Blood products, for which CMV testing was performed incorrectly, were distributed.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Kerry Ingredients is recalling two products, Italian Pork and Beef Meatball Seasoning, and Beef and Chicken Meatball Seasoning, because they were processed on the same equipment as Breakfast Sausage Seasoning which tested positive for Salmonella.  Kerry determined that the source of the Salmonella was an ingredient used in the Breakfast Sausage Seasoning.
Kerry 52-0189-02 All Purpose Beef & Chicken Meatball Seasoning, Net WT 43.42 lbs (19.69 Kg) , B18517.01.
Kerry determined that eleven products they manufactured contained an ingredient which was found positive for Salmonella.
Item Number B17017.02, 96051707, Kerry  Chicken Noodle Soup Seas 17017, 29.0 LB ( 13.18 KG),  Lot Number : 0402409101
Item Number B18780.01, Kerry Breakfast Sausage Seasoning, Net WT  50 Lb (22.68 KG),  Lot Number: 0407424305
Item Number 30511785.01, Kerry  Breakfast Sausage Seas, Net Wt  50 Lb (22.68 Kg),  Lot Number: 0329460108
Item Number B00584.01, Kerry, Breakfast Sausage Seasoning, Net WT  50 lb (22.68 KG),  Lot Number: 0417424306
Item Number B17416.01, Kerry,  Rosemary & Olive Oil Seas Baptistas Item # 00391, Net WT 50.0 lb (22.68 KG),  Lot Number: 0416424101, 0501424101
Item Number 721698.01, Kerry,  Breakfast Sausage Seasoning, Net WT  50 Lb (22.68 KG),  Lot Number: 0417424307
Item Number 30600397.01, 96005094, Kerry,  Chicken Noodle Soup Seasoning, Net WT  40 Lb (18.18 KG),  Lot Number: 0418409102
Instructions for Use for the blue endo moresolution Morcellator System, Model 55-000011, consisting of the control unit, hand-grip, flexible shaft, trocars/obturators, sleeves, valves, and blades.
Some of the information in the Instructions for Use was omitted.
nSpired Natural Foods, Division of the Hain Celestial Group
Products were distributed through out the United States, Canada, Dominican Republic, Hong Kong, Jordan, Mexico, and United Arab Emirates.     The products also were available for purchase on the internet: Harristeeter.com; Quidsi (1-800 diapers.com); Walmart.com; Kehe Foods (eyelevelsolutions.com); and Target.com.    Products were also donated at Oregon Food Bank in Oregon and was further distributed to regional food bank facility in Washington.
MaraNatha Roasted Crunchy Almond Butter, 16 oz., UPC 51651092012; Whole Foods 365 Crunchy Almond Butter, 16 oz.., UPC 99482406561.
Best By Dates Range:  26DEC14 thru 06JUN15 and  24DEC14 thru 26DEC14
Products have the potential to be contaminated with Salmonella.
MaraNatha Organic Roasted Crunchy Almond Butter, 16 oz.,  UPC 51651092036.
MaraNatha Organic Raw Crunchy Almond Butter, 16 oz., UPC 51651092128.
Best By Dates Range: 22DEC14 thru 01JUL15
Trader Joe's Raw Crunchy Almond Butter Unsalted, 16 oz., UPC 919890.
Best By Dates Range: 28DEC14 thru 18JUN15
MaraNatha No Stir Crunchy Almond Butter, 12 oz., UPC 51651093699.
Best By Dates Range:  17DEC14 thru 20JUL15 and  17DEC14 thru 18JUL15
MaraNatha No Stir Crunchy Almond Butter low in sodium, 340 grams, UPC 51651093460.
Best By Dates Range: 16DEC14 thru 14MAY15
MaraNatha Raw Creamy Almond Butter, 16 oz., UPC 51651092180 Trader Joe's Raw Creamy Almond Butter Unsalted, 16 oz., UPC 00569958.
Best By Dates Range:  05APR15 thru 02JUL15;  27DEC14 thru 18JUL15;
MaraNatha Raw Almond Butter, 340 grams, UPC 51651093064.
Best By Dates Range:  07MAY15 thru 05JUN15;
MaraNatha Organic Raw Creamy Almond Butter, 8 oz., UPC 51651092630; MaraNatha Organic Raw Creamy Almond Butter, 16 oz., UPC 51651092173.
Best By Dates Range:  13APR15 thru 30JUN15;  14APR15 thru 01JUL15;
MaraNatha Roasted Almond Butter, 340 grams, UPC 51651093057.
Best By Dates Range: 11DEC14 thru 02JUN15
MaraNatha Roasted Creamy Almond Butter, 16 oz., UPC 51651060325; MaraNatha Roasted Creamy Almond Butter, 26 oz., UPC 51651092897;  Whole Foods 365 Creamy Almond Butter, 16 oz., UPC 99482406578.
Best By Dates Range:  24DEC14 thru 17JUN15;  04DEC14 thru 21APR15;  23DEC14 thru 24DEC14;
MaraNatha Organic Roasted Creamy Almond Butter, 16 oz., UPC 51651060219; Whole Foods 365 Organic Creamy Almond Butter, 16 oz., UPC 99482405960.
Best By Dates Range:  23DEC14 thru 04JUN15;   23DEC14
MaraNatha No Stir Creamy Almond Butter, 12 oz., UPC 51651093682; MaraNatha No Stir Creamy Almond Butter, 340 grams, UPC 51651093453;  Kroger No Stir Creamy Almond Butter, 12 oz., UPC 11110791214;
Best By Dates Range: 16DEC14 thru 11MAY15  11DEC14 thru 05JUL15;  14DEC14 thru 14JUL15;  12DEC14 thru 21JUL15;
MaraNatha No Stir Raw Maple Creamy Almond Butter, 12 oz., UPC 51651093866.
Best By Dates Range: 30MAY15 thru 31MAY15
Safeway Open Nature Creamy Almond Butter Salted, 12 oz., UPC 79893113746
Best By Dates Range: 11DEC14 thru 03JUL15
MaraNatha Roasted Creamy Almond Butter No Sodium, 737 grams, UPC 51651092869
Best By Dates Range: 08DEC14 thru 03JUL15
Arrowhead Mills Organic Crunchy Peanut Butter No Salt Added, 16 oz., UPC 74333470328.
Best By Dates Range: 31DEC14 thru 14MAY15
MaraNatha Organic Roasted Crunchy Peanut Butter, 16 oz., UPC 51651092203.
