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U.S. Department of Health and Human Services

Enforcement Report - Week of April 23, 2014

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Product Type Product Description Code Info Classification Reason for Recall Recalling Firm
Biologics Red Blood Cells Leukocytes Reduced 42FC23201; 50LJ98127: 50LW49978; 50LW51367; 50X33786 Class III Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. American National Red Cross (The)
Biologics Red Blood Cells Leukocytes Reduced Irradiated 16GJ47521 Class III Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. American National Red Cross (The)
Biologics Platelets Leukocytes Reduced 16GJ47521 Class III Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. American National Red Cross (The)
Drugs Prolifta Dietary Supplement Prolifta, 400mg/capsule, Packaged in 1 and 2 capsule blister packs and 4, 12, and 24 capsule bottles Made in the USA Distributed by: Prolifta LLC 1+877.239.8231 www.proliftaherbal.com. All lot codes and expiration dates. Class I Marketed without an Approved NDA/ANDA: Dietary supplement may contain amounts of an active ingredient found in some FDA-approved drugs for erectile dysfunction (ED) making the dietary supplement an unapproved drug. Haute Health, LLC
Drugs PHUK Sexual Enhancement Ultimate Pleasure, 400mg/capsule, packaged in 1 and 2 capsule blister packs and 4,12,24 capsule bottles, Distributed by UME Supplements, INC www.phukherbal.com. All lot codes and expiration dates. Class I Marketed without an Approved NDA/ANDA: Dietary supplement may contain amounts of active ingredients found in some FDA-approved drugs for erectile dysfunction (ED) making the dietary supplement an unapproved drug. Haute Health, LLC
Drugs Virilis Pro, 450mg/capsule, Packaged in a 1 and 2 capsule blister packs and 10 capsule bottles, Manufactured for Haute Health Williamstown, NJ 08094 website: http://www.virilispro.com All lot codes and expiration dates. Class I Marketed without an Approved NDA/ANDA: Dietary supplement may contain amounts of active ingredients found in some FDA-approved drugs for erectile dysfunction (ED) making the dietary supplement an unapproved drug. Haute Health, LLC
Drugs 1% Lidocaine HCl Injection, USP, 10 mg/mL, NDC 0409-4276-01, Hospira, Inc., Lake Forest, IL 60045. Lot #25090DK; Exp 01/15 Class I Presence of Particulate Matter: Oxidized stainless steel found in vial of 1% Lidocaine Hydrochloride Injection, USP. Hospira, Inc.
Drugs Slim Fortune capsules Dietary Supplement. Each bottle contains 30 capsules. ALL LOTS Class I Marketed Without an Approved NDA/ANDA; undeclared Sibutramine B @ B Trade Inc.
Drugs Lidiy capsules Dietary Supplement. Each bottle contains 30 capsules. ALL LOTS Class I Marketed Without an Approved NDA/ANDA; undeclared Sibutramine B @ B Trade Inc.
Drugs Slim Expert softgel capsules Dietary Supplement. One month supply/ 30 softgels. 1 softgel - 650 mg. ALL LOTS Class I Marketed Without an Approved NDA/ANDA; undeclared Sibutramine B @ B Trade Inc.
Devices Synthes CMF Battery Powered Driver, Part no. 305.840. Used to place screws in the cranialfacial bones, and to drill and/or tap holes to prepare cranialfacial bones for screw insertion. Part no. 305.840, with lot nos.: 5680577, 5701123, 5713215, 5763130, 5783316, 5787131, 5828296, 6124867, 6136125, 6150803, 6167974, 6167975, 6218358, 6222322, 6258395, 6365430, 6365431, 6390225, 6425013, 6456634, 6487035, 6556704, 6624880, 6650136, 6668870, 6743859, 6844968, 6926708, 6983799, 7008819, 7038706, 7221395, 7138319. Class II The CMF Battery Powered Driver graphic case contains outlines of the Battery Powered Driver, taps, screwdriver blades, and a screw holding sleeve. However, the device is not intended to be used in conjunction with a tap for tapping holes in a patient's skull, upper and/or lower jaw. Therefore some outlines in the graphic case suggest a potential use of this device that is considered off-label. Synthes, Inc.
Devices The Synthes Hohmann Retractor, 43 mm Long Shank, Angled 235 mm Product Usage: Used to expose bone for procedures. part no. 399.24, lot number T974302 Class II The Synthes Hohmann Retractor was mis-etched on the product and package as part number 399.24 instead of part number 399.22. Synthes, Inc.
