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U.S. Department of Health and Human Services

Enforcement Report - Week of November 26, 2014

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Product Type Product Description Code Info Classification Reason for Recall Recalling Firm
Food GOLDEN LION brand DRIED ZIZIPHUS JUJUBA MILL (DRIED DATES), NET WT. 12 oz (340 g), UPC 7 34765 04008 6 -- PRODUCT OF CHINA -- PACKED FOR AND EXCLUSIVELY DISTRIBUTED BY: BLOOMING IMPORT INC. 45 BOWNE STREET BROOKLYN, N.Y. 11231 --- The product is packaged in a sealed flexible plastic bag. --- Nutrition Facts: Serving Size: 1.4 oz. Serving Per Container: 8.5 UPC 7 34765 04008 6 and no other coding Class I The product contained undeclared sulfites (1519 ppm) based on sampling and analysis by New York State Department of Agriculture & Markets. Blooming Import Inc.
Devices BAG 9732315 MOUSE STERILE 15 PK Lot No.: 5246110712 5316560113 Class II Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility. Medtronic Navigation, Inc.
Devices BIOPSY NEEDLE KIT, 9733068, PASSIVE Lot No.: 66516213 66501413 66518413 66507713 Class II Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility. Medtronic Navigation, Inc.
Devices BIT 9733516 2.9mm DRILL STERILE Lot No.: 130204G Class II Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility. Medtronic Navigation, Inc.
Devices DISP 9730950 STRL SPHERE, 1 PK INSERT Lot No.: B135276281 Class II Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility. Medtronic Navigation, Inc.
Devices DISP 9730951 STRL SPHERE, 5PK INSERT Lot No.: B155300281 Class II Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility. Medtronic Navigation, Inc.
Devices DRAPE 9732722 TUBE STERILE O-ARM 20PK Lot No.: D120065 D121495 D121515 D120175 D122611 D101555 Class II Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility. Medtronic Navigation, Inc.
Devices ENT PRGM 9734636 ADD FUSION NAV AxiEM Lot No.: 6917614 Class II Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility. Medtronic Navigation, Inc.
Devices INST 9731132 KIT CR REF FRAME DRIVER 5PK Lot No.: r683 Class II Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility. Medtronic Navigation, Inc.
Devices INSTRUMENT TRACKER 9733533XOM ENT 1PK Lot No.: 130904C 131203A 131003 131024B 130815 130904C 130510 130815 130708B 130815 130815 130716D 130204C 130418B 121128C 121218B 121218A 121128D 130409C 130409D 130123 Class II Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility. Medtronic Navigation, Inc.
Devices KIT, 9731427, THORACIC TACTILE PROBES Lot No.: 6688089 6095124 6095129 Class II Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility. Medtronic Navigation, Inc.
Devices MOUSE 9732721 STERILE O-ARM 10PK Lot No.: 5051140611 5336060213 5162060112 4734921009 Class II Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility. Medtronic Navigation, Inc.
Devices PACK 9731975 TUMOR RESECTION AXIEM CR Lot No.: 0006922410 Class II Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility. Medtronic Navigation, Inc.
Devices PAK 9733497 NAV NIM-SPINE PEDICLE ACC KT Lot No.: 121130B Class II Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility. Medtronic Navigation, Inc.
Devices PATIENT TRACKER 9733534XOM ENT 1PK Lot No.: 131212C 130827E 130827E 131113B 131203C 131113D 131018A 130212B 131105B 130429E 130815D 130815D 130815C 130409G 130409G 130510E 130422A 130410A 130510E 130409G Class II Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility. Medtronic Navigation, Inc.
Devices PIN, 9733235, 100MM, STERILE, PERC REF Lot No.: 2012110744 2013010347 2012081458 Class II Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility. Medtronic Navigation, Inc.
Devices PIN, 9733236, 150MM, STERILE, PERC REF Lot No.: 2013041109 Class II Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility. Medtronic Navigation, Inc.
Devices SHUNT KIT 9733605 NON-INVASIVE Lot No.: 120628B 130204E 130314H 121113H 130508B 130612A 130709 130325 130710 130729A 130826 130923B 131016C 131025F 130923B 131127A Class II Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility. Medtronic Navigation, Inc.
Devices SPHERES 8801071 1/TRAY 12PK Lot No.: 1203122 1205291 1206251 1306081 1309101 Class II Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility. Medtronic Navigation, Inc.
Devices SPHERES 8801075 5/TRAY 12PK Lot No.: 1207251 1301091 1301081 1211141 1301151 1302051 1303141 1303121 1303191 1304031 1304081 1303071 1305221 1305281 1306181 1306231 1307041 1307051 1307111 1307131 1307121 Class II Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility. Medtronic Navigation, Inc.
Devices TRAJ GUIDE KIT, 9733065, BIOPSY, EXT Lot No.: 0066225613 0066207713B 0066202413 0066212611 0066209012a 0066209012a Class II Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility. Medtronic Navigation, Inc.
Devices TRAJ GUIDE KIT, 9733066, BIOPSY, INT Lot No.: 0066233912C 0066201113B 0066212611B 0066233912C 066209012 066209012 Class II Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility. Medtronic Navigation, Inc.
Devices TUMOR RES. PACK 9733553 AxiEM S.M. Lot No.: 6402019 6402024 Class II Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility. Medtronic Navigation, Inc.