Best By Dates Range:  06APR15 thru 07APR15
MaraNatha Organic Roasted Crunchy Peanut Butter Hint of Sea Salt, 16 oz., UPC 51651092333; MaraNatha Organic Crunchy Peanut Butter Hint of Sea Salt, 26 oz., UPC 51651092920;  MaraNatha Organic Crunchy Peanut Butter, 500 gram, UPC 51651093316
Best By Dates Range:  31DEC14 thru 15MAY15;  02JAN15 thru 15MAY15;  02JAN15 thru 25JUN15;
MaraNatha Organic No Stir Roasted Crunchy Peanut Butter, 16 oz, UPC 51651092364.
Best By Dates Range:  05JAN15 thru 28JUN15;
MaraNatha No Stir Crunchy Peanut Butter, 500 grams, UPC 51651093415.
Best By Dates Range: 13MAR15 thru 28JUN15
MaraNatha Organic Roasted  Creamy Peanut Butter, 16 oz., UPC 51651092197; Arrowhead Mills Organic Creamy Peanut Butter, 16 oz., UPC 74333470526.
Best By Dates Range:  7-Apr-15;  31DEC14 thru 14MAY15.
MaraNatha Organic Creamy Peanut Butter with Hint of Sea Salt, 16 oz., UPC 51651092326; MaraNatha Organic Creamy Peanut Butter with Hint of Sea Salt, 26 oz., UPC 51651092913;  MaraNatha Organic Creamy Peanut Butter, 500 grams, UPC 51651093309.
Best By Dates Range:  03JAN15 thru 25JUN15;  03JAN15 thru 24JUN15;
MaraNatha Organic No Stir Creamy Peanut Butter, 16 oz, UPC 51651092357.
Best By Dates Range:  04JAN15 thru 27JUN15;
MaraNatha No Stir Creamy Peanut Butter, 16 oz., UPC 51651092210; MaraNatha No Stir Creamy Peanut Butter, 500 gram, UPC 51651093408.
Best By Dates Range:  06JAN15 thru 20MAY15;  20-May-15;
Worldwide Distribution - USA (nationwide) including Puerto Rico and the states of AL , AR , AZ , CA , CT , FL , GA , IL , IN , KS , LA , MA , MD , MI , MN , MO , MS , MT , NC , NJ , NV , NY , OH , OK , PA , SC , SD , TN , TX , UT , VA , WA , WI and WV., and the countries of : Andorra , Angola , Argentina , Armenia , Austria , Azerbaijan , Bangladesh , Barbados , Belarus , Belgium , Bosnia & Herzegovina , Brazil , Burkina Faso , Canada , Cayman Islands , Chile , China , Colombia , Costa Rica , Croatia , Czech Republic , Ecuador , Egypt , El Salvador , Ethopia , Georgia , Germany , Greece , Greenland , Guatemala , Honduras , Hong Kong , India , Indonesia , Iran , Ireland , Israel , Italy , Jamaica , Japan , Kazakhstan , Kenya , Korea , Kuwait , Latvia , Lebanon , Libya , Malaysia , Mexico , Moldova , Montenegro , Oman , Pakistan , Gaza & Jericho , Panama , Paraguay , Peru , Philippines , Poland , Portugal , Qatar , Romania , Russia , Saudi Arabia , Serbia , Singapore , Slovakia , Spain , Sri Lanka. , Switzerland , Taiwan , Tajikistan , Thailand , The Netherlands , Trinidad & Tobago , Turkey , Ukraine ,United Arab Emirates , United Kingdom , Venezuela , Vietnam and Yemen.
ARCHITECT Total T3 Reagent Kit (7K64) consists of:    - 1 or 4 Bottle(s) (6.6 mL/27.0 mL) anti-T3 (sheep) coated microparticles in MES buffer with sheep IgG stabilizers. Minimum Concentration: 0.08% solids. Preservative: ProClin 300.     - 1 or 4 Bottle(s) (5.9 mL/26.3 mL) T3 acridinium-labeled conjugate in citrate buffer with NaCl and Triton X-100 stabilizers. Minimum concentration: 0.33 ng/mL. Preservative: ProClin 300.    The ARCHITECT Total T3 (TT3) assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of total triiodothyronine (Total T33) in human serum and plasma.
Product List Numbers, Lot Numbers, and Expiration Dates:    1) List Number: 7K64-20, Lot Number 38901UI00, Expires: 29-Jan-15;   2) List Number: 7K64-25; Lot Number 38901UI01, Expires: 29-Jan-15
17% of ARCHITECT Total T3 Reagent Kit, LN 7K64-20/-25 reagent lots 38901UI00 and 38901UI01 may exhibit lower Relative Light Units (RLUs) than expected, which in turn may result in controls out of range or patient results higher than expected.
Whole Foods Market  Plain Streusel Coffeecake (no nuts), 20 oz.. packaged in a clear plastic dome/black plastic base
Worldwide Distribution - US Nationwide in the state of AL, CA, CO, FL, GA, HI, IA, ID, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, ND, NH, NJ, NV, NY, OH, OR, PA, SC, TX, VA, WI, NC, TN, OK, AZ, UT, AK, PR, DC. and the countries of: Germany, China, Canada, Australia, Japan, United Arab Emirates, Austria, Belgium, Switzerland, Germany, Denmark, Spain, Finland, France, United Kingdom, Greece, Iceland, Italy, Malta, Netherlands, Norway, Poland, Russian Fed., Saudi Arabia, Sweden, Slovakia, and South Africa.
Trabecular Metal Tibial Impactor.   Product Usage:  TM Tibial Impactor pads are used in conjunction with the TM Tibial Impactor to impact the tibial tray onto the tibia.
To provide clarifying instructions relating to the assembly/disassembly of the Trabecular Metal Tibial Impactor with/from TM tibial Impactor Pads due to complaints regarding Tibal Impactor pad fracture.
Trabecular Metal Tibial Impactor Replacement Pads.   Product Usage:  TM Tibial Impactor pads are used in conjunction with the TM Tibial Impactor to impact the tibial tray onto the tibia.
Worldwide Distribution: US Distribution in states of: CA, PA, FL, IL, including Puerto Rico; and countries of: Honduras, Dominican Republic, Turkey, Nicaragua, Colombia, Pakistan, Trinidad & Tobago, Guatemala, Phillipines, Saudi Arabia, and United Arab Emirats.
During an FDA inspection, it was found that the products are being marketed without a cleared 510k.
During an FDA inspection it was found that the products are marketed without a cleared 510k.