Devices Brainlab, Spine & Trauma 3D 2.0, Navigation Software. An intraoperative image-guided localization system to enable minimally invasive surgery. Catalog Number: 22264 Catalog Number: 22264; Serial Numbers: 000000000038012001 , 000000000060912001 , 000000000189912001 , 000000000224912001 , 000000000235512001 , 000000000282912001 , 000000000313612001 , 000000000319412001 , 000000000351112001 , 000000000356912001 , 000000000367212001 , 000000000433712001 , 000000000482012001 , 000000000502812001 , 000000000645612001 , 000000000731112001 , 000000000837312001 , 000000000898312001 , 000000000956812001 , 000000000998412001 , 000000001012812001 , 000000001105412001 , 000000001231812001 , 000000001353512001 , 000000001355412001 , 000000001433712001 , 000000001473712001 , 000000001493512001 , 000000001493712001 , 000000001566212001 , 000000001579112001 , 000000001635112001 , 000000001758212001 , 000000001770212001 , 000000001789312001 , 000000001868312001 , 000000001895412001 , 000000001909912001 , 000000002036112001 , 000000002309812001 , 000000002439112001 , 000000002468312001 , 000000002503012001 , 000000002573012001 , 000000002682913001 , 000000003000913001 , 000000003053313001 , 000000003066813001 , 000000003071613001 , 000000003087613001 , 000000003109513001 , 000000003109613001 , 000000003230113001 , 000000003246713001 , 000000003304113001 , 000000003331913001 , 000000003379313001 , 000000003453413001 , 000000003453513001 , 000000003622213001 , 000000003671813001 , 000000003744413001 , 000000003758413001 , 000000003819613001 , 000000003824913001 , 000000003866013001 , 000000003937813001 , 000000004094013001 , 000000004147413001 , 000000004356413001 , 000000004404013001 , 000000004489313001 , 000000004489413001 , 000000004505313001 , 000000004821913001 , 000000004882013001 , 000000004905013001 , 000000005396313001 , 000000005407413001 , 000000005505113001 , 000000005506013001 , 000000005531913001 , 000000005552313001 , 000000005578713001 , 000000005659713001 , 000000005702513001 , 000000005788213001 , 000000005817113001 , 000000005904513001 , 000000005904613001 , 000000005904713001 , 000000005904813001 , 000000005946713001 , 000000006046413001 , 000000006046513001 , 000000006096913001 , 000000006136313001 , 000000006233113001 , 000000006296713001 , 000000006426913001 , 000000006427213001 , 000000006621613001 , 000000006621613002 , 000000006656613001 , 000000006792613001 , 000000006833413001 , 000000006839413001 , 000000006998813001 , 000000007000113001 , 000000007122113001 , 000000007172913001 , 000000007405013001 , 000000007588513001 , 000000007637114001 , 000000007679714001 , 000000007698714001 , 000000007784614001 , 000000007859414001 , 000000007906314001 , 000000008020214001 , 000000008031314001 , 000000008184514001 , 000000008193214001 , 000000008199814001 , 000000008214014001 , 000000008259514001 , 000000008383314001 , 000000009718312001 , 000000009720812001 , 000000009781112001 , 000000009802512001 , 000000009901612001 , 000000009983912001 Class II The "fluoro match registration" function of the Navigation Software Spine & Trauma 3D 2.0 allows the user to intraoperatively match e.g., CT data sets to the current patient anatomy visible on fluoroscopic images, used by the navigation software during spinal surgeries to display the position and orientation of instruments. For this registration function in combination with a digitally integrated C-arm, the software algorithm may not find an adequate match between the intraoperatively acquired 2D fluoroscopic images and the preoperative CT or other compatible 3D data sets. If such an incorrect match would occur, the display of instruments by the navigation system would be shifted compared to the actual patient anatomy. Brainlab AG
Devices BIOMET 3i Endosseous Dental Implant. Model Number(s): Affected devices catalog names are: BNES310, BNET3210, BNPS6511, BNPS6513, BNPS6585, BNPT6510, BNPT6511, BNPT6513, BNPT6585, BNSS310, BNSS311, BNSS313, BNSS610, BNSS613, BNSS615, BNSS685, BNST3210, BNST3211, BNST3213, BNST3215, BNST3285, BNST611, BNST613, BNST685, BOPS6510, BOPS6511, BOPS6515, BOPS6585, BOPT6510, BOPT6511, BOPT6513, BOPT6585, BOSS310, BOSS311, BOSS313, BOSS315, BOSS611, BOSS613, BOSS685, BOST3210, BOST3211, BOST3213, BOST3215, BOST3285, BOST610, BOST611, BOST613, BOST685, FNT3210, FNT3211, IFNT3210, IFNT3211, IFNT3213, IFNT3215, IFNT3285, IFNT610, IFNT611, IFNT613, IFNT685, IFOSS5611, IFOS5685, IFOS610, IFOS611, IFOS615, IFOSM310, IFOSM311, IFOSM313, IFOSM385, IIOS5610, IIOS5611, INT3210, INT3211, INT3213, INT3215, INT3285, INT610, INT611, INT613, INT685, IOSM311, IOSM313, IOSM315, IOSM385, IOSS610, IOSS613, NIIITP6510, NIIITP6511, NIIITP6513, NIIITP6515, NIIITP6585, NINT3210, NINT3211, NINT3213, NINT3215, NINT610, NINT611, NINT613, NINT685, NIOSM311, NIOSM313, NIOSS610, NT3210, NT3211, OSM310, XIFNT3210, XIFNT3211, XIFNT3213, XIFNT3215, XIFNT3285, XIFN610, XIFNT611, XIFNT613, XIFNT685, XIFOSM310, XIFOSM311, XIFOSM313, XIFOSS610, XIFOSS611, XIIOS6510, XIIOS6511, XIIOS6513, XIITP6510, XIITP6511, XIITP6513. Manufactured dates from November 5, 2012 through August 21, 2013. Class II Due to residual machining fluid identified by discoloration (darker in appearance) on the external dental implant surface. Biomet 3i, LLC
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced W201613063294 (2 units) Class II Blood products, collected from donors for whom donor suitability was not adequately determined, were distributed. American National Red Cross
Biologics Red Blood Cells Leukocytes Reduced W201613030441, W201613030442, W201613030443, W201613030445, W201613030450, W201613036325, W201613037354, W201613037364, W201613038749, W201613039963, W201613048178, W201613050691, W201613051040, W201613051075, W201613054010, W201613054460, W201613054474, W201613056396, W201613056417, W201613057188, W201613057199, W201613058622, W201613058682, W201613061118, W201613061587, W201613065155 Class II Blood products, collected from donors for whom donor suitability was not adequately determined, were distributed. American National Red Cross
Biologics Platelets Pooled Leukocytes Reduced W201613900233 Class II Blood products, collected from donors for whom donor suitability was not adequately determined, were distributed. American National Red Cross
Biologics Red Blood Cells Leukocytes Reduced W035213230655I; Class II Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. Carter BloodCare
Biologics Platelets W035213230655I; Class II Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. Carter BloodCare
Biologics Blood and Blood Products for Reprocessing W035213230655I; Class III Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. Carter BloodCare
Biologics Platelets Pheresis Leukocytes Reduced W115113365044B Class II Blood product, with a low pH, was distributed. Lifesouth Community Blood Centers - Montgomery Region
Biologics Red Blood Cells Irradiated 1451519; Class II Blood products, collected from a donor whose suitability to donate was not fully evaluated, were distributed. OneBlood, Inc.