Devices TUMOR RESECTION KIT 9733607 NON-INVASIVE Lot No.: 120416C 121030D 130605B 121010F 130923C 131009A 130923C Class II Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility. Medtronic Navigation, Inc.
Devices TUMOR RESECTION KIT 9733608 SKULL MOUNT Lot No.: 120725D 130404B Class II Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility. Medtronic Navigation, Inc.
Devices UPGRD PRGM 9734638 ADD AxiEM NAVIGATION Lot No.: 6148186 Class II Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility. Medtronic Navigation, Inc.
Drugs Calcium Chloride Preservative Free Sterile injection, 100 mg/ml, 10 ml vial, Rx only, Abrams Royal Compounding Pharmacy, 8220 Abrams Rd, Dallas, TX 75231. Lot #: 05152013@4 (also written as 051513-4), Exp 11/11/13 Class I Non-Sterility: The firm's contract testing laboratory found sterility failures. Abrams Royal Pharmacy
Drugs Lidocaine 18.18 mg/mL/Bupivacaine 2.27 mg/mL/Epinephrine 0.0022 mg/mL/Hyaluronidase13.64 u/mL, supplied in 11 mL Sterile Syringes, Rx only, Compounded med, Single use only, (Red Block) ABRAMS ROYAL Compounding Pharmacy, Dallas, TX Lot# 041013-13 (also been written as "041013@13") Exp: 06/09/2013 Class I Non-Sterility Abrams Royal Pharmacy
Drugs Trace Mineral-5 MDV, supplied in 10 mL vials, Each ML contains: 1 mg Zinc (as sulfate), 0.4 mg Copper (as sulfate), 0.1 mg Manganese (as sulfate), 4 mcg Chromium (as chloride), 20 mcg Selenium (as sodium), 0.9% Benzyl alcohol in water for injection, Rx Only, Compounded Medication, ABRAMS ROYAL Compounding Pharmacy, Dallas, TX Lot number 04302013@21 (also written as 043013-21), exp 10/27/2013 Class I Non-Sterility; contract laboratory identified Staphylococcus warneri in the product Abrams Royal Pharmacy
Devices MediChoice Dual-Release Folding Walker with 5" wheel Item 1314077745. Lot#/Serial #s: 1304CA07A 1307000381-1307001520; 1306CA07A 1307001521-1307002184; 1307CA07A 1307002185-1307002888; 1309CA07A 1307002889-1307003292; 1310CA07A 1307003293-1307004044; 1311CA07A 1307004045-1307004752; 1312CA07A 1307004753-1307005236; Class II Product wheels may be too loose, too tight, or fall off. Owens & Minor Distribution, Inc.
Devices ADVIA Centaur® and ADVIA Centaur® XP and ADVIA Centaur® CP Cleaning Solution (For in vitro diagnostic use with the ADVIA® Centaur systems) Catalog Number: 112748 (Siemens Material Number (SMN): 10310041 The Cleaning Solution is a component of the ADVIA Centaur® and ADVIA Centaur® XP and ADVIA Centaur® CP instruments, and therefore does not have independent Instructions for Use (IFU). Information regarding use of the Cleaning Solution is contained in the owner's manual for the instruments. Lot Numbers: 459356 Exp. Date: November 2014; 443105 Exp. Date: November 2014 Class III Stability of the ADVIA Centaur Cleaning Solution is not assured Siemens Healthcare Diagnostics, Inc
Food THE ORIGINAL SOUPMAN Lobster Bisque, Net Wt 17 oz (482 g). Product is packed as a tetra pak and ships as a pack of 12 or 6 containers per carton. Distributed exclusively by: SoupMan Inc. Staten Island, NY 10314 Lot numbers: 0314435801, 0411435801, 0523435801, 0709435803, 0822435801, 0709435802 and 0821435801 Class II The Original Soup Man has recalled Lobster Bisque due to the presense of Undeclared Shrimp, Tilapia and Perch. Original Soup Man
Food Anti-Aging Naturals GENE STRENGTH Purple Longevity Dietary Supplement, 60 Vegetarian Capsules. Manufactured for Anti-Aging Naturals Venetia, Pennsylvania 15367 USA. Lot # 405130 Class II Formulations For Life has recalled 3 varieties of Dietary Supplements due to lack of Good Manufacturing Practices and misbranding. Formulations For Life
Food FORMULATIONS FOR LIFE Resevera Action High Potency Longevity Complex DIETARY SUPPLEMENT, 60 VEGETARIAN CAPSULES. Distributed by: Formulations for LIfe Hauppauge, New York 11788 USA. Lot # 405130 Class II Formulations For Life has recalled 3 varieties of Dietary Supplements due to lack of Good Manufacturing Practices and misbranding. Formulations For Life
Food FORMULATIONS FOR LIFE Vision Assure Extra Strength Vision Formula DIETARY SUPPLEMENT, 1) 60 VEGETARIAN CAPSULES, 2) 120 VEGETARIAN CAPSULES. Distributed by: Formulations for Life Hauppauge, New York 11788 USA. Lot # 404120 Class II Formulations For Life has recalled 3 varieties of Dietary Supplements due to lack of Good Manufacturing Practices and misbranding. Formulations For Life
