Industrias Alimenticias Kern's y Cia. S.C.A.
Distribution was retail outlets in TX, OK, LA, CO, and  TN
Ducal Brand Prepared Sauce Queso/Cheese, UPC 088313-08328-6, Net Wt 4 oz, Product of Guatemala, C.A. Central American product made with quality by:  Industrias Alimenticias Kern's Y/Cia, S.C.A., Km. 6 1/2 Carretera al Atlantico. Reg. D.G.R.V.C.S.D.R.C.A. B 658    The product was shipped in cases each of which included 4 paperboard cartons.  Each paper board carton held 12-4 oz pouches.
84 cases distributed from Goya Foods of Texas
Lab analysis detected the pH to be greater than 4.4
US: Nationwide (AL, CO, DE, FL, IA, IL, IN, KS, LA, MN, MO, NC, NY, OK, PA, TN, TX, VA) + District of Columbia
The Plum XL Family is indicated for intravenous. arterial, sort-term epidural, and parenteral administration of general I.V. fluids, medications, nutritional fluids, and blood/blood products to patients in hospital and home care environments.
There is the potential for the door roller assembly on the Plum XL family of infusers to break. In the event of a broken door roller pin, the door cannot appropriately lock the cassette in the right position. Depending on the conditions of a broken door toller pin, a number of events can occur. The door cannot be closed or a cassette/door alarm or a false occlusion alarm might be triggered. Broken door roller pins can also cause the cassette door to be very loosely seated and, when jostled, may come out of position and stop infusion in the middle of therapy. And lastly, when the cassette door is opened, the cassette door mechanism may not fully clamp the IV tubing.
US: Nationwide (AL, CO, FL, IA, ID, IL, IN, KS, LA, MN, MO, NC, NY, OK, PA, TN, TX, VA) + District of Columbia
The Plum A+ Infusion System is designed to meet the fluid delivery requirements of today's evolving healthcare environments. It is a cassette based multi-function infusion system. The Plum A+ allows two lines in and one line out. The pump can be used for standard, piggyback, or concurrent delivery. Therapy modes include: Standard Infusions, Multistep Programming, Loading Dose, and Dose Calculation. The Plum A+ is designed to deliver parenteral, enteral, or epidural infusions over a broad range of infusion rates from multiple fluid container types. Each system includes a pumping module and an assortment of disposable IV sets, optional accessories, and an operator's manual.
Certain Plum A+ fluid shield diaphragms may be out of specification and may cause N250 ''Door Open while pumping'' or N100 ''Unrecognizable Cassette'' alarms. Both the N250 and N100 alarm conditions trigger an audible and visual warning to the user, which may occur during setup, infusion or Performance Verification Testing (PVT). If an N250 or N100 alarm is triggered, a delay or interruption in therapy may result.
There is a potential for the Plum A+ fluid shield to inadequately prevent fluid from entering into the Plum A+ device (fluid ingress) and potentially causing damage to the pumping mechanism, and/or sensors. Fluid ingress could result in the device being unable to recognize installed cassettes, cause Valve Cassette Test Failures, or result in one or more of the following error codes being displayed: E/N180, E/N181, E/N186, E/N187, E/N250, E/N251, and E346 and cause the devices set up to be interrupted or infusion to stop.
Worldwide Distribution.  US nationwide including Puerto Rico, China, Philippines, Mexico, Korea, Japan, Colombia, Chile, Canada, Brazil, and Australia
SHAPE ARM, SINGLE, an articulating, arm bracket that is attached to the service head of boom systems which are used for supporting and positioning equipment in operating rooms and patient care areas. The product comes as a component of kit part number 0682400253 and the Arm part number in the kit is P17085. .  The kit, when assembled, supports a flat-panel video monitor that is attached to one of two types of Stryker Communications boom systems, EDS or FLEXiS.
Serial numbers  111018DE001 through 140210DE020   Serial and part numbers are located on underside of the cover of the portion of the Arm that is attached to the boom's service head.  Screws must be removed and the cover detached to view these numbers.
During the use of the SHAPE Arm there is the potential for the monitor mount to come off of the SHAPE Arm if the lock washer and screw are not present.
SHAPE ARM, DUAL SH2, an articulating, arm bracket that is attached to the service head of boom systems which are used for supporting and positioning equipment in operating rooms and patient care areas. The product comes as a component of kit part number 0682400254 and the Arm part number in the kit is P17084 .  The kit, when assembled, supports a flat-panel video monitor that is attached to one of two types of Stryker Communications boom systems, EDS or FLEXiS.
Serial numbers  111018DF001 through 120409DF045    Serial and part numbers are located on underside of the cover of the portion of the Arm that is attached to the boom's service head.  Screws must be removed and the cover detached to view these numbers.
953 total STRYKER SHAPE Arms of all types
SHAPE ARM, SINGLE WITH GCX MOUNT, an articulating, arm bracket that is attached to the service head of boom systems which are used for supporting and positioning equipment in operating rooms and patient care areas.  The product comes as component of kit part number 0682400256 and the Arm part number in the kit is P17087 .  The kit, when assembled, supports a flat-panel video monitor that is attached to one of two types of Stryker Communications boom systems, EDS or FLEXiS.
Serial numbers  111108DD001 through 131115DD020 Serial and part numbers are located on underside of the cover of the portion of the Arm that is attached to the boom's service head.  Screws must be removed and the cover detached to view these numbers.
BAM (SHAPE) ARM, LEFT, an articulating, arm bracket that is attached to the service head of boom systems which are used for supporting and positioning equipment in operating rooms and patient care areas.  The product comes as component of kit part number 0682000976, and the Arm part number in the kit is P17087.  The kit, when assembled, supports a flat-panel video monitor that is attached to one of two types of Stryker Communications boom systems, EDS or FLEXiS.
