Helixate FS Antihemophilic Factor (Recombinant), Formulated with Sucrose
Antihemophilic Factor (Recombinant), lacking assurance of proper temperature maintenance during storage, was distributed.
Blood products, collected from a donor who lived in the past 3 years in an area considered endemic for malaria, were distributed.
Blood products, collected from a donor who traveled to an area considered endemic for malaria, were distributed.
Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed.
Blood product, which did not meet acceptable product specifications, was distributed. .
Blood product, collected from a donor in whom donor suitability was not adequately determined, was distributed.
Blood products, collected from a donor who had been incarcerated, were distributed.
Blood product, collected from a donor who received a tattoo within 12 months of donation, was distributed.
Blood product, collected from a donor who received a mumps, measles , rubella (MMR) vaccination, was distributed
Blood products, which were collected from a donor with a history of high risk behavior, were distributed.
Blood products, collected from donors for whom donor suitability was not adequately determined, were distributed.
Blood products, collected from a donor who was previously deferred, were distributed.
Blood product, for which the additive solution was not added during manufacturing, was distributed.
Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
Blood and Blood Products for Reprocessing
Blood products, which were incorrectly tested for human T-lymphotropic virus (HTLV), were distributed.
Nationwide distribution: USA including states of: AK, CA, CO,  CT, DC, FL, GA, HI, IA, IL IN, KS, KY, MA, MD, MI, MN, MO, NE, NJ, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, and WA.
PT Link Waterbath, Model#PT100.   Lab Vision PT Module Plus provides an automated standarized alternative to labor intensive and time consuming dewaxing and epitote retrieval procedures.
Dako is recalling the PT Link Waterbath because of a possible electrical hazard.   Specifically, if the heater pad under the reagent tank becomes wet, it may present an electrical shock hazard when the lid is open.
Blood products, collected from deferred donors, were distributed.
Worldwide distribution: USA (nationwide) including states of:  AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, VA, WA, WI, WV, and WY; and countries of:  ARGENTINA, AUSTRALIA, BANGLADESH, BRAZIL, CALI COLOMBIA, CALLO PERU, GERMANY, GUAYQUIL ECUADOR, HONG KONG, INDIA, INDONESIA, JAPAN, LEBANON, MADRID SPAIN, MEXICO, NEW ZEALAND, SANTIAGO, SANTIAGO CHILE, SINGAPORE, SOUTH AFRICA, SOUTH KOREA, SRI LANKA, TAIWAN, THAILAND, and UNITED ARAB EMIRATES (UAE).
Perfusion System 8000, base 4 pump, 115V safety monitor included   The Sarns'' Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.
Terumo Cardiovascular Systems (Terumo CVS) has received multiple reports since 2007 of various malfunctions of the arterial and cardioplegia monitors for the Sarns Modular Perfusion System 8000. The malfunctions can be broadly categorized as follows monitor power malfunctions, inability to measure pressure and inaccurate and/or false pressure  alarms.  If the malfunction of the arterial or cardioplegia monitor occurs prior to initiating cardiopulmonary bypass, it could inconvenience the user or delay the case; the risk to the  patient is dependent on the patient's status.  If the failure occurs during cardiopulmonary bypass, the risk to the patient ranges from negligible to severe and is dependent on the patient's condition, the user's experience  and competency and the user's knowledge of the instructions in the Operator's Manual.  While the Operator's Manual for the Sarns system 8000 provides instruction on how to respond to the malfunctions, Terumo CVS is informing users of the risks associated with  these malfunctions, reminding users to review the instructions in the Operator's Manual and providing an Addendum to clarify the instruction for responding to an inaccurate pressure reading or false alarm.  There are no known reports of patient injury as a result of these issues.
Perfusion System 8000, base 5 pump, 115V safety monitor included   The Sarns'' Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.
Perfusion System 8000, base 4 pump, 220V/240V safety monitor included   The Sarns'' Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.
catalog number: 16405 serial numbers: 1001-1466.
Perfusion System 8000, base 5 pump, 220V/240V safety monitor included   The Sarns'' Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.
Perfusion System 8000, base 4 pump, 100V safety monitor included   The Sarns'' Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.
catalog number: 16409 serial numbers: 1001-1026
Perfusion System 8000, base 5 pump, 100V safety monitor included   The Sarns'' Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.
MEDITECH Blood Bank Software - Client Server Releases 5.63, 5.64,  5.65, 6.0, 6.04, 6.05, 6.06, 6.1 and 6.12.
