Recalling Firm
Lifesouth Community Blood Centers - Montgomery Region
American National Red Cross (The) - North Central Region
Micro Therapeutics Inc, Dba Ev3 Neurovascular

Initial Firm Notification of Consignee or Public
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Distribution Pattern
Nationwide and internationally via internet sales.
Worldwide Distribution - USA Nationwide Distribution in the states of: TN, MD, NY, IN, NJ, WA, VA,and the country of Canada.
Worldwide Distribution - US Distribution including the states of AZ, CA,GA, IL, IN, LA, MA, MI, NY, NC, OH, PA, TN, TX and WI and the countries of Australia, Austria, Belgium, Brazil, Chile, Czech Republic, France, Germany, Italy, Japan, Malaysia, Netherlands, Norway, Philippines, Poland, Russian Federation, Singapore, South Africa, Spain, Sweden, Switzerland, Thailand, Turkey and United Kingdom.
Worldwide Distribution - USA and countries of United Arab Emirates, Argentina, Austria, Australia, Belgium, Brazil, Canada, Switzerland, Chile, Columbia, Costa Rica, Germany, Dominican Republic, Spain, France, Great Britain (UK), Greece, Hong Kong, Ireland, Israel, India, Italy, Japan, Korea (South), Lebanon, Liechtenstein, Lithuania, Mexico, Netherlands, Poland, Portugal, Paraguay, Saudi Arabia, Sweden, Singapore, Turkey, Taiwan, Uruguay, Vietnam and South Africa.
CA, FL, GA, IN, MA, NC, NV, NJ, NY, PA, VA, WA and Canada
Worldwide Distribution:US ( Nationwide) Including stages of MI, OR, PA, TX & WV; and Countries of: Australia, Bangladesh, Belgium, Brazil, Bulgaria, China, France, Germany, India, Indonesia, Ireland, Japan, Nicaragua, Oman, Palestine, Russia, South Korea, Spain, Switzerland, Thailand, Turkey & United Kingdom.
USA Nationwide Distribution in the states of: AR, AZ, CA, CO, FL, ID, MD, MI, NC, NV, OK, OR, PA, TX, VA, WI
USA Nationwide Distribution in the states of North Carolina and South Carolina
US Distribution to states of: IN, MD, and TN.
Worldwide Distribution-USA (nationwide) and the countries of Canada, Mexico, and Colombia.
Nationwide. No distribution outside the US.
Nationwide Distribution - USA including the states of CA, FL, IL, IN, KY, MD,SC, and TX.
AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA , IL, IN, KS, MA, MD, ME, MI, MT, NC NH, NJ , NJ, NM , NV, NY, OH, OR, PA , RI, SC, TN, TX, UT, VT, WA, WI, WY.
United States including: AL, AZ, CA, FL, GA, IL, KS, KS, NM, NY, OH, OK, SD, TX, UT, WA, and WI.
Canada only; no product distributed in the USA
Worldwide Distribution - USA, and the countries of Australia, Argentina, Canada, China, Cambodia, Columbia, Japan, Ecuador, Japan, Korea, Hong Kong, India, Israel, Libya, Mexico, Nigeria, Peru, Russia, Thailand, Taiwan, Saudi Arabia and Singapore.
Worldwide Distribution-USA (nationwide) including Puerto Rico and the countries of Australia, Germany, France, UK, Turkey, Argentina, Canada, Colombia, Mexico, , Austria, Belgium, Denmark, Hungary, Italy, Netherlands, Norway, Poland, Portugal, Russia, Slovakia, Slovenia, Spain, Switzerland, and UAE.
One consignee - Medline Industries, Inc. HQ located in IL One Medline Place, Mundelein, Illinois 60060 1-800-MEDLINE. Products distributed Nationwide (AL, CA, CO,FL, GA, IL, MA, MO, NC, NY, OH, TX, and WA) to Medline Industries distribution centers.
California Bay area only to 38 retail location.
Product was shipped to two retailers in Kentucky.
Nationwide, including foreign, govt/VA/Military consignees.

Product Description
Red Blood Cells Leukocytes Reduced Irradiated
Prolifta Dietary Supplement Prolifta, 400mg/capsule, Packaged in 1 and 2 capsule blister packs and 4, 12, and 24 capsule bottles Made in the USA Distributed by: Prolifta LLC 1+877.239.8231 www.proliftaherbal.com.
PHUK Sexual Enhancement Ultimate Pleasure, 400mg/capsule, packaged in 1 and 2 capsule blister packs and 4,12,24 capsule bottles, Distributed by UME Supplements, INC www.phukherbal.com.
Virilis Pro, 450mg/capsule, Packaged in a 1 and 2 capsule blister packs and 10 capsule bottles, Manufactured for Haute Health Williamstown, NJ 08094 website: http://www.virilispro.com
1% Lidocaine HCl Injection, USP, 10 mg/mL, NDC 0409-4276-01, Hospira, Inc., Lake Forest, IL 60045.
Slim Fortune capsules Dietary Supplement. Each bottle contains 30 capsules.
