Red Blood Cells (Apheresis) Leukocytes Reduced
Blood product, for which the quality control testing for red blood cell volume was not performed, was distributed.
Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed.
Platelets Pheresis Leukocytes Reduced Irradiated
Blood product, which may have been out of controlled storage for greater than 30 minutes, was distributed.
Blood products, collected from a donor who traveled to an area considered endemic for malaria, were distributed.
Red Blood Cells (Apheresis) Leukocytes Reduced.
Blood products, held in quarantine pending results of an investigation, were distributed
Blood products, collected from a donor who did not have a complete physical examination, were distributed.
Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
Blood product, collected from a donor who reported post donation information regarding IV drug use, was distributed.
Blood products, collected from a donor who reported travel to a malarial endemic area, were distributed
Blood product, which was not quarantined after receiving post donation information concerning an illness following donation, was distributed.
Presbyterian Intercommunity Hospital, Inc. Blood Bank
Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
Poway, California and Escondido, California
Blood products, tested for communicable diseases using unsuitable samples, were distributed.
Blood products, which did not undergo the required quality control testing, were distributed.
Blood product, which was not quarantined after receiving information regarding the donor's contact with a person who tested reactive for HBsAg, was distributed.
Blood products, which were not quarantined after receiving information regarding a risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
Blood product, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
Products were distributed to a hospital in Akron, OH
Blood product, with donor hematocrit determined using an analyzer for which the normal control was out of range, was distributed.
Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
Blood and Blood Products for Reprocessing
Blood product, collected from a donor during a one year period of deferral for travel to a malarial endemic area.
Blood products, quality control and distribution of products which did not meet specifications, were distributed. .
Blood products, collected from  donors in which donor suitability was not adequately determined, were distributed.
Red Blood Cells Leukocytes Reduced Irradiated
Blood products, collected from  donors in which donor suitability was not adequately determined, were distributed..
Blood product, which was not quarantined subsequent to receiving information regarding a post donation information, was distributed.
Blood products, which were not quarantined subsequent to receiving information regarding  post donation information, were distributed.
Blood product,  in which donor gave history which warranted deferral or follow up questions was not asked, was distributed.
Lightning ROD capsules, 500 mg/capsule, packaged in 3-count bottles (UPC 6 89076 20257 2).
Marketed Without An Approved NDA/ANDA: Lightning Rod capsules are being recalled because FDA analysis found it to contain an undeclared analogue of sildenafil.  Sildenafil is the active ingredient in an FDA-approved product indicated for the treatment of male erectile dysfunction (ED), making this product an unapproved new drug.
Lightning ROD capsules, 550 mg/capsule, packaged in 12-count bottles (UPC 6 89076 20297 8).
Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
Blood products, which labels were applied to products with incorrect or missing information, were distributed.
Blood products, collected in a manner that may have compromised the sterility of the collection system, were distributed.
Worldwide Distribution-USA (nationwide, including Puerto Rico) and the countries of Algeria, Angola, Australia, Austria, Bahrain, Belgium, Bosnia and Herzegovia, Botswana, Brazil, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cuba, Czech Republic, Denmark, Ecuador, Egypt, Falkland Islands, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Jordan, Kenya, Kuwait, Lebanon, Libyan Arab Jamahira, Lithuania, Malaysia, Malta, Mauritius, Mexico, Morocco, the Netherlands, New Zealand, Nigeria, Nordic, Norway, Oman, Panama, Poland, Qatar, Romania, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sri Lanka, Switzerland, Syrian Arab Republic, Thailand, Turkey, United Kingdom, United Arab Emirates, Uruguay, Venezuela and Yemen.
Enterprise 8000 Bed; an AC-powered adjustable hospital bed; ArjoHuntleigh AB, Eslov, Sweden; Models 8000, 8001, 8002, 8003, 8500, 8600, 8700 and 8800   General medicine, general and specialist surgery, care of the elderly, HDU, ITU, coronary care and oncology. The bed is appropriate for high dependency patients who pose a movement and handling risk and/or whose clinical condition requires that they are positioned with the minimal physical handling.
94 beds in U.S., 31 beds in Canada, 26,010 beds in ROW
ArjoHuntleigh has received reports of unintended movement where the backrest and/or thigh sections of the bed have moved without anyone consciously pressing the control button.  These incidents have occurred in High Dependency and Intensive Therapy environments where unintended movement of the patient may have serious consequences.
Enterprise 9000 Bed; an AC-powered adjustable hospital bed with built-in electronic weigh scale, patient bed exit alarm, and under bed anti-entrapment system; ArjoHuntleigh AB, Eslov, Sweden; Models 9000, 9600, 9700 and 9800   General medicine, general and specialist surgery, care of the elderly, HDU, ITU, coronary care and oncology. The bed is appropriate for high dependency patients who pose a movement and handling risk and/or whose clinical condition requires that they are positioned with the minimal physical handling.
1,324 beds in USA, 138 beds in Canada, 1,877 beds ROW
Worldwide Distribution-USA (nationwide) and Puerto Rico and the countries of  Germany, China, Austria, Brazil, Italy, Argentina, Korea, Vietnam, Hungary, Ireland, France, Spain, Turkey, Switzerland, Israel, Australia, India, United Kingdom, Netherlands, Malaysia, Russian Federation, Japan, Taiwan, and Canada
Beckman Coulter AU5800 Clinical Chemistry Analyzer, All Serial Numbers.   An automated chemistry analyzer that measures analytes in samples, in combination with appropriate reagents, calibrators, quality control (QC), material and other accessories.
Beckman Coulter is recalling the AU8500 Clinical Chemistry Analyzer because there is no labeling on the diluted detergent tank to show the proper disposition of the on/off valve.
Reumofan Plus, 30-count tablets per bottle, distriubted by Reumofan Plus USA, LLC and Reumofan USA, LLC, Springfield, PA, and manufactured by Riger Natural S.A., Mexico.
Marketed without an approved NDA/ANDA: Product may contain undeclared active pharmaceutical ingredients Diclofenac Sodium, Dexamethasone, and Methocarbamol.
Worldwide distribution: USA (nationwide) and country of: Germany.
VENTANA (a member of the Roche Group) BenchMark ULTRA; REF/MU 750-600; Research Use Only     Product Usage:  Research Use Only-The DISCOVERY ULTRA Advanced Staining System is intended to automatically stain histological or cytological specimens on microscope slides with specific inununohistochemistry or in situ hybridization reagents.
