Blood products, collected using a scale for which the quality control results were not documented, were distributed.
Red Blood Cells Leukocytes Reduced Irradiated
Blood products, which may have reached unacceptable temperatures during shipment, were distributed.
WHOLE PAWS (TM), MAINTENANCE FORMULA, CHICKEN AND BROWN RICE RECIPE, dog food, NET WT 6 LBS, UPC 0 99482 44710 6
Lot Number: BEST BY TD2 09 NOVEMBER 2014
A sample of one lot of product was found to contain levels of thiamine below the FDA recommended limit.
Coconut Bun, NET WT. 4 OZ.  Product is packaged in an uncoded, plastic bag with green font.  MADE BY GOLDEN KING BAKERY, INC.  90 Bowery New York, NY 10013 212-680-0138.
The product was found to contain Undeclared Egg  based on samplings and analyses by New York State Department of Agriculture & Markets
The Synthes Mandible External Fixator; all lots of part nos.:    04.305.003  04.305.004  04.305.005  04.305.010  04.305.011  04.305.012  03.305.006  04.305.100  04.305.101  04.305.102  04.305.103  04.305.128  04.305.130  04.305.134  04.305.138  04.305.140  04.305.142  03.305.105  03.305.500  03.305.500S    Intended to stabilize and provide treatment for fractures of the maxillofacial area, including severe open mandibular fractures, highly comminuted closed fractures, nonunions and delayed unions (especially associated with infection), fractures associated with infections, tumor resections, facial deformity corrections, gunshot wounds, pan facial fractures, burn maintenance, and bone grafting defects.
Under new testing protocols for MR Environment safety and compatibility, metal devices are no longer designated MR Safe. Some components in the CMF Mandible External Fixator Systems were labeled and/or etched with information indicating they are MR Safe.  They can no longer be labeled MR Safe
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Bologna & Cheese, Net Wt. 3.00 oz., UPC 7-01248-00309-9, MFG Code 1038; Thick Bologna & Cheese, Net Wt. 4.50 oz., UPC 7-01248-00913-7, MFG Code 258
Chicken Salad on White Bread, Net Wt. 4.00 oz., UPC 7-01248-00104-9, MFG Code 105; Deluxe Chicken Salad on Toast, Net Wt. 5.00 oz., UPC 7-01248-01019-5, MFG Code 1716; Chicken Salad on White, Net Wt. 4.30 oz., UPC 7-01248-01101-7, MFG Code 1817
Combo Sandwich (Ham, Bologna & Cheese), Net Wt. 4.00 oz., UPC 7-01248-00532-0, MFG Code 638
Ham & Cheese on Wheat, Net Wt. 3.00 oz., UPC 7-01248-00827-7, MFG Code 1035; Ham & Cheese on Wheat, Net Wt. 3.80 oz., UPC 7-01248-01095-9, MFG Code 1811
Fresh Bites Pimento Cheese, Net Wt. 3.50 oz., UPC 7-01248-00114-8, MFG Code 115
Turkey & Swiss on Wheat Bread, Net. Wt. 4.00 oz., UPC 7-01248-00531-3, MFG Code 637; Turkey and Swiss on 100% Whole Wheat, Net Wt. 5.25 oz., UPC 7-01248-01062-1, MFG Code 1776
Chicken, Egg and Cheese Biscuit, Net. Wt. 6.10 oz., UPC 7-01248-01003-4, MFG Code 1712
Country Link Sausage (on bun), Net Wt. 3.50 oz., UPC 7-01248-00120-9, MFG Code 121
Jumbo Breakfast (Sausage, Ham, Egg & Cheese on Bun), Net Wt. 5.25 oz., UPC 7-01248-00507. MFG Code 607
Twin Ham Biscuits, Net Wt. 2.50 oz. and 3.00 oz., UPC 7-01248-00124-7, MFG Code 125
Deli Ham and Cheese, Net Wt. 6.00 oz. , UPC 7-01248-00518-4, MFG Code 618