Lidiy capsules Dietary Supplement. Each bottle contains 30 capsules.
Slim Expert softgel capsules Dietary Supplement. One month supply/ 30 softgels. 1 softgel - 650 mg.
Synthes CMF Battery Powered Driver, Part no. 305.840. Used to place screws in the cranialfacial bones, and to drill and/or tap holes to prepare cranialfacial bones for screw insertion.
The Synthes Hohmann Retractor, 43 mm Long Shank, Angled 235 mm Product Usage: Used to expose bone for procedures.
Brainlab, Spine & Trauma 3D 2.0, Navigation Software. An intraoperative image-guided localization system to enable minimally invasive surgery. Catalog Number: 22264
Red Blood Cells (Apheresis) Leukocytes Reduced
Blood and Blood Products for Reprocessing
Simply Lite brand 50% CaCao Low Carb Sugar Free Dark Chocolate (NET WT 3 oz (85g), packaged in a brown plastic foil wrapper. Produced by Simply Natural Foods, LLC. 74 Mall Drive Commack, New York 11725.
Ingenuity Core 128, Computed Tomography X-ray systems, Philips Medical Systems (Cleveland), Inc.
Strawberry Fruit Bar, 3 oz., Helados La Tapatia Fresno, CA 93706
Lemon Fruit Bar, 3 oz.,. Also packaged in six pack box. Helados La Tapatia Fresno, CA 93706
Pineapple Fruit Bar, 3 oz.,. Also packaged in 9 oz. cup, 4 oz. HLT packaged for Canadian distribution and 4 pack 9 oz. cups. Helados La Tapatia Fresno, CA 93706
Tamarindo Fruit Bar, 3 oz.,. Also packaged in 9 oz. cup and Bolis 4 oz. Helados La Tapatia Fresno, CA 93706
Bubblegum Fruit Bar, 3 oz.,. Also packaged in six pack boxes and Bolis 4 oz. Helados La Tapatia Fresno, CA 93706
Watermelon Fruit Bar, 3 oz.,. Also packaged in 9 oz. cups. Helados La Tapatia Fresno, CA 93706
Jamaica Fruit Bar, 3 oz.,. Helados La Tapatia Fresno, CA 93706
Guava Fruit Bar, 3 oz.,. Helados La Tapatia Fresno, CA 93706
Nance Fruit Bar, 3 oz.,. Helados La Tapatia Fresno, CA 93706
Pica de Gallo Fruit Bar, 3 oz.,. Helados La Tapatia Fresno, CA 93706
Chicle Fruit Bar,4 oz.,. Helados La Tapatia Fresno, CA 93706
Mandarina Fruit Bar,4 oz.,; also packaged in 9 oz. cups and 4 pack of 9 oz cups Helados La Tapatia Fresno, CA 93706
Pink Lemonade Fruit Bar,4 oz., Helados La Tapatia Fresno, CA 93706
Fresa Fruit Bar,4 oz.,; Also packaged as Bolis 4 oz. and 4 oz. milk bar. Helados La Tapatia Fresno, CA 93706
Lemon Lime (french) Fruit Bar,4 oz.,; Also packaged for Canada 4 oz. HLT. Helados La Tapatia Fresno, CA 93706
Lemonade 9 oz cups Also packaged in 4 pack 9 oz cups; Helados La Tapatia Fresno, CA 93706
Changunga/Nance 9 oz cups Helados La Tapatia Fresno, CA 93706
Elote 9 oz cups Helados La Tapatia Fresno, CA 93706
Cappuccino 9 oz cups Helados La Tapatia Fresno, CA 93706
Limon Bolis - 4 oz. Helados La Tapatia Fresno, CA 93706
Rompope Bolis - 4 oz.; Also packages in six pack boxes. (9 oz cups) Helados La Tapatia Fresno, CA 93706
Coco Bolis - 4 oz.; Also packaged in 4 oz. milk bars and ice cream container. Helados La Tapatia Fresno, CA 93706
Coffee Bolis - 4 oz. Helados La Tapatia Fresno, CA 93706
Mango c/chile Chamoy Bolis - 4 oz. Helados La Tapatia Fresno, CA 93706
Dozen Mix Bag Bolis - 4 oz. Helados La Tapatia Fresno, CA 93706
Coconut Frutero; Helados La Tapatia Fresno, CA 93706
Vanilla Ice Cream Sandwich Helados La Tapatia Fresno, CA 93706
Vanilla Sundae Cup. Helados La Tapatia Fresno, CA 93706
Strawberry Milk Bars, 3 oz. Also packaged as six pack boxes; Canada 4 oz. HLT and ice cream containers. Helados La Tapatia Fresno, CA 93706
Coconut Milk Bars, 3 oz. Also packaged as six pack boxes of 9 oz cups.. Helados La Tapatia Fresno, CA 93706
Chocolate Milk Bars, 3 oz; Also packaged as 4 oz, bars and in ice cream containers; Helados La Tapatia Fresno, CA 93706