Devices ADVIA Centaur BNP Assay for in vitro diagnostic use in the quantitative determination of B-type Natriuretic Peptide (BNP) in human plasma using the ADVIA Centaur, Centaur XP, Centaur CP Systems; Catalog Numbers: Cat No. 02816138/SMN 10309044 (100 test) 02816634/SMN 10309045 (500 test) Lot 038174: 100 Test - 43305174 and 43278174; 500 Test - 43306174 and 43279174. Class III Siemens Healthcare Diagnostics has confirmed that approximately 2000 ReadyPacks from the ADVIA Centaur® Systems BNP reagent contains an ADVIA Centaur Systems FT4 human-readable side label. Siemens Healthcare Diagnostics, Inc
Devices Transport Chair and Rollator in 1, Model HE21630011 Burgundy and HE21630011 Blue. This is a walker/rolling chair. Used to assist injured and infirm people to walk or be ambulatory. SKU 348709 404, SKU348709 605 Class II Silver Star Brands is recalling the Transport Chair and Rollator in One because they have received several reports of the wheel assembly failing resulting in damaged wheels.. Silver Star Brands
Devices Nidek Excimer Laser Corneal Surgery System, model EC-5000 CXIII. Opthalmic Device. The system is composed as a laser generator which produces an excimer laser radiation of wavelength 193nm, a beam delivery unit, an optical system for observation, a gas system and a computer for system control. Serial numbers: 530054 530055 530070 530073 530078 530082 530086 530087 530098 530106 530121 530123 530150 530155 Class II Contact failure in F1 and F4 fuse holders was detected on the EC-5000 CXIII Excimer Laser Corneal Surgery System that could cause a serious adverse event for the patient. Nidek Inc
Food NEW HOPE MILLS GLUTEN FREE CHIA PANCAKE & WAFFLE MIX, NET WT 16 OZ (1 LB) 454g, UPC 074703530126. Packed as 8 units per carton. Each unit is held within a red and white front box. Made in the USA. Best By Dates: 11/13/2014, 11/14/2014, 2/26/2015, 7/29/2015, 10/4/2015, 12/13/2015 Class I New Hope Mills, Inc. has recalled New Hope Mills Gluten Free Chia Pancake and Waffle Mix due to the presence of Undeclared Soy. New Hope Mills Mfg., Inc.
Devices SideFire Directional Laser Probe, REF: NBP101-01, NBP201-01, NBP301-01, NBP401-01, NBP501-01. These laser probes are part of the NeuroBlate System, a unique collection of MRI-compatible laser devices and accessories that create an MRI guided delivery of precision thermal therapy in the brain. The NeuroBlate System components include Gas-cooled Laser Delivery Probes to deliver controlled energy to a target zone. serial numbers: 20368-1-C1112-01, 20368-1-C1112-02, 20368-1-C1112-03, 20368-1-C1112-04, 20368-1-C1112-05, 20368-1-C1112-06, 20368-1-C1112-07, 20368-1-C1112-08, 20368-1-C1112-09, 20368-1-C3173-02, 20368-1-C3173-03, 20368-1-C3173-04, 20368-1-C3173-05, 20368-1-C3173-06, 20368-1-C3173-07, 20368-1-C3173-08, 20368-1-C3173-09, 20368-1-C3173-10, 20368-1-C3173-11, 20368-1-C3173-12, 20368-1-C3173-13, 20368-1-C3173-14, 20368-1-C3173-15, 20368-1-C3173-16, 20368-1-C3173-17, 20368-1-C3173-18, 20368-1-C3173-19, 20368-1-C3173-20, 20368-1-C3258-01, 20368-1-C3258-02, 20368-1-C3258-04, 20368-1-C3258-05, 20368-1-C3258-06, 20368-1-C3258-07, 20368-1-C3258-12, 20368-1-C3258-13, 20368-1-C3258-14, 20368-1-C3462-01, 20368-1-C3462-02, 20368-1-C3462-03, 20368-1-C3462-04, 20368-1-C3462-05, 20368-1-C3462-06, 20368-1-C3462-07, 20368-1-C3462-08, 20368-1-C3462-09, 20368-1-C3462-10, 20368-1-C3462-11,  ...
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Class II Monteris Medical received a complaint of a separation of the distal sapphire tip from the laser delivery probe. Monteris Medical Corp
Devices FullFire Diffusing Tip Laser Probe, REF: DTP101-01, DTP201-01, DTP301-01, DTP401-01, DTP501-01. These laser probes are part of the NeuroBlate System, a unique collection of MRI-compatible laser devices and accessories that create an MRI guided delivery of precision thermal therapy in the brain. The NeuroBlate System components include Gas-cooled Laser Delivery Probes to deliver controlled energy to a target zone. serial numbers: 20414-1-C1274-03, 20414-1-C1274-04, 20414-1-C1274-06, 20414-1-C1274-07, 20414-1-C1274-08, 20414-1-C1274-09, 20414-1-C1274-11, 20414-1-C1274-12, 20414-1-C1274-13, 20414-1-C1274-17, 20414-1-C1274-19, 20414-1-C1274-20, 20414-1-C1367-01, 20414-1-C1367-02, 20414-1-C1367-04, 20414-1-C1367-05, 20414-1-C1367-06, 20414-1-C1367-07, 20414-1-C3302-02, 20414-1-C3302-05, 20414-1-C3302-08, 20414-1-C3302-10, 20414-1-C3302-12, 20414-1-C3302-13, 20414-1-C3302-14, 20414-1-C3302-15, 20414-1-C3302-16, 20414-1-C3302-17, 20414-1-C3502-01, 20414-1-C3502-02, 20414-1-C3502-03, 20414-1-C3502-05, 20414-1-C3502-06, 20414-1-C3502-07, 20414-1-C3502-08, 20414-1-C3502-09, 20414-1-C3502-10, 20414-1-C3502-11, 20414-1-C3502-12, 20414-1-C3502-13, 20414-1-C3502-14, 20414-1-C3502-15, 20414-1-C3502-16, 20414-1-C3502-17, 20414-2-C1275-01, 20414-2-C1275-02, 20414-2-C1275-03, 20414-2-C1275-04,  ...