Cheese Cubes with Crackers (Vac Pack), Net Wt. 3.50 oz., UPC 7-01248-00160-5, MFG Code 1049
Ham & Turkey Hoagie, Net Wt. 5.30 oz., UPC 7-01248-00148-3, MFG Code 166
Philly-Style Cheese Steak, Net Wt. 5.75 oz., UPC 7-01248-00194-0, MFG Code 237
Barbecue Chicken (on bun), Net Wt. 4.60 oz., UPC 7-01248-00144-5, MFG Code 162
Double Cheese Dogs, Net WT., 6.40 oz., UPC 7-01248-00802-4, MFG Code 650
Bacon Cheese Burger, Net Wt. 3.50 oz., UPC 7-01248-01049-2, MFG Code 1761; Jumbo Bacon Cheeseburger, Net Wt. 5.20 oz., UPC 7-01248-01080-5, MFG Code 1795; Junior Bacon Cheeseburger, Net Wt., 3.40 oz. UPC 7-01248-01079-9, MFG Code 1794
Grilled Cheese, Net. Wt. 1.65 oz., UPC 7-01248-00883-3, MFG Code 1593
Pork Ribette (on Bun), Net Wt. 6.00 oz., UPC 7-01248-00805-5, MFG Code 653
Skippy Peanut Butter and Grape Jelly w/White Bread Net Wt. 1.50 oz., UPC 7-01248-01114-7, MFG Code 1597
Deluxe Caesar Salad, Net Wt. 3.24 oz.,UPC 7-01248-00946-5, MFG Code 1655; Caesar Salad, Net Wt., 3.25 oz., UPC 7-01248-01028-7, MFG Code 1740; Caesar Salad, Net Wt. 3.25 oz., UPC 7-01248-00623-5, MFG Code 1522
Ham & Cheese Omelet on Toast w/Hash Brown, Net Wt. 7.25 oz., UPC 7-01248-00955-7, MFG Code 1664
Potato Wedges, Net Wt. 5.50 oz. UPC 7-01248-00924-5, MFG Code 1636
Apple Cobbler, Net Wt. 3.75 oz., UPC 7-01248-01041-6, MFG Code 1729
Jello with Fruit, Net Wt. 7050 oz., UPC 7-01248-01026-3, MFG Code 1738
Broccoli & Cauliflower with Buttermilk Ranch Dressing, Net Wt. 2.50 oz., UPC 7-01248-01069-0, MFG Code 1784
Stawberry Yogurt & Granola, Net Wt. 8.50 oz, UPC 7-01248-01040-9, , MFG Code 1752
Robust Spaghetti w/Meat Sauce, Net Wt. 8.00 oz., UPC 7-01248-00806-2, MFG Code 1560
Zesty Chicken Parmigiana w/Spaghetti, Net Wt. 9.50 oz., UPC 7-01248-00808-6, MFG Code 1562
Macaroni & Cheese w/Smoked Sausage, Net Wt. 7.50 oz., UPC 7-01248-01020-5, MFG Code 1717
French Toast w/Sausage, Net Wt. 4.00 oz., UPC 7-01248-00607-5, MFG Code 1506
Cheesy Eggs w/Link Sausage & Dinner Roll, Net Wt. 7.50 oz., UPC 7-01248-00619-8, MFG Code 1518
Bologna and Cheese on White, Net Wt. 4.80 oz., UPC 7-01248-01106-2, MFG Code 1821
Bologna and Cheese Sub, Net Wt. 6.75 oz., UPC 7-01248-01108-6, MFG Code 1823
Chicken Salad on Wheat, Net Wt. 4.00 oz., UPC 7-01248-00809-3, MFG Code 1563; Chicken Salad on Wheat, Net Wt. 4.30 oz., UPC 7-01248-01102-4, MFG Code 1818
Chicken Salad Croissant, Net Wt. 5.75 oz., UPC 7-01248-00918-2, MFG Code 1632
Gourmet Sub (Ham, Bologna & Cheese), Net Wt. 4.00 oz., UPC 7-01248-00307-4, MFG Code 1048
Ham & Cheese on White, Net Wt. 3.00 oz., UPC 7-01248-00301-2, MFG Code 1034; Ham & Cheese on White, Net Wt. 3.80 oz., UPC 7-01248-01096-6, MFG Code 1812; Grilled Ham & Cheese Sandwich, Net Wt. 3.00 oz., UPC 7-01248-00156-8, MFG Code 270
Ham & Cheese on Bun, Net Wt. 3.70 oz., UPC 7-01248-01050-8, MFG Code 1762
Ham & Cheese Club, Net Wt. 6.50 oz., UPC 7-01248-01018-8, MFG Code 1715
Ham & Cheese Croissant, Net Wt. 5.50 oz., UPC 7-01248-01097-3, MFG Code 1813
Ham & Cheese Pretzel Roll, Net Wt. 7.50 oz., UPC 7-01248-01082-9, MFG Code 1798
Shaved Ham & Cheese, Net Wt. 4.00 oz., UPC 7-01248-00100-1, MFG Code 101
Turkey on Wheat, Net Wt. 3.40 oz., UPC 7-01248-00110-1, MFG Code 111
Fried Bologna & Egg on Bun, Net Wt. 5.40 oz., UPC 7-01248-00804-8, MFG Code 652