Banana Milk Bars, 3 oz; Helados La Tapatia Fresno, CA 93706
Vanilla Milk Bars, 3 oz; Also packaged as Vanilla Ice Cream container. Helados La Tapatia Fresno, CA 93706
Walnut Milk Bars, 3 oz; Helados La Tapatia Fresno, CA 93706
Mango Milk Bars, 3 oz; also packed in ice cream containers and Canada 4 oz. HLT. Helados La Tapatia Fresno, CA 93706
Rice Milk Bars, 3 oz; Helados La Tapatia Fresno, CA 93706
Eggnog Milk Bars, 3 oz; Helados La Tapatia Fresno, CA 93706
Cookie Milk Bars, 3 oz; Helados La Tapatia Fresno, CA 93706
Vainilla con Membrillo Milk Bar, 4 oz. Helados La Tapatia Fresno, CA 93706
Peach Yogurt Milk Bars, 3 oz; Helados La Tapatia Fresno, CA 93706
Esquimal Milk Bars, 3 oz; Helados La Tapatia Fresno, CA 93706
Coffee Milk Bars, 3 oz; Helados La Tapatia Fresno, CA 93706
Pina Colada Milk Bars, 3 oz;, 4 oz. Helados La Tapatia Fresno, CA 93706
Mamey Milk Bars, 3 oz; Also packaged in 9 oz. cups six pack. Helados La Tapatia Fresno, CA 93706
Pecan Ice Cream container . Helados La Tapatia Fresno, CA 93706
Cookies n Cream Ice Cream container . Also packaged as 4 oz. milk bar (cookies n Cream french), Canada 4 oz. HLT and six pack of 9 oz cups. Helados La Tapatia Fresno, CA 93706
Orange n Cream Milk Bar, 4 oz. Helados La Tapatia Fresno, CA 93706
Choco-Coco Milk Bar, 4 oz; Also packages as Canada 4 oz. HLT.. Helados La Tapatia Fresno, CA 93706
Nuez Pecan Milk Bar, 4 oz; Helados La Tapatia Fresno, CA 93706
Pistachio Almond Milk Bar, 4 oz; Also packages as Canada 4 oz. HLT.. Helados La Tapatia Fresno, CA 93706
Granola for Canada 4 oz. HLT.. Helados La Tapatia Fresno, CA 93706
Manhattan Tropical for Canada 4 oz. HLT.. Helados La Tapatia Fresno, CA 93706
Sandia Fruit Bar,4 oz.,; Helados La Tapatia Fresno, CA 93706
SmartSite Extension Set, Model No. 20029E, intravascular administration set
AXIOM Vertix MD Trauma systems radiographic X-ray
SpaceLabs Arkon Anesthesia Delivery System with Version 2.0 Software installed. This system includes a ventilator.
VITROS Chemistry Products CRBM Slides, REF 889 2382, IVD -- Ortho-Clinical Diagnostics, Inc. For in vitro diagnostic use only. VITROS Chemistry Products CRBM Slides quantitatively measure carbamazepine (CRBM) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
Poor Boy Sandwich, 7oz. Product labeling reads in part:''POOR BOY SANDWICH***Perishable Keep Refrigerated***Net Wt. 7 oz***Mrs. Riggs Sandwiches 1792 Callens Rd Ventura CA 93003***''
Italian Torpedo Sandwich, 10oz. Product labeling reads in part:''ITALIAN TORPEDO SANDWICH***Net Wt. 7 oz***Mrs. Riggs Sandwiches 1792 Callens Rd Ventura CA 93003***''
CODMAN CERTAS Programmable Valves, central nervous system shunt, models as follows: 82-8800 In Line Valve Only, 82-8801 In Line Valve with Catheter and Accessories, 82-8802 In Line Valve with Unitized Catheter and Accessories, 82-8803 In line Valve with Unitized BACTISEAL Catheter and Accessories, 82-8804 In Line Valve only with SIPHONGUARD Device, 82-8805 In Line Valve with SIPHONGUARD Device, Catheter and Accessories, 82-8806 In Line Valve with SIPHONGUARD, Unitized Catheter and Accessories, 82-8807 In Line Valve with SIPHONGUARD Device, Unitized BACTISEAL Catheter and Accessories, 82-8850 Certas Therapeutic Management System
Gambro Cartridge Blood Set, blood transport system for hemodialysis, Model Number(s): 101025 (003410510) - Cartridge set, STND PRM LN and 103401 (003414500) - Cartridge set, PRM_LN_INJ_PT. The Gambro Cartridge Sets are single use sterile tubing sets intended to provide extracorporeal blood transport circuit for hemodialysis treatments for Gambro Phoenix and COBE Centrisystem 3 (and 3+) Dialysis Delivery Systems.