Biologics Cryoprecipitated AHF 1775267; 2046554; Class II Blood products, collected from a donor whose suitability to donate was not fully evaluated, were distributed. OneBlood, Inc.
Biologics Platelets 1775267; 2046554; Class II Blood products, collected from a donor whose suitability to donate was not fully evaluated, were distributed. OneBlood, Inc.
Biologics Plasma Frozen Cryoprecipitated Reduced 2046554; Class II Blood products, collected from a donor whose suitability to donate was not fully evaluated, were distributed. OneBlood, Inc.
Biologics Red Blood Cells 1775267; 2046554; 2321193; 2411016; Class II Blood products, collected from a donor whose suitability to donate was not fully evaluated, were distributed. OneBlood, Inc.
Biologics Fresh Frozen Plasma 2321193; 2411016; Class II Blood products, collected from a donor whose suitability to donate was not fully evaluated, were distributed. OneBlood, Inc.
Biologics Cryoprecipitated AHF, Pooled W036313927961; W036313927960; W036313927962; W036313927963; W036313927965; W036313927967; Class II Blood products, not prepared in accordance with specifications, were distributed. BloodCenter of Wisconsin, Inc
Biologics Red Blood Cells Leukocytes Reduced W201713076276 Class III Blood product which was not quarantined after the donor reported having had a shingles vaccination prior to donation was distributed. American National Red Cross (The) - North Central Region
Biologics Platelets Pooled Leukocytes Reduced W356514000875 Class II Blood products, collected in a manner that may have compromised the sterility of the units, were distributed. Community Blood Center of Carolinas
Biologics Red Blood Cells Leukocytes Reduced W227014007259, W227014007255 Class II Blood products, collected in a manner that may have compromised the sterility of the units, were distributed. Community Blood Center of Carolinas
Biologics Fresh Frozen Plasma W227014007263, W227014007829, W227014007824 Class II Blood products, collected in a manner that may have compromised the sterility of the units, were distributed. Community Blood Center of Carolinas
Biologics Red Blood Cells Leukocytes Reduced W037712092426 Class II Blood products, collected from a donor who lived in an area considered endemic for malaria, were distributed. Hoxworth Blood Center
Biologics Platelets Leukocytes Reduced W037712092426 Class II Blood products, collected from a donor who lived in an area considered endemic for malaria, were distributed. Hoxworth Blood Center
Biologics Source Plasma 12MTNC4364; 12MTNC3952; Class II Blood products, collected from a donor who received a tattoo within 12 months of donating, were distributed. Plasma Biological Services Inc
Food Simply Lite brand 50% CaCao Low Carb Sugar Free Dark Chocolate (NET WT 3 oz (85g), packaged in a brown plastic foil wrapper. Produced by Simply Natural Foods, LLC. 74 Mall Drive Commack, New York 11725. lot codes: Best By: 01 18 2015A or Best By: 01 19 2015A Class I Simply Natural Foods, LLC manufactured and distributed Simply Lite brand Dark Chocolate with high levels of Undeclared Milk. Simply Natural Foods LLC
Devices Ingenuity Core 128, Computed Tomography X-ray systems, Philips Medical Systems (Cleveland), Inc. System code: 728323; Serial #: 320002, 320003, 320004, 320005, 320006, 320007, 320008, 320009, 320010, 320011, 320013, 320014, 320015, 320017, 320018, 320019, 320020, 320022, 320023, 320024, 320025, 320026, 320027, 320028, 320029, 320031, 320032, 320034, 320035, 320036, 320037, 320038, 320039, 320040, 320041, 320043, 320044, 320045, 320046, 320047, 320048, 320049, 320050, 320051, 320052, 320053, 320054, 320055, 320056, 320057, 320059, 320060, 320062, 320063, 320064, 320065, 320066, 320067, 320068, 320069, 320070, 320071, 320072, 320074, 320075, 320078, 320079, 320080, 320081, 320082, 320083, 320084, 320085, 320086, 320087, 320088, 320089, 320090, 320092, 320093, 320095, 320096, 320097, 320098, 320099, 320101, 320102, 320103, 320104, 320105,320106, 320107, 320109, 320110, 320111, 320112, 320114, 320115, 320116, 320117, 320118, 320119, 320120, 320121, 320122, 336013 & 336015. Class II A customer reported that after upgrading to software version 3.5.5 from 3.5.4, reconstructions would intermittently not complete. Philips Medical Systems (Cleveland) Inc
Food Strawberry Fruit Bar, 3 oz., Helados La Tapatia Fresno, CA 93706 All units with UPC 6 34242-10001 5 Class II FDA environmental sampling found 21 of 50 positive for Listeria monocytogenes, 11 of these on food contact surfaces. Helados La Tapatia, Inc
Food Lemon Fruit Bar, 3 oz.,. Also packaged in six pack box. Helados La Tapatia Fresno, CA 93706 All units with UPC 6 34242-10002 2 (3 oz. bar) and 6 34242-16001 9 (six pack box). Class II FDA environmental sampling found 21 of 50 positive for Listeria monocytogenes, 11 of these on food contact surfaces. Helados La Tapatia, Inc