Blood Bank Software, with a defect or glitch, was distributed.
Blood products, which were not quarantined after receiving post donation information,  were distributed..
Blood products, which were not quarantined after receiving post donation information,  were distributed.
Tobramycin Ophthalmic Oint., 0.3%, 5ml bottle, (Generic for: Tobrex), Rx only, Sterile, Mfg By Akorn, Inc., Lake Forest, IL 60045, NDC 16590-224-05,
Labeling: Label Mix-up: The affected units were labeled incorrectly describing the product as ''ointment'' instead of ''solution.''
Amer.  National Red Cross-Greater Chesapeake & Potomac Reg.
The American National Red Cross - Southern Region
Platelets Pheresis Leukocytes Reduced Irradiated
Blood products, which were exposed to unacceptable temperature during storage, were distributed.
Nationwide Foreign: Canada, UK, Virgin Islands
MEDITECH Blood Bank Software, Client Server Releases 5.6, 5.65, 6.0,6.05, 6.06, and 6.13.
DCI Donor Services Tissue Services Division
Skin allografts, lacking assurance of proper temperature maintenance during transportation, were distributed.
Worldwide Distribution - US Nationwide and countries of: Canada, Chile, Sweden and United Kingdom
Special Orthopaedic Solution  Peri-Acetabular Prosthesis  V40 Femoral Extension Component    Product Usage:  The PAR extension piece is a component of the PAR assembly. The Peri-Acetabular Reconstruction (PAR) endoprosthesis was developed to meet the unique needs of patients who require reconstruction of large acetabular defects after a Type I and II pelvic resection.
Multiple codes C-2051-7-004 RX00138D FEMORAL PELVIC EXTENSION C-2052-5-004 RX00146D FEMORAL PELVIC EXTENSION C-HM42-7-802 RX4278C 40MM EXT W/FEMALE V40 TAPER C-HM42-7-803 RX4278D 50MM EXT W/FEMALE V40 TAPER C-HM42-7-804 RX4278E 60MM EXT W/FEMALE V40 TAPER C-HM49-4-401 RX4944B PAR 40MM EXT W/FEMALE V40 TAPE C-HM49-4-402 RX4944C PAR 50MM EXT W/FEMALE V40 TAPE C-HM49-4-403 RX4944D PAR 60MM EXT W/FEMALE V40 TAPE C-HM49-9-202 RX4992C PAR EXTENSION C-TAPER 40MM C-HM49-9-203 RX4992D PAR EXTENSION C-TAPER 50MM C-HM49-9-204 RX4992E PAR EXTENSION C-TAPER 60MM C-HM52-1-802 RX5218C PAR FEMORAL EXT V40 TAPER 40MM C-KM10-9-400 HG102AA FEMORAL PELVIC EXTENSION C-KM26-5-204 RX2652E PAR FEM EXT V-40, 40MM C-KM26-5-205 RX2652S PAR FEM EXT V-40 50MM C-KM26-5-206 RX2652T PAR FEM EXT V-40 60MM C-KM28-1-501 RX2815B PAR FEM EXT V-40, 40MM C-KM28-1-502 RX2815C PAR FEM EXT V-40 50MM C-KM28-1-503 RX2815D PAR FEM EXT V-40 60MM C-KM28-4-201 RX2842B PAR FEM EXT V-40, 40MM C-KM28-4-202 RX2842C PAR FEM EXT V-40, 50MM C-KM28-4-203 RX2842D PAR FEM EXT V-40, 60MM C-KM28-6-901 RX2869B PAR FEM EXT V-40, 40MM C-KM28-6-902 RX2869C PAR FEM EXT V-40, 50MM C-KM28-6-903 RX2869D PAR FEM EXT V-40, 60MM C-KM28-7-801 RX2878B PAR FEM EXT V-40, 40MM C-KM28-7-802 RX2878C PAR FEM EXT V-40 50MM C-KM28-7-803 RX2878D PAR FEM EXT V-40 60MM C-KM29-6-101 KM2961B PAR FEM EXT V-40, 50MM C-KM29-6-102 RX2961C PAR FEM EXT V-40, 60MM C-KM29-9-101 RX2991B PAR FEM EXT V-40, 50MM C-KM29-9-102 RX2991C PAR FEM EXT V-40 60MM C-KM30-0-901 RX3009B PAR FEM EXT V-40, 50MM C-KM30-0-902 RX3009C PAR FEM EXT V-40, 60MM C-KM30-1-101 RX3011B PAR FEM EXT V-40, 50MM C-KM30-1-102 RX3011C PAR FEM EXT V-40 60MM C-KM32-0-801 RX3208B PAR FEM EXT V-40, 50MM C-KM32-0-802 RX3208C PAR FEM EXT V-40 60MM C-KM32-9-201 RX3292B 40MM EXT W/FEMALE V40 TAPER C-KM32-9-202 RX3292C 50MM EXT W/FEMALE V40 TAPER C-KM32-9-203 RX3292D 60MM EXT W/FEMALE V40 TAPER C-KM33-6-601 RX3366B 40MM EXT W/FEMALE V40 TAPER C-KM33-6-602 RX3366C 50MM EXT W/FEMALE V40 TAPER C-KM33-6-603 RX3366D 60MM EXT W/FEMALE V40 TAPER C-KM34