Peanut Butter sold under the following sizes, brands, and textures: 1. 16 oz tubs with snap on lid (12 tubs in box) Parkers Farm CREAMY (55100) 2. 34 oz. tubs with snap on lid (6 tubs in box) Parkers Farm CREAMY (55300) 3. 5 lb. pail (2 pails in box) Parkers Farm Creamy (55105) 4. 34 oz. tubs with snap on lid (8 tubs in box) Costco Peanut Butter (55300)
Sharp Cheddar Cold Pack Cheese sold under the following sizes and brands: 1. Parkers Farm or Parkers label in 8 ounce cups with snap-on lid (14001), 14 ounce cups with snap on lid (17001), and 16 ounce round or square plastic containers (tub with snap on lid) (17001UL), 5 lb. pail with snap on lid (11341 & 11441), 10 lb. pail with snap on lid (12341). 2. Amish Classic in 8 oz. cups with snap on lid (AC14001) 3. Biery in 5 lb. pail with snap on lid (5004). 4. Block & Barrel in 5 lb. pail with snap on lid (2388254). 5. Bucky Badger in 8 oz. (31411), 12 oz. (51411), and 14 oz. (41411) cups with snap on lid. 6. Central Markets in 8 oz cups with snap on lid (27056). 7. Cobblestone Market in 5 lb. pail (42403) and 30 lb. pails (42803) with snap on lid. 8. Dierks Waukesha in 5 lb. pail with snap on lid (11442)
Port Wine Cold Pack Cheese sold under the following sizes and brands: 1. Parkers Farm or Parkers label in 8 ounce (14010), 14 ounce (17010), 5 lb. (11951), 10 lb. (12951), white tub with snap on lid; 2. Amish Classic in 8 ounce cup with snap on lid (AC14010). 3. Biery in 5 lb. pail with snap on lid (5010). 4. Block & Barrel in 5.5 lb. pail with snap on lid (2388247). 5. Bucky Badger in 8 oz. (31511), 12 oz. (51511), and 14 oz. (41311) cups with snap on lid. 6. Central Markets in 8 oz cups with snap on lid (27057). 7. Cobblestone Market in 5 lb. pail pails with snap on lid (42503). 8. Dierks Waukesha in 5 lb. pail with snap on lid (11952). 9. Happy Farms in 8 ounce cup with snap on lid (43316).
Cheddar Cold Pack Cheese sold under the following sizes and brands: 1. Parkers Farm or Parkers label in 8 ounce (10201) cup with snap on lid, and 10 lb. (12341OS), white tub with snap on lid; 2. Win Schuler in 10 lb. pail with snap on lid (01498)
Swiss Almond Cold Pack Cheese sold under the following sizes and brands: 1. Parkers Farm or Parkers label in 8 ounce (14005), 13.5 ounce (17005) cups with snap on lid; 5 lb. (52244) and 10 lb. (53244) pail with snap on lid; 2. Amish Classic in 8 ounce cup with snap on lid (AC14005). 3. Block & Barrel in 5.5 lb. pail with snap on lid (2388270). 4. Bucky Badger in 8 oz. (31711) cups with snap on lid. 5. Central Markets in 8 oz cups with snap on lid (27058). 6. Cobblestone Market in 5 lb. pail pails with snap on lid (42703). 7. Dierks Waukesha in 5 lb. pail with snap on lid (52242).
Horseradish Cold Pack Cheese sold under the following sizes and brands: 1. Parkers Farm or Parkers label in 8 ounce (13006), 14 ounce (17006), 16 ounce (17006UL) cups with snap on lid; 5 lb. (41550) and 10 lb. (42550 pail with snap on lid; 2. Amish Classic in 8 ounce cup with snap on lid (AC13006). 3. Block & Barrel in 5.5 lb. pail with snap on lid (2593424). 4. Bucky Badger in 12 oz. (51311) cups with snap on lid. 5. Central Markets in 8 oz cups with snap on lid (27055). 6. Cobblestone Market in 5 lb. pail pails with snap on lid (42603). 7. Dierks Waukesha in 5 lb. pail with snap on lid (41552).
Bacon Cold Pack Cheese sold under the following sizes and brands: 1. Parkers Farm or Parkers label in 8 ounce (14002) and 14 ounce (17002) cups with snap on lid; 5 lb. Cheeseball Base - Bacon (14441) and 10 lb. (61760) pail with snap on lid; 2. Bucky Badger in 8 oz. (31611) and 14 oz. (41611) cups with snap on lid.
Swiss & Cheddar Cold Pack Cheese sold under the following sizes and brands: Parkers Farm or Parkers label in 8 ounce (13012) cups with snap on lid; and 10 lb. (81774) pail with snap on lid;
Onion Cheddar Cold Pack Cheese sold under the following sizes and brands: Parkers Farm or Parkers label in 8 ounce (14003) cups with snap on lid;
Cheddar Ranch Cheeseball Base Cold Pack Cheese sold under the following sizes and brands: Parkers Farm or Parkers label in 5 lb. (12221) pail with snap on lid.
Green Onion Cheeseball Base Cold Pack Cheese sold under the following sizes and brands: Parkers Farm or Parkers label in 5 lb. (13331) pail with snap on lid;
Smoked Cheddar Cold Pack Cheese sold under the following sizes and brands: Parkers Farm or Parkers label in 8 ounce (13004) cups with snap on lid;
Garlic Cold Pack Cheese sold under the following sizes and brands: 1. Parkers Farm or Parkers label in 8 ounce (13008) cups with snap on lid; 10 lb. (11269) pail with snap on lid; 2. Bucky Badger in 8 oz. (31811) and 14 oz. (41811) cups with snap on lid.