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Class II Monteris Medical received a complaint of a separation of the distal sapphire tip from the laser delivery probe. Monteris Medical Corp
Devices MC-500 Multicolor Laser Photocoagulator using software version 2.20. Opthalmic device used for retinal photocoagulation for treatment of ocular fundus diseases. MC-500; Serial numbers: 50011, 50382, 50425, 50558, 50609 Class II Retrospective review found that a Engineering Change Order initiated in May 2013 for a memory function problem was not reported as required. Nidek Inc
Devices Nidek MC-500 Multicolor Laser Photocoagulator using software version 2.20. Opthalmic Device. The Nidek Multicolor Laser photocoagulator Model MC-500 is indicated for use in retinal photocoagulation for treatment of ocular fundus diseases. Model MC-500 Serial numbers: 50277 50310 50330 50331 50357 50358 50383 50408 50417 50418 50425 50426 50439 50440 50445 50446 50471 50514 50311 50359 50382, Class II When the MC-500 is turned on and coagulation is performed without changing the laser color, the delivery unit occasionally fails to emit the laser, or the power output is lower than the set program. Nidek Inc
Food Oven Fresh Lemon Pound Cake, Net Wt. 5 oz., Oven Fresh Baking, LLC, 70 Clinton Road. Fairfield, NJ 07004, UPC 089595901145 None Class III Masiero Brothers LLC initiated a voluntary recall for their Lemon Pound Cake because of misbranding. MASIERO BROS.INC
Devices Edwards Lifesciences Vent Catheters, . Packaged sterile and non-pyrogenic in a sealed, peel-type pouch. Model Numbers: E061, E060, PE062, EM012 Atrial Vent Catheters are intended for venting the left heart during short-term ( d 6 hrs) cardiopulmonary bypass. Avoid direct ventriculotomy with entry into the left atrium across the mitral valve and into the left ventricle. Left Ventricular Vent Catheters are intended for venting the left ventricle during short-term ( 6 hrs) cardiopulmonary bypass. Entrance is made into the left ventricle. Extracorporeal circuit components with a Duraflo coating are intended for use in cardiopulmonary surgery when a heparin coated blood path is desired. Vent Catheters may be used in pediatric or adult populations based on individual patient anatomy. Lots: 59134589;59346136;59499481;59609044;59717943;59138591;59192007;59149674;59350916;59514123;59620244;59723313;59138592;59199148;59202405;59370449;59528372;59625386;59723318;59148881;59207364;59222648;59409903;59528392;59634884;59735991;59149673;59211452;59245610;59414824;59541717;59651860;59747795;59149675;59211456;59245648;59453572;59555076;59662625;59758989;59151406;59216325;59266772;59456447;59563964;59680248;59769429;59161706;59218844;59283731;59458072;59568501;59691477;59774986;59163769;59229509;59309184;59463365;59577224;59695811;59791798;59179981;59229512;59319451;59490087;59604744;59706987;59813426;59182987;59232182;59342295;59491855;59604746;59717942;59839270;59192002;59235535;59245625;59328438;59409901;59509316;59615872;59680180;59758991;59245650;59328440;59413359;59518784;59615876;59680270;59759002;59245652;59329235;59414819;59523751;59620242;59684868;59763554;59258285;59346138;59431972;59531242;59620243;59702379;59774995;59271794;59346146;59453598;59536690;59620327;59706982;59780342;59271795;59350911;59456450;59541842;59630423;59706985;59786179;59283729;59350921;59458056;59555081;59634892;59712080;59796688;59287254;59354987;59458061;59563850;59634893;59712081;59796692;59290438;59354988;59463367;59568469;59640081;59723317;59801791;59295439;59365157;59473421;59572996;59640085;59723320;59813418;59295506;59365159;59473422;59577180;59640108;59729757;59824882;59299876;59378069;59484139;59581494;59651780;59729759;59824891;59304307;59383861;59490088;59581564;59651850;59729761;59836965;59304308;59390115;59490089;59583327;59662626;59735981;59839272;59304310;59390121;59491856;59589933;59662638;59735983;59844549;59312984;59391051;59491858;59589951;59675187;59735987;59319447;59404539;59499480;59604747;59680142;59747805;59321329;59409878;59504238;59609041;59680148;59751061; Class II Edwards Lifesciences is conducting a field action on the Vent Catheters due to the potential for disruption of the white plastic coating on the stylet. Edwards Lifesciences, LLC
Food Raw Serrano Peppers packed in white cardboard box with label reading: John Vena, Inc. Serrano 5 lb Product of Mexico Packed by John Vena, Inc. Philadelphia, PA 19153 101570 or 101619 101570 101619 Class I John Vena repacked Serrano Peppers currently being recalled by Bailey Farms, Oxford, NC. John Vena, Inc.