Stryker has become aware that insufficient taper torsional strength may result when a PAR extension piece is used with a forged CoCr stem.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Zatarain's New Orleans Style Beef Flavor Rice Mix, packaged in 6.8 oz boxes, 12 boxes per carton, Box UPC: 7142901001
BEST BY JUN 09 14 H, BEST BY JUL 29 14 H, BEST BY AUG 28 14 H
Food product containing wheat was packaged into containers which do not declare wheat on the label.
Zatarain's New Orleans Style Chicken Flavor Rice Mix, Item No. Z09705, packaged in 6.3 oz boxes, 12 boxes per carton, Box UPC: 7142901001
BEST BY JUN 10 14 H,  BEST BY JUL 30 14 H,   BEST BY AUG 31 14 H
Zatarain's Chicken/Cheddar Brocolli Mix, Item Number: 900108337, a combination pack containing, 6.3 oz boxes of New Orleans Style Chicken Flavor Rice Mix and Cheddar Broccolli Mix.
BEST BY MAY 09 13Z,  BEST BY JUN 15 13Z,   BEST BY AUG 05 13Z and   BEST BY AUG 08 13Z
US, Canada, Saudi Arabia, Brazil, China, Japan, Mexico, New Zealand, Puerto Rico, Singapore, Taiwan, and Thailand.
LABScreen Product  LABScreen Single Antigen HLA Class II Antibody Detection Test -GROUP 1   Product Number: LS2A01    510(K) Number : BK 030069  Product Code : MZI  PMA Number : N/A  Preamendment : No
Product Number: LS2A01   Lot Numbers : 003 - 008       Expiration Date:  Lot 003                                      11/2007  Lot 004                                       09/2008  Lot 005                                       10/2009  Lot 006                                        05/2010  Lot 007                                        04/2012  Lot 008                                         04/2013    Product Insert Number: LS_LSCN-PI-EN-00, Rev. 17
LABScreen HLA Class II Antibody Detection Test, associated with false reactions with the DP20 antigen, was distributed.
Community Blood Centers of Florida, Inc.
Blood product, collected from a donor whose arm inspection prior to collection was not performed, was distributed.
Distribution was made to fund-raising organizations located in AZ, IL, and WI.  There was no foreign, military, or government distribution.
Aunt Marie's Bakery Gourmet Cookie Dough, Chocolate Chunk, packaged in 3-lb. plastic tubs.  Distributed by Racine Danish Kringles, Racine, WI.
Human Corneas, recovered from donors whose donor eligibility was not determined by using appropriate FDA-licensed, approved, or cleared donor screening tests, in accordance with the manufacturer's instructions, to adequately and appropriately reduce the risk of transmission of relevant communicable disease agents or diseases, were distributed.
FL, NJ and US Virgin Islands Barbados, St. Kitts, Dutch Antilles and Aruba
***Fresh Point***Fresh Cuts***Service Salsa Mango***2 x 5lb Tray***Net Wt. 50 lb.***
Item # 302940 - Used by date 08/04 though 08/17 or Julian production date 215 through 230
Coast Citrus Distributors, Inc. and its divisions Coast Tropical and Olympic Fruit & vegetables are conducting a voluntary product recall of ''KENT'S'' & ''KEITT'S'' mangos packed at AGRICOLA DANIELLA.