Jalapeno Cold Pack Cheese sold under the following sizes and brands: 1. Parkers Farm or Parkers label in 10 lb. pail (91347) with snap on lid; 5 lb. Cheeseball Base - Jalapeno (15551) pail with snap on lid; 2. Bucky Badger in 8 oz. (31911) and 14 oz. (41911) cups with snap on lid.
Sharp Cheddar & Port Wine Cold Pack Cheese sold under the following sizes and brands: Aldi label in 14 oz. (112699 / #7742) cup with snap on lid.
Spicy Beer Cheese Spread sold under the following sizes and brands: Parkers Farm or Parkers label in 5 lb. (01508) pails with snap on lid, Say Cheez Beer cheese - spicy (17050) in 14 oz. cups with snap on lid
Pimento Cheese Spread sold under the following sizes and brands: 1. Parkers Farm or Parkers label in 12 ounce (20100) cup with snap on lid; 2. Block & Barrel in 4 lb. pail with snap on lid (2382588). 3. HYTOP label in 12 ounce (952549) and 20 ounce (952556) cups with snap on lid.
Bacon Cheese Spread sold under the following sizes and brands: Bucky Badger label in 12 ounce (51611) cups with snap on lids.
Garlic Cheese Spread sold under the following sizes and brands: Bucky Badger label in 12 ounce (51811) cups with snap on lids.
Jalapeno Nacho Dip sold under the following sizes and brands: Parkers Farm or Parkers label in 12 ounce (20200) cups with snap on lids.
Restaurant Bar Cheese sold under the following sizes and brands: Parkers Farm or Parkers label in 5 lb. (21811) pails with snap on lids.
Sharp Cheddar Cheese Ball and Logs sold under the following sizes and brands: 1. Parkers Farm and Parkers label in 10 ounce logs (40506) and balls (40106) in film overwrap.
Cheddar Cheese Ball and Logs sold under the following sizes and brands: 1. Aldi label in 10 ounce balls (1087 / #7713) in film overwrap; 2. Win Schuler Original label in 10 ounce balls (55560) and logs (55570) in film overwrap; 3. CP in 8 ounce cheese logs (CH111000) in film overwrap.
Port Wine Cheese Ball and Logs sold under the following sizes and brands: 1. Parkers Farm and Parkers label in 10 ounce logs (40306) and balls (40606) in film overwrap.
Ranch Cheese Ball sold under the following sizes and brands: 1. Parkers Farm and Parkers label in 10 ounce balls (40406) in film overwrap.
Jalapeno Cheese Logs sold under the following sizes and brands: 1. Parkers Farm and Parkers label in 8 ounce logs (12208) in film overwrap.
Jalapeno Bacon Cheese Ball sold under the following sizes and brands: 1. Parkers Farm and Parkers label in 10 ounce ball (40906) in film overwrap.
Garlic Cheddar Cheese Logs sold under the following sizes and brands: 1. Parkers Farm and Parkers label in 8 ounce logs (11108) in film overwrap.
Smokey Bacon Cheese Ball sold under the following sizes and brands: 1. Parkers Farm and Parkers label in 10 ounce ball (40206) in film overwrap.
Pimento Cheese Ball sold under the following sizes and brands: 1. Parkers Farm and Parkers label in 10 ounce ball (80208) in film overwrap.
Beer Cheese Ball sold under the following sizes and brands: 1. Parkers Farm and Parkers label in 10 ounce ball (80408) in film overwrap and Say Cheez Beer cheese - Creamy (17051) in 14 oz. cups with snap on lid.
Mild Salsa sold under the following sizes and brands: 1. Parkers Farm or Parkers label in 16 ounce (51305) container with snap on lid, 32 ounce (10794) and 1 gallon (11600) jug with screw on lid; 2. San Pablo in 16 ounce container with snap on lid (12826).
Hot Salsa sold under the following sizes and brands: 1. Parkers Farm or Parkers label in 16 ounce (51205) container with snap on lid, 32 ounce (10894) jug with screw on lid;
Fire Roasted Salsa sold under the following sizes and brands: 1. Parkers Farm or Parkers label in 16 ounce (51605) container with snap on lid, 1 gallon (11900) jug with screw on lid; 2. San Pablo in 1 gallon jug with screw on lid (12827).
Garlic Salsa sold under the following sizes and brands: 1. Parkers Farm or Parkers label in 16 ounce (51505) container with snap on lid, 32 ounce (41596) jug with screw on lid;
Black Bean & roasted Chili Salsa sold under the following sizes and brands: 1. Parkers Farm or Parkers label in 32 ounce (80598) jug with screw on lid;
Peanut Butter sold under the following sizes, brands: Honey CREAMY (55200) Peanut Butter in 16 oz tubs with snap on lid.