North Carolina; Alabama; Colorado; Michigan; Georgia
Human tissue allografts, not processed in a manner that prevents the introduction, transmission, or spread of communicable disease, were distributed.
Blood products, collected from donors, whose suitability to donate was not adequately determined, were distributed.
nationwide and internationally to Mexico, Canada, and China.
All lots of non-medicated, scented, unscented, and sensitive varieties of baby wipes, packaged in 14 count to 1000 count sizes of plastic flow wrap soft packs, refill, trial, and plastic tubs, labeled as:    Kidgets Baby Wipes, Distributed by  Family Dollar, Charlotte, NC 28201; Walgreen's Well Beginnings  Baby Wipes, Distributed by Walgreens, Deerfield, IL.; Member's Mark Baby Wipes, Distributed by Walmart de Mexico, Ciudad De Mexico, Mexico; Simply Right Baby Care Wipes, Distributed by Sam's Club, Bentonville, AR; Cuties Premium Baby Wipes Distributed by First Quality, Great Neck, NY, Manufactured by First Quality Products, Inc., McElhattan, PA; Tender Touch Baby Wipes, Manufactured by First Quality Products, Inc., McElhattan, PA ; Well Beginnings Wipes, Distributed by Walgreens, Deerfield, IL; Femtex Premium Feminine Wipes, Distributed by  Family Dollar, Charlotte, NC 28201; Fred's Kids Baby Wipes, Distributed by Fred's Inc. Memphis, TN; and Sunny Smiles Baby Wipes, Distributed by Walgreens, Deerfield, IL.            Also sold as trial packs inside DIAPERS.COM DIAPER SZ 5 CLUB 1/156; IAPERS.COM DIAPER SZ 3 CLUB 1/200;DIAPERS.COM DIAPER SZ 4 CLUB 1/176; WELL BEGINNINGS DIAPER SZ 3 JR CLUB 1/96;WELL BEGINNINGS DIAPER SZ 4 JR CLUB 1/82;WELL BEGINNINGS DIAPER SZ 5 JR CLUB 1/70;   SIMPLY RIGHT DIAPER SZ 5 CLUB 1/196; SMPLY RIGHT DIAPER SZ 3 CLUB 1/252; SMPLY RIGHT DIAPER SZ 4 CLUB 1/225;  KIDGET DIAPER SZ5 JR CLUB 1/62; KIDGET DIAPER SZ 3 JR CLUB 1/86; KIDGET DIAPER SZ4 JR CLUB 1/74;  KIDGET DIAPER SZ 6 JR CLUB 1/54; FRED DIAPER SZ 3 JR CLUB 1/86; and DIAPER SZ 5 JR CLUB 1/62.
All lots of Disposable baby wipes manufactured by Nutek Disposables, Inc., were recalled due to complaints of discoloration and/or odor and irritation, later determined to be the result of bacterial contamination confirmed as B. cepacia.
Worldwide Distribution: US (nationwide) and internationally to: Canada.
Siemens Dimension HB1C Flex reagent cartridge; Dimension Hemoglobin A1c (HB1C) Flex reagent cartridge on the Dimension clinical chemistry system is an in vitro diagnostic assay for the quantitative determination of hemoglobin A1c (HbA1c) in human anticoagulated whole blood.  Measurements of hemoglobin A1c are effective in monitoring long-term glucose control in individuals with diabetes mellitus.
Siemens Dimension Vista HbA1c Flex reagent cartridge: Catalog Number K3105A, Siemens Material Number (SMN)  10470481, Lot Numbers  13294BA 13308BA  13329AA 13350AA  14006AA 14041BA  14069BB 14083BA      Siemens Dimension HB1C Flex reagent cartridge:  Catalog Number  DF105A, Siemens Material Number (SMN)  10483822, Lot Numbers  GA4266 BA4273 BA4280  BA4287 GA4301 GA4315  GC4322 GA4343 GA4350  GA4357 GA5013 GA5020
Siemens Healthcare Diagnostics is conducting a field recall for certain lots of the Dimension Vista&reg; HbA1c Flex&reg; reagent cartridge and lots of Dimension&reg; HB1C Flex&reg; reagent cartridge due to confirmed positive bias averaging 0.4% Hemoglobin A1c units and occasionally up to 1.0% HbA1c units for patient samples when compared to the National Glycohemoglobin Standardization Program (NGSP).   QC samples may exhibit a similar bias.
Blood products, collected from an ineligible donor, were distributed.
Blood product, collected from a donor, whose suitability to donate was not adequately determined, was distributed.
Germany, Federal Republic of; Switzerland
Blood products, collected from a donor, whose suitability to donate was not adequately determined, were distributed.
Nationwide, Puerto Rico, and U.S. Virgin Islands.
Normosol-R pH 7.4 Multiple Electrolytes Injection Type 1, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7670-09.
Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container which may result in IV bag leaks.
Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045 NDC 0409-7902-09.
5% Dextrose Injection, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045 NDC 0409-7922-09.
5% Dextrose and 0.45% Sodium Chloride Injection, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7926-09.
Lactated Ringer's and 5% Dextrose Injection, USP; 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045  NDC 0409-7929-09.
5% Dextrose and 0.9% Sodium Chloride Injection, USP, 1000 mL container,  Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045,  NDC 0409-7941-09.
Lactated Ringer's Injection, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045 NDC 0409-7953-09.
Normosol-R Multiple Electrolytes Injection Type 1, USP, 1000 mL container,  Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7967-09.
0.9% Sodium Chloride Injection, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045,  NDC 0409-7983-09.
0.45% Sodium Chloride Injection, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045 NDC 0409-7985-09.
Sterile Water for Injection, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045  NDC 0409-7990-09.
Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 75 mg/0.2 mg, 60-count bottle, Rx only. Manufactured by: Watson Laboratories, Inc., Corona, CA 92880, NDC: 0591-0398-60, UPC 3 05910 39860 6.
Failed Tablet/Capsule Specifications: Presence of split or broken tablets.
Worldwide Distribution - US: Nationwide and the countries of Australia, Austria, Bahrain, Belgium, Croatia, Egypt, Finland, France, Germany, Gibraltar, Greece, Hungary, Icelanofd, Ireland, Israel, Italy, Jordan, Kuwait, Lebanon, Luxembourg, Malta, Netherlands, New Zealand, Oman, Portugal, Qatar, Romania, Saudi Arabia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, United Kingdom
GemStar infusion pump, list numbers 13000 and 13100, GemStar Infusion Pump (pain management) list number 13150. Product Usage The pump is suitable for intravenous, arterial, subcutaneous, short-term epidural infusion and parenteral administration of general I.V. fluids, medications, nutritional fluids, and blood/blood products. The epidural route is recommended to provide anesthesia or administer analgesia for periods up to 96 hours.