Serial numbers  080924DC001 through 120227DC025     Serial and part numbers are located on underside of the cover of the portion of the Arm that is attached to the boom's service head.  Screws must be removed and the cover detached to view these numbers.
BAM (SHAPE) ARM, RIGHT, an articulating, arm bracket that is attached to the service head of boom systems which are used for supporting and positioning equipment in operating rooms and patient care areas.  The product comes as a component of kit part number 0682000977, and the Arm part number in the kit is 01000221456.   The kit, when assembled, supports a flat-panel video monitor that is attached to one of two types of Stryker Communications boom systems, EDS or FLEXiS.
Serial numbers  080909DB001 through 131021DB015   Serial and part numbers are located on underside of the cover of the portion of the Arm that is attached to the boom's service head.  Screws must be removed and the cover detached to view these numbers.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Product was distributed in US to AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO,MMS, MT, NC, ND, NE, NH, NJ, NM, NV, OH, OK, OR, PA, RI, SC, SD, TN, TX, VT, VA, VT, WA, AND WI. Product was distributed outside the US to British Columbia, Ontario and Quebec, Canada.
There are 2 different labels for this same product with the same UPC.   Label #1 Individual Bars:  100% natural Zing Complete Nutrition, DARK CHOCOLATE HAZELNUT, Gluten, Soy & Dairy Free, NET WT. 1.76 OZ. (50g), Manufactured For: Zing Bars Seattle, WA 98125.      Label #1 Display Carton:  Zing Complete Nutrition, Gluten, Soy & Dairy Free, DARK CHOCOLATE HAZELNUT, 100% natural, 12/1.76 OZ (50g) Bars, NET WT 1 LB 5.12 OZ (600g)    Label #2 Individual Bars:  100% natural Zing Nutrition Bar, DARK CHOCOLATE HAZELNUT, Gluten Free, Vegan & Non GMO, NET WT. 1.76 OZ. (50g).      Label #2 Display Carton:  ''100% natural Zing Nutrition Bar, Gluten Free, Vegan & Non GMO, DARK CHOCOLATE HAZELNUT, 12/1.76 oz (50g) Bars, NET WT 1 LB 5.12 OZ (600g)    Chocolate covered nutrition bar packaged in 2 layer metallized BOPP film, 1.76 oz each. 12 individually wrapped bars per display box.    Bar UPC code: 8-55531-00216-6;  Display Carton UPC code:  8-55531-00217-3;   Master Case UPC code: 1-08-55531-00217-0.
Undeclared milk found in bars labeled ''dairy free'' or ''vegan.''
There are two different labels for this product same UPC codes.     Version #1 individual bars:  100% natural Zing Complete Nutrition, CHOCOLATE COCONUT, Gluten, Soy & Dairy Free, NET WT. 1.76 OZ. (50g).    Version # 1 display carton:  Zing Complete Nutrition, Gluten, Soy & Dairy Free, Zing Nutrition Bar, 100% natural CHOCOLATE COCONUT, 12/176 OZ (50g) Bars, NET WT 1 LB 5.12 OZ (600g), Gluten, Soy & Dairy Free.      Version # 2 individual bars:  100% Natural Zing Nutrition Bar, DARK CHOCOLATE  COCONUT, Gluten Free, Vegan & Non GMO, NET WT. 1.76 OZ, Manufactured For: Zing Bars Seattle, WA 98125.      Version # 2 display carton:  100% Natural Zing Nutrition Bar, Gluten Free, Vegan & Non GMO, DARK CHOCOLATE COCONUT, NET WT. 1.76 OZ (50g) Bars, NET WT 1 LB 5.12 OZ (600g), Manufactured For: Zing Bars Seattle, WA 98125.       Chocolate covered nutrition bar packaged in 2 layer metallized BOPP film, 1.76 oz each. 12 individually wrapped bars per display box.    UPC code for Bar: 8-55531-00205-0;   UPC code for Display Box:    8-55531-00212-8;   UPC code for Master Case: 1-08-55531-00212-5.
There are three different labels for this product.    Label #1 individual bar   100% Natural Zing Nutrition Bar, DARK CHOCOLATE SUNFLOWER MINT, Gluten Free & Vegan, NET WT. 1.76 OZ. (50g), Manufactured For: Zing Bars Seattle, WA 98125.    Label #1 display Carton  100% Natural Zing Nutrition Bar, Gluten Free & Vegan, DARK CHOCOLATE SUNFLOWER MINT, 12/1.76 OZ(50g) Bars, NET WT. 1 LB 5.12 OZ. (600g).    Label #2 individual bar  100% Natural Zing Nutrition Bar, NUT FREE DARK CHOCOLATE SUNFLOWER  MINT, Gluten Free & Vegan, NET WT. 1.76 OZ. (50g), Manufactured For: Zing Bars Seattle, WA 98125.    Label #3 individual bar  100% Natural Zing Nutrition Bar, NUT FREE DARK CHOCOLATE MINT, Gluten Free, Vegan & Non GMO, NET WT. 1.76 OZ. (50g), Manufactured For: Zing Bars Seattle, WA 98125.    Chocolate covered nutrition bar packaged in 2 layer metallized BOPP film, 1.76 oz each. 12 individually wrapped bars per display box.    Bar UPC code: 8 55531 00206 7;  Display Box UPC code: 8 55531 00213 5;   Master Case UPC code: 1 08 55531 00213 2.