Drugs Mercaptopurine Tablets, USP 50mg, a) 60-count bottle (NDC 49884-922-02), b) 250-count bottle (NDC 49884-922-04), RX only, Manufactured by Stason Pharmaceuticals, Inc., 11 Morgan, Irvine, CA 92618 for Prometheus Laboratories, Inc., 9410 Carroll Park Drive, San Diego, CA 92121 Mercaptopurine Tablets, USP 50mg, a) 60-count bottle (NDC 49884-922-02), b) 250-count bottle (NDC 49884-922-04), RX only, Manufactured by Stason Pharmaceuticals, Inc., 11 Morgan, Irvine, CA 92618 for Prometheus Laboratories, Inc., 9410 Carroll Park Drive, San Diego, CA 92121 Lot #: a) 140B11, Exp  ...
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Class II Failed Dissolution Specifications: Product found to be out of specification (OOS) during stability testing. Prometheus Laboratories Inc.
Devices Etest® Ceftaroline (CPT32) WW B30. Etest® (Antimicrobial Susceptibility Testing) is a quantitative technique for determining the antimicrobial susceptibility of Gram negative and Gram positive aerobic bacteria. Ref #537500, Lot #1003160540, Right Expiry date: 27-APR-2016 Class III The products have a wrong expiration date on their labeling, 5 years instead of 2 years. Biomerieux
Devices Etest® Ceftaroline (CPT32) WWB100. Etest® (Antimicrobial Susceptibility Testing) is a quantitative technique for determining the antimicrobial susceptibility of Gram negative and Gram positive aerobic bacteria. Ref #537508, Lot #1003160510, Right Expiry date: 27-APR-2016 Class III The products have a wrong expiration date on their labeling, 5 years instead of 2 years. Biomerieux
Devices Etest® Ceftaroline (CPT32) US B30. Etest® (Antimicrobial Susceptibility Testing) is a quantitative technique for determining the antimicrobial susceptibility of Gram negative and Gram positive aerobic bacteria. Ref #537540, Lot #1003202200, Right Expiry date: 27-APR-2016 Class III The products have a wrong expiration date on their labeling, 5 years instead of 2 years. Biomerieux
Devices Etest® Ceftaroline (CPT32) US B100. Etest® (Antimicrobial Susceptibility Testing) is a quantitative technique for determining the antimicrobial susceptibility of Gram negative and Gram positive aerobic bacteria. Ref #537548, Lot #1003202820, Right Expiry date: 27-APR-2016 Class III The products have a wrong expiration date on their labeling, 5 years instead of 2 years. Biomerieux
Devices Etest® Ceftaroline (CPT32) US B30. Etest® (Antimicrobial Susceptibility Testing) is a quantitative technique for determining the antimicrobial susceptibility of Gram negative and Gram positive aerobic bacteria. Ref #537540, Lot #1003301830, Right Expiry date: 30-APR-2016 Class III The products have a wrong expiration date on their labeling, 5 years instead of 2 years. Biomerieux
Drugs LOSARTAN POTASSIUM TABLETS USP, 25 mg, 1000 Tablet Bottles, Rx Only. Manufactured by: Micro Labs Limited, Goa-403 722, INDIA. Manufactured for: Micro Labs USA, Inc., Princeton, NJ 08540. NDC 42571-110-10 Lot #LJAG003, Expiry: 05/2015 Class II Failed Content Uniformity Specifications; Dry mix failed blend uniformity. Micro Labs Usa, Inc S
Food Lundberg Rice Chips (Croustilles de Riz), Sea Salt (Sel Marin) 6 oz. (170 g) package; Wheat Free, Gluten Free (Sans Ble, Sans Gluten); US product number: F11070; Canadian Product number: F11160. Ingredient: Organic Whole Grain Brown Rice, Organic Rice Flour (Organic Whole Brown Rice Flour, Organic Rice Flour), Organic High Oleic Expeller-Pressed Safflower or Sunflower Oil, Organic Whole Masa Corn Flour, Organic Sesame Seeds, Sea Salt, Natural Caramel Color. Contains Sesame. Lundberg Family Farms Richvale, CA 95974 Code: 140811; Best Befroe Date: 2015-JUN 08; Case Code : 200-73416-03530-4; UPC - US: 0-73416-03530-0; UPC - CANADA: 0-73416-03540-9 Class I Recall Sea Salt Rice Chips (6 oz.) due to presence of undeclared allergen - customer found a ranch flavor chip in the bag which contains dairy. Wehah Farms
Devices Siemens SimView NT and SimView NT with IDI simulation system components: Product Usage: The intended use of the Radiation Therapy Simulation system is used for simulation of treatment planning prior to the therapeutic treatment of cancer. Model numbers: 5496992, 5497016 with Serial numbers: 6035, 6080, 6029, 6032, 6019, 6001 Class II Siemens became aware of a very rare occurrence where an intended movement of the SimView NT simulation system components could not be stopped with usual hand control commands or by use of the collision detection functionality. It is possible that simulation system components could collide with patient and/or system equipment. Siemens Medical Solutions USA, Inc
Food M & M brand Number 2 Florida Avocados, packed in 50 lb cardboard boxes Lot # 101315 and 101326 Class I Samples of avocados tested by FDA were positive for Salmonella. M & M Farm Inc.
Devices LANX, REF, PCR8XXX-XXX, LOT, RXONLY. Packaged within aluminum sterilization case. Product Usage: The Durango implant is intended for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous spinal levels from L2S1. Lot numbers L532655, L532690, Product code 8503XXXX Class II Biomet Spine, LLC. announces voluntary recall of Durango Anchored ALIF Plate due to the set screw component potentially becoming dislodged from the plate assembly. Biomet Spine LLC.
