manufactured For Marketside, a division of Wal-Mart Stores, Inc., Bentonville, AR 72716.
Portsmouth, NH; Raynham, MA; Taunton, MA
Nautifish Frozen Cooked Lobster Meat.  CKL 12 X 11.3 oz.  Metal Cans. 12 items/case.  Keep Frozen.
This product was found with Listeria monocytogenes through laboratory analysis.
Apollo Frozen Cooked Lobster Meat. BCKL Lobster Meat 6X2 lb, plastic bags, 6 individual items per case, keep frozen
Date of Manufacture: 10/05/12; Lot # 11244
The product or a previous product from this date code was found with Listeria monocytogenes through laboratory analysis.
Captain Homard Frozen Cooked Lobster Meat. Broken Tail Meat, 6X2 lb, plastic bags, 6 individual items per case.  Keep Frozen.
Frozen Cooked Lobster Tail Meat. Nautifish. 2 lb plastic bags, 6 items/case. Keep Frozen
Date of Manufacture: 10/05/12. Date Code 12 279; Product Number: 339538
Frozen Cooked Lobster Meat. Salad Meat 6 X 2 lb. plastic bags, 6 individual items per case. Captain Homard and Apollo. Keep Frozen
Frozen Cooked Lobster Meat. TCK Nautifish 6 X 2 lbs. Plastic Bags, 6 individual per case.  Keep Frozen
13 cases - 6 X 2 lb plastic bags per case
Perindopril Erbumine Tablets, 8mg, 100 Tablets per Bottle, Rx Only, Boehringer Ingelheim, Roxane Laboratories Inc., Columbus, OH 43216, NDC 0054-0112-25.
Impurities/Degradation Products: Out of Specification results found for impurity B, identified as the drug's metabolite.
Prednisone tablets, USP, 10mg, Rx Only, Units of Use, NDC: a) 45802-303-67, 48-count Cartons, b) 45802-303-21, 21-count Cartons, Manufactured by: West-Ward Pharmaceutical Corporation, Eastown, NJ 07724, Distributed by: Perrigo, Allegan, MI 49040.
Presence of Foreign Substance(s); Perrigo has been notified of a recall by the manufacturer of this product, West-Ward Pharmaceuticals. This is a sub-recall due to tablets contaminated with trace amounts of food-grade lubricant, as well as stainless steel inclusions
Candy Canes, Peppermint Flavor, 5 oz boxes, packed 12 individually candy canes/box, and labeled in part ***Distributed by Greenbriar International, Inc., Chesapeake, VA 23320, MADE IN CHINA***
Candy product may contain metal and/or plastic pieces embedded in the candy.
Candy Canes, Cherry Flavor, 5 oz boxes, packed 12 candy canes/box, and labeled in part ***Distributed by Greenbriar International, Inc., Chesapeake, VA 23320, MADE IN CHINA***
Local Baking, Co, Inc. T/A Joey's Fine Foods
JOEY'S GOURMET LEMON CAKE; NET WT 3 oz. (85 g); UPC 026104613403; Joey's Fine Foods, Inc., Newark, NJ 07104; 973-482-1400
Product contains undeclared FD&C Yellow #5.
Nationwide and worldwide: AL , AR , AZ , CA , CO , CT , FL , GA , HI , IA , IL , IN , KS , KY , LA , MA , ME , MI, MO , NC , ND , NV , NY , OH , OK , PA , SD , TN , TX , UT , VA , WA , and WI. Bahrain, BRAZIL, CANADA, CHILE, Honduras, Singapore, Taiwan, Trinidad and Tobago, and UNITED ARAB EMIRATES (UAE).
Sarns flexible arterial cannula, 6.7 mm (20Fr) OD with 3/8 in. connector, suture ring, 9.5 in (24 cm) long   The Sarns High Flow Aortic Arch Cannula and Sarns Flexible Arterial Cannulae are indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery
Lot number: 0677286 and Catalog number: 13010.
Flexible Arterial Cannula and High-Flow Aortic Arch Cannula connectors were identified to contain flash on the exterior of the cannula connector that exceeded established specifications. Because the flash has the potential to detach in the operative field, TCVS has decided to remove all affected lots that were manufactured with the affected connector part.
Sarns flexible arterial cannula, 7.3 mm (22 Fr) OD with 3/8in connector, suture ring, 9.5in (24 cm) long   The Sarns High Flow Aortic Arch Cannula and Sarns Flexible Arterial Cannulae are indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery
Lot number: 0677284 and Catalog number: 13020
Sarns flexible arterial cannula, 8.0 mm (24 Fr) with 3/8in connector, suture ring, 9.5in (24 cm) long   The Sarns High Flow Aortic Arch Cannula and Sarns Flexible Arterial Cannulae are indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery
Lot number: 067728 and 0681074 and Catalog number: 13030
Sarns high-flow aortic arch cannula, 5.2 mm (16 Fr) OD with 3/8in connector, 7.5in (19 cm) long   The Sarns High Flow Aortic Arch Cannula and Sarns Flexible Arterial Cannulae are indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery
Sarns high-flow aortic arch cannula, 6.5 mm (20 Fr) OD with 3/8in connector, 11in (28 cm) long   The Sarns High Flow Aortic Arch Cannula and Sarns Flexible Arterial Cannulae are indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery
Lot number: 0680122, 0680751and Catalog number: 12325
Sarns high-flow aortic arch cannula, 6.5 mm (20 Fr) OD with 3/8in connector, 11in (28 cm) long, with X coating surface   The Sarns High Flow Aortic Arch Cannula and Sarns Flexible Arterial Cannulae are indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery
Lot number: 0677299 and Catalog number: 12325X
Yangsheng Eggs Preserved Duck Eggs Content 6 pcs Net Wt: approx 12.69 oz (360g) S&M (USA) Enterprise Corp Rm3 8/F., Yuexiu Bldg., 160-174 Lockhart Road, Wan Chai, HK Distributed by : S & M Int'l Inc 100 Pulaski ST., Bayonne NJ 07002 Product of China  UPC 6949682803551
855 cases (24 individual packages of eggs)
Preserved Duck Eggs do not meet pH standard of 10 for boiled/preserved eggs.