Potiential for a waste fluid overflow condition to accur while running decontamination cycles on the BenchMark ULTRA automated staining platform or the DISCOVERY ULTRA automated staining platform. This type of overflow event can lead to migration of fluid across tubing and wiring within the instrument cabinet resulting in contact with electrical circuitry. This may create shorting conditions and ultimately damage and failure of the component.
VENTANA (a member of the Roche Group) DISCOVERY ULTRA; REF/MU 750-601; Research Use Only     Product Usage:  Research Use Only-The DISCOVERY ULTRA Advanced Staining System is intended to automatically stain histological or cytological specimens on microscope slides with specific inununohistochemistry or in situ hybridization reagents.
Potential for a waste fluid overflow condition to accur while running decontamination cycles on the BenchMark ULTRA automated staining platform or the DISCOVERY ULTRA automated staining platform.The waste fluid drainage system may become restricted by build-up of debris in the tubing and in-line filter, thereby inhibiting optimal flow rates. This type of overflow event can lead to migration of fluid across tubing and wiring within the instrument cabinet resulting in contact with electrical circuitry. This may create shorting conditions and ultimately damage and failure of the component.
Distributed to four distributors in CA, TN, RI, and MN. No foreign, government, or military distribution.
Steve's Real Food TURDUCKEN CANINE RECIPE, 5 lbs bags of 8 oz patties, UPC 6-91730-14204-9, Expiration 10/27/13, MFR # 83. Raw Frozen Dog Food, Distributed by Steve's Real Food Inc, Aumsville, OR 97086
Steve's Real Food is recalling certain lots of Turducken Canine Recipe due to possible salmonella contamination.
Blood products, collected from a donor who received a piercing within 12 months of donation, were distributed.
BARF Juicy Lamb Recipe contains 12 Lamb Patties per bag, 6 lbs. bag, 4 bags per case, sold under BARF brand name. The UPC is 8 37528 00104 8.
BARF Juicy Lamb Recipe patties from lot 209 sold under BARF brand are recalled due to a potential contamination with Salmonella.
BARF Juicy Combo Recipe Patties, 12 pieces per bag, 6 lbs. bag, 4 bags per case, sold under BARF brand name. The UPC is 8 37528 00106 2.
BARF Juicy Combo Recipe patties from lot 209 sold under BARF brand are recalled due to a potential contamination with Salmonella.
Combo Diet  Bulk Pack 06306, 24 lbs. bag, sold under BARF brand name. There is no UPC for this item.
Combo Bulk from lot 209 sold under BARF brand are recalled due to a potential contamination with Salmonella.
Variety Pack 04107, consists of one retail unit of BARF Combo, Beef, Chicken, and Lamb product. There are total 4 individual units per case. There is NO UPC for this product.
Lot 214.  USE BY 08-01-13.   Individual unit in this case bears LOT# T209, LOT# E212, LOt# E209, and LOT # T214.
Variety Pack from lot 214 sold under BARF brand are recalled due to a potential contamination with Salmonella.
0.9% Sodium Chloride Injection, USP, 1000 mL flexible container, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7983-09.
Lot #: 25-037-JT*, Exp 1JAN2015, Note: the lot number may be followed by 01 or 90
Presence of Particulate Matter: reports of small grey/brown particles found in the primary container identified as brass particulates
Rev E PedFuse Return Screw Inserter, Part Number:  11-80030   Screw inserters are instruments which capture, hold and drive pedicle screw assemblies. There is a capturing feature that engages and holds the screw in place. There is also a feature used to lock the screw to the inserter before insertion of the screw. They can also be used to remove screws or back screws out. Screw inserters are used during the implantation of spinal pedicle screws intended to provide immobilization and stabilization of spinal segments in skeletally mature patients. Used in conjunction with Pedicle Screw Spinal system marketed as KRD1 PedFuse Pedicle Screw System .
Inserters have a set screw that fixes a collar to the inserter.  The screw set can loosen and fall out of the inserter which allows the collar to slide off the proximal end of the inserter.  When the collar is not in place the locking sleeve can also slide off the inserter.
US Distribution including Puerto Rico and the states of CO, KS, MA and TX.
Drill Guide - Chameleon FacetFuse Fixation System, Model: 11-00028 Rev. A   FacetFuse Drill Guides were designed to provide a concentric pathway for the drills and taps to access the bone while protecting the soft tissue from the cutting geometry of the drills/taps. In addition the drill guide is used as a reference to measure depth that the drills and taps are protruding into bone, which is measured by depth markings at the proximal end of the drills/taps relative to the proximal end of the drill guide. These devices were used during implantation of spinal intervertebral body fusion devices intended for intervertebral body fusion of the spine of skeletally mature patients.
Prior to use in surgery, the Drill Guides were presenting noticeable degrees of denting and/or bending.  As a result, drills and taps could not be directed down guides during surgery due to mechanical interference.
US Distribution including the states of MA, NV and  TX.
T-Handle, Strike Plate, Push Connection, Part Number: SI50023 Rev A   T-handles are silicone handled instruments that have a quick release end. The silicone T-handle has an impactor cap on the proximal end of the handle which is designed to be struck with a mallet. T-handles are used primarily to attach to, and operate a wide range of instruments used during implantation of spinal intervertebral body fusion devices intended for intervertebral body fusion of the spine of skeletally mature patients.
During an operation the strike plate of a T-Handle loosened and separated from the T-Handle.
Nationwide distribution: US including states of : AK, AL, AR, AZ, CA, CO, CT, DC, GA, GU, FL, 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, PR, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY.
Dimension(R) Mass Creatine Kinase MB Isozyme Calibrator (RC420)   The Mass Creatine Kinase MB isozyme Calibrator is an in vitro diagnostic product intended to be used to calibrate the Creatine Kinase MB Isozyme method for the Dimension(R) clinical chemistry system with heterogeneous immunoassay module.
Product - MMB CAL, Catalog Number RC420, Siemens Material Number 10445023 with lot numbers 2GD053, 2KD024, and 3AD051.
Siemens Healthcare Diagnostics has received complaints that the lyophilized cake is not fully dissolved after the stated time in the MMB calibrator Instructions For Use (IFU).  The frequency of this occurrence is low but if it occurs, gel-like clumps may be observed.
OneBlood, Inc. dba  Southeastern Comm. Blood Center
Blood products, collected in a manner that may have compromised the sterility of the products, were distributed.