List Numbers: 13000, 13100, 13150; Serial Numbers: All Serial Numbers
The GemStar User/Service Manual should be removed from these websites as soon as possible to ensure that individuals will not have access to the codes that would allow them to manipulate the infusion rates set by their physicians. The dosage reset codes required to change the settings on GemStar infusion pumps have been accessed via website sponsors (by downloading the GemStar User/Service Manual featured on the sponsors' websites) and subsequently used in changing the infusion rate set by their doctors.
GemStar infusion pump, list numbers 13086 and 13087, GemStar infusion pump (pain management) list number 13088. Product Usage The pump is suitable for intravenous, arterial, subcutaneous, short-term epidural infusion and parenteral administration of general I.V. fluids, medications, nutritional fluids, and blood/blood products. The epidural route is recommended to provide anesthesia or administer analgesia for periods up to 96 hours.
List Numbers: 13086, 13087, 13088; Serial Numbers: All Serial Numbers
Worldwide Distribution: US distribution in states of: CA, MN, TX, and UT; and internationally to: Republic of Ireland.
AlignRT-  Intended for prescription use. The system is indicated for use during simulation, setup and stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body where radiation is indicated.
7 (Six Units distribited in the US and One in OUS.)
Potential failure of AlignRT to assert interlock.
Potassium Chloride Injection, 10mEq per 100mL, 100 mL Sterile single dose container bags, Rx only, Baxter USA, NDC 0338-0709-48, Product Code 2B0826.
Labeling: Label Error On Declared Strength: Bags of Potassium Chloride 10 mEq per 100 mL were incorrectly overpouched with wraps labeled as Potassium Chloride Injection, 20 mEq per 100 mL.
Worldwide Distribution: US Distribution in states of: CA, CT, FL, NC, PA, SC + Washington DC; and countries of: Algeria , Australia , Austria , Belgium , Bosnia and Herzegovina , Cameroon , Canada , Chad , Columbia , Costa Rica , Croatia , Denmark , Egypt , Ethiopia , Finland , France , Germany , Greece , Guinea , Honduras , Hong Kong , India , Indonesia , Ireland , Israel , Italy , Japan , Kenya , Korea , Lithuania , Mali , Mexico , Netherlands , New Zealand , Nigeria , Norway , Pakistan , Paraguay , Poland , Portugal , Romania , Russia , Saudi Arabia , Senegal , Slovenia , South Africa , Spain , Sweden , Switzerland , Taiwan , Tanzania , Thailand , Turkey , Uganda , Ukraine , United Arab Emirates, United Kingdom , and Vietnam.
Abbott m2000sp is intended use as an automated system for performing sample preparation for nucleic acid testing.
List Number: 09K14; Models: E series, G series
Abbott Molecular identified some versions of Application Specifications (App Spec) are incompatible with m2000sp system software version 6.0 and 7.0. This may cause Error Code 9000 (&quot;An unexpected error has occurred: Software error&quot;) to generated when &lt;Available Reagent Packs&gt; screen is selected.
Nationwide Distribution including AZ, CA, DC, FL, IL, ME, NJ, NY, PA, VA, and VT.
Oxoid Legionella Pneumo Groups 2-14 Latex Test, DR0802M, containing 50 tests per box. The box contains a variety of components, one of which is Oxoid L. pneumophila Group 2-14 Latex Reagent, DR0802.  The product is a latex agglutination test for the identification of predominant Legionella species grown on plate media from patients with suspected Legionellosis or from environmental sources. The test allows a separate identification of Legionella pneumophila serogroup 15 and serogroups 1-14 and detection of other pathogenic non L. pneumophila, Legionella strains.
A reagent within the test may return false negative results.
Oxoid Legionella Latex Test, DR0800M, containing 50 tests per box. The box contains a variety of components, one of which is Oxoid L. pneumophila Latex Reagent, DR0802. The responsible firm on the label is Oxoid Ltd.
Worldwide Distribution - USA (nationwide) and Internationally to: Canada, Australia, Austria, Belgium, France, Germany, Iceland, Ireland, Italy, Japan, Kuwait, Netherlands, New Zealand, Norway, Portugal, Reunion, Romania, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Thailand, and the United Kingdom.
Gel-E Donut :  92025-A (Extra Small), 92025-B (Small),  92025-C (Medium)  and Squishon 2 91033-2.  The products are intended to support and cradle a baby's head and/or body.
Mold  on gel filled Gel-E and Squishon products
Worldwide Distribution: US (Nationwide) and countries of: Canada, Vietnam, and Europe.
Gyrus ACMI Disposable Falope-Ring Band Applicator Kits. REF 006889-901 and REF 005280-901 (with 8 mm Disposable Trocan). Sterile EO. Single Use Only. The disposable Falope-Ring Band Applicator is a sterile, two-band, dual-incision instrument. The two-band applicator enables the physician to occlude both Fallopian tubes without removing the applicator from the abdominal cavity. The Falope-Ring Band and Applicator Kits are indicated for use for female sterilization (permanent contraception).
All packages of Falope Ring Band Applicator kits are being recalled due to compromises in sterile packaging that could be associated with bacterial contamination that might lead to patient infection.
Simply Nourish Dog Treats Biscotti with Beef & Sweet Potato Net Wt. 4 oz. Distributed by: Simply Nourish Pet Food Company 19601 N. 27th Avenue, Phoenix, AZ USA 85027 Made in USA  UPC 73725747061
Simply Nourish Beef Biscotti with Sweet Potatoes contain improper bag seals which allow moisture into the packaging.
NM, CO, WA, KS, LA, NY, TX, AZ, NC, OH; potentially nationwide; Australia (relabeled by the distributor in Australia).  No govt/VA/military
Los Chileros de nuevo mexico gourmet southwestern cuisine Blue Corn Waffle & Pancake Mix, Net Wt. 16 oz (453.6 grams), Los Chileros de Nuevo Mexico, PO Box 6215, Santa Fe, NM 87502
Los Chileros De Nuevo Mexico is conducting a field action for Blue Corn Waffle & Pancake Mix (BWPB), Sopaipilla Mix (SOPP), Santa Fe Chile Seasoning (SFCS), Green Chile Blue Cornbread (GCBB), Cream of Green Chile Chicken Soup (GCCS), Green Chile Stew with Tortilla Mix (GCSB) and Carne Adovada with Sopaipilla Mix (CADB) due to undeclared wheat.