Individual Bars: 100% Natural Zing Nutrition Bar, CASHEW CRANBERRY ORANGE, Gluten, Dairy & GMO Free, NET WT. 1.76 OZ (50g), Manufactured For: Zing Bars Seattle, WA 98125.    Display Carton:  Zing Complete Nutrition, Gluten, Soy & Dairy Free, 100% natural CASHEW CRANBERRY ORANGE, 12/1.76 OZ (50g) Bars, NET WT 1 LB 5.12 OX (600g).      Nutrition bar packaged in 2 layer metallized BOPP film, 1.76 oz each. 12 individually wrapped bars per display box.    Bar UPC code: 8-55531-00203-6;  Display Carton UPC code: 8-55531-00210-4;   Master Case UPC code: 1-08-55531-00210-1.
Just Great Stuff Chocolate Dream Greens, 42 g bar,    The bars are individually wrapped and packed in a display containing 12 bars.  The displays are shrink wrapped.
Produced: 6/1/2013 Code Date: BB 1JUN14  Produced: 6/15/2013 Code Date: BB 15JUN14  Produced: 8/13/2013 Code Date: BB 13AUG14 F1 2253  Produced: 10/24/2014 Code Date: BB 24OCT14 F2 2973  Produced: 12/31/2013 Code Date: BB31DEC14 F4 3653  Produced: 2/20/2014 Code Date: BB20FEB15 F2 0514    Best By date/F1 thru F4 represents the machine the product was wrapped on and the last four digits represent the Julian date. The three numbers are the day of the year and the last digit is the last digit of the year.
70,397 - 42g bars (product distributed in 12 ct displays)
Undeclared milk which was a contaminant of the dark chocolate ingredient.
Sarns Disposable Centrifugal Pump without X-Coating,164275, is a sterile, single use device.    For use in cardiopulmonary bypass procedures.
During set-up and priming of the bypass circuit, leaks were detected on the centrifugal pumphead.
Sarns Disposable Centrifugal Pump with X-Coating, 164275X, is a sterile, single use device.   For use in cardiopulmonary bypass procedures.
Product was distributed in Colorado; some may have gone to Idaho, Kansas, New Mexico, and Utah. No military/govt/VA or foreign consignees.
Certified Organic, Owl Canyon Whole Eggs, packed in one dozen and half-dozen cardstock packages, with a packing date of 93, 94, 97, or 98.
Expiration date of 5/18/14, 5/19/14, 5/22/14, or 5/23/14;  location code of 1 or 3
Eggs have the potential to be contaminated with Salmonella Enteritidis
Blood Centers of the Pacific - Irwin Center
Blood products, collected from a donor who received a piercing within 12 months of donation, were distributed.
Blood products, collected from a donor who traveled to a malarial endemic area, were distributed.
Platelets Pheresis Leukocytes Reduced Irradiated
Platelets, with a low platelet count, were distributed.
Whole Blood, collected in misbranded collection sets, were distributed.
Red Blood Cells Leukocytes Reduced Irradiated
Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.
Blood and Blood Products for Reprocessing
Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
Worldwide Distribution - US including the states of OR and PA., and the countries of  Denmark and UK.
Siemens RAPIDComm Data Management System.   The RAPIDComm Data Management System manages the process of sending and receiving data from Siemens POC devices and hospital systems located in the hospital network,
RAPIDComm 5.0 Screen Layout will display incorrect test names
VetOne Vetrimycin 100, Oxytetracycline Hydrochloride Injection, 100 mg/mL Sterile, 500 mL, ANDA 200-452, Distributed by: MWI, Meridian, ID.  Made in UK
The product appears cloudy when it should be a clear amber solution.
Terra-Vet 100, Oxytetracycline Hydrochloride Injection, 100 mg/mL, Multiple Dose Sterile Vial, 500 mL, ANDA 200-452, Veterinary Resources, LTD. Manufactured for: Aspen Veterinary Resources, Ltd., Liberty, MO.
The product appears cloudy or milky when it should be a clear amber solution.
US Nationwide Distribution in the states of NH, TN, OH, VA, and TX.
Siemens syngo RT Dosimetrist 2.7 system   Product Usage:  The intended use of syngo Suite for Oncology Systems is as an accessory to the linear accelerator system to aid and support in the planning and delivery of x-ray radiation for the therapeutic treatment of cancer.
An update to the Virtual Simulation software of the syngo RT Dosimetrist is necessary to address a safety issue. In special scenarios within the Structure Operations function the system did not store the selected name from the list of predefined names. After reloading of the data, this structure name had been changed by the system. Additionally, a performance issue was addressed where import of DICOM data failed because the loaded CD was not recognized by the system.
Blood product, which did not meet the acceptable product specifications for release, was distributed.
Blood products, collected from a donor with an invalid result for body temperature, were distributed.
Blood products, collected from a donor who had traveled to a malarial endemic area, were distributed.
Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.
Blood products, collected from a donor who traveled to an area considered endemic for malaria, were distributed.
Mt. Olive, PepperPAK Jalapeno Slices, 4-3.7fl oz cups, Net fl oz 14.8 (438 ml), Mt Olive Pickled Co., Inc., Corner of Cucumber and Vine, P.O. Box 609, Mt. Olive, NC 28365-0609.
Case UPC = 0930010016 Jalapeno PepperPak code date 1FI1114A and 1FI1114B; Sleeve UPC = 0930010015 Hamburger Dill Chips code date 1FI1114A and 1FI1114B
Worldwide Distribution -  US (nationwide),  Australia, Belgium, Canada, Colombia, China, Indonesia, India, Japan, Korea, Mexico, Malaysia, Peru, Philippines, Singapore, Thailand, and Taiwan.