Food Pineapple Fruit Bar, 3 oz.,. Also packaged in 9 oz. cup, 4 oz. HLT packaged for Canadian distribution and 4 pack 9 oz. cups. Helados La Tapatia Fresno, CA 93706 All units with UPC 6 34242-10003 9 (3 oz. bar); 6 34242-22003 4 (9 oz. cup); 6 34242-21003 5 (Canada 4 oz HLT); 6 34242-23003 4 (4 pack cups 9 oz.) Class II FDA environmental sampling found 21 of 50 positive for Listeria monocytogenes, 11 of these on food contact surfaces. Helados La Tapatia, Inc
Food Tamarindo Fruit Bar, 3 oz.,. Also packaged in 9 oz. cup and Bolis 4 oz. Helados La Tapatia Fresno, CA 93706 All units with UPC 6 34242- 10004 6 (3 oz. bar); 6 34242-22004 1 (9 oz. cup); 6 34242-40006 (Bolis 4 oz.) Class II FDA environmental sampling found 21 of 50 positive for Listeria monocytogenes, 11 of these on food contact surfaces. Helados La Tapatia, Inc
Food Bubblegum Fruit Bar, 3 oz.,. Also packaged in six pack boxes and Bolis 4 oz. Helados La Tapatia Fresno, CA 93706 All units with UPC 6 34242- 10005 3 (3 oz. bar); 6 34242-16002 6 (six pack boxes); 6 34242-40001 6 (Bolis 4 oz.) Class II FDA environmental sampling found 21 of 50 positive for Listeria monocytogenes, 11 of these on food contact surfaces. Helados La Tapatia, Inc
Food Watermelon Fruit Bar, 3 oz.,. Also packaged in 9 oz. cups. Helados La Tapatia Fresno, CA 93706 All units with UPC 6 34242- 10006 0 (3 oz. bar) and 6 34242-22007 2 (9 oz. cups). Class II FDA environmental sampling found 21 of 50 positive for Listeria monocytogenes, 11 of these on food contact surfaces. Helados La Tapatia, Inc
Food Jamaica Fruit Bar, 3 oz.,. Helados La Tapatia Fresno, CA 93706 All units with UPC 6 34242- 10008 4 (3 oz. bar) Class II FDA environmental sampling found 21 of 50 positive for Listeria monocytogenes, 11 of these on food contact surfaces. Helados La Tapatia, Inc
Food Guava Fruit Bar, 3 oz.,. Helados La Tapatia Fresno, CA 93706 All units with UPC 6 34242- 10009 1 (3 oz. bar) Class II FDA environmental sampling found 21 of 50 positive for Listeria monocytogenes, 11 of these on food contact surfaces. Helados La Tapatia, Inc
Food Nance Fruit Bar, 3 oz.,. Helados La Tapatia Fresno, CA 93706 All units with UPC 6 34242- 10011 4 (3 oz. bar) Class II FDA environmental sampling found 21 of 50 positive for Listeria monocytogenes, 11 of these on food contact surfaces. Helados La Tapatia, Inc
Food Pica de Gallo Fruit Bar, 3 oz.,. Helados La Tapatia Fresno, CA 93706 All units with UPC 6 34242- 10012 1 (3 oz. bar) Class II FDA environmental sampling found 21 of 50 positive for Listeria monocytogenes, 11 of these on food contact surfaces. Helados La Tapatia, Inc
Food Chicle Fruit Bar,4 oz.,. Helados La Tapatia Fresno, CA 93706 All units with UPC 6 34242- 61001 9 (4 oz. bar) Class II FDA environmental sampling found 21 of 50 positive for Listeria monocytogenes, 11 of these on food contact surfaces. Helados La Tapatia, Inc
Food Mandarina Fruit Bar,4 oz.,; also packaged in 9 oz. cups and 4 pack of 9 oz cups Helados La Tapatia Fresno, CA 93706 All units with UPC 6 34242- 61002 6 (4 oz. bar) ; 6 34242-22001 0 (9 oz cups); 6 34242-23001 0 (4 pack 9 oz. cups). Class II FDA environmental sampling found 21 of 50 positive for Listeria monocytogenes, 11 of these on food contact surfaces. Helados La Tapatia, Inc
Food Pink Lemonade Fruit Bar,4 oz., Helados La Tapatia Fresno, CA 93706 All units with UPC 6 34242- 61003 3 (4 oz. bar) ; Class II FDA environmental sampling found 21 of 50 positive for Listeria monocytogenes, 11 of these on food contact surfaces. Helados La Tapatia, Inc
Food Fresa Fruit Bar,4 oz.,; Also packaged as Bolis 4 oz. and 4 oz. milk bar. Helados La Tapatia Fresno, CA 93706 All units with UPC 6 34242- 61004 0 (4 oz. bar) ; 6 34242-4004 7 (Bolis 4 oz.); 6 34242-60002 7 (4 oz. milk bar) Class II FDA environmental sampling found 21 of 50 positive for Listeria monocytogenes, 11 of these on food contact surfaces. Helados La Tapatia, Inc
Food Lemon Lime (french) Fruit Bar,4 oz.,; Also packaged for Canada 4 oz. HLT. Helados La Tapatia Fresno, CA 93706 All units with UPC 6 34242- 61005 7 (4 oz. bar) ; 6 34242 61005 7 (Canada 4 oz. HLT) Class II FDA environmental sampling found 21 of 50 positive for Listeria monocytogenes, 11 of these on food contact surfaces. Helados La Tapatia, Inc
Food Lemonade 9 oz cups Also packaged in 4 pack 9 oz cups; Helados La Tapatia Fresno, CA 93706 All units with UPC 6 34242- 22002 7 (9 oz. cup) ; 6 34242-23002 7 (4 pack 9 oz. cups). Class II FDA environmental sampling found 21 of 50 positive for Listeria monocytogenes, 11 of these on food contact surfaces. Helados La Tapatia, Inc
Food Changunga/Nance 9 oz cups Helados La Tapatia Fresno, CA 93706 All units with UPC 6 34242- 22006 5. Class II FDA environmental sampling found 21 of 50 positive for Listeria monocytogenes, 11 of these on food contact surfaces. Helados La Tapatia, Inc