Sausage & Egg (on bun), Net Wt. 3.75 oz., UPC 7-01248-00130-8, MFG Code 131
Sausage, Egg & Cheese Croissant, Net Wt. 5.00 oz., UPC 7-01248-00523-8, MFG Code 623
Twin Sausage Biscuits, Net Wt. 3.50 oz., UPC 7-01248-00126-1, MFG Code 127
Two 1/2 Foot Ham & Turkey Sub, Net Wt. 11.30 oz., UPC 7-01248-00939-7, MFG Code 1648
Two 1/2 Foot Turkey & Cheese Hoagies, Net Wt. 11.50 oz., UPC 7-01248-00950-2, MFG Code 1659
Barbecue Beef, Net Wt. 4.30 oz., UPC 7-01248-00176-6, MFG Code 294
Chicken Fillet w/Swiss Cheese (on bun), Net Wt. 5.50 oz., UPC 7-01248-00150-6, MFG Code 168
Double Cheeseburger, Net Wt. 5.20 oz., UPC 7-01248-00140-7, MFG Code 158; Cheeseburger, Net Wt. 3.50 oz., UPC 7-01248-00306-7, MFG Code 1037
Fried Bologna Sandwich (on bun), Net Wt. 3.80 oz., UPC 7-01248-00329-6, MFG Code 275
Fried Chicken Leg Quarter w/Bone on Bread, Net Wt. 7.00 oz., UPC 7-01248-01046-1, MFG Code 1758
Fried Chicken w/Bone Sandwich, Net Wt. 9.50 oz., UPC 7-01248-00333-3, MFG Code 284
Fried Red Hot Link w/Cheese on Bun, Net Wt. 3.50 oz., UPC 7-01248-01048-5, MFG Code 1760
Hot Smoked Sausage on Bun, Net Wt. 3.70 oz., UPC 7-01248-010857-7, MFG Code 1769
Single All Beef Hot Dog, Net Wt. 2.50 oz., UPC 7-01248-00172-8, MFG Code 286
Single Plain Hot Dog, Net Wt. 2.50 oz., UPC 7-01248-00837-6, MFG Code 283; Single Plain Hot Dog, Net Wt., 2.10 oz., UPC 7-01248-00837-6, MFG Code 283
Smoking Joe (Smoked Sausage on Bread), Net Wt. 5.25 oz., UPC 7-01248-00122-3, MFG Code 123
Spicy Chicken Sandwich, Net Wt. 5.15 oz., UPC 7-01248-00940-3, MFG Code 1649
Deluxe Chef Salad, Net Wt. 5.10 oz., UPC 7-01248-00944-1, MFG Code 1653; Chef Salad, Net Wt. 5.10 oz, UPC 7-01248-00603-7, MFG Code 1502
Deluxe Garden Salad, Net Wt. 5.80 oz., UPC 7-01248-00945-8, MFG Code 1654; Garden Salad, Net Wt. 5.80 oz., UPC 7-01248-01027-0, MFG Code 1739; Garden Salad, Net Wt. 5.80oz,, UPC 7-01248-00323-4, MFG Code 280
Deluxe Italian Salad, Net Wt. 5.50 oz., UPC 7-01248-00927-4, MFG Code 1596
BBQ Chicken on 100% Wheat Roll w/Baby Carrots, Net Wt. 7.80 oz., UPC 7-01248-010775-5, MFG Code 1792
Ham & Swiss on Sourdough, Net. Wt. 6.10 oz., UPC 7-01248-00916-8, MFG Code 1630
Chicken Finger Sub w/Potato Wedges, Net. Wt. 8.75 oz., UPC 7-01248-00903-8, MFG Code 1619
Ham & Swiss on Sourdough w/Baby Carrots, Net. Wt. 10.30 oz., UPC 7-01248-00957-1, MFG Code 1666
Jumbo Chili Cheese Burger w/ Potato Wedges, Net. Wt. 9.75 oz., UPC 7-01248-00904-1, MFG Code 1620
Sausage & Egg on Croissant w/Hash Brown Patty, Net. Wt. 7.00 oz., UPC 7-01248-00961-1, MFG Code 1670
Chicken Finger Sub w/Honey Mustard Sauce, Net. Wt. 5.35 oz., UPC 7-01248-01015-7, MFG Code 1719
Ham & Turkey on Multi Grain, Net. Wt. 10.00 oz., UPC 7-01248-01016-4, MFG Code 1728
Turkey & Swiss on 12 Grain, Net. Wt. 6.75 oz., UPC 7-01248-01017-1, MFG Code 1714
Egg Salad on White, Net. Wt. 3.30 oz., UPC 7-01248-01103-1, MFG Code 1819
Turkey and Cheese on Wheat, Net. Wt. 3.80 oz., UPC 7-01248-01091-1, MFG Code 1807
Turkey and Cheese on White, Net. Wt. 3.80 oz., UPC 7-01248-01090-4, MFG Code 1806
All American Hoagie w/Turkey Ham, Bologna & Cheese, Net. Wt. 7.75 oz., UPC 7-01248-01087-4, MFG Code 1803
BBQ Pork on Bun, Net. Wt. 5.35 oz., UPC 7-01248-00880-2, MFG Code 1587