Devices AxoTrack I Sterile Procedure Kit 18G, K1001-18XTW, (24/case labeled for US, 5/case labeled for US, 24/case labeled for EU, 5/case labeled for EU). Sterile Procedure Kit for use AxoTrack enabled Ultrasound Transducer for magnetic needle tracking. Product Ref#70956, Lot #62191-000, Expiration Date: 2/28/2014, Lot #62193-000, Expiration  ...
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Class II There is a possibility the sterile packaging may fail before the expiration date specified on the package. Soma Access Systems LLC
Food Saxon Creamery Greenfields Monastery Washed Rind Wisconsin Handcrafted Cheese, 7 lb wheel. Ingredients: Pasteurized Cow's Milk, culture, salt, enzymes, contains milk. Keep Refrigerated. 259010114 Class II Saxon Cheese LLC is recalling one lot of GreenFields Monastery Washed Rind Wisconsin handcrafted Cheese because product tested positive for E.coli. Saxon Cheese, LLC
Food Mt. Olive, Kosher Dill Chips in 1 gallon glass jars, UPC 09300 12841, Mt. Olive, Corner of Cucumber & Vine, P.O. Box 609, Mt Olive, NC 28365-0609. Production Code: 1FE1624A and 1FE1624B, Best by May 31, 2016;  ...
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Class II Product may contain glass fragments. Mt. Olive Pickle Company Inc
Food Exotic Superfoods 100% Raw Young Thai Coconut Water, 32 oz. SKU: 7 05105 50171 0 Exotic Superfoods 100% Raw Young Thai Coconut Water, 11.7 oz. SKU: 7 05105 50161 1 Description of the Product: - 32 oz (1 quart): - The product is consumed in individual clear plastic bottles. - Each bottle has a white label. - There are 12 bottles in a case. - 11.7 oz: - The product is sold in individual clear plastic bottles. - Each bottle has a white label. - There are 12 bottles in a case Product of Thailand Distributed by Exotic Superfoods www.exoticsuperfoods.com NY e-mail: info@exoticsuperfoods.com CA e-mail: caliinfo@exoticsuperfoods.com Lot Numbers: - 343592 (32 oz) - 340073 (11.7 oz) Class II It appears that these batches were not subjected to 5-log reduction as part of their processing. Exotic Superfoods New York, Inc.
Devices CyberKnife Robotic Radiosurgery System with the first generation IRIS Variable Aperture Collimator. The CyberKnife is indicated for treatment planning and image guided stereotactic Radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated. Catalog/Part number 054000-0001; Serial numbers: C0141 C0182 C0225 C0256 C0137 C0112 C0244 C0210 C0160 C0208 C0118 C0090 C0207 C0181 C0034 C0047 C0197 C0174 C0101 C0186 C0178 Serial # C0198 C0214 C0059 C0172 C0068 C0057 C0263 C0092 C0199 C0151 C0179 C0226 C0158 C0131 C0144 C0223 C0071 C0094 C0183 C0143 Serial # C0192 C0055 C0072 C0061 C0134 C0177 C0247 International Sites Serial # C0175 C0189 C0191 C0215 C0227 C0187 C0242 C0185 C0218 C0237 C0240 C0265 C0268 C0251 C0235 C0229 C0212 C0239 Serial # C0043 C0211 C0255 C0270 C0176 C0093 C0234 C0221 C0249 C0232 C0180 C0238 C0231 C0202 C0230 C0264 C0266. Class II Software upgrade to correct potential safety issue related to CyberKnife System that occurs when upgrading the Treatment Delivery Software for the first generation Iris Variable Aperture Collimator. Accuray Incorporated
Devices MOSAIQ Product Usage: MOSAIQ is an oncology information system used to manage workflows for treatment planing and delivery. It supports information flow among healthcare facility personnel and can be used wherever radiotherapy and/or chemotherapy are prescribed. MOSAIQ Release 2.60.257 Class II A problem can exist in MOSAIQ resulting in the display of incorrect numeric data due to a dose rounding error on printed reports. Elekta, Inc.
Cosmetics Comfort Rinse-Free Shampoo Caps, fabric-lined caps pre-moistened with rinse-free shampoo used to cleanse hair, individually packaged in a film packet. There are 40 packets per carton. Product Code: 7909; Lot Numbers: 45812, 45923 Class III A preservative ingredient was not added during the manufacture of two lots of product. Sage Products Inc
Drugs Sterile powder Vancomycin Hydrochloride for Injection, USP, Equivalent to 1 g in 25 ml fliptop vial, 10-count tray, Rx only, Manufactured by Hospira, Inc. Lake Forest, IL 60045, NDC 0409-6533-01. Lot# 43-240-DD; Exp. 07/16 Lot# 44-205-DD,44-455-DD,44-460-DD,44-465-DD; Exp. 08/16 Class III Correct Labeled Product Mispack: Product tray containing vials was mislabeled to contain another product. Hospira Inc.