HYTOP Jalapeno Pimento cheese spread in 12 ounce (952754) cups with snap on lid
Peanut Butter sold under the following sizes, brands: HONEY CRUNCHY (55204) Peanut Butter in 16 oz tubs with snap on lid.
Peanut Butter sold under the following sizes, brands, and textures: 1. 16 oz tubs with snap on lid (12 tubs in box) Parkers Farm CRUNCHY (55104), 2. 34 oz. tubs with snap on lid (6 tubs in box) Parkers Farm CRUNCHY (55304)
FRAXEL DUAL 1550/1927 Laser System, (FRAXEL SR 1500 DUAL Laser System), for dermatological procedures.
Brilliance CT 16, Brilliance CT 64, Brilliance CT Big Bore Oncology, Brilliance CT Big Bore Radiology, Brilliance iCT, Ingenuity CT, Ingenuity Core, Ingenuity Core 128 and Ingenuity Flex scanners are Computed Tomography X-ray systems.
Luna Chocolate Chunk; Whole Nutrition Bar for Women; 15 count box. Clif Bar & Company, Emeryville, CA
2521 Cherry Glaze Pop (Flavoring for popcorn) - Paperboard Carton
327 Ace Cherry Berry Flossugar (Flavoring for cotton candy)- Paperboard Carton
1031 GA Artifical Cherry Concentrate (Flavoring for shaved ice) - Plastic Gallon
1358 Artificial Cherry Kola (Flavoring for shaved ice)- Plastic Gallon
Kellogg's Eggo Buttermilk au babeurre waffles 280g 8ct, UPC 0 64100 23817 6 Ingredients/ Ingredients: Water, Wheat Flour, soybean and palm oil shortening, whole egg, baking powder, sugar, salt milk ingredients, hydrogenated soybean oil, soy lecithin Contains wheat, egg, milk and soy ingredients .... Imported by / Importe par Kellogg Canada Inc. Mississauga, Ontario L4W5S1 Case Label: Kellogg's Eggo Frozen Waffles 64100,12/280 g 23817 Buttermilk Waffles UPC 0 64100 23817 3
Herring Fillets in Wine Sauce sold under the ELF brand in 12 oz. plastic jars.
The OEC 9900 Elite mobile fluoroscopy system (image intensified fluoroscopic x-ray) is designed to provide fluoroscopic and spot-film images of the patient during diagnostic surgical and interventional procedure. Examples of clinical application may include cholangiography, endoscopy, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedure. The system may be used for other imaging applications at the physician's discretion.
''Honey Roasted Peanuts Golden Roast'' sold under the Fisher brand and packaged in 14 oz. plastic jars.
Pipeline Embolization Device (PED). Used endovascular treatment of adults with intracranial aneurysms in the internal carotid artery.
Alligator Retrieval Device (ARD). Used in the peripheral and neurovasculature for foreign body removal.
OPTIMUM E-1000 IU Gluten Free Dietary Supplement 100 SOFTGELS Product is packaged in a white HDPE bottle with foil cap under the white plastic cap. Bottle contains 100 softgel caps. UPC 0 43292 56291 7.
The Kitchen Whole Foods Chipotle Chicken Wrap; Good to Go. Net Weight: 10 oz.. (283 g) individually wrapped sandwich wraps. Distributed by Green Shoots Distribution' So. San Francisco, 94083
Terumo Cardiovascular Procedure Kit- X-Coated Pump and Table Pack with FX25RE Catalog Number: 73431
Graeter's Ice Cream Big Scoop COOKIES AND CREAM Ingredients: cream, milk, cane sugar***locust bean gum. Manufactured Under Authority of Graeter's Inc., 1175 Regina Graeter Way Cincinnati, Ohio 45216 022715''
Edwards Lifesciences Fem-Flex II Arterial and femoral Cannulae, arterial cannula sizes 16, 18 and 20 French, models: FEMII016A, FEMII016AS, FEMII018A, FEMII018AS, FEMII020A, and FEMII020AS.
Edwards Lifesciences Fem-Flex II Arterial and femoral Cannulae with Duraflo Coating, arterial cannula sizes 16, 18 and 20 French, Models DFEMII016AS, DFEMII018AS, DFEMII020AS, DIIFEMII016A, DIIFEMII018A, and DIIFEMII020A.