Food Elote 9 oz cups Helados La Tapatia Fresno, CA 93706 All units with UPC 6 34242- 22008 9. Class II FDA environmental sampling found 21 of 50 positive for Listeria monocytogenes, 11 of these on food contact surfaces. Helados La Tapatia, Inc
Food Cappuccino 9 oz cups Helados La Tapatia Fresno, CA 93706 All units with UPC 6 34242- 22009 6. Class II FDA environmental sampling found 21 of 50 positive for Listeria monocytogenes, 11 of these on food contact surfaces. Helados La Tapatia, Inc
Food Limon Bolis - 4 oz. Helados La Tapatia Fresno, CA 93706 All units with UPC 6 34242- 40002 3. Class II FDA environmental sampling found 21 of 50 positive for Listeria monocytogenes, 11 of these on food contact surfaces. Helados La Tapatia, Inc
Food Rompope Bolis - 4 oz.; Also packages in six pack boxes. (9 oz cups) Helados La Tapatia Fresno, CA 93706 All units with UPC 6 34242- 40003 0 (Bolis, 4 oz; 6 34242-15005 8 (six pack boxes 9 oz. cups) Class II FDA environmental sampling found 21 of 50 positive for Listeria monocytogenes, 11 of these on food contact surfaces. Helados La Tapatia, Inc
Food Coco Bolis - 4 oz.; Also packaged in 4 oz. milk bars and ice cream container. Helados La Tapatia Fresno, CA 93706 All units with UPC 6 34242- 40005 4; 6 34242-60001 0 (4 oz. milk bars); 6 34242-14001 1 (ice cream container) Class II FDA environmental sampling found 21 of 50 positive for Listeria monocytogenes, 11 of these on food contact surfaces. Helados La Tapatia, Inc
Food Coffee Bolis - 4 oz. Helados La Tapatia Fresno, CA 93706 All units with UPC 6 34242- 40005. Class II FDA environmental sampling found 21 of 50 positive for Listeria monocytogenes, 11 of these on food contact surfaces. Helados La Tapatia, Inc
Food Mango c/chile Chamoy Bolis - 4 oz. Helados La Tapatia Fresno, CA 93706 All units with UPC 6 34242- 40007. Class II FDA environmental sampling found 21 of 50 positive for Listeria monocytogenes, 11 of these on food contact surfaces. Helados La Tapatia, Inc
Food Dozen Mix Bag Bolis - 4 oz. Helados La Tapatia Fresno, CA 93706 All units with UPC 6 34242- 30010 1. Class II FDA environmental sampling found 21 of 50 positive for Listeria monocytogenes, 11 of these on food contact surfaces. Helados La Tapatia, Inc
Food Coconut Frutero; Helados La Tapatia Fresno, CA 93706 All units with UPC 6 34242- 23001. Class II FDA environmental sampling found 21 of 50 positive for Listeria monocytogenes, 11 of these on food contact surfaces. Helados La Tapatia, Inc
Food Vanilla Ice Cream Sandwich Helados La Tapatia Fresno, CA 93706 All units with UPC 6 34242- 70001 7. Class II FDA environmental sampling found 21 of 50 positive for Listeria monocytogenes, 11 of these on food contact surfaces. Helados La Tapatia, Inc
Food Vanilla Sundae Cup. Helados La Tapatia Fresno, CA 93706 All units with UPC 6 34242- 50002 1. Class II FDA environmental sampling found 21 of 50 positive for Listeria monocytogenes, 11 of these on food contact surfaces. Helados La Tapatia, Inc
Food Strawberry Milk Bars, 3 oz. Also packaged as six pack boxes; Canada 4 oz. HLT and ice cream containers. Helados La Tapatia Fresno, CA 93706 All units with UPC 6 34242- 20001 2, (3 oz bar); 6 34242-15001 0 (Six pack boxes); 6 34242-21005 (Canada 4 oz. HLT); 6 34242-14006 9 (ice cream container) Class II FDA environmental sampling found 21 of 50 positive for Listeria monocytogenes, 11 of these on food contact surfaces. Helados La Tapatia, Inc
Food Coconut Milk Bars, 3 oz. Also packaged as six pack boxes of 9 oz cups.. Helados La Tapatia Fresno, CA 93706 All units with UPC 6 34242- 20002 9, (3 oz bar); 6 34242-15002 7 (Six pack boxes). Class II FDA environmental sampling found 21 of 50 positive for Listeria monocytogenes, 11 of these on food contact surfaces. Helados La Tapatia, Inc
Food Chocolate Milk Bars, 3 oz; Also packaged as 4 oz, bars and in ice cream containers; Helados La Tapatia Fresno, CA 93706 All units with UPC 6 34242- 20003 6, (3 oz bar); 6 34242-60008 9 (4 oz. bar); 6 434242-14007 3. Class II FDA environmental sampling found 21 of 50 positive for Listeria monocytogenes, 11 of these on food contact surfaces. Helados La Tapatia, Inc
Food Banana Milk Bars, 3 oz; Helados La Tapatia Fresno, CA 93706 All units with UPC 6 34242- 20004 3, (3 oz bar); Class II FDA environmental sampling found 21 of 50 positive for Listeria monocytogenes, 11 of these on food contact surfaces. Helados La Tapatia, Inc
Food Vanilla Milk Bars, 3 oz; Also packaged as Vanilla Ice Cream container. Helados La Tapatia Fresno, CA 93706 All units with UPC 6 34242- 20005 0, (3 oz bar); 6 34242-14001 2 (ice cream container) Class II FDA environmental sampling found 21 of 50 positive for Listeria monocytogenes, 11 of these on food contact surfaces. Helados La Tapatia, Inc