Food Wawa Garden Rotini Salad with Lite Creamy Caesar Dressing, Net Wt 8 oz. (227 g) Bottom of container - Wawa Kale & Quinoa Salad Distributed by: Wawa, Inc. Wawa, PA 19063 UPC 726191066402 sell by 11/04/2014 TFNJ 303 1 5:00am Class I Product recalled due to the potential of undeclared fish, wheat and egg allergens. Taylor Farms New Jersey, NJ
Food Avocado label: Unity Groves Avocados # 4221 Born in the USA Box label: Pride of the Redlands brand 32ct Green skin avocados, packaged in 1/2 BU Box Lot # 14061006 Class I FDA sample positive for Salmonella. Unity Groves Corporation
Devices 10 mm/135 degree Titanium Cannulated Trochanteric Fixation Nail 170 MM - Sterile: intended to treat stable and unstable fractures of the proximal femur part number: 456.316S, lot number: 7782247 Class II The 10 mm/135 degree Titanium Cannulated Trochanteric Fixation Nail 170 MM (Sterile) was assembled incorrectly. If the non conformance goes undetected, it may impact the locking function post-operatively and compromise the bone reduction and construct stability which may lead to non-union/malunion. Synthes, Inc.
Food Taro Toast, Net Wt 20 oz.. (1.25 lb) 99 Ranch Market 338 Barber Ln, Milpitas, CA 95035 UPC 2 92210 00275 6, sell by dates up to and including 11/4/2014 Class I Various varieties of Toast products are being recalled due to lack of allergen statement for wheat, soy, and/or milk. Welcome Market Inc
Food Family Toast, Net Wt 20 oz.. (1.25 lb) 99 Ranch Market 338 Barber Ln, Milpitas, CA 95035 UPC 2 92216 00249 1, sell by dates up to and including 11/4/2014 Class I Various varieties of Toast products are being recalled due to lack of allergen statement for wheat, soy, and/or milk. Welcome Market Inc
Food U-TA-NE Toast, Net Wt 20 oz.. (1.25 lb) 99 Ranch Market 338 Barber Ln, Milpitas, CA 95035 UPC 2 92223 00275 0, sell by dates up to and including 11/4/2014 Class I Various varieties of Toast products are being recalled due to lack of allergen statement for wheat, soy, and/or milk. Welcome Market Inc
Food Raisin Toast, Net Wt 20 oz.. (1.25 lb) 99 Ranch Market 338 Barber Ln, Milpitas, CA 95035 UPC 2 92208 00275 1, sell by dates up to and including 11/4/2014 Class I Various varieties of Toast products are being recalled due to lack of allergen statement for wheat, soy, and/or milk. Welcome Market Inc
Food Green Onion Porksung Toast, Net Wt 20 oz.. (1.25 lb) 99 Ranch Market 338 Barber Ln, Milpitas, CA 95035 UPC 2 92219 00275 7, sell by dates up to and including 11/4/2014 Class I Various varieties of Toast products are being recalled due to lack of allergen statement for wheat, soy, and/or milk. Welcome Market Inc
Food Coconut Toast, Net Wt 20 oz.. (1.25 lb) 99 Ranch Market 338 Barber Ln, Milpitas, CA 95035 UPC 2 92212 00275 4, sell by dates up to and including 11/4/2014 Class I Various varieties of Toast products are being recalled due to lack of allergen statement for wheat, soy, and/or milk. Welcome Market Inc
Food Pineapple Toast, Net Wt 20 oz.. (1.25 lb) 99 Ranch Market 338 Barber Ln, Milpitas, CA 95035 UPC 2 92211 00275 5, sell by dates up to and including 11/4/2014 Class I Various varieties of Toast products are being recalled due to lack of allergen statement for wheat, soy, and/or milk. Welcome Market Inc
Food Multi-9 Grain, Net Wt 20 oz.. (1.25 lb) 99 Ranch Market 338 Barber Ln, Milpitas, CA 95035 UPC 2 92203 00275 6, sell by dates up to and including 11/4/2014 Class I Various varieties of Toast products are being recalled due to lack of allergen statement for wheat, soy, and/or milk. Welcome Market Inc
Food Cheese Toast, Net Wt 20 oz.. (1.25 lb) 99 Ranch Market 338 Barber Ln, Milpitas, CA 95035 UPC 2 92213 00275 3, sell by dates up to and including 11/4/2014 Class I Various varieties of Toast products are being recalled due to lack of allergen statement for wheat, soy, and/or milk. Welcome Market Inc
Food Wheat Bran Toast, Net Wt 20 oz.. (1.25 lb) 99 Ranch Market 338 Barber Ln, Milpitas, CA 95035 UPC 2 92228 00275 5, sell by dates up to and including 11/4/2014 Class I Various varieties of Toast products are being recalled due to lack of allergen statement for wheat, soy, and/or milk. Welcome Market Inc
Food Red Bean Toast, Net Wt 20 oz.. (1.25 lb) 99 Ranch Market 338 Barber Ln, Milpitas, CA 95035 UPC 2 92209 00275 0, sell by dates up to and including 11/4/2014 Class I Various varieties of Toast products are being recalled due to lack of allergen statement for wheat, soy, and/or milk. Welcome Market Inc
Devices The MectaLIF Oblique Handle, model number 03.22.10.0262, is used to insert the MectaLIF oblique spinal cage implants. Model Number: 03.22.10.0262; Lot Number: 1314256 Class II The MectaLIF Oblique Handle has the laser marking "MEDIAL" on the incorrect side and could result in incorrect insertion of the device during surgery. Medacta Usa
Food InHarvest Garden Vegetable Seasoning, Item 61104, Net Wt 4 oz. Lots 4020501 and 4041401 Class I Firm is recalling Garden Vegetable Seasoning due to an undeclared milk allergen. Karlsburger Foods, Inc.