Los Chileros de nuevo mexico gourmet southwestern cuisine Sopaipilla Mix, Net Wt. 12 oz (340 grams), Los Chileros de Nuevo Mexico, PO Box 6215, Santa Fe, NM 87502
All products sold between 4/21/13 to 10/21/14
Los Chileros de nuevo mexico gourmet southwestern cuisine Santa Fe Chile Seasoning,  4.5oz (127.6 grams), Los Chileros de Nuevo Mexico, PO Box 6215, Santa Fe, NM 87502
Los Chileros de nuevo mexico gourmet southwestern cuisine Green Chile Blue Cornbread, 9.84 oz., Los Chileros de Nuevo Mexico, PO Box 6215, Santa Fe, NM 87502
Los Chileros de nuevo mexico gourmet southwestern cuisine Carne Adovada with Sopaipilla Mix, 13 oz.., Los Chileros de Nuevo Mexico, PO Box 6215, Santa Fe, NM 87502
Los Chileros de nuevo mexico gourmet southwestern cuisine Cream of Green Chile Chicken Soup, 5.92 oz.., Los Chileros de Nuevo Mexico, PO Box 6215, Santa Fe, NM 87502
Los Chileros de nuevo mexico gourmet southwestern cuisine Green Chile Stew with Tortilla Mix, 13oz., Los Chileros de Nuevo Mexico, PO Box 6215, Santa Fe, NM 87502
US Distribution in states of: MI, MT, and CO.
Synthes Titanium Polyaxial Reduction Head for Titanium Matrix Spine Screws: The Titanium Polyaxial Reduction Head is a part of the Matrix Spine System.    Intended for posterior pedicle screw fixation (Tl OS2- ilium), posterior hook fixation (Tl-L5), or anterolateral fixation (T8-L5).
Part  Number  04.634.002     Lot Number  6816781
Two nonconforming parts of the Titanium Polyaxial Reduction Head for Titanium Matrix Spine Screws may have been inadvertently packaged and shipped. It is believed that the inner diameter of the Reduction Head may not have been machined to the correct specification.
Worldwide Distribution -- USA, including the states of NH, CA, NJ, FL; and, the countries of Russia, Ukraine, Switzerland, Spain, Italy, Serbia, China, France, Pakistan, Austria, United Kingdom, Egypt, and India.
Calcitonin ELISA Kit, Code No. 7024, 7024BU.   Intended use of this product is the quantitative determination of Calcitonin in human serum.
A potential issue with false high values.
CA, FL, MD, NY, OH, PA, TN, UT, WI International:  Quebec, CN; Delta, BC, CN; Bermuda
Alfalfa seed:  Organic, Alfalfa, NOP Oregon Tilth, Net Wt. 55 LB, International Specialty Supply
A sample taken by FDA of one lot of alfalfa seed tested positive for Salmonella
Worldwide distribution including Nationwide (U.S.) and the countries of New Zealand, Australia, Canada, Germany, Switzerland, Italy, Austria, Finland, South Africa, United Arab Emirates, Korea, Turkey, Egypt, Jordan, Thailand, Lebanon, Kuwait, Tunisia, India, and Dominican Republic.
Relief ACP Oral Care Gel intended to relieve discomfort from dentin sensitivity.  Sold separately in single, single syringe, 4 packs, 6 packs and in teeth whitening kits
20,251 distributed in U.S. on nationwide level and 14,653 internationally
Product sold after April 1, 2014 were inadvertently filled with hydrogen peroxide teeth whitening gel (6% concentration as dispensed) on one side of the dual barrel syringe instead of the intended component (phosphate gel).  Consequently, use of this product by patients may result in a neutral effect or increased sensitivity.
Macadamia nuts in various formats: (1.) Western Family Macadamia Diced Nuts, Net Wt 5 oz. plastic bags Distributed by:Western Family Foods, Inc.  Portland, OR  UPC 0 15400 16635 5   (2.) Shur Fine Macadamia Diced Nuts, Net Wt 5 oz. plastic bags. Distributed by:Western Family Foods, Inc.  Portland, OR  UPC 0 15400 86635 4   (3.) HyVee Macadamia Nuts, Net Wt 2 oz. plastic bags. Distributed by:Hy-Vee Inc, West Des Moines Iowa, UPC 0 75450 13287 815400 16635   (4.) market pantry Chopped Macadamia Nuts, Net Wt 2.25 oz. plastic bags. Distributed by:Target Corp., MN, UPC 0 85239 52108 3  (5.) Pears Gourmet Macadamia Nuts Raw, Net Wt 1 LB, plastic bags with gold adhesive label. Distributed by:Marathon Ventures, Bellevue, NE  UPC 0 75049 42186 4  (6.) CWD Cash-Wa Distributing, Co. Macadamia Nuts Raw, Net Wt 5 LBS, Distributed by:Cash-Wa Distributing, Co, Kearney, North Platte and Sidney, NE   (7.) Macadamia Nuts Raw, Net Wt 5 LBS, Distributed by:Pegler Sysco, Lincoln, NE  (8.) Bulk Case Mayan Gold Macadamia Nuts Style #5, Net Wt 25 LBS, Distributed by:Marathon Ventures, Bellevue, NE.
Macadamia nuts in various formats: (1.) ''Western Family'' Best by Dates: 11MAR2014, 23JUN2014, 11AUG2015 and 6OCT2015  (2.) ''Shur Fine'' Best by Dates: 11MAR2015, 23JUN2015 and 11AUG2015  (3.) ''HyVee'' Best by Dates: 27AUG2015, 28AUG2015 and 10OCT2015   (4.) ''market pantry'' Best by Dates: 28APR2015, 1MAY2015, 28MAY2015, 1JUL2015, 23JUL2015, 21AUG2015 and 16OCT2015   (5.) ''Pears Gourmet'' Best by Date: 23JUL2015   (6.) ''CWD Cash-Wa Distributing, Co.'' , 14170 and 14261  (7.) ''Pegler Sysco'', 14052, 14094, 14128, 14181 and 14267  (8.) Bulk Case ''Mayan Gold'', SDC 0034
Macadamia nuts may have possible contamination with Salmonella florida.
Worldwide Distribution - US Distribution including the states of LA, GA, OR, MA, NJ, FL and CA., and the countries of Canada, France, Japan, Netherlands and United Kingdom.