***Fresh Point***Fresh Cuts***Fruit Mango/Papaya Diced***2 x 5lb Tray***Net. Wt. 10 lb.***
Item # 300735 - Used by date 08/04 though 08/17 or Julian production date 215 through 230
***Fresh Point***Fresh Cuts***Salsa Mango and Papaya*** 2 x 5lb Tray***Net Wt. 10 lb.***
Item # 302942- Used by date 08/04 though 08/17 or Julian production date 215 through 230
***Fresh Point***Fresh Cuts***Retail Mango Sliced***6 X 8oz Cups Packages***Net Wt. 27 lb.***
Item # 301348 - Used by date 08/04 though 08/17 or Julian production date 215 through 230
Fresh Mango peeled and cut into cubes, slices, or halves labeled as listed: ***Fresh Point***Fresh Cuts***Food Service Fruit Mango PLD Cubed 1/2***2 x 5lb Tray***Net Wt. 310 lb.***  ***Fresh Point***Fresh Cuts***Food Service Fruit Mango Peeled / Halved***2 X 2.5 lb Tray***Net Wt. 245 lb.***  ***Fresh Point***Fresh Cuts***Food Service Fruit Mango PLD/Sliced***2 x 5lb Tray***Net Wt. 30 lb.***  ***Fresh Point***Fresh Cuts***Food Service Fruit Mango PLD/Cubed 1***2 x 5lb Tray***Net Wt. 30 lb.
Item # 380780, 300825, 300810, 300760 - Used by date 08/04 though 08/17 or Julian production date 215 through 230
Nationwide Distribution including CA, HI, KS, LA, MI, MO, OR, PA, UT, and WI
HX2 Temp Manage SYS 120V   The Terumo HX2 Temperature Management System is a selfcontained, dual channel system for supplying temperature controlled water to heat exchangers used in an extracorporeal circuit.
Based on a retrospective review of quality data, AC Control boards used in the manufacture of the HX2 Temperature Management System were identified as being manufactured using the incorrect  flux material. Use of the incorrect flux may contribute to premature board failure. A search of  TCVS complaints revealed 3 complaints received related to the HX2 failure. Each failure occurred  during set up, not during a procedure. When a failure occurred at start-up, the clinicians mitigated  the failure by shutting down the devices and using a back-up system as recommended in the  user's manual.
Tested AC Control BD, 120V, X2   The Terumo HX2 Temperature Management System is a selfcontained, dual channel system for supplying temperature controlled water to heat exchangers used in an extracorporeal circuit.
Amniotic membrane allografts, recovered from a donor whose preprocessing tissue culture indicated growth of Group D Enterococcus, were distributed.
American Vines band Natural Vines Black Soft Licorice Twists;    All Natural Ingredients, 8 oz (226g), No Preservatives,  Product is processed and packaged by American Licorice Company, Union City, CA;        Displays and Pallets info:     ----6 ct. Case, Item: #8483, Case UPC: 00-41364 08483-8;    ----12 ct. Case,   Item:                                      #8481,   Case UPC:                    100-41364 08481-4;    ----36/8oz Combo Floor Display (Black Only),  Item:                  #8484,   Item UPC:                     041364084817,  Case UPC:              100-41364 08484-5;      ----18/8oz Combo Wing Display (Black Only),  Item:                 #8485,  Item UPC:          041364084817,  Case UPC:               100-41364 08485-2
Affected Date Codes: 01 04 13,  01 05 13,  01 26 13,  01 27 13,  03 02 13,  03 16 13,  04 07 13,  04 09 13,  04 19 13;     Date Code is printed on white sticker located on back of package
Firm's internal sampling of the product found elevated levels of lead in the product.
Product distributed to retail stores in Alaska only
Salmon Wrap.  Two wraps per package.  Net Wt 8 oz
Product manufactured using cooking spray which contains soy oil and soy was not declared on the label.
Lemon Hand Sanitizing Wipes [n-alkyl dimethyl benzyl ammonium chloride (0.1%) and n-alkyl dimethyl ethyl benzyl ammonium chloride (0.1%)], labeled as a) Genuine Joe Cleaning Supplies, Lemon Scent, Anti-microbial Hand Sanitizing Wipes, 120-count premoistened wipes per bucket, 6 buckets per case, Manufactured for S.P. Richards Co., 6300 Highlands Pkwy., Smyma, GA  30082, UPC 0 35255 10477 7; b) Pro Chem Lemon Aid, Hand Sanitizing Wipes, 85-count premoistened wipes per bucket, 6 buckets per case, An exclusive product of: Pro Chem, Inc., 1475 Bluegrass Lakes Parkway, Alpharetta, GA  30004; c) Scrubs, Lemon Hand Sanitizer Wipes, 120-count premoistened wipes per bucket, 6 buckets per case, Manufactured in the U.S.A. by ITW Dymon, 805 E. Old 56 Highway, Olathe, KS  66061, UPC 7 64769 92991 9.