Worldwide Distribution-USA (nationwide) and the countries of  Canada, AE, AR, AT, AU, BA, BD, BE, BG, BO, BR, BY, CH, CL, CM, CN, CO, CR, CY, CZ, DE, DK, DO, DZ, EC, EE, EG, ES, FI, FR, GB, GR, GT, HK, HN, HR, HU, ID, IE, IL, IN, IR, IS, IT, JO, JP, KA, KR, KW, KZ, LB, LK, LT, LV, LY, MA, MK, MT, MX, MY, NI, NL, NO, NP, OM, PA, PE, PH, PK, PL, PT, PY, QA, RO, RU, SA, SE, SG, SK, SV, SY, TH, TM, TN, TR, TW, UA, UY, UZ, VE, VN, XS, and ZA.
ADVIA Centaur Systems TSH3 Ultra ReadyPack ((REF 06491072 - 100 Tests, REF 06491080 - 500 Tests, REF 04862625 - 2500T).   Intended to quantitatively measure human thyroid stimulating hormone (TSH, thyrotropin).
A rare variant of TSH, identified in a small cluster of patients, is not detected.
Dimension TSH Flex Reagent Cartridge (REF RF412).   Intended to quantitatively measure human thyroid stimulating hormone (TSH, thyrotropin).
Dimension EXL LOCI Module TSHL Flex Reagent Cartridge (REF RF612).   Intended to quantitatively measure human thyroid stimulating hormone (TSH, thyrotropin).
Dimension Vista System TSH Flex Reagent Cartridge (REF K6412).   Intended to quantitatively measure human thyroid stimulating hormone (TSH, thyrotropin).
IMMULITE Systems Third Generation TSH (REF LKTS1 - 100T, LKTS5 - 500T, L2KTS2 - 200T, L2KTS6 - 600T).   Intended to quantitatively measure human thyroid stimulating hormone (TSH, thyrotropin).
IMMULITE Systems Rapid TSH (REF LKRT1 - 100T, LKRT5 - 500 T, L2KRT2 - 200T, L2KRT6 - 600T).   Intended to quantitatively measure human thyroid stimulating hormone (TSH, thyrotropin).
Piperacillin and Tazobactam for Injection, USP, 40.5 grams per Pharmacy Bulk Package vial, Rx only, Mfg. by: Hospira Healthcare India Pvt. Ltd., Irungattukottai - 602 105, India; Mfg. for: Apotex Corp., Weston, FL 33326, NDC 60505-0773-0
Crystallization: Potential to exhibit precipitation/crystallization in IV bag or IV line upon reconstitution.
Methotrexate Injection, USP, Preservative-Free, 1 g/40 mL (25 mg/mL), 40 mL Single Dose Vial, Rx only, Manufactured for: Sandoz Inc., Princeton, NJ  08540; Manufactured by: EBEWE Pharma Ges.m.b.H. Nfg.KG, A-4866 Unterach, AUSTRIA, NDC 66758-041-01.
Presence of Particulate Matter: Found during examination of  retention samples.
DCI Donor Services dba Sierra Donor Services
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.
Ondansetron Injection, USP, 4mg/2mL, (2mg/ml), 2mL single-dose Fliptop Vial, Rx only, Sterile, NDC 0409-4755-03, Hospira, Inc, Lake Forest, IL 60045.
Presence of Particulate; lot being recalled as a precaution due to the discovery of 2 particles found in a lot which preceded the recalled lot
BD Vacutainer Multiple Sample and Direct Draw Luer Adapter BD Franklin Lakes, NJ 07417 USA    A sterile non-invasive device used to connect venous access devices such as needles, blood collection sets, ad infusion sets to blood collection tubes.
Marketing Status: Class II, 510K #  K991088 Device Listing Number:  D030347    Catalog number 367290, 367300 (CE), 368491, and 303380.
BD Vacutainer Multiple Sample and Direct Draw Luer Adapter may have blood leakage and low draw volume.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Worldwide Distribution-USA including the states of PA, WA, TX, FL, IA, MI, WI, TN, KY, IN, NY, MO and OR, and the countries of India, Canada, Chile, Venezuela, Dubai, South Africa, Australia, Poland, Romania, Belgium, Germany and United Kingdom.
R3 (TM) XLPE ACETABULAR LINER UHMWPE, 20o OVERHANG, 36 MM ID, 62 MM OD, QTY: (1), STERILE H2O2, REF 71335762.   Orthopaedic.
One batch of 60 mm 20o R3 XLPE liner may be laser etched and packaged as a 62 mm 20o liner and one batch of 62 mm 20o R3 XLPE liner may be laser etched and packaged as a 60 mm 20o liner.
R3 (TM) XLPE ACETABULAR LINER UHMWPE, 20o OVERHANG, 36 MM ID, 60 MM OD, QTY: (1), STERILE H2O2, REF 71335760.   Orthopaedic.
Warfarin Sodium Tablets, USP 2 mg,  Rx Only, 1000 Tablets per bottle,  Manufactured by: Cadila Healthcare Ltd Ahmedabad, India,  Distributed by: Zydus Pharmaceuticals USA Inc., Pennington, NJ  08534, NDC 68382-053-10
Failed Tablet/Capsule Specifications: A product complaint was received from a pharmacist who discovered that 3 tablets in a 1000-count bottle were oversized.
Nationwide, Puerto Rico, Brazil and Panama
Excedrin Extra Strength (Acetaminophen 250 mg, Aspirin (NSAID) 250 mg and Caffeine 65 mg),  a) 2-ct tablets in pouches b) boxes of 50/2-ct packages, Distributed by Novartis Consumer Health, Inc., Parsippany, NJ, NDC 0067 2030 02   Foreign packaging: c) Parsel Forte and d) Cibalenaa (250 mg Acetaminophen, 250 mg Aspirin, 65 mg Caffeine), boxes of 48/4-ct pouches  Foreign packaging do not have NDC numbers.
a) 4,178,000 pouches; b) 101,300 boxes and  c) & d) 38,235 pouches and boxes (combined)
Defective container: products are packaged in pouches which may not have been fully sealed
Excedrin Migraine (Acetaminophen 250 mg, Aspirin (NSAID) 250 mg and Caffeine 65 mg), a) 2-count tablets packaged in pouches, Distributed by Novartis Consumer Health, Inc., Parsippany, NJ, NDC 0067 203 702    Foreign packaging: b) Excedrin Migrana (Acetaminophen 250 mg, Aspirin 250 mg and 65 mg Caffeine) 2-ct pouches.  The foreign packaging do not have NDC numbers
No Doz, Max Strength (200 mg caffeine) caplets, 2-count caplets per pouch, Distributed by Novartis Consumer Health, Inc., Parsippany, NJ, NDC 0067 2070 02
Parsel Plus (reference US product: Excedrin Tension Headache)  (Acetaminophen 500 mg and Caffeine 65 mg), packaged in 2-count pouches, Distributed by Novartis Consumer Health, Inc., USA and Novartis Consumer Health S.A., Brazil, for Novartis de Venezuela.     The foreign packaging do not have NDC number    This product was only distributed to Novartis Brazil by the recalling firm
Nationwide Distribution including Texas, Ohio, and Missouri.