BBL CrystaLEAD Enteric/Nonfermentor (E/NF) Identification (ID) System,  catalog number 245000.  in vitro diagnostic for the identification of aerobic gram-negative bacteria that belong to the family Enterobacteriaceae as well as some of the more frequently isolated glucose fermenting and nonfermenting gram-negative bacilli.
A portion of the BBL Crystal Enteric/Nonfermentor (E/NF) Identification kits from lot numbers 3224281 and 3290379 are labeled with incorrect expiration dates.    A portion of these kits contain Crystal Inoculum fluid bottles that will expire prior to the date that was printed on the kit carton. The expiration date printed on the individual Crystal Inoculum fluid bottles is correct.
US distribution was made to end users in: TX, CA, FL, PA, Washington, DC, MO, RI, AZ, HI, and GA, and Internationally to distributors in Mexico, Canada, and Venezuela.
Olerup SSP HLA Typing Kits   The kit contains dried primer solutions are pre-aliquoted into cut PCR trays with 0.2 ml wells.    These trays, one for each test, are packaged in inner boxes of paper and then together with mastermix vials in outer paper boxes. The kits are available in two formats, kits containing PCR Master Mix including Taq polymerase respective kits containing PCR Master Mix without Taq polymerase.
Olerup SSP HLA Typing Kits   ALow:   Lot 44V, exp. September 1, 2015;   ALow Screening:  Lot 28V, exp. July 1, 2016;   A-B-C:  Lots  64S, exp. March 1, 2016, and 63V, exp. September 1, 2016;  A-B-DR:  Lot 63S, exp. March 1, 2016;  A-B-DR-DQ:   Lot 70S, exp. March 1, 2016
HLA typing assay, associated with false negative results, were distributed.
Calcium Hydroxide Powder, USP   For use in root canal therapy by health care professional. Product Application or Usage: Provides bactericidal effect on carious dentine. Paste delivered to root apex provides pulp insulation. Protects the vital pulp from infections and further decay. Calcium Hydroxide Powered is mixed with appropriate vehicle (i.e. Eugenol) prior to administration.
One lot of Calcium Hydroxide Powder is being recalled because it was manufactured and distributed without an approved 510k, and the current label does not include instructions for use.
Hemo-Stat Solution, Aluminum chloride 25%, in 37.2 g glass bottles, distributed by Benco Dental, Pittston, PA; Also distributed by Henry Shein, Melville, NY; and Hemoban distributed by iSmile Dental Products, Sacramento, CA
Marketed without an Approved NDA/ANDA; product is being manufactured and distributed without a NDC number
DISTRIBUTION PATTERN: Is as follows - The total number of consignees (customers) that received the recall product as per  Company Response: 25    Sales by Customer Detail Sheet List: 37 (including one retail customer)    The total  number of wholesaler dealers that received the recall product as per company's response,  2      The total  number of distributors that received the recall product  as per company's response - 2    The total number of retailers that received the recall product as per company's response - 23    The total  number of consumers / users that received the recall product as per company's response - 25
Plank Road Round (Pasteurized Cows Milk Cheese), 4 ounce plastic cups are sealed with a protective band.
Lot # 922 - Plank Road Round, Production Date : 04/16/14
Failure to achieve proper pasteurization due to one or more of the following critical factors:  Improper Air space temperature, Pasteurization time, and/or Milk Temperature.
Chevre (Pasteurized Goats Milk Cheese) .-Four oz. cups Fresh Chevre  /   Bulk Chevre - One, two, and five pound sizes
Lot # 937 - Chevre, Production Date : 05/12/14
Human tissue allografts, processed in a manner that could cause contamination or cross-contamination during processing, as well as the introduction, transmission, or spread of communicable disease through the use of the HCT/P, were distributed.
University Of Miami Miller School of Medicine Tissue Bank
Human bone allografts, mislabeled with an incorrect expiration date, were distributed.
The product was distributed to MO.  The firm's consignee reports distributing the recalled product to two customers, one in OR and one in GA.
Huvepharma Amprol 25% (amprolium), Type A medicated article, NADA 012-650, Manufactured by: Huvepharma, Inc., St. Louis, MO, Distributed by: Huvepharma, Inc., Peachtree City, GA.
Lot # HSC119; expiration date: February 2017
Echinacea Agustifolia Root PE 4:1   The product is in powder form extracted from the Echinacea root packed in varying size lined cardboard boxes containing 10 kg or 25 kg.
Products contain Azoxystrobin for which no tolerance is allowed per 40 CFR 180.507.
Echinacea Agustifolia PE 4& echinosides   The product is in powder form extracted from the Echinacea root packed in varying size lined cardboard boxes containing 10 kg or 25 kg.
Echinacea Angustifolia Root PE 4: The product is in powder form extracted from the Echinacea root packed in varying size lined cardboard boxes containing 10 kg or 25 kg.
Botanos Los 3 Chavos Mango Enchilado Net Wt. 1 1/2 OZ.  (42 g) Oaxaca Mexican Products 100 8th Street, Passaic, NJ 07055
Mango Enchilado contains undeclared colors and sulfites. It is also contaminated with lead.
Distribution has been made to AL, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MD, MN, MO, MS, NE, NJ,NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WA, WI and WY.
Surpass (1% diclofenac sodium) Topical Anti-Inflammatory Cream, 124 g tube, UPC 012313449810,  NADA 141-186. Manufactured for: Boehringer Ingelheim Vetmedica, Inc., St. Joseph, MO.
During stability testing, the product was found out of specification.
New York, Pennsylvania, New Jersey, Massachusetts, Virginia, and Maryland
Wegmans Cinnamon Raisin Buns, NET WT. 12 OZ (340g), UPC 77890 92218 ---Baked by Wegmans Food Markets Inc. - Rochester, NY 14603
BEST IF USED BY 6/19  TU  (stamped on top of package)
The Raisin Cinnamon Buns contain undeclared eggs which may also be raw.  This poses a potential health risk to consumers if the product is consumed.