CGMP Deviations: The products were manufactured with raw material which contain unknown particles believed to be water and dirt.
Albertsons retail stores in OR, UT, WA, ID, MT and Walmart stores in WA only.
Ice Cream - label reads in part ''*** Lovin' SCOOPFUL CHURNED LIGHT ICE CREAM *** SUPER DUPER PEANUT BUTTER CUP***
The firm received product from a raw material supplier which was recalled by Sunland, Inc. the raw material has the potential to be contaminated with Salmonella
USA  (nationwide) including the states of  CO, IN, KS, MA, MN, MO, NE, OH, SC, TN, TX, VA, and WI.
Progressive Medical PMI Endoscopic Dissector with Kittner Tip (5mm x 40cm), Reorder Number: PMILK40, Product Sterile in Unopened/Undamaged pouch, Cotton Tip - X-Ray Detectable, 1 Pc/Pouch, 10 Pouches/Box, 20 boxes/case.  Exclusively Distributed in the U.S. Market by: Progressive Medical, Inc., St. Louis, MO, Made in China.   The product is used for pushing tissue from the incision or wound during medical procedures. Per the IFU, the indications for use are for gynecological laparoscopy, laparoscopic cholecystectomy, and other laparoscopic procedures.
Some of the sterile packages had broken seals.
Nationwide Distribution-including the states of CA, MN, NC, and TN.
Synthes External Fixation System Tube to Tube Clamp, Part Number 390.007.   Intended for use to provide treatment for long bone and pelvic fractures that require external fixation. Specifically, the components can be used for: Stabilization of soft tissues and fractures; Polytrauma/multiple orthopedic trauma; Vertically stable pelvic fractures, or as treatment adjunct for vertically unstable pelvic fractures; Arthrodeses and osteotomies with soft tissue problems - failures of total joints; Neutralization of fractures stabilized with limited internal fixation; Non-unions/septic non-unions; Intra-operative reductions/stabilization tool to assist with indirect reduction; and Unilateral rectilinear bone segment transport or leg lengthening.
The insert provided with the product for the specific lot number indicates that this product is MR safe.  This product is MR Conditional and is etched as MR Conditional.  The insert is incorrect.
Pierre Peanut Butter & Grape Jelly on White Bread, 2.80oz, AdvancePierre Foods, Inc., 9990 Princeton Glendale Road, Cincinnati, OH 45246.
3.2 Million lbs. (total for all products)
Products were manufactured with peanut butter products recalled by Sunland, Inc. found to be contaminated with Salmonella.
Pierre Peanut Butter & Strawberry Jelly on White Bread, 2.80oz, AdvancePierre Foods, Inc., 9990 Princeton Glendale Road, Cincinnati, OH 45246.
Pierre Peanut Butter & Grape Jelly on Whole Grain, 2.80oz, AdvancePierre Foods, Inc., 9990 Princeton Glendale Road, Cincinnati, OH 45246.
Pierre Peanut Butter & Jelly Squarewich, 2.70oz., AdvancePierre Foods, Inc., 9990 Princeton Glendale Road, Cincinnati, OH 45246.
PB & J Jamz, 2.80oz., Distributed by: AdvancePierre Foods, Inc., 9990 Princeton Glendale Road, Cincinnati, OH 45246.
Pierre Jamwich Crustless Peanut Butter & Jelly Sandwich, 2.8oz., AdvancePierre Foods, Inc., 9990 Princeton Glendale Road, Cincinnati, OH 45246.
Pierre Peanut Butter & Strawberry Jelly on White, 8/12PK, AdvancePierre Foods, Inc., 9990 Princeton Glendale Road, Cincinnati, OH 45246.
Market Day, Peanut Butter & Jelly Grahamwich, 12/2.20oz., Manufactured for: Market Day, Inc., Itasca, IL 60143.
Pierre On The Go PB Jamwich Honey, 2.00oz, AdvancePierre Foods, Inc., 9990 Princeton Glendale Road, Cincinnati, OH 45246.