Buffalo Chicken Salad on 100% Whole Wheat Roll, Net. Wt. 5.50 oz., UPC 7-01248-01061-4, MFG Code 1775
Deluxe Chicken Salad on 100% Whole Wheat Roll, Net Wt. 5.30 oz., UPC 7-01248-016063-8, MFG Code 1777
Deli Ham and Cheese on Marble Rye, Net Wt. 5.55 oz., UPC 7-01248-01094-2, MFG Code 1810
Grilled Chicken Croissant, Net Wt. 6.00 oz., UPC 7-01248-01098-0, MFG Code 1814
Grilled Chicken Pretzel Roll, Net Wt. 7.00 oz., UPC 7-01248-01082-9, MFG Code 1798
Ham and Cheese Sub, Net Wt. 6.75 oz., UPC 7-01248-01109-3, MFG Code 1824
Oven Roasted Turkey & Cheese on Wheat Sub, Net Wt. 6.50 oz., UPC 7-01248-01112-3, MFG Code 1827
Oven Roasted Turkey Breast on Pretzel Roll, Net Wt. 6.75 oz., UPC 7-01248-01081-2, MFG Code 1797
Sunrise Sandwich (French Toast, Sausage & Egg), Net Wt. 3.60 oz., UPC 7-01248-01059-1, MFG Code 1773
Turkey and Provolone on Marble Rye, Net Wt. 4.55 oz., UPC 7-01248-01088-1, MFG Code 1804
Turkey and Provolone on Whole Wheat Sub, Net Wt. 8.00 oz., UPC 7-01248-01104-8, MFG Code 1820
Turkey and Swiss on Croissant, Net Wt. 5.50 oz., UPC 7-01248-01092-8, MFG Code 1808
Turkey and Swiss Sub, Net Wt. 6.75 oz., UPC 7-01248-01093-5, MFG Code 1809
Blazing Sausage Dog, Net Wt. 5.50 oz., UPC 7-01248-01065-2, MFG Code 1780
Fried Chicken Strips Hero, Net Wt. 5.80 oz., UPC 7-01248-01110-9, MFG Code 1825
Ham and Cheese Omelet on Toast, Net Wt. 5.25 oz., UPC 7-01248-01078-2, MFG Code 1793
Turkey Breast & Bacon on Wheat (Wedge), Net Wt. 4.80 oz. UPC 7-01248-01072-0, MFG Code 1787
Blueberry Crunch Cake, Net Wt. 4.50 oz. UPC 7-01248-01037-9, MFG Code 1749
Cherry Crunch Cake, Net Wt. 4.50 oz. UPC 7-01248-01038-6, MFG Code 1750
Peach Cobbler, Net Wt. 5.10 oz. UPC 7-01248-00848-2, MFG Code 695
Strawberry Shortcake, Net Wt. 5.25 oz. UPC 7-01248-00549-8, MFG Code 648
Carrots with Buttermilk Ranch Dressing, Net Wt. 2.50 oz. UPC 7-01248-01070-6, MFG Code 1785
Celery with Peanut Butter, Net Wt. 2.50 oz. UPC 7-01248-01071-3, MFG Code 1786
Honeydew Melon, Net Wt. 3.75 oz. UPC 7-01248-01074-4, MFG Code 1789
Strawberries, Net Wt. 2.50 oz. UPC 7-01248-01067-6, MFG Code 1782
Ham Omelet with Dinner Roll, Net Wt. 5.80 oz., UPC 7-01248-00855-0, MFG Code 1582
Pancake w/Sausage, Net Wt. 4.50 oz., UPC 7-01248-00628-1, MFG Code 1528
Sausage & Egg w/Rice, Net Wt. 7.50 oz., UPC 7-01248-00609-9, MFG Code 1508
Chicken Tenders, Net Wt. 8.00 oz., UPC 7-01248-00942-7, MFG Code 1651
Ham & Cheddar on 100% Whole Wheat Roll, Net Wt. 5.30 oz., UPC 7-01248-01060-7, MFG Code 1774
Western Omelet, Net WT. 8.25 oz., UPC 7-01248-00650-1, MFG Code 1551
Pimento Cheese on White, Net Wt. 4.30 oz., UPC 7001248-01099-7, MFG Code 1815
Single Hot Dog w/Chili, Net Wt., 3.10 oz., UPC 7-01248-00800-0, MFG Code 285
Worldwide Distribution - USA (nationwide) and Internationally to  Canada, Algeria, Argentina, Australia, Austria, Bahrain, Belgium, Brazil, China, Czech Republic, Denmark, Dominican Republic, Egypt, Finland, France, Gabon, Germany, Greece, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Lebanon, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Norway, Oman, Palestine, Panama, Philippines, Poland, Portugal, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Thailand, Turkey, Ukraine, United Arab Emirates, United Kingdom, United Kingdom, and Viet Nam.