Distribution was made to MO, IL, IN, IA and WI.
Schnucks Bakery 8'' Devil's Food Cake, net wt. 2 lb 13 oz, UPC: 04131831186. Also packaged as Schnucks Bakery Half Devil's Food Cake, net wt. 1 lb 7 oz plastic, UPC: 04131831078   Schnuck Markets, Inc., St. Louis, MO.
8'' Devil's Food Cake: Item: 31-40080;  Half Devil's Food Cake: Item: 31-40503.
The product contains pecan pieces as a top garnish and the product label does not include pecan or tree nuts.
Human corneas, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, were distributed.
Worldwide Distribution - USA (nationwide) and Internationally to Australia, Belgium, Denmark, France, Germany, Great Britain, Italy, Netherlands, Norway, Portugal, Spain, and Sweden.
SUTUREFIX Ultra Anchor XL with one (#2) Ultrabraid Blue Product Code: 72203841      Fastener, fixation, nondegradable, soft tissue
Sterility of device is compromised due to breach in sterile barrier
SUTUREFIX Ultra Anchor XL with one (#2) Ultrabraid Cobraid Suture Product Code: 72203842    Fastener, fixation, nondegradable, soft tissue
SUTUREFIX Ultra S with 1 #2 Ultrabraid (blue) Product Code: 72203852    Fastener, fixation, nondegradable, soft tissue
SUTUREFIX Ultra S with 1 #2 Ultrabraid Suture (blue/white) Product Code: 72203853    Fastener, fixation, nondegradable, soft tissue
SUTUREFIX Ultra S Double Loaded Suture Product Code: 72203854    Fastener, fixation, nondegradable, soft tissue
ChloraPrep With Tint,  2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), 26 mL APPLICATOR, Hi-Lite Orange. Rx Only.  CareFusion, El Paso, TX 79912.  NDC: 054365-400-13.
Lack of Assurance of Sterility; Immediate product pouches may not be properly sealed.
Distributed in the states of CA, FL, IL, KY, MA, MD NJ, NY, and RI.
Lynx TM20 Torquemaster Low Speed Handpiece MTI Dental Products
P/N Lynx TM20-4H-01: T41202012, T41202013, T41203001, T41203002,  T41203003, T41203010, T41204001 to T41204006    P/N Lynx TM20-4H-03 distributed to end user accounts with serial number T41204001    P/N Lynx TM20-2H-03 distributed to Medidenta private labeled as ''Meditorque I 20 K'' with serial numbers M21203001 to M21203025.    P/N Lynx distirbuted to Medidenta private labeled as ''Meditorque I 20 K'' with serial numbers M21203026 to M21203055.    P/N Lynx TM20-4H-01 distributed to Johnson-Promident with serial numbers T41204001-T41204020    P/N Lynx TM20-2H-01 distirbuted to Johnson-Promident with serial numbers T21204001-T21204020.
MTI Precision Products LLC received a complaint regarding a sharp edge on the body/housing of the Lynx TM20 TorqueMaster Low Speed Handpiece.
CTF Brand Tapioca Pearl Net Wt: 14 oz. (400G.) Exporter: Combine Thai Foods Co., Ltd. 359/716-17 Spot Chalaem Nimit, Chalaem Nimit Rd. (Pradu 1) Bangkro, Bangkholaem, Bangkok 10120 Thailand Product of Thailand UPC 8851381560506
Tapioca pearl contains unapproved and undeclared colors.
Worldwide Distribution - USA (nationwide) and Canada.
Excelsior Medical Sterile Triple Lead Tubing Set and Sterile Heavy Duty Triple Lead Tubing Set.  To be used with the Pharm-Assist Dispensing Pump.   Used for drug reconstitution and/or fluid transfer
4250 tubing sets (PA03 - 78 cases; BX03 - 92 cases (each case contains 25 tubing sets))
There is a potential for a leak.   A molding defect in the connector that joins the three leads to the main flow line may allow fluid to escape or air to enter the fluid path during transfer of fluids from one container to another.
US: Nationwide (NY, MA, VM, NH, TX, AL, FL, GA, and SC)
Vita Classic Premium Sliced Smoked Atlantic Nova Salmon, packaged in a black vacuum-sealed, plastic film package for retail sale. Product is labeled ''ready to serve'' and each package contains 4 ounces of product.
626 cases, each case contains 12/4 ounce packages, TOTAL PACKAGES = 7,512 packages
This voluntary recall is being initiated due to a positive Listeria monocytogenes sample taken by the Florida Department of Agriculture and Consumer Services.
Worldwide Distribution-USA (nationwide) including the states of  AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV, and the countries of Canada, Mexico, Argentina, Australia, Austria, Belarus, Belgium, Bolivia, Brazil, Brunei, Chile, China, Costa Rica, Croatia, Czech Republic, Denmark, Dominican Republic, El Salvador, Finland, France, Germany, Gibraltar, Great Britain, Greece, Guatemala, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Korea, Kuwait, Libya, Lithuania, Luxembourg, Malaysia, Mexico, Netherlands, New Zealand, Norway, Panama, Peru, Philippines, Poland, Portugal,Quatar, Romania, Russia, Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, UAE, Uruguay, Venezuela, Vietnam.
ACL TOP (Base), automated coagulation laboratory instrument.
Start SN and Date: 03110101 Nov 2003 and End SN and Date 11111174 Nov 2011
ACL TOP 700, automated coagulation laboratory instrument.
Start SN and Date: 09080100 Aug 2009 and End SN and Date 14050732 May 2014
ACL TOP CTS, automated coagulation laboratory instrument.