Cannulaide, Model 101, 102, 103.   The Cannulaide product is composed of die-cut hydrocolloid-coated polyurethane film with an integral hook strip (i.e., Velcro) to allow for the use of a loop material to help secure a nasal interface.     The Cannulaide is applied under and over the nose of infants to provide a protective barrier to the philtrum, columella, septum, nares, and tip of nose.     It is available in multiple sizes that vary the external geometry and nare hole size and spacing to allow for use on infants ranging from less than 700 grams to greater than 3000 grams. It is a non-sterile, single patient use, disposable device.
16,575 units total (15,625 units in US and 950 units outside US)
Cannulaide recalled May 2008 due to improper seal of the pouch.
Worldwide Distribution to USA including AL, CA, CO, IA, MO, NC, NY, NV, OH, PA, SC, SD, TN, TX, VA, WI and Internationally to Canada.
Remel TB Potassium Permanganate (.5% Aqueous) 40192, packaged in 250 ml bottles, 5/pkg.   A stain for use in qualitative procedures as a counterstain in the fluorescent microscopic detection of mycobacteria.
The product may appear cloudy or discolored and may not perform correctly in presumptive diagnosis of mycobacterial disease.
US Distribution including the states of:  AZ, CO, IL, KY, LA, NE, NY, OH, PA, TN, TX, VA, WA and WV.
The J700 Floor Mounted Tube Stand (FMTS) is intended to support and position the diagnostic x-ray tube housing assembly for a medical radiographic procedure. The product consists of a vertical column (with counterbalanced vertical carriage, counterweight and pulley system), horizontal floor car and a floor mounted track to ride on.
The welds on J700 tube stands may be insufficient resulting in tube stand breakage, damage to the X-Ray machine, and/or patient or healthcare provider injury.
Zimmer Patient Specific Instrument PERSONA CR Pin Guides (Femur adn Tibia) is intended to be used as a surgical instrument to assist in the positioning of Total Knee Replacement components intraoperatively and in guiding the marking of bone before cutting provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans.
The box of guides for case JTOMA-JL-0636-L  contained two (2) femoral guides instead of one (1) femoral guide and one (1) tibial guide. The device did not meet specification: One tibia guide missing and one femur guide contained an edge which was +0.04 mm over specification.
Heparin Sodium in 0.9% Sodium Chloride Injection, 1000 USP Heparin Units, 500 mL in a VIAFLEX Plus Container
Subpotent Drug: Heparin raw material was found to have low potency
Worldwide Distribution - USA (Nationwide) and Internationally to  Canada, Portugal, and Hong Kong.
CooperSurgical LEEP RADIUS LOOP ELECTRODE (W 2.0 cm x D 1.0 cm D, 12 cm shaft ). Box of 5 Model Number(s): R2010  Intended Use: Diagnosis and treatment of non-invasive HPV-related or unrelated lesions of the lower genital tract.
Outer box is mislabeled as P/N R2010- Large Radius Loop Electrode instead of P/N R1010- Medium Radius Loop Electrode
US Distribution -- FL, TX, NY, NV, OR, IN, UT, and MA.
8MM,POTTS SCISSORS;   Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Part number: 470001-04; All 8mm da Vinci Xi (IS4000) Surgical System instruments  manufactured with white colored housings.
Deviations in reprocessing steps from those stated in the reprocessing instructions, can cause surface degradation of the housing; and/or, accelerate mechanical wear of the instrument.
8MM,LARGE NEEDLE DRIVER;   Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Part number: 470006-04; All 8mm da Vinci Xi (IS4000) Surgical System instruments  manufactured with white colored housings.
8MM,BLACK DIAMOND MICRO FORCEPS; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Part number: 470033-04; All 8mm da Vinci Xi (IS4000) Surgical System instruments  manufactured with white colored housings.
509 units - total all affected instruments
Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface degradation of the housing and/or accelerate mechanical wear of the instrument.
8MM,LONG TIP FORCEPS;   Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Part number:470093-04; All 8mm da Vinci Xi (IS4000) Surgical System instruments  manufactured with white colored housings.
8MM,MICRO BIPOLAR FORCEPS;   Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Part number: 470171-05; All 8mm da Vinci Xi (IS4000) Surgical System instruments  manufactured with white colored housings.
8MM,PROGRASP FORCEPS;   Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Part number: 470093-04 ; All 8mm da Vinci Xi (IS4000) Surgical System instruments  manufactured with white colored housings.
8MM,MARYLAND BIPOLAR FORCEPS;   Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Part number: 470172-05; All 8mm da Vinci Xi (IS4000) Surgical System instruments  manufactured with white colored housings.
8MM  MONOPOLAR CURVED SCISSORS;   Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Part number: 470179-04 All 8mm da Vinci Xi (IS4000) Surgical System instruments  manufactured with white colored housings.
8MM RESANO FORCEPS,;   Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Part number: 470181-04 ; All 8mm da Vinci Xi (IS4000) Surgical System instruments  manufactured with white colored housings.
8MM PERMANENT CAUTERY HOOK,;   Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Part number:470183-04; All 8mm da Vinci Xi (IS4000) Surgical System instruments  manufactured with white colored housings.
8MM PERMANENT CAUTERY SPATULA,;   Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Part number 470184-04; All 8mm da Vinci Xi (IS4000) Surgical System instruments  manufactured with white colored housings.
8MM FENESTRATED BIPOLAR FORCEPS,;   Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Part number 470205-05; All 8mm da Vinci Xi (IS4000) Surgical System instruments  manufactured with white colored housings.
8MM, TENACULUM FORCEPS;   Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Part number; 470207-04 All 8mm da Vinci Xi (IS4000) Surgical System instruments  manufactured with white colored housings.
8MM, CARDIAC PROBE GRASPER;   Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Part number;470215-04; All 8mm da Vinci Xi (IS4000) Surgical System instruments  manufactured with white colored housings.
8MM, LARGE HEM-O-LOK CLIP APPLIER;   Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Part number; 470230-04; All 8mm da Vinci Xi (IS4000) Surgical System instruments  manufactured with white colored housings.
8MM, ATRIAL RETRACTOR SHORT RIGHT ;   Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Part number; 470246-04 ; All 8mm da Vinci Xi (IS4000) Surgical System instruments  manufactured with white colored housings.
8MM, DUAL BLADE RETRACTOR;   Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Part number; 470249-04; All 8mm da Vinci Xi (IS4000) Surgical System instruments  manufactured with white colored housings.
8MM, MEGA SUTURECUT ND;   Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Part number; 470309-04; All 8mm da Vinci Xi (IS4000) Surgical System instruments  manufactured with white colored housings.