BrightView model number: 882478 BrightView X model number: 882480  BrightView XCT model number: 882482 and 882454    Medical Device for imaging
Unintended detector and gantry movement due to software issues.
LaBree's Bakery Chocolate Chip Mini Muffins, 12 pack.  Net wt. 10 oz. packaged in plastic clamshell. Frozen  Product Code: 7778
PA, NY, MI, AL, NJ, FL, KY, OH, MN, MA, DE, VT, and MS CA, IN, IL, MD, VA.
Gastrotec (Omeprazole 2.28 g / Misoprostol 1.4 mg.)
Gastrotec, must have an approved new animal drug application to be legally marketed in the United States. Gastrotec is not approved by the FDA.
American National Red Cross Southeastern Michigan Region
Blood products, which were not quarantined subsequent to receiving information regarding a post donation illness, were distributed.
Blood products, collected from a donor for whom there was no documentation of an arm inspection, were distributed.
Blood products, which were not quarantined subsequent to receiving information regarding unexplained weight loss, were distributed.
American Red Cross Blood Services Heart of America Region
Platelets Pheresis Leukocytes Reduced Irradiated
Blood products, in which Quality Control and Distribution of products did not meet specifications, were distributed.
US Distribution to the states of : IL, MI, NY, CA, VA and NV.
Verasense Knee System, Model SYK-TRCR 02.  Intelligent disposable tibial insert that measures dynamic loads during orthopedic knee surgery.
Presence of one inoperable (&quot;dead&quot;) sensor pad.
Blood products, collected from a donor with a history of high risk behaviors, were distributed.
Oklahoma Blood Institute - Sylvan N Goldman Center
Blood products, which did not meet the acceptable product specifications, were distributed.
Blood product, not prepared according to  specifications, was distributed.
Blood product, collected from a donor with a history of incarceration, was distributed.
USA including AK, IL, WA, MA, NY, WV, NC, TX, CA, PA and Internationally to Germany, Netherlands, Belgium, Switzerland, Saudi Arabia, Egypt.
Airo Mobile Intraoperative CT I Airo; Model #: MobiCT-32
21 devices distributed.  15 of these devices affected by the software v. 1.1.1+ patch
There is a risk that during the transfer of an image and navigation data to the Brainlab Curve Image Guided Surgery Navigation System after a CT scan, an error may occur, causing either no navigation data or incorrect navigation data being transferred to the curve.
Red Blood Cells Leukocytes Reduced Irradiated Washed
Blood products, labeled with an incorrect expiration date, were distributed.
Blood and Blood Products for Reprocessing
Blood product, which were collected from a donor in which donor suitability was not adequately determined, was distributed.
Blood products, which were labeled as leukoreduced, but were not tested to verify the White Blood Cell count, were distributed.
Worldwide Distribution -- US and Canada.
2.0 Mandible Locking Plate (MLP) Bender / Cutter (part number 329.143)   Intended to be used for bending and/or cutting Mandible Locking Plates.
Certain lots have the potential for tip breakage while bending 2.0 mm thick plates.  If device is used and breaks while in the Operating Room, surgical delay may occur while alternate bending or cutting instruments are located.
ASSY, POWER SUPPLY 130V 50HZ.  This component is used with the following machines: 2008T Hemodialysis Machine, 2008K Hemodialysis Delivery Equipment, 2008 K2 Hemodialysis Delivery Equipment 2008K@home Hemodialysis Delivery System
Unqualified power assemblies shipped to customers.
Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
Nationwide in US and Puerto Rico.   World Wide: Albania, Algeria, Australia, Austria, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia-Herzegovina, Botswana, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyrus, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, Eritrea, Ethiopia, Finland, France, Germany, Ghana, Gibraltar, Greece, Guadeloupe, Guam, Honduras, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Jordan, Kazakhstan, Kenya, Korea, Kuwait, Lebanon, Lesotho, Liberia, Libyan Arab Jamahiriya, Lithuania, Malawi, Malaysia, Mexico, Morocco, Mozambique, Myanmar, Namibia, Netherlands, New Zealand, Nigeria, Oman, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Serbia, Sierra Leone, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Viet Nam, Zambia, and Zimbabwe
Beckman Coulter, Lipase Assay, Catalog No. OSR6X30
Beckman Coulter has recently confirmed that N-Acetyl Cysteine (NAC), when administered in therapeutic concentrations for the treatment of acetaminophen overdose, interferes with the assays for the following analytes: Cholesterol OSR6X16, Uric Acid OSR6X98, Lactate OSR6X93, and Lipase OSR6X30.  NAC interference may lead to falsely low results.