Start SN and Date: 06020101 Feb 2006 End SN and Date 10080662 Aug 2010
ACL TOP 700 LAS, automated coagulation laboratory instrument.
Start SN and Date: 08120100 Dec 2008 End SN and Date 14050198 May 2014
ACL TOP 500 CTS, automated coagulation laboratory instrument.
Start SN and Date: 08010100 Jan 2008 End SN and Date 14052901 May 2014
ACL TOP 700 CTS, automated coagulation laboratory instrument.
Start SN and Date: 09120101 Dec 2009 End SN and Date 14050368 May 2014
ACL TOP 300 CTS, automated coagulation laboratory instrument.
Start SN and Date: 11110101 Nov 2011End SN and Date 14051302 May 2014
Shape HF Cardiopulmonary System.   Made up of Shape HF System Analyzer (PN 0001-9001) and Disposable Patient Interface (DPI), (PN 0004-4001).  A pulmonary gas exchange testing system used during cardiopulmonary exercise testing where collection and review of gas exchange variables are indicated.  The system will provide physiological data to physicians to aid in  patient assessment.
DPIs with Lot Number 1405006 and higher.
Shape Medical has initiated a correction due to a mandatory software upgrade for the Shape HF Cardiopulmonary Testing System prior to use of the impacted DPI lot numbers.  Use of the incorrect software version with the impacted DPIs could result in erroneous testing results potentially leading to incorrect diagnosis and incorrect treatment.
Mindray DS USA, Inc. dba Mindray North America
Worldwide Distribution - US including the states of Louisiana, New Jersey, Montana, South Carolina and Wyoming.
V-Series Patient Monitoring System, Manufactured for Mindray DS USA, Inc.    Used for monitoring of human physiological parameters.     The V-Series Monitor also has the capability of performing IV Drug and Hemodynamic Calculations and interfacing with network devices.
113 units (57 United States; 56 International)
Several issues with the V-Series Monitoring System 12-lead ECG interpretation feature.  These issues impact the 12-lead ECG feature only; standard 12-lead ECG monitoring is not affected.  (1) The 12-lead Standard and Extended Measurement Report will include false measurements when the P wave or QRS axis cannot be accurately determined by the algorithm.  (2) The Median Complex and Extended Measurement Report will display the representative beat as 25% larger than actual signal input.  (3) When a patient date of birth is imported into the V Series from an external source, such as Mindray's Gateway, e-Gateway, Panorama Central Station or Panorama Workstation, the age will not pass into the 12-lead ECG interpretation algorithm.  The algorithm analysis will use the default adult criteria of ''50 year adult'' in which case the interpretive statements may be incorrect, depending on the actual age of the patient. Note:  when the patients date of birth is manually entered into the V-Series the correct age is accepted and the appropriate interpretation algorithm is applied.
Distribution was made to CO, IL, IN, NE, NJ, PA, SD, and a government facility located in VA.
Thermo Scientific VersaTREK REDOX 1, Ref 7102-44, 80ml with Stir Bar (O2 aerobic), 50 bottles/box, IVD.  The firm name on the label is Remel Inc., Lenexa, KS.
Segments 1, 5, and 6 only of Lot 492571, Exp. 2015-10
Bottles did not provide positive signals within the time frame of the quality control specification for one of two strains of Streptococcus pneumoniae.
Zimmer Dental Tapered Screw-Vent Implant, Catalog TSVT6B13, Lot 62284006
Catalog Number TSVT6B13, Lot Number 62284006. 5-year expiration. January 2018.
Zimmer Dental is conducting a voluntary recall of a single lot of the Tapered Screw-Vent Implant, Catalog Number TSVT6B13, Lot number 62284006, due to a potential crack in the cap of the outer vial.
Distributed USA (nationwide) and Canada.
Baxter MiniCap with Povidone-Iodine Solution, 5C4466P, Baxter Healthcare Corporation. For dialysis.
Inadequate iodine and packaging related defects.
Worldwide Distribution.  US nationwide including CA, MI, NC, NE, NY, OH, PA, TX, and VA; Argentina, Austria, Belgium, Bolivia, Canada, Chile, Colombia, Finland, Germany, Great Britain, Greece, India, Ireland, Italy, Japan, Korea, Netherlands, Paraguay, Peru, South Africa, Spain, Sweden, Switzerland, and Uruguay
Coat-A-Count Direct Androstenedione, SMN 10381049, Catalog Number TKAN1.  Siemens Healthcare Diagnostics
Lot No. TKAN1 batch 587  TKAN1 batch 588  TKAN1 batch 589  TKAN1 batch 590  TKAN1 batch 591  TKAN1 batch 592  TKAN1 batch 593  TKAN1 batch 594  TKAN1 batch 595  TKAN1 batch 596  TKAN1 batch 597  TKAN1 batch 598  TKAN1 batch 599  TKAN1 batch 600
The assay is demonstrating a higher frequency of results greater than 10 ng/mL compared to alternate platforms.
US Distribution in the states of : IN, TN, and WA.
Titan T 5K Motor    Product Usage:  Low-speed motor is used with various attachments to perform a variety of dental procedures including caries removal, finishing, polishing, pin setting and prophy.The motor has a speed range of 100 to 5000 rpm capability.
The housing of 5K motor was laser marked incorrectly as a 20K motor.
Apri (desogestrel and ethinyl estradiol tablets USP), 0.15 mg/0.03 mg,  6 Cyclic dispensers X 28 tablets, Rx only, Teva Pharmaceuticals, Sellersville, PA. NDC 0555-9043-58
Failed Impurities/Degradation Specifications: Teva Pharmaceuticals USA, Inc. is voluntarily recalling one lot of Aprif  tablets due to out of specification impurity test results.