Food Walnut Milk Bars, 3 oz; Helados La Tapatia Fresno, CA 93706 All units with UPC 6 34242- 20006 7, (3 oz bar); Class II FDA environmental sampling found 21 of 50 positive for Listeria monocytogenes, 11 of these on food contact surfaces. Helados La Tapatia, Inc
Food Mango Milk Bars, 3 oz; also packed in ice cream containers and Canada 4 oz. HLT. Helados La Tapatia Fresno, CA 93706 All units with UPC 6 34242- 20007 4, (3 oz bar); 6 34242-14006 6 (Ice Cream container); 6 34242-21002 (Canada 4 oz. HLT. Class II FDA environmental sampling found 21 of 50 positive for Listeria monocytogenes, 11 of these on food contact surfaces. Helados La Tapatia, Inc
Food Rice Milk Bars, 3 oz; Helados La Tapatia Fresno, CA 93706 All units with UPC 6 34242- 20008 1, (3 oz bar) Class II FDA environmental sampling found 21 of 50 positive for Listeria monocytogenes, 11 of these on food contact surfaces. Helados La Tapatia, Inc
Food Eggnog Milk Bars, 3 oz; Helados La Tapatia Fresno, CA 93706 All units with UPC 6 34242- 20009 8, (3 oz bar) Class II FDA environmental sampling found 21 of 50 positive for Listeria monocytogenes, 11 of these on food contact surfaces. Helados La Tapatia, Inc
Food Cookie Milk Bars, 3 oz; Helados La Tapatia Fresno, CA 93706 All units with UPC 6 34242- 20010 4, (3 oz bar) Class II FDA environmental sampling found 21 of 50 positive for Listeria monocytogenes, 11 of these on food contact surfaces. Helados La Tapatia, Inc
Food Vainilla con Membrillo Milk Bar, 4 oz. Helados La Tapatia Fresno, CA 93706 All units with UPC 6 34242- 60004 1. Class II FDA environmental sampling found 21 of 50 positive for Listeria monocytogenes, 11 of these on food contact surfaces. Helados La Tapatia, Inc
Food Peach Yogurt Milk Bars, 3 oz; Helados La Tapatia Fresno, CA 93706 All units with UPC 6 34242- 20011 1, (3 oz bar) Class II FDA environmental sampling found 21 of 50 positive for Listeria monocytogenes, 11 of these on food contact surfaces. Helados La Tapatia, Inc
Food Esquimal Milk Bars, 3 oz; Helados La Tapatia Fresno, CA 93706 All units with UPC 6 34242- 20011 1, (3 oz bar) Class II FDA environmental sampling found 21 of 50 positive for Listeria monocytogenes, 11 of these on food contact surfaces. Helados La Tapatia, Inc
Food Coffee Milk Bars, 3 oz; Helados La Tapatia Fresno, CA 93706 All units with UPC 6 34242- 20013 5, (3 oz bar) Class II FDA environmental sampling found 21 of 50 positive for Listeria monocytogenes, 11 of these on food contact surfaces. Helados La Tapatia, Inc
Food Pina Colada Milk Bars, 3 oz;, 4 oz. Helados La Tapatia Fresno, CA 93706 All units with UPC 6 34242- 20014 2, (3 oz bar); 6 34242-60010 2 (4 oz. bar) Class II FDA environmental sampling found 21 of 50 positive for Listeria monocytogenes, 11 of these on food contact surfaces. Helados La Tapatia, Inc
Food Mamey Milk Bars, 3 oz; Also packaged in 9 oz. cups six pack. Helados La Tapatia Fresno, CA 93706 All units with UPC 6 34242- 20054 9, (3 oz bar); 6 34242-15004 1 (six pack boxes of 9 oz cups). Class II FDA environmental sampling found 21 of 50 positive for Listeria monocytogenes, 11 of these on food contact surfaces. Helados La Tapatia, Inc
Food Pecan Ice Cream container . Helados La Tapatia Fresno, CA 93706 All units with UPC 6 34242- 14002 8 ). Class II FDA environmental sampling found 21 of 50 positive for Listeria monocytogenes, 11 of these on food contact surfaces. Helados La Tapatia, Inc
Food Cookies n Cream Ice Cream container . Also packaged as 4 oz. milk bar (cookies n Cream french), Canada 4 oz. HLT and six pack of 9 oz cups. Helados La Tapatia Fresno, CA 93706 All units with UPC 6 34242- 14003 5; 6 34242-60007 2 (4 oz. mik bar); 6 34242-60007 2 (Canada 4 oz. HLT); 6 34242-15003 4 (six pack boxes). ). Class II FDA environmental sampling found 21 of 50 positive for Listeria monocytogenes, 11 of these on food contact surfaces. Helados La Tapatia, Inc
Food Orange n Cream Milk Bar, 4 oz. Helados La Tapatia Fresno, CA 93706 All units with UPC 6 34242- 600003 4. Class II FDA environmental sampling found 21 of 50 positive for Listeria monocytogenes, 11 of these on food contact surfaces. Helados La Tapatia, Inc
Food Choco-Coco Milk Bar, 4 oz; Also packages as Canada 4 oz. HLT.. Helados La Tapatia Fresno, CA 93706 All units with UPC 6 34242- 60005 8; 6 34242-21007 (Canada 4 oz. HLT. Class II FDA environmental sampling found 21 of 50 positive for Listeria monocytogenes, 11 of these on food contact surfaces. Helados La Tapatia, Inc
Food Nuez Pecan Milk Bar, 4 oz; Helados La Tapatia Fresno, CA 93706 All units with UPC 6 34242- 60006 5; Class II FDA environmental sampling found 21 of 50 positive for Listeria monocytogenes, 11 of these on food contact surfaces. Helados La Tapatia, Inc
Food Pistachio Almond Milk Bar, 4 oz; Also packages as Canada 4 oz. HLT.. Helados La Tapatia Fresno, CA 93706 All units with UPC 6 34242- 60009 6; 6 34242-21004 (Canada 4 oz HLT) Class II FDA environmental sampling found 21 of 50 positive for Listeria monocytogenes, 11 of these on food contact surfaces. Helados La Tapatia, Inc