Invue Split Driver, Assembly with Handle, Model SI70006 Rev G.  Used in conjunction with the Invue Anterior Cervical Plate System under 501(k) clearance number K121060.     The Invue Driver is an instrument consisting of a Radel handle, a shaft and hexalobe-like tip with a 4.0mm split, which allows the driver to collapse to fit into a screw and expand to retain the screw.
Worldwide distribution: US (nationwide) and countries of: Argentina, Australia, Austria, Bahrain, Belarus, Benelux, Brazil, Bulgaria, Canada, Chile China, Costa Rica, Croatia, Czech Republic, Dominican Republic, Dutch Antilles, Ecuador, Egypt, France, Germany, Hong Kong, Hungary, India, Indonesia, Israel, Italy, Japan, Kazakhstan, Korea, Kuwait, Libya, Lithuania, Macedonia, Malaysia, Malta, Mexico, Morocco, Myanmar, Netherlands, Nicaragua, Nigeria, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Romania, Russia, Serbia, Singapore, Slovenia,  Spain, Sweden, Switzerland, South Africa, Thailand, Tunisia, United Arab Emirates, United Kingdom, Uruguay, and Vietnam.
bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, V2S 6.01 RP5800-WES7 Media.  Part number: 413861.   The product is used with the VITEK 2 automated system which consists of instruments, software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast.
A product issue has been identified for customers using software version 6.01 and are interfaced with a Laboratory Information System (LIS). During the update of software from version 5.xx to 6.01, the Bid-directional Computer interface (BCI) antibiotic codes are not updated properly for Cefovecin, Prulifloxacin and Ceftaroline. For the referenced antibiotics, the firm code in the reference table does not match the default host code in version 6.01 software.
bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01ML1.  Part number: 414537.   The product is used with the VITEK 2 automated system which consists of instruments, software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast.
bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01ML2.  Part number: 414538.   The product is used with the VITEK 2 automated system which consists of instruments, software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast.
bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01 DE.  Part number: 414539.   The product is used with the VITEK 2 automated system which consists of instruments, software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast.
bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01 EN.  Part number: 414560.   The product is used with the VITEK 2 automated system which consists of instruments, software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast.
bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01 ES.  Part number: 414561.   The product is used with the VITEK 2 automated system which consists of instruments, software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast.
bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01 FR.  Part number: 414562.   The product is used with the VITEK 2 automated system which consists of instruments, software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast.
bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01 IT.  Part number: 414563.   The product is used with the VITEK 2 automated system which consists of instruments, software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast.
bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01 JA.  Part number: 414564.   The product is used with the VITEK 2 automated system which consists of instruments, software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast.
bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01 NO.  Part number: 414565.   The product is used with the VITEK 2 automated system which consists of instruments, software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast.
bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01 PT.  Part number: 414566.   The product is used with the VITEK 2 automated system which consists of instruments, software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast.
bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01 DA, SV.  Part number: 414567.   The product is used with the VITEK 2 automated system which consists of instruments, software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast.
bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01 EL, TR.  Part number: 414568.   The product is used with the VITEK 2 automated system which consists of instruments, software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast.
bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01 ZH.  Part number: 414569.   The product is used with the VITEK 2 automated system which consists of instruments, software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast.
bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit V2S RP5800XPE TO 6.01 WES7.  Part number: 6201773.   The product is used with the VITEK 2 automated system which consists of instruments, software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast.
Worldwide Distribution - USA Nationwide in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, 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, including Hawaii and Puerto Rico  and the countries of Canada & Panama
Cordis OPTEASE Retrieval Inferior Vena Cava (IVC) Filter***REF Cat. No.***466F220A and 466F220B***Vena Cava Filter and Introduction Kit***(BRITE TIP Catheter Sheath Introducer and Angiographic Vessel Dilator)***Cordis***a Johnson and Johnson Company***ENDOVASCULAR*** Label No. SB 10247519.2/***LB466F220AO.5***omoraoro/2012.050794***Do not resterilize***.     Product Usage:  The OPTEASE Vena Cava Filter is indicated for use in the prevention of recurrent pulmonary embolism (PE) via percutaneous placement in the vena cava in several situations: Pulmonary thromboembolism when anticoagulants are contraindicated; Failure of anticoagulant therapy for thromboembolic disease; Emergency treatment following massive pulmonary embolism where anticipated benefits of conventional therapy are reduced and Chronic, recurrent pulmonary embolism where anticoagulant therapy has failed, or is contraindicated.
Correction to provide clarification and additional labeling to minimize likelihood on implanting filter backwards.
Stryker Instruments Div. of Stryker Corporation
Worldwide - USA Nationwide including the states of CA, CO, FL, HI, IA, IL, KS, KY, LA, MD, MI, MN, MS, NC, NH, NJ, NV, NY, OH, PA, TX, VA, ITALY, and the countries of AUSTRALIA, CANADA, UNITED KINGDOM, NETHERLANDS, INDIA, JAPAN, NEW ZEALAND, SWITZERLAND, HONG KONG, and TAIWAN.
Sonopet Ultrasonic Aspirator Console (Console 110V with Pedal & Pole)    Product Usage:  The Sonopet Console is indicated for use in surgical procedures where fragmentation, emulsification, and aspiration of soft and hard tissue is desirable, including neurosurgery, gastrointestinal and affiliated organ surgery, urological surgery, plastic and reconstructive surgery, general surgery, orthopedic surgery, gynecological surgery, thoracic surgery, laparoscopic surgery, and thoracoscopic surgery.