Mircette (desogestrel/ethinyl estradiol and ethinyl estradiol) Tablets  0.15 mg/0.02 mg and 0.01 mg, 6 Cyclic dispensers X 28 tablets, Rx only Teva Pharmaceuticals, USA, Sellersville, PA. NDC 51285-114-58
Failed Impurities/Degradation Specifications: Teva Pharmaceuticals USA, Inc. is voluntarily recalling one lot of Mircette tablets due to out of specification impurity test results.
Kariva (desogestrel/ethinyl estradiol and ethinyl estradiol) Tablets   0.15 mg/0.02 mg and 0.01 mg, 6 Cyclic dispensers X 28 tablets, Rx only,  Teva Pharmaceuticals, Sellersville, PA NDC 0555-9050-58
Failed Impurities/Degradation Specifications: Teva Pharmaceuticals USA, Inc. is voluntarily recalling one lot of  Kariva tablets due to out of specification impurity test results.
Velivet (desogestrel and ethinyl estradiol tablets - triphasic regimen),  0.1 mg/0.025 mg; 0.125 mg/0.025 mg; 0.15 mg/0.025 mg, 3 Dispensers x 28 Tablets, Barr Laboratories, Inc., Pomona, NY  NDC 0555-9051-67
Failed Impurities/Degradation Specifications: Teva Pharmaceuticals USA, Inc. is voluntarily recalling one lot of  Velivet distributed by Barr Laboratories, Inc.  due to out of specification impurity test results.
Worldwide Distribution - US in the state of Georgia and in the countries of :  Malaysia, Paraguay, and France.
Spacelabs Healthcare Ultraview SL Multigas Module, Model 92518 (Software V1.00.00-09).  Provides a means of monitoring a variety of gas concentrations and alert clinical personnel when the concentration of anesthetic agent(s), oxygen, carbon dioxide or nitrous oxide moves outside of user-defined limits.
With this software version, the Minimum Alveolar Concentration (MAC) value displayed is extremely high (20.1) and physiologically invalid.
Product was shipped to the following states: OH and WI
Walnut Creek Farmers Cheese- 6lbs in plastic bags- 4 per case
Milk used in the products tested positive for antibiotics.
Walnut Creek Marble Cheese-- 6lbs of cheese in plastic bags; 4 per case
Milk used in the products tested positive for antibiotics
Whey Protein Concentrate -- No labeling sold in bulk tanker
None  -  ship date: 06/12/13 Load # 36866
US Nationwide Distribution in the states of TX and FL
Tritium Sternal Plate System, Screw, 02.7mm X 12mm, 12 Pack, Sterile.   The Pioneer Surgical Cable Plate System is used in the stabilization and fixation of fractures of the anterior chest wall including Sternal fixation following Sternotomy and Sternal reconstructive surgical procedures. The screws are packaged as a 12 pack using a double tray packaging configuration.
Velveeta Original Pasteurized Ripe Cheese Product sold under the Kraft brand and individually wrapped in plastic and sold in a card stock carton with a net weight of 2 lb. (32 oz.).
Consumer Package Code: 17 DEC 2014 09:34 - 13:35
Kraft Foods is recalling part of one sku of Velveeta Original Pasteurized Recipe Cheese Product because a preservative ingredient was found to be present at levels below specification.
Worldwide Distribution-*** US: Nationwide (AK ; AL ; AR ; AZ ; CA ; CO ; CT ; DE ; FL ; GA ; HI ; IA ; ID ; IL ; IN ; KS ; KY ; LA ; MA ; MD ; ME ; MI ; MN ; MO ; MS ; MT ; NC ; ND ; NE ; NH ; NJ ; NM ; NV ; NY ; OH ; OK ; OR ; PA ; RI ; SC ; SD ; TN ; TX ; UT ; VA ; VT ; WA ; WI ; WV ; WY) + District of Columbia + Puerto Rico; *** FOREIGN: Albania ; Algeria ; Angola ; Argentina ; Australia ; Austria ; Azerbaijan ; Bahrain ; Bangladesh ; Belarus ; Belgium ; Botswana ; Brazil ; Bulgaria ; Canada ; Chile ; China ; Colombia ; Costa Rica ; Croatia ; Cuba ; Czech Republic ; Dominican Rep. ; Ecuador ; Egypt ; El Salvador ; Finland ; France ; Georgia ; Germany ; Ghana ; Greece ; Hong Kong ; India ; Indonesia ; Iran ; Iraq ; Ireland ; Israel ; Italy ; Jamaica ; Japan ; Jordan ; Kazakhstan ; Kuwait ; Macedonia ; Malaysia ; Mexico ; Morocco ; Myanmar ; Netherlands ; New Zealand ; Niger ; Nigeria ; Norway ; Oman ; Pakistan ; Palestinian Territory ; Peru ; Philippines ; Poland ; Portugal ; Qatar ; Romania ; Russia ; Saudi Arabia ; Serbia ; Singapore ; Slovakia ; Slovenia ; South Africa ; South Korea ; Spain ; Sri Lanka ; Sweden ; Switzerland ; Syria ; Taiwan ; Thailand ; Trinidad and Tobago ; Tunisia ; Turkey ; Ukraine ; United Arab Emirates ; United Kingdom ; Uruguay ; Vietnam ; Yemen.
e.cam camera system.  Emission Computed Tomography System used to detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588 keV.  Nuclear medicine diagnostic device.
Siemens Medical Solutions USA, Inc. has received reports indicating the collimator cart rear casters may become loose.
Symbia E camera system.  Emission Computed Tomography System used to detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588 keV.  Nuclear medicine diagnostic device.