Food Granola for Canada 4 oz. HLT.. Helados La Tapatia Fresno, CA 93706 All units with UPC 6 34242-21006. Class II FDA environmental sampling found 21 of 50 positive for Listeria monocytogenes, 11 of these on food contact surfaces. Helados La Tapatia, Inc
Food Manhattan Tropical for Canada 4 oz. HLT.. Helados La Tapatia Fresno, CA 93706 All units with UPC 6 34242-21008. Class II FDA environmental sampling found 21 of 50 positive for Listeria monocytogenes, 11 of these on food contact surfaces. Helados La Tapatia, Inc
Food Sandia Fruit Bar,4 oz.,; Helados La Tapatia Fresno, CA 93706 All units with UPC 6 34242- 61006 (4 oz. bar) ; Class II FDA environmental sampling found 21 of 50 positive for Listeria monocytogenes, 11 of these on food contact surfaces. Helados La Tapatia, Inc
Devices SmartSite Extension Set, Model No. 20029E, intravascular administration set Lot No. 13085791 Class II CareFusion is recalling the SmartSite Extension Set because there are reports of disconnections and leakages at the connection of the smallbore tubing and the SmartSite Y-port. CareFusion 303, Inc.
Devices AXIOM Vertix MD Trauma systems radiographic X-ray AXIOM Vertix MD Trauma systems (material no. 08908290) with serial numbers 1022 through 1058. Class II There is a potential issue and possible hazard to patients when using the AXIOM Vertix MD Trauma systems. In rare cases, steel ropes inside the lift column of the system can be defective without triggering the safety lock, which can result in the U-arm dropping down unexpectedly during movement in vertical direction, potentially causing serious injury. Siemens Medical Solutions USA, Inc
Devices SpaceLabs Arkon Anesthesia Delivery System with Version 2.0 Software installed. This system includes a ventilator. SERIAL NUMBERS OF UNITS DISTRIBUTED IN THE US: ARKN-000011, ARKN-000016, ARKN-000017, ARKN-000019, ARKN-000020, ARKN-000021, ARKN-000022, ARKN-000023, ARKN-000024, ARKN-000025, ARKN-000026, ARKN-000027, ARKN-000028, ARKN-000029, ARKN-000030, and ARKN-000031. Class I The System may go into a controlled failed state if a series of parameters on the user interface are activated in a specific sequence. Del Mar Reynolds Medical, Ltd.
Devices VITROS Chemistry Products CRBM Slides, REF 889 2382, IVD -- Ortho-Clinical Diagnostics, Inc. For in vitro diagnostic use only. VITROS Chemistry Products CRBM Slides quantitatively measure carbamazepine (CRBM) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. Lot 3920-0080-8403, expiry date 15-JUNE-2014 Class II The firm identified a potential for biased carbamazepine (CRBM) results to be generated when using VITROS CRBM Slides, Lot 3920-0080-8403. Ortho-Clinical Diagnostics
Food Poor Boy Sandwich, 7oz. Product labeling reads in part:"POOR BOY SANDWICH***Perishable Keep Refrigerated***Net Wt. 7 oz***Mrs. Riggs Sandwiches 1792 Callens Rd Ventura CA 93003***" Lot Numbers/Production Dates: Jan 31, 2014, Feb 7, 2014, Feb 14, 2014. Class II Mrs. Rigg's Sandwiches is recalling certain lots (Lot Number Jan 31, 2014, Feb 7, 2014, Feb 14, 2014) of Poor Boy Sandwiches and Italian Torpedo Sandwiches because they were produced using meat recalled by Rancho Feeding Company for meat distributed without the benefit of a federal inspection. Mrs Rigg's Sandwiches
Food Italian Torpedo Sandwich, 10oz. Product labeling reads in part:"ITALIAN TORPEDO SANDWICH***Net Wt. 7 oz***Mrs. Riggs Sandwiches 1792 Callens Rd Ventura CA 93003***" Lot Number/Production Dates: Jan 31, 2014, Feb 7, 2014, Feb 14, 2014 Class II Mrs. Rigg's Sandwiches is recalling certain lots (Lot Number Jan 31, 2014, Feb 7, 2014, Feb 14, 2014) of Poor Boy Sandwiches and Italian Torpedo Sandwiches because they were produced using meat recalled by Rancho Feeding Company for meat distributed without the benefit of a federal inspection. Mrs Rigg's Sandwiches
Devices CODMAN CERTAS Programmable Valves, central nervous system shunt, models as follows: 82-8800 In Line Valve Only, 82-8801 In Line Valve with Catheter and Accessories, 82-8802 In Line Valve with Unitized Catheter and Accessories, 82-8803 In line Valve with Unitized BACTISEAL Catheter and Accessories, 82-8804 In Line Valve only with SIPHONGUARD Device, 82-8805 In Line Valve with SIPHONGUARD Device, Catheter and Accessories, 82-8806 In Line Valve with SIPHONGUARD, Unitized Catheter and Accessories, 82-8807 In Line Valve with SIPHONGUARD Device, Unitized BACTISEAL Catheter and Accessories, 82-8850 Certas Therapeutic Management System All serial numbers Class II Ensuring all customers have the tools to assist in verifying the setting of the valve on x-ray images and the location and orientation of implanted CODMAN CERTAS Programmable Valves. Codman & Shurtleff, Inc.