Somersault brand Cinnamon Crunch.  Crunchy nuggets baked with sunflower seeds and toasted grains. Sunflower seed snack. .5 oz, 1 oz., 2 oz., 6 oz., and 16 oz.
Cinnamon Crunch 12ct; 6oz. Case Code10-8-98403-002-27-4;Product Code 8-98403-002-27-7; Sell By: 8/30/2013 or earlier Cinnamon Crunch 16ct; 2oz.Case Code10-8-98403-002-27-4; Product Code8-98403-002-27-7; Sell By: 8/30/2013 or earlier    Cinnamon Crunch 100ct; 0.5oz., Case Code10-8-98403-002-24-3; Product Code 8-98403-002-24-6;  Sell By: 8/30/2013 or earlier Cinnamon Crunch 36ct; 1oz.Case Code10-8-98403-002-23-6; Product Code 8-98403-002-22-2;  Sell By: 8/30/2013 or earlier,  Cinnamon Crunch 50ct; 1oz., Case Code 10-8-98403-002-22-9; Product Code 8-98403-002-22-2; Sell By: 8/30/2013 or earlier   Cinnamon Crunch Bulk 8ct; 16oz. (for samples only, no case and product code)Sell By: 8/30/2013 or earlier   Shipper 36ct; 1oz. SS CC, Case Code10-8-98403-002-26-7; Product Code 8-98403-002-22-2; Sell By: 8/30/2013 or earlier
During ingredient review for kosher certification, the firm discovered that the finished product package did not bear a milk allergen declaration, although a flavor ingredient was found to contain milk
Class II Recall - Worldwide Distribution - USA including TX, AZ, OR, and CO. Only US product is affected by this recall.
Q-Plus T Powered Laser Surgical Instrument   Nd:YAG 1064 nm and 532 nm: Treatment of vascular lesions and pigmented lesions; Hair and tattoo removal; The incision, excision, ablation, vaporization of soft tissue for general dermatology. Ruby 694nm: Cutting, vaporization and ablation of soft tissue; Tattoo removal; Treatment of benign pigmented lesions.
Quanta System S.p.A, Italy, is notifying U.S. consignees that their website contained promotional materials for products distributed in the U.S. which did not specify that some of the claims made therein were not meant to apply to the U.S. distributed devices.
Eterna Giovinezza System, Powered Laser Surgical Instrument.   Permanent hair reduction; Photocoagulation of dermatological vascular lesions; Photothermolysis of blood vessels (treatment of facial and leg veins); Treatment of benign pigmented lesions; Inflammatory acne
Ultrawave II EX 1320/ Ultrawave III EX 1320 Powered Laser Surgical Instrument. Nd:YAG 1064 nm: Coagulation and hemostasis of benign vascular lesions (e.g. port wine stains, hemangiomas, warts, telangiectasia, rosacea, venus lake, leg and spider veins, scars, straie and psoriasis; Treatment of benign pigmented lesions to reduce lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments; Treatment of facial wrinkles (e.g. periocular and periorbital); Removal of unwanted hair, for the stable longterm, or permanent, hair reduction, including Fitzpatrick IVI and suntanned skin types; For the treatment of pseudofolliculitis barbae (PFB); Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar; For use on all skin types (Fitzpatrick IVI) including tanned skin. Alexandrite 755 nm: Coagulation and hemostasis of vascular lesions and the removal and permanent reduction of unwanted hair in Fitzpatrick skin types 1VI, including suntanned skin types; Pigmented lesions; Wrinkles. Nd: YAG 1320 nm: General surgery and dermatology for the incision, excision, ablation, vaporization, coagulation and hemostasis of soft tissue; Treatment of periorbital and periocular wrinkles, fine lines and wrinkles, treatment of back acne and atrophic acne scars. IPL: Permanent hair reduction; Photocoagulation of dermatological vascular lesion (i.e. face telangiectasia); Photothermolysis of blood vessels (treatment of facial and leg veins); Treatment of benign pigmented lesions.
Alabama, Connecticut, Florida, Georgia, Illinois, Maine, Maryland, Massachusetts, Michigan, Minnesota, Missouri, New Hampshire, New Jersey, New York, North Carolina, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Vermont, Virginia, Wisconsin, and District of Columbia
Woodstock All Natural Tamari Almonds, 7.5 OZ in a gusseted re-sealable poly bag.
67 cases, each containing 8 packages per shipping case
Undeclared soy ingredient on mislabeled back panel.  While the Tamari Almonds contain soy, the ingredient statement does not include soy.  In addition, the nutrition facts and UPC# are incorrect which corresponds to another almond product. People who have an allergy or severe sensitivity to soy run the risk of serious or life-threatening allergic reaction if they consume this product.
Divalproex Sodium Delayed-Release Tablets, USP, 500 mg Valproic Acid Activity, 100-count tablets per bottle, Rx only, Manufactured by Upsher-Smith Laboratories, Inc., Minneapolis, MN 55447, NDC 0245-0182-11.
Labeling: Label Error On Declared Strength; Some bottles of product were missing the color-coded strength on the primary display panel of the label.