A supplied component exhibiting corrosion was built into the power supply boards of the Sonopet Consoles listed above. The issue is limited to 2 lots of the supplied component. The presence of the corrosion on the relay of the power supply board can  potentially lead to a conduction defect which could cause the irrigation pump to stop working. The purpose of the irrigation  pump is to supply saline solution to the end of the handpiece tip. If the irrigation pump stopped, the saline would not be  supplied to the tip end, resulting in the loss of the cooling function and potentially cause the tip to heat up. The devices affected  were distributed October 13, 2011 through October 19, 2012.
Sonopet Ultrasonic Aspirator Console 5450-851-000(Console 100V)      Product Usage:  The Sonopet Console is indicated for use in surgical procedures where fragmentation, emulsification, and aspiration of soft and hard tissue is desirable, including neurosurgery, gastrointestinal and affiliated organ surgery, urological surgery, plastic and reconstructive surgery, general surgery, orthopedic surgery, gynecological surgery, thoracic surgery, laparoscopic surgery, and thoracoscopic surgery.
Sonopet Ultrasonic Aspirator Console 5450-852-000 (Console 230V)    Product Usage:  The Sonopet Console is indicated for use in surgical procedures where fragmentation, emulsification, and aspiration of soft and hard tissue is desirable, including neurosurgery, gastrointestinal and affiliated organ surgery, urological surgery, plastic and reconstructive surgery, general surgery, orthopedic surgery, gynecological surgery, thoracic surgery, laparoscopic surgery, and thoracoscopic surgery.
Zolpidem Tartrate Tablets 5 mg, 10 tablets per blister, 10 blisters per carton, 100 cartons per box, Rx Only, Manufactured for Wockhardt USA LLC., Parsippany, NJ 07054 by Wockhardt Limited, Mumbai, India, NDC 68084-225-01
Unit Dose Mispackaging: This recall event is due to a random undetected packaging issue which could increase the potential for a small number of individual unit dose blisters to be packed with more than one tablet.
Methylphenidate Hydrochloride Extended-Release Capsules (LA), 20 mg, 100 count bottle, Rx only, TEVA PHARMACEUTICALS USA, NDC 0093-5346-01
Failed Dissolution Specifications: Product is being recalled due to out of specification dissolution results obtained during routine stability testing.
Methylphenidate Hydrochloride Extended-Release Capsules (LA), 30 mg, 100 count bottle, Rx only, TEVA PHARMACEUTICALS USA, NDC 0093-5347-01
Methylphenidate Hydrochloride Extended-Release Capsules (LA), 40 mg, 100 count bottle, Rx only, TEVA PHARMACEUTICALS USA, NDC 0093-5348-01
MERREM I.V. (meropenem for injection), 1 g meropenem equivalent, 30 mL vial, Rx only, Mfd for: AstraZeneca Pharmaceuticals LP, Wilmington, DE by ACS Dobfar SpA Viale Addetta, Tribiano, Milano Italy NDC  0310 0321 30
NDC 0310-321-30, lot JX109, expiration 2/2015; lot JY042, expiration 2/2015
Presence of Precipitate; potential for incomplete constitution upon addition of diluent.
Worldwide distribution: US (nationwide) and countries of: Australia, Canada and Europe.
Alaris PC unit, model 8015, with version 9.12-Keyboard Processor and logic board assembly part number TC10006584.   The Alaris PC Unit is the main user interface unit and power supply of the Alaris System, a modular system to be used with Alaris System modules intended for use in todays growing professional healthcare environment for facilities that utilize infusion and/or monitoring devices.
26,564 total units (26,220 units for US)
CareFusion is recalling the Alaris PC units model 8015 (PC unit), version 9.12, because it is operating at an incorrect voltage and it could potentially experience a loss of communication between the PC Unit main Processor and Keyboard Processor.
VersaPharm Incorporated, Ethambutol Hydrochloride Tablets, USP 400 mg 60 tablets, Rx Only, Mfd. for VersaPharm Incorporated Marietta, GA 30065-1509; Mfd. by: West-ward Pharmaceuticals Corp., Eatontown, NJ 07724  NDC 61748-014-06,
Discoloration: Ethambutol HCl Tablets 400 mg is being recalled due to a Out of Specification result for description  testing  for a surface defect of ink.
US Distribution including the states of  IA, SD, NC, WI, OH, NE, TX, KS, ID, MI, GA, AR and IL.
Siemens issued a Field Safety Alert about the potential risk to users when operating the Mobilett Mira. When a Mobilett Mira is regularly exposed to extensive mechanical strain (driven over high thresholds for doors or elevators), it is possible that one of its main wheel shafts could break because of material fatigue, resulting in the chassis falling on the ground on the affected wheel side. This imposes a potential risk of squeezing the toes of the user or another person.
Worldwide Distribution - USA, including the states of  CT, VA, FL, TX, CO and MS. and the country of Jamaica.
Indus Invue Screw Caddy, Model: SI70097   The caddy holds, in an organized fashion within the case, a variety of shapes and sizes of plates and screws used during fixation of anterior cervical plates to provide stabilization during the development of spine fusions. There is an array of 108 holes that store 3 types of screws. O4.2mm Self-Drilling, O4.2mm Self-Tapping, and O4.5mm Self-Tapping screws which are separated by type and screw length. The caddy has features to hold the screws in place.
Difficulty removing screws from the Invue caddies.
Worldwide Distribution - USA (nationwide) and Puerto Rico and Internationally to Costa Rica.
List No. 14200-28; SECONDARY BLOOD SET; 200 Micron Filter, 36 Inch, Non-DEHP; For Blood Product Administration; Made in Costa Rica; Product Inquiries should be directed to Hospira., Inc., Lake Forrest, IL 60045 USA   Hospira Blood sets are designed for Blood Product Administration
It was discovered that there was a potential for the piercing pin on certain Hospira blood sets to puncture the outer wall of blood bags during insertion of the pin into the blood bag.