Code Info
Model Number(s): Affected devices catalog names are: BNES310, BNET3210, BNPS6511, BNPS6513, BNPS6585, BNPT6510, BNPT6511, BNPT6513, BNPT6585, BNSS310, BNSS311, BNSS313, BNSS610, BNSS613, BNSS615, BNSS685, BNST3210, BNST3211, BNST3213, BNST3215, BNST3285, BNST611, BNST613, BNST685, BOPS6510, BOPS6511, BOPS6515, BOPS6585, BOPT6510, BOPT6511, BOPT6513, BOPT6585, BOSS310, BOSS311, BOSS313, BOSS315, BOSS611, BOSS613, BOSS685, BOST3210, BOST3211, BOST3213, BOST3215, BOST3285, BOST610, BOST611, BOST613, BOST685, FNT3210, FNT3211, IFNT3210, IFNT3211, IFNT3213, IFNT3215, IFNT3285, IFNT610, IFNT611, IFNT613, IFNT685, IFOSS5611, IFOS5685, IFOS610, IFOS611, IFOS615, IFOSM310, IFOSM311, IFOSM313, IFOSM385, IIOS5610, IIOS5611, INT3210, INT3211, INT3213, INT3215, INT3285, INT610, INT611, INT613, INT685, IOSM311, IOSM313, IOSM315, IOSM385, IOSS610, IOSS613, NIIITP6510, NIIITP6511, NIIITP6513, NIIITP6515, NIIITP6585, NINT3210, NINT3211, NINT3213, NINT3215, NINT610, NINT611, NINT613, NINT685, NIOSM311, NIOSM313, NIOSS610, NT3210, NT3211, OSM310, XIFNT3210, XIFNT3211, XIFNT3213, XIFNT3215, XIFNT3285, XIFN610, XIFNT611, XIFNT613, XIFNT685, XIFOSM310, XIFOSM311, XIFOSM313, XIFOSS610, XIFOSS611, XIIOS6510, XIIOS6511, XIIOS6513, XIITP6510, XIITP6511, XIITP6513. Manufactured dates from November 5, 2012 through August 21, 2013.
lot codes: Best By: 01 18 2015A or Best By: 01 19 2015A
All units with UPC 6 34242-10002 2 (3 oz. bar) and 6 34242-16001 9 (six pack box).
All units with UPC 6 34242- 10008 4 (3 oz. bar)
All units with UPC 6 34242- 10009 1 (3 oz. bar)
All units with UPC 6 34242- 10011 4 (3 oz. bar)
All units with UPC 6 34242- 10012 1 (3 oz. bar)
All units with UPC 6 34242- 61001 9 (4 oz. bar)
All units with UPC 6 34242- 61003 3 (4 oz. bar) ;
All units with UPC 6 34242- 40003 0 (Bolis, 4 oz; 6 34242-15005 8 (six pack boxes 9 oz. cups)
All units with UPC 6 34242- 20004 3, (3 oz bar);
All units with UPC 6 34242- 20005 0, (3 oz bar); 6 34242-14001 2 (ice cream container)
All units with UPC 6 34242- 20006 7, (3 oz bar);
All units with UPC 6 34242- 20008 1, (3 oz bar)
All units with UPC 6 34242- 20009 8, (3 oz bar)
All units with UPC 6 34242- 20010 4, (3 oz bar)
All units with UPC 6 34242- 20011 1, (3 oz bar)
All units with UPC 6 34242- 20013 5, (3 oz bar)
All units with UPC 6 34242- 20054 9, (3 oz bar); 6 34242-15004 1 (six pack boxes of 9 oz cups).
All units with UPC 6 34242- 61006 (4 oz. bar) ;
AXIOM Vertix MD Trauma systems (material no. 08908290) with serial numbers 1022 through 1058.
Lot Numbers/Production Dates: Jan 31, 2014, Feb 7, 2014, Feb 14, 2014.
Lot Number/Production Dates: Jan 31, 2014, Feb 7, 2014, Feb 14, 2014
Model MC-SYS-SR1500-D, Revisions A and B.
Individual Bar UPC: 7-22252-10068-9; 15 Count Box UPC: 7-22252-20068-6: Best By Dates of 11NOV14 and 14OCT14.
UPC Code on Cases: 10073302221111. UPC Code on Jars: 73302 12111. Item Number: 005725. Best Before Date: 21 May 14. Lot Number: 03553.
Best By Date: 5/20/15 N; UPC: 70690 23990; Case Item Code: P27750
Lot code 401090104 with best by date of April 6; UPC: 046319-97076.

Product Quantity
19,119 packaging units ; 15 individual bars per box

Reason for Recall
Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
Marketed without an Approved NDA/ANDA: Dietary supplement may contain amounts of an active ingredient found in some FDA-approved drugs for erectile dysfunction (ED) making the dietary supplement an unapproved drug.
Marketed without an Approved NDA/ANDA: Dietary supplement may contain amounts of active ingredients found in some FDA-approved drugs for erectile dysfunction (ED) making the dietary supplement an unapproved drug.
Presence of Particulate Matter: Oxidized stainless steel found in vial of 1% Lidocaine Hydrochloride Injection, USP.
Marketed Without an Approved NDA/ANDA; undeclared Sibutramine
The CMF Battery Powered Driver graphic case contains outlines of the Battery Powered Driver, taps, screwdriver blades, and a screw holding sleeve. However, the device is not intended to be used in conjunction with a tap for tapping holes in a patient's skull, upper and/or lower jaw. Therefore some outlines in the graphic case suggest a potential use of this device that is considered off-label.
The Synthes Hohmann Retractor was mis-etched on the product and package as part number 399.24 instead of part number 399.22.