8MM, SMALL GRASPING RETRACTOR ;   Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Part number; 470318-04 ; All 8mm da Vinci Xi (IS4000) Surgical System instruments  manufactured with white colored housings.
8MM,MEDIUM-LARGE CLIP APPLIER ;   Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Part number; 470327-04; All 8mm da Vinci Xi (IS4000) Surgical System instruments  manufactured with white colored housings.
8MM, CURVED BIPOLAR DISSECTOR;   Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Part number; 470344-04; All 8mm da Vinci Xi (IS4000) Surgical System instruments  manufactured with white colored housings.
8MM, TIP-UP FENESTRATED GRASPER;   Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Part number; 470347-04; All 8mm da Vinci Xi (IS4000) Surgical System instruments  manufactured with white colored housings.
US Distribution including the states of: VA, NH, OH and TX.
GDC-10 360 SOFT 3mm x 6cm SR ;   GDC 360 Detachable Coils are intended for embolization of those intracranial aneurysms that- because of their morphology, their location, or the patient 's  general medical condition - are considered by the treating neurosurgical team to be     a) very high risk for management by traditional operative techniques, or(     b) inoperable
Units of GDC 360 coils, Target coil and Gateway PTA Balloon Catheter were shipped to US customers beyond the expiration date.
US Distribution including the states of and in only five locations in VA, NH, OH and TX.
GDC-10 360 10mm x 30cm SR ;   GDC 360 Detachable Coils are intended for embolization of those intracranial aneurysms that- because of their morphology, their location, or the patient 's  general medical condition - are considered by the  treating neurosurgical team to be    a) very high risk for management by traditional operative techniques, or b) inoperable
GDC-18 360 20mm x 33cm ;   GDC 360 Detachable Coils are intended for embolization of those intracranial aneurysms that- because of their morphology, their location, or the patient 's  general medical condition - are considered by the  treating neurosurgical team to be    a) very high risk for management by traditional operative techniques, or b) inoperable
Target 360 Standard 12mm x 30cm;   Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.  Target Detachable Coils are indicated for endovascular embolization of:  '' Intracranial aneurysms  '' Other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae  '' Arterial and venous embolizations in the peripheral vasculature
Gateway OTW 2.75mm x 9mm;   The Gateway PTA balloon catheter is indicated for balloon dilation of the stenotic portion of intracranial arteries for the purpose of improving intracranial perfusion.
Testosterone CYP-250/PROP-20 mg, 10 Ml Syringe, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS --- NDC 88888-0326-44
Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are within expiry were recalled due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
Methyl B12 25 mg/mL Inj., 10 Syringes, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS --- NDC 88888-2014-37
Tri-Mix (PGE-10MCG/PAP-30MG/PT 5Ml vials, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS --- NDC 88888-5123-09
Leuprolide 50 mcg/0.1 mL Micro Lupron Kit, 5Ml, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS --- NDC 88888-1124-57
Phenylephrine HCl (100 mcg/mL syr) in 0.9% NaCl 1 mg / 10 mL, 3Ml Syringes, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS --- NDC 88888-5230-12
Testosterone Cyp 200 mg/mL Sesame Inj., 4Ml Syringes, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS --- NDC 88888-7906-71
HCG Low Dose 30 IU/0.1 mL, 5 Ml vial, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS --- NDC 88888-0231-54
Tri-mix Antidote 10 each Syringes, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS --- NDC 88888-0205-17
HCG Low Dose 10 IU / 0.1 mL, 5 Ml vials, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS ---NDC 88888-2596-17
HCG 200 IU/mL Injection, 30Ml, 10 mL vials, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS --- NDC 88888-7745-68
HCG 10,000 U/ 10 mL PF Inj, 8Ml vials, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS --- NDC 88888-5012-34
2Ml HCG 10,000 U/ MB12 - 12,000 MCG/10 Ml Inj, 0.25ML (250IU), Rx, Perry Drug Compounding Pharmacy, Overland Park, KS ---NDC 88888-7945-17
Cyclosporine 0.045 % Sol PF, 12 mL bottle, Rx, Perry Drug Compounding Pharmacy, Overland Park, KS --- NDC 88888-5120-67
HCG-20,000 U/2 mL Vial, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS ---NDC 88888-2195-47
Tri Mix PF SYR 0.5 mL Inj., Compounded Rx, 10 each, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS --- NDC 88888-5036-49
HCG - 10,000 Unit PF Inject, 1mL Syringe, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS NDC 88888-0216-49
Sodium Tetradecyl SO4 0.3% Inj., 30 Ml vials, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS --- NDC 88888-6427-90
Amlodipine Besylate Tablets, USP 10 mg, Rx Only, 90 Tablets per bottle, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals USA Inc., Pennington, NJ 08534, NDC 68382-123-16
Discoloration: Brown spots were noted embedded in Amlodipine Besylate Tablets, 10 mg, Lot # MP4344.
CA, FL, HI, IA, MA, MD, MT, NY, OH, and Canada
Alfalfa Seed in plastic lined bags labeled in part *** VNS Alfalfa, NET WT. 25 KG Lot SAL2-3BJ Product of AUSTRALIA, International Specialty Supply ***
A sample of one lot of product tested positive for salmonella.
Worldwide Distribution - USA (nationwide) and Internationally to Argentina, Australia, Brazil, Bulgaria, Canada, Chile, China, Colombia, Ecuador, Egypt, Greece,  Hong Kong, India, Italy,  Korea, Lebanon, Malaysia, Mexico, Pakistan, Panama, Peru, Philippines, Saudi Arabia, Singapore, South Africa, Spain, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Venezuela, Vietnam, and Yemen.
Esprit V1000 Ventilator, Model No. V1000 and Esprit/V200 Conversions   The Esprit V1 000 and EspriW200 Conversion Ventilators are microprocessor-controlled, electrically powered mechanical ventilators. Intended for use by medical personnel to provide continuous or intermittent ventilator support for adult, pediatric and neonatal patients.
All Esprit V1000 ventilators manufactured prior to December 31, 2004 and those units manufactured prior to 12/2004 that have been converted to V200.
If the power supply fan mounting screws are installed incorrectly, the ends of the screws may touch the power supply printed circuit board assembly (PCBA) and short to ground.  This may prevent the ventilator to switch to battery power if AC power is disrupted..
7F NeuroFlo Catheter, Model 1027   The NeuroFlo Catheter is a multi-lumen device with two balloons mounted near the distal tip for the treatment of cerebral ischemia resulting from  symptomatic vasospasm following aneurysmal subarachnoid hemorrhage.  The NeuroFlo Catheter is under Humanitarian Device Exemption and not commercially released under a premarket notification or premarket approval.