List No. 14203-28; BLOOD SET; 200 Micron Filter, 80 Inch, Non-DEHP; For Blood Product Administration; Made in Costa Rica; Product Inquiries should be directed to Hospira., Inc., Lake Forrest, IL 60045 USA   Hospira Blood sets are designed for Blood Product Administration
List No. 14206-28; Y-TYPE BLOOD SET; 200 Micron Filter, Cylinder Pump, Convertible Pin and Non-Vented Pin, 80 Inch, Non-DEHP; For Blood Product Administration; Made in Costa Rica; Product Inquiries should be directed to Hospira., Inc., Lake Forrest, IL 60045 USA   Hospira Blood sets are designed for Blood Product Administration
List No. 14207-28; BLOOD SET; 200 Micron Filter, 105 Inch, Non-DEHP; For Blood Product Administration; Made in Costa Rica; Product Inquiries should be directed to Hospira., Inc., Lake Forrest, IL 60045 USA   Hospira Blood sets are designed for Blood Product Administration
List Number: 14207-28;  Lot Number: 962295H
List No. 14210-28; PLUM BLOOD SET; 100 mL Burette with Prepierced Injection Site, 170 Micron Filter, Prepierced Port, Non-Vented, 105 Inch, Non-DEHP; For Blood Product Administration; Made in Costa Rica; Product Inquiries should be directed to Hospira., Inc., Lake Forrest, IL 60045 USA   Hospira Blood sets are designed for Blood Product Administration
List Number: 14210-28;  Lot Number: 053835H
List No. 14211-28; PLUM BLOOD SET; Prepierced Port, 200 Micron Filter, 110 Inch, Non-DEHP; For Blood Product Administration; Made in Costa Rica; Product Inquiries should be directed to Hospira., Inc., Lake Forrest, IL 60045 USA   Hospira Blood sets are designed for Blood Product Administration
List No. 14212-28; PLUM Y-TYPE BLOOD SET; 200 Micron Filter, CLAVE Port, Non-Vented, 110 Inch, Non-DEHP; For Blood Product Administration; Made in Costa Rica; Product Inquiries should be directed to Hospira., Inc., Lake Forrest, IL 60045 USA   Hospira Blood sets are designed for Blood Product Administration
List No. 14217-28; Y-TYPE BLOOD SET; 200 Micron Filter, Prepierced Y-Site, Non-Vented, 80 Inch, Non-DEHP; For Blood Product Administration; Made in Costa Rica; Product Inquiries should be directed to Hospira., Inc., Lake Forrest, IL 60045 USA   Hospira Blood sets are designed for Blood Product Administration
List Number: 14217-28;  Lot Number: 962255H
List No. 14219-28; Y-TYPE BLOOD SET; 200 Micron Filter, Cylinder Pump, CLAVE Y-Site, Non-Vented, 80 Inch, Non-DEHP; For Blood Product Administration; Made in Costa Rica; Product Inquiries should be directed to Hospira., Inc., Lake Forrest, IL 60045 USA   Hospira Blood sets are designed for Blood Product Administration
List Number: 14219-28;  Lot Number: 962245H
Rifadin, Rifampin capsules, 150 mg, packaged in 30-count bottle, Rx only, Mfd. for Sanofi-Aventis, U.S., LLC, Bridgewater, NJ 08807, NDC 0068-0510-30
Subpotent drug: low fill volume in some of the capsules
US states: '' Connecticut  '' Delaware  '' Florida  '' Georgia  '' Maine  '' Maryland  '' Massachusetts  '' New Hampshire  '' New Jersey  '' New York  '' North Carolina  '' Ohio  '' Pennsylvania  '' Rhode Island  '' Virginia
Earth's Pride Organics: Organic Oregano, 2.2 oz. Packaged at 12 units per case.   Packaged in a glass jar with cork closure.    Product labeling reads in part:''earth's pride organics PANTRY COLLECTION***ORGANIC OREGANO***NET WT. 2.2 OZ (62.4g)***DISTRIBUTED BY BJWC 25 RESEARCH DRIVE  WESTBOROUGH, MA 01581  1-800-934-1204***''.
Olde Thompson Inc. Oxnard, CA is recalling Earths Pride Organics: Organic Oregano packaged in a 2.2 oz. glass jar with cork closure, Lot #: 060367, 060692, 061252 and 061864 due to possible contamination by Salmonella.
USA Nationwide Distribution including the states of:  TX, NC, GA, TN, UT, NJ, MI, VA, AR, LA, MO, FL, AZ, CA, DC, PA, NH, WI, SD, SC, NM, MD, and IN.
Dimension Tacrolimus Flex reagent cartridge (DF107) and Dimension TACR CAL (DC107)   Product Usage:  The TACR method is an in vitro diagnostic test intended to quantitatively measure Tacrolimus in human whole blood on the Dimension clinical chemistry system. Measurements of Tacrolimus are used as an aid in the management of tacrolimus therapy in kidney and liver transplant patients.
TACR Flex Reagent cartridge, material #10444938, (DF107) lot BB4087 with expiation date 3/28/14 and its linked calibrator, material #10445012, (DC 107) lot 3BD029 with expiration date 03/01/14.
Siemens initiated a recall due to confirmed complaints of low patient sample recovery with Dimension TACR Flex Reagent cartridge (DF107) lot BB4087 and its linked calibrator (DC 107) lot 3BD029. Falsely low Tacrolimus results across the assay range may lead to alterations in dosing.
KY, VA, MS, MO, FL, OH, IN, AL, CA,SC,OK
Sunny Sea Sardines in Tomato Sauce, 24 cans/case, 15 oz.
Golden Beach Inc. is recalling Sunny Sea Sardines in Tomato Sauce  for decomposition.
US Distribution including the states of  SC, TX, TN, WA, OK.
Non-sterile Viscot Surgical Skin Markers   Part Number 1437-100     Non-sterile Viscot Part Number 143-100 Surgical Skin Markers are pen-like devices intended to be used to write on the patient's skin, e.g., to outline surgical incision sites or mark anatomical sites for accurate blood pressure measurement; available in nonsterile configuration.
Part Number: PDC PN STERVIS (Viscot PN 1437-100)    Lot: 061313.
PDC Healthcare initiated this recall of Non-Sterile Viscot Part Number 1437-100 Surgical Skin Markers, becuase they were inadvertently mislabeled as PN STER-VIS Sterile Skin Marker Pen with Labels and Flex Ruter.
Products were directly distributed to NJ and MA and further distributed to PA, NJ, and NY.
The master case Bar Code is 20731149654062 and the Retail UPC is  7 31149 65406 8.    The Retail Label reads in part ''*** Aqua Star Raw Shrimp Easy-Peel Shell-On*** Ready to Cook *** Net Wt 1 lb (454g) ***''
Date Code SGE-12/282 and Retail UPC 7 31149 65406 8.