Beckman Coulter, Uric Acid Assay, Catalog No. OSR6X98
Beckman Coulter, Cholesterol Assay, Catalog No. OSR6X16
Beckman Coulter, Lactate Assay, Catalog No. OSR6X93
Product was distributed to: CA, CO, FL, GA, IA, IL, IN, MD, MI, MN, MO, MS, OH, OR, PA, TN, TX, VA, WI and Puerto Rico
Virbac Clintabs Tablets, clindamycin hydrochloride tablets, USP, 25 mg., packaged in 400-count bottles, For Use in Dogs Only, RX, ANDA #200-316, NDC 051311-400-40.  Mfd. for Virbac AH, Inc., Fort Worth, TX.
Virbac Clintabs Tablets, clindamycin hydrochloride tablets, USP, 75 mg., packaged in 200-count bottles, For Use in Dogs Only, RX, ANDA #200-316, NDC 051311-402-75.  Mfd. for Virbac AH, Inc., Fort Worth, TX.
Virbac Clintabs Tablets, clindamycin hydrochloride tablets, USP, 150 mg., packaged in 100-count bottles, For Use in Dogs Only, RX, ANDA #200-316, NDC 051311-404-15.  Mfd. for Virbac AH, Inc., Fort Worth, TX.
Portex Anaerobic Pulsator Arterial Blood Sampling Kit, with Liquid Sodium Heparin for Gases and Electrolytes Reorder Number: G1392      Product Usage:  The Arterial Blood Sampling Kit is intended for sampling arterial blood for the measurement of blood gasses, Cooximetry, electrolytes, total magnesium, and metabolites, (Glucose and Lactate
The outer box label is marked with the correct expiration date of 08/2016. The inner Tyvek Unit Label is marked with 08-2017 which exceeds the actual expiration date by one year.
AZ, CO, NH, TX, MS, AL, GA, NC, VA, NY, PA, MO, MN, KY, IL, WA
Market Pantry Brand Dark Chocolate Covered Almonds 9 oz., UPC 085239555644
The recalled lot code is: R4112D  Best Before Date: 7/4/2015
Product includes peanuts which are not declared on the label.
HEPFLUSH-10 (HEPARIN LOCK FLUSH SOLUTION, USP) 100 USP units per 10 mL (10 USP units per mL), Single Dose Vial, Rx only -- Fresenius Kabi USA, LLC  -- NDC 63323-017-10, Product Code 1710
Nationwide, United Arab Emirates, and Columbia
Fluconazole Injection, USP, 200 mg/100 mL (2 mg/mL), 100 mL Single-Dose INTRAVIA Container bag, packaged in 10 x 100 mL Single Dose INTRAVIA container bags per carton, Rx only, Baxter Healthcare Corporation, Deerfield, IL  60015 USA, NDC 0338-6046-48, Product Code 2J1446.
Lack of Assurance of Sterility: Complaints of leaks due to an incomplete seal at the bag seam.
VC150 Vital Signs Monitor (VC150 monitor equipped with Masimo SpO2 technique only); Innokas Medical CARESCAPE VC150 Rx Only Innokas Medical Oy. Catalog numbers 2067980-002, 2067980-006, 2067980-010, and 2067980-014.
If the SpO2 or RRa value is violating the respective alarm limit at the time of switching to monitoring mode, the monitor does not issue visual and audible alarms.
Product was distributed to: CA, FL, HI, IA, IN, MI, MN, MO, NE, OR, PA, TN, TX, WI, Guam and Puerto Rico.
Virbac Soloxine (levothyroxine sodium) Tablets, 0.1mg packaged in 250 and 1000 count bottles. NDC 051311-831-25. Virbac AH Inc., Fort Worth, TX.
Product missing expiration dates, lot numbers and the presence of a foreign tablet.
Virbac Soloxine (levothyroxine sodium) Tablets, 0.2mg., packaged in 250 count bottles. NDC 051311-832-25. Virbac AH Inc., Fort Worth, TX.
Product missing expiration dates and lot numbers
Virbac Soloxine (levothyroxine sodium) Tablets, 0.8mg., packaged in 250 and 1000 count bottles. NDC 051311-838-25. Virbac AH, Inc., Fort Worth, TX.
Miethke Shunt System accessories     Product Usage: - The Miethke Shunt System is intended to shut cerebrospinal fluid from the lateral ventricles of the brain into the peritoneum.
material numbers: FV400T FV401T  FV402T  FV403T  FV404T  FV405T  FV406T  FV407T  FV408T  FV409T  FV499T  FV790T  FV791T  FV792T  FV793T  FV794T  FV795T  FV796T
Some Miethke Shunt System accessories may have an incorrect MR safety symbol on the cardboard shelf box label.  The label should have NO symbol but instead is marked with the MR conditional symbol.  The product is actually MR unsafe but this information is only required to be in the Instructions for Use (IFU).