Pierre On The Go PB Jamwich Grape, 2.00oz, Pierre On The Go PB Jamwich Grape, 2.00oz, AdvancePierre Foods, Inc., 9990 Princeton Glendale Road, Cincinnati, OH 45246.
PB & Grape Jamwich, 2.80oz, AdvancePierre Foods, Inc., 9990 Princeton Glendale Road, Cincinnati, OH 45246.
PB & Grape Jelly on Whole Grain Graham Wafers, AdvancePierre Foods, Inc., 9990 Princeton Glendale Road, Cincinnati, OH 45246.
Pierre Peanut Butter Cup, 1.11oz., AdvancePierre, Inc., 9990 Princeton Glendale Road, Cincinnati, OH 462476.
Pierre Peanut Butter & Grape Jelly Cups., 1.50oz. and 2.80oz, AdvancePierre Foods, Inc., 9990 Princeton Glendale Road, Cincinnati, OH 45246.
Pierre Peanut Butter & Straw Jam on Whole Grain, 2.80oz, AdvancePierre Foods, Inc., 9990 Princeton Glendale Road, Cincinnati, OH 45246.
Peanut Butter & Jelly on Graham Wafers, 2.20oz., AdvancePierre Foods, Inc., 9990 Princeton Glendale Road, Cincinnati, OH 45246.
Pierre Peanut Butter & Straw. Jam on White Bread, 2.80oz, AdvancePierre Foods, Inc., 9990 Princeton Glendale Road, Cincinnati, OH 45246.
Pierre Peanut Butter Jamwich & Banana on Whole Grain Bread, 2.80oz., AdvancePierre Foods, Inc., 9990 Princeton Glendale Road, Cincinnati, OH 45246.
Pierre On The Go Peanut Butter + Strawberry Jam, Jamwich, 2.00oz, AdvancePierre Foods, Inc., 9990 Princeton Glendale Road, Cincinnati, OH 45246.
Product was only sold to one customer, Chris Candies, 1557 Spring Garden Avenue Pittsburg, PA 15212
Organic Toffee Peanuts;Bulk packaging - 20 pound cases; Ingredients: Organic Peanuts, Organic Sugar, Salt.
Sconza Candy Company is recalling organic toffee peanuts that were manufactured with peanuts from Sunland which are under recall because of the possibility of Salmonella contamination.
Worldwide Distribution - USA (nationwide) and Internationally to Belgium, Czech Republic, Egypt, France, Germany, Morocco, Netherlands, Romania, Saudi Arabia, Spain, Switzerland, Turkey, and UAE.
ATS 3000 Automatic Tourniquet System w/HOSES AND LOP SENSOR      Intended to be used by qualified medical professionals to temporarily occlude blood flow in a patient's extremities during surgical procedures on those extremities.
Zimmer is conducting a voluntary removal of some Zimmer A.T.S. 3000 tourniquets after receiving complaints of both out-of-box failures and failures during surgical procedures on some of the affected units. During failure the unit will alarm, lock into a non-operational mode, and the display screen will go blank.  Based on  investigation, this problem appears to be due to a counterfeit chip on the control board.
Massachusetts, Connecticut, New York and New Jersey
Whole Foods Meal Shrimp Stir Fry, 16 oz plastic container, Refrigerated, Product Code 3640630222
Label fails to declare tree nuts (almond and cashews) in the ''Contains:'' allergen statement.
Human Corneas, recovered from a donor who had not been properly evaluated, were distributed.
Iskream brand Peanut Butter and Jelly  No Sugar Added, reduced fat, packaged in  Pint (retail)  an 2.5 gallon bulk cartons
592 Cases cases (8 pack-pint)  and 4 /2.5 Gallon
Ice Cream manufactured with Sunland recalled peanut butter has the potential to be contaminated with salmonella
Kentucky Rose, blue cheese Sizes could be 8oz packages, 1.5lbs packages, 3.5lbs packages, 7lbs packages, or 15lb wheel  Packaging could be vacuum packed bags, paper wrap, or plastic wrap
Due to possible Listeria monocytogenes contamination
Kentucky Blue, bleu cheese Sizes could be 8oz packages, 1.5lbs packages, 3.5lbs packages, 7lbs packages, or 15lb wheel  Packaging could be vacuum packed bags, paper wrap, or plastic wrap
Awe Brie Sizes could be 8oz packages, 1.5lbs packages, 3.5lbs packages, 7lbs packages, or 15lb wheel  Packaging could be vacuum packed bags, paper wrap, or plastic wrap
Tomme de Nena Sizes could be 8oz packages, 1.5lbs packages, 3.5lbs packages, 7lbs packages, or 15lb wheel  Packaging could be vacuum packed bags, paper wrap, or plastic wrap
Sold by retailers in AZ, CA, CO, ID, MT, ND, NV, OR, UT, WA, and WY.