The ''fluoro match registration'' function of the Navigation Software Spine & Trauma 3D 2.0 allows the user to intraoperatively match e.g., CT data sets to the current patient anatomy visible on fluoroscopic images, used by the navigation software during spinal surgeries to display the position and orientation of instruments. For this registration function in combination with a digitally integrated C-arm, the software algorithm may not find an adequate match between the intraoperatively acquired 2D fluoroscopic images and the preoperative CT or other compatible 3D data sets. If such an incorrect match would occur, the display of instruments by the navigation system would be shifted compared to the actual patient anatomy.
Due to residual machining fluid identified by discoloration (darker in appearance) on the external dental implant surface.
Blood products, collected from donors for whom donor suitability was not adequately determined, were distributed.
Blood product, with a low pH, was distributed.
Blood products, collected from a donor whose suitability to donate was not fully evaluated, were distributed.
Blood products, not prepared in accordance with specifications, were distributed.
Blood product which was not quarantined after the donor reported having had a shingles vaccination prior to donation was distributed.
Blood products, collected in a manner that may have compromised the sterility of the units, were distributed.
Blood products, collected from a donor who lived in an area considered endemic for malaria, were distributed.
Blood products, collected from a donor who received a tattoo within 12 months of donating, were distributed.
Simply Natural Foods, LLC manufactured and distributed Simply Lite brand Dark Chocolate with high levels of Undeclared Milk.
A customer reported that after upgrading to software version 3.5.5 from 3.5.4, reconstructions would intermittently not complete.
FDA environmental sampling found 21 of 50 positive for Listeria monocytogenes, 11 of these on food contact surfaces.
CareFusion is recalling the SmartSite Extension Set because there are reports of disconnections and leakages at the connection of the smallbore tubing and the SmartSite Y-port.
There is a potential issue and possible hazard to patients when using the AXIOM Vertix MD Trauma systems. In rare cases, steel ropes inside the lift column of the system can be defective without triggering the safety lock, which can result in the U-arm dropping down unexpectedly during movement in vertical direction, potentially causing serious injury.
The System may go into a controlled failed state if a series of parameters on the user interface are activated in a specific sequence.
The firm identified a potential for biased carbamazepine (CRBM) results to be generated when using VITROS CRBM Slides, Lot 3920-0080-8403.
Mrs. Rigg's Sandwiches is recalling certain lots (Lot Number Jan 31, 2014, Feb 7, 2014, Feb 14, 2014) of Poor Boy Sandwiches and Italian Torpedo Sandwiches because they were produced using meat recalled by Rancho Feeding Company for meat distributed without the benefit of a federal inspection.
Ensuring all customers have the tools to assist in verifying the setting of the valve on x-ray images and the location and orientation of implanted CODMAN CERTAS Programmable Valves.
Occluded heparin tubing events preventing anticoagulation dosing on the Gambro Cartridge Blood Sets.
Various Peanut butters, cheese spreads, cold pack cheese, salsa, cheese balls/logs have the potential to be contaminated with Listeria monocytogenes.
Solta Medical became aware that obsolete versions of the Laser Treatment Settings card for the Fraxel DUAL 1550/1927 Laser system may have contained incorrect indication for use for treatment of Melasma.
Block assembly-lock stop subframe of service latch was not manufactured to engineering specifications from the supplier, causing premature fracture of the threaded rod on the patient support service latch. As a result, the table top can become free floating due to the disengaged service latch in the table top's subframe.
Chocolate Chunk Luna Bars made with macadamia nut butter but macadamia nuts are not included in the ingredient listing or allergen statement.
There may be small pieces of plastic found in a limited number of Eggo Buttermilk waffles distributed in Canada.
Vita Food Products, Inc. of Chicago, Illinois is notifying the public that it is recalling 2,280 individual plastic jars of 12 ounce Elf Herring Fillets in Wine Sauce that actually contains herring fillets in sour cream and therefore contains undeclared milk.
GE Healthcare has identified a potential safety issue related to the screws that attach the workstation monitor spring arm to the extension arm on certain OEC 9900 systems, causing the spring arm and monitor to fall forward.
Cases containing 12 x 14 oz. plastic jars of Fisher ''Honey Roasted Peanuts Dry Roasted'' with a ''Best By'' date of ''5/20/15 N'' may contain plastic jars that are mislabeled as Fisher ''Peanuts Dry Roasted Golden Roast''. Dry roasted honey roasted peanuts contain wheat, which is an allergen, and this allergen is not declared on the dry roasted peanut label.
Potential for the PTFE (polytetrafluoroethylene) coating to delaminate and detach from the delivery wire.
Magno Humphries Laboratories is recalling Vitamin E softgels because the principle display panel states the product contains 1000 IU of Vitamin E however the Supplement Facts label indicated 200 IU of Vitamin E. The supplement actually contains 1000 IU of Vitamin E.
One production date of Chicken Chipotle Chicken wraps are actually filled with Chicken Caesar mix which contains a fish allergen (anchovies) that are not declared on the label.
Incorrect customer notification label applied to the Tyvek lid of this specific lot of Terumo Cardiovascular Procedure Kits
During an inspection on 03/04/2014 by the FDA and the Kentucky State Health Department, the firm was notified that they fail to include the allergens wheat and soy on the label.
Potential for separation of dilator tips.