Product Code 2C4013, Four Lead TUR Irrigation Set, for use with UROMATIC Plastic Containers, Approximate Length 85'' (2.2 m)
Potential for failure of the pouch packaging seal at high altitudes.
Raw Milk Cheddar Cheese, packaged in 8-oz. blocks and 5-lb. loafs.
Product may be contaminated with Listeria monocytogenes
All consigness are located within the U.S. on a nationwide level.  The firm has no listed foreign consignees.
Obagi C-Cleansing Gel Lot Number: 13D1049  Product/Part Number 362032070544  Fill Size: 1L  Expiration Date: 04/2016    For Professional Use Only  Obagi Medical   C-Cleansing Gel  Deeply Cleans to Remove Makeup and Excess Oil  33.8 fl. oz. (1L)    Ingredients: water (aqua), sodium laureth sulfate, sodium lauroyl oat amino acids, cocamidopropyl betain, aloe barbadensis leaf juice (aloe barbadensis), ascorbic acid, glycerin, medicago sativa (alfalfa) extract, borago officinalis extract, chamomilla recutita (matricaria) flower extract (chamomilla recutita extract), sodium chloride, saponins, xanthan gum, phenoxyethanol, methylparaben, ethylparaben, butylparaben, propylparaben, isobutylparaben, fragrance (parfum), Red 33 (Cl 17200), Yellow 5 (Cl 19140)    Not For Retail Sale    The Obagi logo is a registered trademark of OMP, Inc.  Distributed by OMP, Inc., Long Beach, CA 90806    Product is packaged into a  plastic pre-labeled bottle containing all labeling information.
Lot Number: 13D1049 Product/Part Number 362032070544  Fill Size: 1L  Expiration Date: 04/2016
The firm is conducting a recall of Obagi C-Cleansing Gel 1L lot #13D1049 product/part number 362032070544 expiration date 04/2016 due to the product Obagi Gentle Cleanser lot #13D1049 being packaged in the pre-labeled C-Cleansing Gel bottles in error.
Groove Gluten-Free Chocolate Chip Cookie & French Vanilla Ice Cream Sandwich.  The product is sold in 3 fl. oz. single packs and 6 fl. oz. 2-packs and labeled as Groove.     The UPC codes are 8 52692 00404 6 and 8 52692 00400 8.
431/3 fl oz packages and 1,578/6  fl oz package
Groove Gluten-Free Ice Cream Sandwich products are recalled due to the potential to be contaminated with Listeria monocytogenes. This product contains custard ice cream base, produced and recalled by Snoqualmie Gourmet Ice Cream, Inc., as an ingredient.
Groove Gluten-Free Dark Chocolate Cookie & French Vanilla Ice Cream Sandwich.  The product is sold in 3 fl. oz. single packs and 6 fl. oz. 2-packs and labeled as Groove.     The UPC codes are 8 52692 00405 3 and  8 52692 00403 9.
137/ 3 fl oz packages and 1009/6 fl oz packages
Groove Gluten-Free Oatmeal Raisin Cookie & French Vanilla Ice Cream Sandwich.  The product is sold in 3 fl. oz. single packs and 6 fl. oz. 2-packs and labeled as Groove.     The UPC codes are 8 52692 00406 0 and 8 52692 00402 2.
171/3 fl oz packages and 353/6 fl oz packages
Groove Gluten-Free Peanut Butter Cookie & French Vanilla Ice Cream Sandwich.  The product is sold in 3 fl. oz. single packs and 6 fl. oz. 2-packs and labeled as Groove.     The UPC codes are 8 52692 00407 7 and 8 52692 00401 5.
116/3 fl oz packages and 243/6 fl oz packages
Groove Gluten-Free Ice Cream Sandwich products are  recalled due to the potential to be contaminated with Listeria monocytogenes. This product contains custard ice cream base, produced and recalled by Snoqualmie Gourmet Ice Cream, Inc., as an ingredient.
Groove Gluten-Free Dark Chocolate Cookie & French Chocolate Ice Cream Sandwich.  The product is sold in 3 fl. oz. single packs and 6 fl. oz. 2-packs and labeled as Groove.     The UPC codes are 8 52692 00406 0 and 8 52692 00403 2
64/ 3 fl oz packages and 399/6 fl oz packages
Groove Gluten-Free Peanut Butter Cookie & French Chocolate Ice Cream Sandwich.  The product is sold in 3 fl. oz. single packs and 6 fl. oz. 2-packs and labeled as Groove.     The UPC codes are 8 52692 00411 4 and 8 52692 00410 7
38/3 fl oz packages and 470/6 fl oz packages
Groove Gluten-Free  Ice Cream Sandwich products are  recalled due to the potential to be contaminated with Listeria monocytogenes. This product contains custard ice cream base, produced and recalled by Snoqualmie Gourmet Ice Cream, Inc., as an ingredient.