VIRACEPT (R) (nelfinavir mesylate) Tablets, 625 mg, 120-count bottle, Rx only, Manufactured by: Agouron Pharmaceuticals, Inc. A Pfizer Company,  Distributed by: ViV Healthcare Company, Research Triangle Park, NC 27709  NDC 63010-027-70
Labeling: Incorrect or missing lot and or Exp Date: The bottles were labeled with an incorrect expiry date 11/2016.  The correct expiry date is 09/2016.
POLY-TUSSIN AC LIQUID, Each 5 mL (1 teaspoonful) contains: Brompheniramine Maleate 4 mg, Codeine Phosphate 10 mg, Phenylephrine HCl 7.5 mg, 16 fl oz. (473 mL) Bottle, Rx Only. Manufactured by: Great Southern Laboratories, Houston, TX 77099, Distributed for: Poly Pharmaceuticals, Mobile, AL  36619. NDC: 50991-713-16.
Does Not Meet Monograph: Phenylephrine and pseudoephedrine are below monograph specifications, and label inaccurately contains wording ''Rx Only''.
LORTUSS EX, Each 5 mL (1 teaspoonful) contains: Codeine Phosphate 10 mg, Guaifenesin 100 mg, Psuedoephedrine HCl 22.5 mg, 16 fl oz. (473 mL),  Rx Only. Manufactured by:  Great Southern Laboratories, Houston, TX 77099, Distributed for: Poly Pharmaceuticals, Mobile, AL 36619.  NDC: 50991-515-16.
Nationwide Distribution to IL, IN, and MD
LP,Surgical Fibers,  Bare Laser Fiber 600 micron, DBLF-60-2, Sterile EO.   Laser surgical instrument for use in general and plastic surgery and in dermatology
Laser Peripherals LLC  is recalling  DBLF-60-2 Bare Laser due to a mislabeling that indicated a sterility expiration date as '2016-16' as opposed to the intended date of '2016-06'.
distributed in District of Columbia, Delaware, Florida, Maryland, North Carolina, New Jersey, New York, Pennsylvania, South Carolina, Virginia and West Virginia.
Hagen-Dazs Chocolate Chocolate Chip Ice Cream, 14 oz, UPC of 74570-08400
BATCH CODE:  4133580418D/  Best By 13 May 2015   Batch Code date Breakdown:YDDDPPPPLLO  Y-Year (2014)  JJJ-Julian date (133)  PPPP-Plant code (5804)  Line (14)  O- D-Shift
Nestle is recalling the Hagen-Dazs Chocolate Chocolate Chip Ice Cream because it mislabeled and the ingredient statement does not identify peanuts.  The affected products are labeled as Hagen-Dazs Chocolate Chocolate Chip Ice Cream, and lid labeled as Hagen-Dazs Chocolate Peanut Butter.  These mismatched packages contain Chocolate Peanut Butter ice cream, and the ingredient statement on the carton applies to Chocolate Chocolate Chip Ice Cream and does not identify peanuts.
Triamcinolone Acetonide Lotion USP, 0.1%, 60 mL Bottle, Rx Only, For Dermatologic Use Only, Not for Ophthalmic Use, E. Fougera & Co, A Division of Fougera Pharmaceuticals Inc., Melville, New York, 11747, NDC 0168-0337-60.
Failed PH Specifications: It has been determined that the pH of the lots recalled, may not meet specification at expiry.
Triamcinolone Acetonide Lotion USP, 0.025%, 60 mL Bottle, Rx Only, For Dermatologic Use Only, Not for Ophthalmic Use, E. Fougera & Co, A Division of Fougera Pharmaceuticals Inc., Melville, New York, 11747, NDC 0168-0336-60.
Algeria, Austria, Belgium, Bulgaria, Cyprus, Egypt, Finland, France, Germany, Great Britain, Greece, Hungary, Greece, Hungary, Ireland, Israel, Italy, Jordan, Lebanon, Lithuania, Luxemborg, Netherlands, Poland, Portugal, Romania, Saudi Arabia, Slovenia, South Africa, Spain, Sweden, Switzerland, Tunisia, Turkey, United Arab Emirates, Argentina, Brazil, Brunei, Chile, China, India, Japan, Korea, Mexico.
Integra Camino 110-4 Intracranial Pressure (ICP) Monitoring Catheters,  Cat. No's. 110-4B, 110-4G, 110-4H, 110-4L
Integra LifeSciences is recalling the Camino Intracranial Pressure Monitoring Kits because of revised labelling to indicate they are unsafe in an MR environment.
Fentanyl Citrate Injection, USP, 2500 mcg Fentanyl/50 mL, C-II, (50 mcg/mL), 50 mL Single-dose Fliptop Vial, Rx only.  Hospira, Inc., Lake Forest, IL 60045. NDC: 0409-9094-61.
Lack of Assurance of Sterility: Fliptop vial crimps are loose or missing.
Distribution US nationwide, including TX, CA, KS, MN, and OK. Foreign distribution to Japan.
Excella II Standard Pedicle Screw, Catalog No. E2S47525 and E2S47535, 4.75 mm x 25 mm. For spinal fixation.   Packaged in heat-sealed plastic bag. Also provided in reusable steam sterilization tray as implant set.
Innovasis is recalling the Excella II Standard Pedicle Screw due to mislabeling of the size and catalog number.
Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
Diltiazem HCl Extended-release Capsules, USP, 120 mg, packaged in 80 Capsules (8 x 10) blister cards per carton, Rx only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV  26505, NDC 51079-947-08.
Failed Impurities/Degradation Specifications: High out-of-specification results for a related compound obtained during routine stability testing.