Albertsons Peanut Butter Cup Ice Cream, 1.5 QTS (1.42 L)(vanilla ice cream with peanut butter cup pieces, fudge and peanut butter swirls)
UPC 41163 45891, any Best By or EXP dates ranging from 4/06/2011 to 9/25/2013, Plant Code 49-11 or 06-20.
Product was manufactured using an ingredient that was recalled due to Salmonella contamination.
Albertsons Peanut Butter Chocoate Ice Cream, 1.5 QTS (1.42 L),  (chocolate ice cream with a peanut butter swirl)
UPC 41163 45903, any Best By or EXP dates ranging from 3/26/2011 to 8/03/2013, Plant Code 49-11 or 06-20.
Western Family ''Creamery Select'' Premium Ice Cream Peanut Butter Cup, 1.5 QTS (1.42 L), (vanilla ice cream with peanut butter cup pieces, fudge swirl, and peanut butter ribbon)
UPC 15400 21432, any Best By dates ranging from 9/09/2011 to 10/03/2013, Plant Code 49-11.
Prime Time brand Buckeye Bites Ice Cream in a paper carton  48 oz containers and 3 gallon tubs
Lot codes between Feb 11 2012 and Mar 14 2013
15,600-48oz cartons and 1,482 3 gallon tubs
Product was distributed to Publix Distribution centers and stores in FL, AL, TN, GA, and SC.
Frozen Publix Brand Premium Tempura Shrimp, 11 oz box packed 10 boxes per case.
On 10/16/2012, Publix Super Markets, Inc. recalled their Publix Premium Tempura Shrimp because it was discovered that a dipping sauce packet was included in the box with the shrimp. The sauce contains undeclared soy.
Mazzio's Marinara Sauce, 6.65-lb pouch, 6 pouches per case Pouches are packed in cardboard box for shipment
The ingredient statement does not declare milk as the source of the butter on the label.
All Sterile Products manufactured by NECC (New England Compounding Center), Framingham, MA.  A complete list of products can be found on their website at www.neccrx.com
All Non Sterile Products manufactured by NECC (New England Compounding Center), Framingham, MA.  A complete list of products can be found on their website at www.neccrx.com
Horiba Instruments, Inc dba Horiba Medical
ABX PENTRA Creatinine 120 CP, Model Number Creatinine Part # A11A01868, Lot Numbers: 203273706, 203273707, 203273808, 203273709.  The ABX PENTRA Creatinine 120 CP is an in vitro diagnostic assay for the quantitative determination of creatinine in human serum, plasma and urine based on a kinetic method using alkaline picrate (Jaffe method). It is composed of a 27 ml monoreagent cassette. Reagent is a chemical solution with additives.    ABX PENTRA Creatinine 120 CP reagent, with associated calibrator and controls, is a diagnostic reagent for quantitative in vitro determination of Creatinine in human serum, plasma and urine based on a kinetic method using alkaline picrate (Jaffe method). Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes. This reagent is intended for use on the ABX PENTRA 400 Clinical Chemistry Analyzer.
This recall was initiated because some customers were experiencing an alarm during Creatinine calibration ''REAG RANGE HIGH''. This alarm caused the calibration to fail and prevented the user from using the Creatinine assay.
Peanut Butter Pave, UPC code 693868102117 & 69386905312, in the following sizes:  1) 5 Piece Peanut Butter Pave, 63 Grams per pack, 12 Packs per case.  2) 2 Piece Peanut Butter Pave, 26 Grams per pack, 10 Packs per case.  3) Bulk Peanut Butter Pave, 415 Grams per pack.
The product has the potential to be contaminated with Salmonella.