US Distribution to the states of CA, FL, IL, NY, UT and WA.
The Revolution CT is a multi-slice (256 detector row) CT scanner consisting of a gantry, patient table, scanner desktop (operator console), system cabinet, power distribution unit (POU). and interconnecting cables.The system includes image acquisition hardware, image acquisition and reconstruction software, and associated accessories.
A required quality control test was not performed during installation associated with the software of the Revolution CT scanner.
Worldwide Distribution - USA (nationwide) and the countries of : Canada, Finland, Estonia, Belgium, Ireland, Sweden, France, Switzerland, Spain, Netherlands, Middle East, Scotland, Germany and Wales.
Ebb Complete Tamponade System, BD-OTS Obstetric Catheter, REF CTS-1000, Rx Only, Sterile EO
Potential for a balloon leak in all lots of (CTS-1000) manufactured since August 2014.
Nationwide Distribution in the states of CO and  ME.
Zippie Zone Pediatric Rigid Wheelchair Model EIRZ1.
There is the potential for the height adjustable handle to dislodge due to failing locking mechanisms on specific identified chairs.
Quickie Q7 Adult Rigid Wheelchair Model EIR4
Chopped walnuts packaged in 8 oz. (226 g) plastic bags under the Fisher brand.
Pecan cookie pieces packaged in 8 oz. (226 g) plastic bags under the Fisher brand.
Domestic: AL, AZ, CA, CO, CT, FL, GA, IL, KY, MA, MI, MO, MS, NC, NE NJ, NY, OH, OR, PA, TN, TX, UT, VA, WA, WI, WV.   Foreign: None    Foreign:
Thera Tablets with Beta Carotene Dietary Supplement
Lot Number:  M-00953 Expiration Date: 06-2015, UPC Code:  3 09040 53961 8
The firm received a complaint that the blister packets were missing labeling information on 12/16/2014, the firm investigated the labeling complaint and found that six 2 x 5 blister cards inside a carton was missing some or all of the product information on the back of the blister card.
Product may be contaminated with Salmonella
Propofol Injectable Emulsion, 1%, 200 mg/20 mL, (10mg/mL), 20 mL, Single patient infusion vial, Contains Benzyl Alcohol, For I.V. Administration, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4699-30
Presence of Particulate Matter: The firm received a complaint of an embedded particulate in the neck of one vial composed primarily of iron.
Syngo RT Therapist: The intended use of the SIEMENS branded ARTISTE, ONCOR  and PRIMUS family of linear accelerator systems is to deliver X-Ray photon and electron radiation for the therapeutic treatment of cancer
Combination of CTVision with syngo RT Therapist / syngo RT Oncologist 4.3.SP1 automatic registration in Adaptive Targeting might result in wrong offset calculations. Applying this offset can lead to patient mistreatment.  Cone Beam imaging is not affected by this problem.
Jumbo, In-shell, Bulk Hazelnuts packed in 50-lb poly weave plastic sacks.  No UPC.
840 / 50 lb sacks; approximately 42,000 lbs.
Product recalled due to the finding of Salmonella.
The affected product was at one store location in GA.
Raw, Shelled Hazelnuts, sold in self-serve bulk bins.
Product confirmed positive result for Salmonella.
HomeChoice/HomeChoice Pro Automated Personal Cycler, for Automated Peritoneal Dialysis. Product codes 5C8310, 5C8310R, R5C8320, and 5C4474.
The keypad buttons on HomeChoice devices may be activated without the operator pressing them.
Arrow Select Kits (ASK), Maximal Barrier Precautions Kits (CDC) and Arterial Catheterization Kit (NA) with Biopatch Dressing
Certain product codes and lot numbers of the Arrow Select Kits (ASK), Maximal Barrier Precautions Kits (CDC) and Arterial Catheterization Kit (NA) with Biopatch&reg; Dressing were packaged with the incorrect size Biopatch&reg; Dressing. No risk to patients is anticipated.
Syngo.plaza: Syngo.plaza is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images.  It supports the physician in diagnosis and treatment planning.  Syngo.plaza also supports storage and archiving of DICOM Structured reports.   In a comprehensive imaging syngo.plaza integrates Hospital/Radiology Information Systems (HIS/RIS) to enable customer specific workflows.   Syngo.plaza optionally uses a variety of advanced postprocessing applications
In case of a system crash, images may not be written to the hard disk and this may result in inconsistencies in the database. In case of a system crash (e.g. blue screen, power outage) images may not be written from cache to the hard disk and might get lost.