After aquisition of assets of CoAxia, Zoll discovered that one lot of NeuroFlo Catheters was manufactured by another firm and an HDE supplement listing as the owner of  the product was not filed.
Cardiac Function Analysis Software Product Data No. MPDCT0301EAD  CSCF-003A  The software is applicable to the following CT systems:  Aquilion ONE TSX-301C   X-ray CT system with a 320-row 0.5 mm detector is provided with a 7.5-MHU large-capacity X-ray tube unit, and permits scanning over large areas at the high-speed of 0.35 s per rotation.  The system features are; 160-mm-wide area detector, station, gantry and patient couch operation controls, image reconstruction, high-speed volume scan, high-quality images, selectable image slice thickness, dual-monitor system, improved image diagnosis functions, high-speed volume data workflow, exposure reduction, ECG-gated scan and reconstruction, and SUREFluoro.  The CT cardiac function analysis software is used to analyze cardiac function using data obtained by performing cardiac MPR processing for ECG-gated scan data according to the cardiac axis. Aquilion ONE is a dynamic volume CT system that supports whole-body scanning. This 320-detector row system generates 640 slices per rotation using the coneXact reconstruction algorithm. In addition, the high-speed rotation mechanism and the fast reconstruction unit of the system allow the rapid image acquisition to further improve throughput in CT examinations.
Item                          CFA Software Serial Number:           Description TSX-301C/2D                 2BA1362093                                 Aquilion One Vision
This recalled is being issued due to a potential problem with the cardiac function analysis software (CFA). It has been found that, due to the problem with the software, incorrect analysis results may be displayed in the Function Parameters for the Entire Heart displayed as analysis results of the CFA and in a Left-Ventricular Volume Curve generated based on some of those parameters.
Cardiac Function Analysis Software Product Data No. MPDCT0301EAD  CSCF-003A    The software is applicable to the following CT systems:  Aquilion ONE TSX-301A/2D     X-ray CT system with a 320-row 0.5 mm detector is provided with a 7.5-MHU large-capacity X-ray tube unit, and permits scanning over large areas at the high-speed of 0.35 s per rotation.  The system features are; 160-mm-wide area detector, station, gantry and patient couch operation controls, image reconstruction, high-speed volume scan, high-quality images, selectable image slice thickness, dual-monitor system, improved image diagnosis functions, high-speed volume data workflow, exposure reduction, ECG-gated scan and reconstruction, and SUREFluoro.
Item                          CFA Software Serial Number:           Description TSX-301A/2D                  1BA07X2002                                  Aquilion One  TSX-301A/2D                  1BA07X2001                                  Aquilion One
Frozen Raw Yellowfin Tuna Ground Meat (Thunnus albacares), Grade: AAA, Net Weight: 10 lbs (100%), Wild Caught, Product of Indonesia, Imported and distributed by Heartlight Seafood LLC, 429 SW 195th Ave., Pembroke Pines, FL 33029, Production Date: 06/10/2014, Best used by 06/10/2016, UPC 207935110006
Sushi House Inc. is conducting a voluntary recall of Heartlight Ground Tuna because it may contain histamines which exceed 50 ppm.
Organic Brown Rice Flour; 25 lb. bulk bags Organic Brown Rice Flour ( UPC # 073416 00500 6) were distributed in retail store bulk bins.  Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems if consumed raw. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain.
Customer notified Lundberg Family Farms of a positive Salmonella test on Organic Brown Rice Flour.
Eco Farm Fine Brown Rice Flour; 25 lb. bulk bags Organic Brown Rice Flour ( UPC # 073416 00500 1) were distributed in retail store bulk bins.  Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems if consumed raw. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain.     Lundberg Family Farms, Richvale, CA
Worldwide Distribution - USA including the states of AR, CA, FL, GA, ID, LA, ME, MI, MN, MO, MS, NJ, NY, OH, OK, PA, and TX. Government Facilities: AR, FL, MN, OH, and OK. and the countries of: Canada, China, Denmark, Germany, Italy, South Korea, Spain, Sweden, Switzerland, Taiwan, and United Kingdom.
BrightView product code: 882478 BrightView X product code: 882480  BrightView XCT product code: 882482 and 882454
Worldwide Distribution: US Distribution in states of: FL, NC, and VT; and the countries of Argentina, Austria, Belgium, Canada, Denmark, France, India, Italy, Japan, Netherlands, United Kingdom, and Viet Nam.
IntelliSpace Portal DX/HX/EX model number: 881001 IntelliSpace Portal DX/HX/EX Upgrade model number: 881011  IntelliSpace Portal DX/HX/EX Demo model number: 881012  IntelliSpace Portal IX model number; 881030
IntelliSpace Portal DX/HX/EX: 96027,96029,96025,96030,96031,85479,79935, 98087,85175,96024,106013,450003, 950002, 950003,35009,35030,870056, 550012, 85081, 97069, 45001985333, 35036, and 85382.  IntelliSpace Portal DX/HX/EX Upgrade: 950100, 55003, and 81178.  IntelliSpace Portal DX/HX/EX Demo: 85451 and 87290.  IntelliSpace Portal IX: 50306, 40219, and 40368.    IntelliSpace Portal DX/HX/EX model number: 881001  IntelliSpace Portal DX/HX/EX Upgrade model number: 881011  IntelliSpace Portal DX/HX/EX Demo model number: 881012  IntelliSpace Portal IX model number; 881030
Nationwide Distribution to IA, LA, GA, MD, ID, FL, TN, OH, TX, NC, MA, KY, KS, WI, IN, SC, OR, CT, CA, WA, PA, OK, and PR.
Non sterile-drape LUNA drape was inadvertently mislabeled with an additional contents sterile label.
AK, AZ, FL, IA, IL, KS, MD, MI, MN, MO, NE, NM, OH, PA, SD, and WI.
Karlsburger Foods Taco Seasoning, Item Numbers 43823 (Packaged in 23 oz resealable plastic containers), Item #43807 (Packaged in 7 lb. resealable plastic containers), Item #43825 (Packaged in 25 lb. bag in a box), and Item #43850 (Packaged in 50 lb. bag in a box).
Taco Seasoning has an allergen of milk in the product that is not declared on the label.
Karlsburger Foods Low Sodium Taco Seasoning, Item Numbers 16423 (Packaged in 23 oz resealable plastic containers), Item #16465 (Packaged in 6.8 lb. resealable plastic containers), and Item #16425 (Packaged in 25 lb. bag in a box).