Aqua Star Raw Frozen Shrimp Easy-Peel Shell-On, Ready to Cook, 1 lb. plastic bags, date code SGE-12/282 was recalled due to Salmonella.
Medtronic Inc. Cardiac Rhythm Disease Management
Worldwide Distribution-USA (nationwide) including DC and the states of AZ, AK, CA, DE, GA, IL, KY, MA, MI, MN, MS, NV, NY, NC, OH, PA, TN, and TX, and the countries of AUSTRALIA, BRAZIL, CHILE, INDIA, and SINGAPORE.
Medtronic Mullins Transseptal Adult 7F,  REF 008551.   Intended for the introduction of cardiovascular catheters into the left side of the heart.
Medtronic identified a specific labeling issue for specific lots of Mullins Transseptal Catheter Introducer Sheath, model 008551, in which packages labeled as Mullins 7F (French) may actually contain an 8F(French) dilator.  Medtronic is requesting the return of potentially mis-labeled Mullins Transseptal Catheter Introducer 7 French Sheaths.  Due to the differences in size, an 8F dilator will not fit into a 7F sheath, making any mis-labeled introducer components unusable in a clinical case.
Product sold at Dollar Tree and Deals, Dollar Express and Dollar Bills stores nationwide.
Mild Chunky Salsa, a Home Style Select brand, in 16oz glass jars, UPC: 3927759137; Product is distributed by Dollar Tree; Product is processed and packaged by Olam Tomato Processors, Inc. Lemoore, CA; The label on the salsa indicates distributed by Greenbrier International, Inc., Chesapeake, VA
The production codes for the Mild Chunky Salsa (UPC 3927759137) are L12142 (Best By Date June 2015) and L04093 (Best By Date October 2015)
The firm received complaints of large fragments of glass that were found inside the Mild and Medium Chunky Salsa.
Medium Chunky Salsa, a Home Style Select brand, in 16oz glass jars, UPC: 3927759139; Product is distributed by Dollar Tree; Product is processed and packaged by Olam Tomato Processors, Inc. Lemoore, CA; The label on the salsa indicates distributed by Greenbrier International, Inc., Chesapeake, VA
For the Medium Chunky Salsa (UPC 3927759139) is L01313 (Best By Date July 2015)
Worldwide distribution: US (nationwide) including states of: AL, CA, CO, FL, GA, IL, KY, LA, MD, MA, MI, MN, NJ, NY, NC, OH, PA, RI, TN, TX, UT, VA, and WA; and countries of: Australia, Austria, Denmark, Epsom, France, Germany, London, Netherlands, Saudia Arabia, and United Kingdom.
MRidium 1145 Dose Reduction System (DERS) drug library kit.  (This is an option for the MRidium 3860+MR Infusion Pump System).   The MRidium 3860+MRI Infusion pump are intended for general hospital or clinical use by medical professional whenever it is required to infuse patients with intra-venous or intra-arterial fluids before, during or after magnetic Resonance imagining (MRI) scans.
The Dose Error Reduction System (DERS) can indicate an incorrect recommended value for the rate via a specific key sequence during the initial infusion setup.  This can result in a risk of over-infusion or under-infusion if the infusion is started with this rate value.
US Nationwide Distribution - including the states of: AK, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KS, KY, MA, MD, MI, MN, MO, NC, NE, NJ, NM, NV, NY, OH, OK, PA, RI, SC, TN, TX, UT, VA, WA.
Nestle Nutrition, Compat, Enteral Feeding Tube, sterile, 8 French (REF 08310400), 10 French (REF 08310600), and 12 French (REF 08310500).      Product Usage:  The Compat Nasogastric Feeding Tube is indicated for the administration of nutrition, fluids and medications into the stomach r small bowel by the naso-enteric, route for patients who have an intact gastrointestinal tract but are physically unable to ingest enough nutrients orally to meet their current needs.
REF 08310400 - Compat Nasogastric Feeding Tube 8 French (8Fr) in the following lots: 01413G   02412K  08211Z  08712W  14212U  14611P  21512Y  35411H    REF 08310500- Compat Nasogastric Feeding Tube 12 French (12Fr) in the following lots:  01211AV  01513N   04111D, 04111P, 04111V  05812F  05912F  06313N  21512G  23412BV  34712V  35411U    REF 08310600 - Compat Nasogastric Feeding Tube 10 French (10Fr) in the following lots:  08111M  08712D  10211E  13712W  21512F  05312N
Nestle HealthCare Nutrition, Inc. is initiating a recall on some of Compat NG Tubes  because they have been delivered in an insufficiently sealed pouch, thus compromising the sterility claimed on the label.
MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK
Worldwide distribution: US (nationwide) including states of TX and FL; and countries of: Belgium, Italy, Japan and Korea.
MHI-TM2000 Linear Accelerator System, Software Version 3.0.0 revision 13 or earlier;  Proprietary and Trade Name: MHI-TM2000/ VERO (TM); Common Name: Medical Linear Accelerator.    MHI-TM2000 Linear Accelerator System is intended for radiation therapy of lesions, tumors and conditions anywhere in the body where radiation treatment is indicated
Software anomaly: Mitsubishi Heavy Industries, Ltd. became aware of a potential safety issue associated with the VERO (TM) Linear Accelerator System.  The VERO (TM) may save treatment delivery record into wrong location under certain conditions.
Giant Eagle Candy Place Chocolate Covered Peanuts NET WT. 5 OZ, UPC code 3003404313    This product was packaged in a facility that also processes peanuts, nuts, milk products, soy, wheat, sesame seeds, whey and eggs.  Distributed By: Giant Eagle, Inc.  Pittsburgh, PA 15328-2809
The firm has issued a recall on Giant Eagle Candy Place Chocolate Covered Peanuts with UPC 3003404313.  The product has whey in the ingredients and the label does not clearly state that there is a milk allergen.  (only whey is listed in the ingredient statement).
Lisinopril Tablets, USP, 2.5 mg, Rx only, packaged in a) 100-count bottles (NDC 0143-1265-01) and b) 1000-count bottles (NDC 0143-1265-10), Manufactured by: West-ward Pharmaceutical Corp., Eatontown, N.J. 07724; and c) 1000-count bottles (NDC 24658-240-10), Manufactured for: Blu Pharmaceuticals, Franklin, KY 42134; Manufactured By: West-ward Pharmaceutical Corp., Eatontown, N.J. 07724.