All Sterile Products manufactured by Ameridose LLC, Westborough, MA.  A complete list of all products subject to this recall can be accessed on-line at www.ameridose.com
All Non-Sterile Products manufactured by Ameridose LLC, Westborough, MA.  A complete list of all products subject to this recall can be accessed on-line at www.ameridose.com
Worldwide Distribution - US Nationwide and the countries of Belgium, Cyprus, Italy, Spain, Switzerland and Turkey. TriVascular stated that no purchased devices are in hospital inventory in Europe or the U.S.
TriVascular brand Fill Polymer Kit, Endovascular Graft, Aneurysm Treatment System, European Model Number: TVFP14-B, (in European distributor inventory only);      PRODUCT Usage:  The TriVascular Ovation Abdominal Stent Graft System is indicated in subjects diagnosed with an aneurysm in the abdominal aorta having vascular morphology suitable for endovascular repair, including: (1) Adequate iliac/femoral access compatible with vascular access techniques, devices, and/or accessories, (2) Non-aneurysmal proximal aortic neck: - with a length of at least 7 mm proximal to the aneurysm, - with an inner wall diameter of no less than 16 mm and no greater than 30 mm, and - with an aortic angle of d 60 degrees if proximal neck is e 10 mm and d 45 degrees if proximal neck is < 10 mm, (3) Non-aneurysmal distal iliac landing zone: - with a length of at least 10 mm, - with an inner wall diameter of no less than 8 mm and no greater than 20 mm
Selected lots of the Fill Polymer Kit (European Model Number: TVFP14- B) in European distributor inventory only that potentially contain leaking stopcocks due to  possible cracks in the stopcock component.  TriVascular indicated that these Fill Polymer Kits are for use with the Ovation or Ovation Prime Abdominal Stent Graft Systems that may display leaks upon initiation of mix but prior to use in the patient.
Domestic and international consignees. US Sates nationwide, Canada, Saudi Arabia, UK, France, Germany, Italy, Russia, Sweden, Portugal and Spain, Turkey, Brazil, China, Chile, Japan, and Malaysia.
Product Name: LABType HD Class II DRB1 Typing Test Product Number: RSSOH2B1/RSSOH2B1X  Lot Number: 07B Expiration Date: 03/2014  Product Insert Number: RSSO_LTYP_PI_EN Rev 21
Lot Number: 07B Expiration Date: 03/2014   Product Insert Number: RSSO_LTYP_PI_EN Rev 21
HLA typing assay, associated with incorrect typing results, was distributed.
Nationwide distribution: USA including states of: DE, KY, LA, MD, NJ, NY, PA, TX, VA, and WV.
Select Medical Products Vinyl Powder-Free Exam Gloves, Medium Model # 6370 and Large Model # 6371, 100 per box; 10 boxes per case.   Usage: Patient Examination.
Lot # (for both sizes) 030212BU216995995 Medium gloves are Model # 6370, Product # 802634  Large gloves are Model # 6371, Product # 80635.
Gulf South Medical Supply recalled their Select Medium and Large size Vinyl Exam Gloves because they were inadvertently shipped prior to U.S. Customs clearing them for sale.
Product was distributed nationwide and to Australia and France.
Multispot HIV-1/HIV-2 Rapid Test has a catalog # 25228.
Bio-Rad Multispot HIV-1/HIV-2 Rapid Test, with reports of decreased reactivity accompanied by a faint speckling appearance on cartridge membrances when using some vials of Conjugate, were distributed.
Venlafaxine ER 150mg, 30 Tabs bottle, Generic for: Effexor, Packaged and Distributed by: Stat Rx USA, LLC, Gainesville, GA 30501 NDC 42549-684-30
Labeling: Label Mix-up: Product was incorrectly labeled,''Tabs'' instead of ''Capsules.''
Worldwide Distribution - USA (nationwide) including the countries of Canada and Lithuania.
EnteraLite Infinity Enteral Feeding Pump identified with the following list numbers: INFKIT2 and INFORNG.  The device is used with disposable PVC administration tubing sets to provide a means for the volumetric delivery of fluids used in enteral applications.   The EnteraLite Infinity enteral feeding pump with disposable PVC administration tubing sets and user accessories provide a means for the volumetric delivery of fluids used in enteral applications.
MOOG Medical Devices Group is conducting a voluntary for a limited set of serial numbers of the EnteraLite Infinity and Infinity Orange Small Volume Enteral Feeding Pumps because certain diodes on the PCB assembly may result in insufficient voltage to a portion of the pump resulting in an error 13 message and shutting the pump down entirely.