Food White and Wild Medley/Garden Vegetable 12/36 oz; Product number 10410. Product contains 4 oz. plastic bags of Garden Vegetable Seasoning mix: Ingredients; Maltodextrin, Dehydrated Onion, Dehydrated carrots, Hydrolyzed Corn Protein, Sun-Dried Tomato, Salt, Autolyzed Yeast Extract, Sugar. contains 2%$ of less of each of the following: dehydrated tomato, spices, natural flavor, Citric Acid, Soybean Oil, Silicon Dioxide (anticaking agent) Seasoning is added to 2 lbs of rice/grain/legume and water. In Harvest, Inc. Bemidji, MN. Seasoning lot: 4020501 - InHarvest lot number 140217; Seasoning lot 4041401 - InHarvest lot numbers: 140624 and 140908 Class I Firm was notified by supplier of Garden Vegetable Seasoning that the product has an ingredient that contains milk, and milk is not declared on the label. InHarvest, Inc.
Food Caviar Medley/Garden Vegetable 12/36 oz Product number 10610; Caviar Medley/Garden Vegetable 6/26 oz. Product number 10644 Product contains 4 oz. plastic bags of Garden Vegetable Seasoning mix: Ingredients; Maltodextrin, Dehydrated Onion, Dehydrated carrots, Hydrolyzed Corn Protein, Sun-Dried Tomato, Salt, Autolyzed Yeast Extract, Sugar. contains 2%$ of less of each of the following: dehydrated tomato, spices, natural flavor, Citric Acid, Soybean Oil, Silicon Dioxide (anticaking agent) Seasoning is added to 2 lbs of rice/grain/legume and water. InHarvest, Inc. Bemidji , MN. Seasoning lot: 4020501 - InHarvest lot numbers: 140214, 140325, 140211; Seasoning lot 4041401 - InHarvest lot numbers: 140211, 140325, 141029 Class I Firm was notified by supplier of Garden Vegetable Seasoning that the product has an ingredient that contains milk, and milk is not declared on the label. InHarvest, Inc.
Food Rio Medley/Garden Vegetable 12/36 oz; Product number 12310; Product contains 4 oz. plastic bags of Garden Vegetable Seasoning mix: Ingredients; Maltodextrin, Dehydrated Onion, Dehydrated carrots, Hydrolyzed Corn Protein, Sun-Dried Tomato, Salt, Autolyzed Yeast Extract, Sugar. contains 2%$ of less of each of the following: dehydrated tomato, spices, natural flavor, Citric Acid, Soybean Oil, Silicon Dioxide (anticaking agent) Seasoning is added to 2 lbs of rice/grain/legume and water. InHarvest, Inc. Bemidji , MN. Seasoning lot: 4020501 - InHarvest lot numbers:130304, 140128, 140626.. Seasoning lot 4041401 - InHarvest lot numbers: 140626, 140128, 140827. Class I Firm was notified by supplier of Garden Vegetable Seasoning that the product has an ingredient that contains milk, and milk is not declared on the label. InHarvest, Inc.
Food Whole Grain 5 Blend/Garden Vegetable 12/36 oz Product number 12410; Product contains 4 oz. plastic bags of Garden Vegetable Seasoning mix: Ingredients; Maltodextrin, Dehydrated Onion, Dehydrated carrots, Hydrolyzed Corn Protein, Sun-Dried Tomato, Salt, Autolyzed Yeast Extract, Sugar. contains 2%$ of less of each of the following: dehydrated tomato, spices, natural flavor, Citric Acid, Soybean Oil, Silicon Dioxide (anticaking agent) Seasoning is added to 2 lbs of rice/grain/legume and water. InHarvest, Inc. Bemidji , MN. Seasoning lot: 4020501 - InHarvest lot numbers: 140218, 131114, 140513,140623 Seasoning lot 4041401 - InHarvest lot numbers: 140820 Class I Firm was notified by supplier of Garden Vegetable Seasoning that the product has an ingredient that contains milk, and milk is not declared on the label. InHarvest, Inc.
Food Garden Vegetable seasoning Mix 12/4 oz. Product number 141000 Garden Vegetable seasoning mix. 4 oz..; Product number 14000 Product contains 4 oz. plastic bags of Garden Vegetable Seasoning mix: Ingredients; Maltodextrin, Dehydrated Onion, Dehydrated carrots, Hydrolyzed Corn Protein, Sun-Dried Tomato, Salt, Autolyzed Yeast Extract, Sugar. contains 2%$ of less of each of the following: dehydrated tomato, spices, natural flavor, Citric Acid, Soybean Oil, Silicon Dioxide (anticaking agent) Seasoning is added to 2 lbs of rice/grain/legume and water. InHarvest, Inc. Bemidji , MN. Seasoning lot: 4020501 - InHarvest lot numbers: 4020501, Seasoning lot 4041401 - InHarvest lot numbers: 4041401. Class I Firm was notified by supplier of Garden Vegetable Seasoning that the product has an ingredient that contains milk, and milk is not declared on the label. InHarvest, Inc.
Drugs Tetrahydrozoline Hydrochloride, USP, 1 KG Bottle. Spectrum Chemical MFG CORP., Gardena, CA 90248. Cat. YY1568. Lot #: 1BJ0479; Expiry: 06/2017 Class II CGMP Deviations; Stored/dispensed in a non-GMP compliant warehouse at S.I.M.S., Italy. Spectrum Laboratory Products
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