Failed Impurities/Degradation Specifications: Out of Specification results for Individual Other Unknown Related Compounds were obtained at the 48 month time-point.
Nationwide Distribution including FL, IA, IL, MI, NC, NY, OH, OR, PA, RI, TX, WA and WI.
CVS Pharmacy Wound Closure Adhesive Surgical Tape Strips  30 strips 1/4 in. x 4 in. Sterile latex free    UPC # 050428102909 item # 409170    Used to secure, close and support small cuts and wounds.
This recall has been initiated by Aspen Surgical Products, Inc., due to the inability to confirm sterility.
Discount Drug Mart Wound Closure Adhesive Surgical Tape Strips  30 strips 1/4 in. x 4 in. Sterile latex free    UPC # 093351120374    Used to secure, close and support small cuts and wounds.
Duane Reade (DR) Wound Closure Adhesive Surgical Tape Strips  30 strips 1/4 in. x 4 in. Sterile latex free    UPC # 639194043885    Used to secure, close and support small cuts and wounds.
HEB Wound Closure Adhesive Surgical Tape Strips  30 strips 1/4 in. x 4 in. Sterile latex free    UPC # 041220302536    Used to secure, close and support small cuts and wounds.
Leader Wound Closure Adhesive Surgical Tape Strips  30 strips 1/4 in. x 4 in. Sterile latex free    UPC # 096295114706    Used to secure, close and support small cuts and wounds.
Meijer  Wound Closure Adhesive Surgical Tape Strips  30 strips 1/4 in. x 4 in. Sterile latex free    UPC # 719283595973    Used to secure, close and support small cuts and wounds.
Premier Value Wound Closure Adhesive Surgical Tape Strips  30 strips 1/4 in. x 4 in. Sterile latex free    UPC # 040986021558    Used to secure, close and support small cuts and wounds.
TopCare Wound Closure Adhesive Surgical Tape Strips  30 strips 1/4 in. x 4 in. Sterile latex free    UPC # 036800165854    Used to secure, close and support small cuts and wounds.
Walgreens (''W'' and ''Well at Walgreens'')  Wound Closure Adhesive Surgical Tape Strips  30 strips 1/4 in. x 4 in. Sterile latex free   UPC # (''W'') 311917111728 item # 479241  UPC # (''Well at Walgreens'') 311917143354 item # 156744    Used to secure, close and support small cuts and wounds.
Terazosin Hydrochloride Capsules,10 mg, 100-count bottle, Rx only, Manufactured for Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0093-4339-01
Labeling -label error on declared strength: unopened, sealed bottle of Terazosin Hydrochloride (HCl) 10mg Capsules contained Terazosin HCl 5 mg Capsules
Worldwide distribution: US (nationwide) 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, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, TX, UT, VA, VT, WA, WI, WV & WY; and country of: Canada.
TCM4 series Base Units, and spare part Power Supply, Radiometer Medical ApS, Akandevej 21, Brnshj, Denmark, www.radiometer.com. The devices are intended for continuous monitoring of carbon dioxide and oxygen partial pressures, oxygen saturation, and pulse rate.
RADIOMETER became aware that the TCM4 series Base Unit does not comply with IEC 60601-1 Sub Clause 15B.
TUMS, Antacid/Calcium Supplement, ULTRA Strength 1000, Assorted Berries, 72 Chewable Tablets, GlaxoSmithKline, Moon Twp, PA 15108,  NDC 0135-0181-02
Presence of Foreign Tablets/Capsules: Product labeled TUMS Ultra Assorted Berries 1000mg Chewable tables, may contain EX TUMS Assorted Berries 750mg tablets
Nationwide: AZ, AK, CA, CT, CO, DE, FL,HI, GA, IL, IN, LA, MA, MD, MI, MN, MT, NC, ND, NE, NH, NJ, NM, NL, NV, NY, OH, OK, PA, SC, SD, TN,TX, VA, WA, WV, WY   Canada
Raw Pistachio Halves, 1 pound bag.  Item Number 11910, UPC Code: 172043119107; Raw Pistachio Halves, 4 pound bag.  Item Number 11911, UPC Code: 172043119114; Raw Pistachio Halves, 10 pound bag in box.  Item Number 11912, UPC Code: 172043119121; Raw Pistachio Halves, 25 pound case, bag in box.  Item Number 11913, UPC Code: 172043119138
120 - 1 pound units; 52 - 4 pound bags; 32 - 10 lb. cases; 23 - 25 pound units
Positive laboratory result for Salmonella sp.  Speciation in progress.
US Pistachio Shelled, Halves, Raw, Net Weight: 30lbs.
Lot#T0010092, expiry date: September 2014
Primex International Trading Corp. is recalling Pistachios Shelled, Halves, because it has the potential to be contaminated with Salmonella.
Introvale (levonorgestrel and ethinyl estradiol) tablets, USP, 0.15 mg/0.03 mg, packaged in 91 day regimen per unit carton, 3 Unit Cartons x 91 tablets per box, Rx only, Manufactured by Laboratorios Leon Farma S.A., Spain for Sandoz Inc., Princeton, NJ 08540, NDC 0781-5584-36
Contraceptive tablets out of sequence: Contraceptive tablets out of sequence: Introvale (levonorgestrel and ethinyl estradiol tablets USP 0.15mg/0.03mg) is voluntarily being recalled due to inactive placebo tablets incorrectly placed in Week 9, and active tablets placed in Week 13 on the blister card
BuPROPion Hydrochloride Extended-Release Tablets (XL), 300 mg, 30-count tablets per bottle, Rx only, Distributed by: Actavis South Atlantic, LLC, Sunrise, FL 33325; Packaged by: American Health Packaging, Columbus, OH 43217, NDC 67767-142-30, UPC 3 67767-142-30 6.
Failed Dissolution Specifications: Dissolution test results at 8 hour time-point were above approved specification limits.
Latanoprost Ophthalmic Solution, 0.005% (125 mcg/2.5 mL), 2.5 mL bottle, Rx only, Manufactured by: Apotex Inc., Toronto, Ontario Canada M9L 1T9; Manufactured for: Apotex Corp., Weston, FL  33326; NDC 60505-0565-1; UPC 3 60505 05651 4.
Lack of Assurance of Sterility: Failed at expiry for Preservative Effectiveness Test (PET), therefore the product may be susceptible to microbial growth before the expiry date.