Devices Gambro Cartridge Blood Set, blood transport system for hemodialysis, Model Number(s): 101025 (003410510) - Cartridge set, STND PRM LN and 103401 (003414500) - Cartridge set, PRM_LN_INJ_PT. The Gambro Cartridge Sets are single use sterile tubing sets intended to provide extracorporeal blood transport circuit for hemodialysis treatments for Gambro Phoenix and COBE Centrisystem 3 (and 3+) Dialysis Delivery Systems. Lot number: 1000039228, 1000048340, 1000050644, 1000050648, 1000054032, 1000058516, 1000064913, 1000065817, 1000065823, 1000066430, 1000063347, 1000067984, 1000068071, 1000071417, 1000071430, 1000073434, 1000073436, 1000073438, 1000074660, 1000074661, 1000074662, 1000075553 Class II Occluded heparin tubing events preventing anticoagulation dosing on the Gambro Cartridge Blood Sets. Gambro Renal Products, Incorporated
Food Peanut Butter sold under the following sizes, brands, and textures: 1. 16 oz tubs with snap on lid (12 tubs in box) Parkers Farm CREAMY (55100) 2. 34 oz. tubs with snap on lid (6 tubs in box) Parkers Farm CREAMY (55300) 3. 5 lb. pail (2 pails in box) Parkers Farm Creamy (55105) 4. 34 oz. tubs with snap on lid (8 tubs in box) Costco Peanut Butter (55300) Sell by Date before 3/20/2015 Class I Various Peanut butters, cheese spreads, cold pack cheese, salsa, cheese balls/logs have the potential to be contaminated with Listeria monocytogenes. Parkers Farm Inc
Food Sharp Cheddar Cold Pack Cheese sold under the following sizes and brands: 1. Parkers Farm or Parkers label in 8 ounce cups with snap-on lid (14001), 14 ounce cups with snap on lid (17001), and 16 ounce round or square plastic containers (tub with snap on lid) (17001UL), 5 lb. pail with snap on lid (11341 & 11441), 10 lb. pail with snap on lid (12341). 2. Amish Classic in 8 oz. cups with snap on lid (AC14001) 3. Biery in 5 lb. pail with snap on lid (5004). 4. Block & Barrel in 5 lb. pail with snap on lid (2388254). 5. Bucky Badger in 8 oz. (31411), 12 oz. (51411), and 14 oz. (41411) cups with snap on lid. 6. Central Markets in 8 oz cups with snap on lid (27056). 7. Cobblestone Market in 5 lb. pail (42403) and 30 lb. pails (42803) with snap on lid. 8. Dierks Waukesha in 5 lb. pail with snap on lid (11442) Sell by Date before 3/20/2015 Class I Various Peanut butters, cheese spreads, cold pack cheese, salsa, cheese balls/logs have the potential to be contaminated with Listeria monocytogenes. Parkers Farm Inc
Food Port Wine Cold Pack Cheese sold under the following sizes and brands: 1. Parkers Farm or Parkers label in 8 ounce (14010), 14 ounce (17010), 5 lb. (11951), 10 lb. (12951), white tub with snap on lid; 2. Amish Classic in 8 ounce cup with snap on lid (AC14010). 3. Biery in 5 lb. pail with snap on lid (5010). 4. Block & Barrel in 5.5 lb. pail with snap on lid (2388247). 5. Bucky Badger in 8 oz. (31511), 12 oz. (51511), and 14 oz. (41311) cups with snap on lid. 6. Central Markets in 8 oz cups with snap on lid (27057). 7. Cobblestone Market in 5 lb. pail pails with snap on lid (42503). 8. Dierks Waukesha in 5 lb. pail with snap on lid (11952). 9. Happy Farms in 8 ounce cup with snap on lid (43316). Sell by Date before 3/20/2015 Class I Various Peanut butters, cheese spreads, cold pack cheese, salsa, cheese balls/logs have the potential to be contaminated with Listeria monocytogenes. Parkers Farm Inc
Food Cheddar Cold Pack Cheese sold under the following sizes and brands: 1. Parkers Farm or Parkers label in 8 ounce (10201) cup with snap on lid, and 10 lb. (12341OS), white tub with snap on lid; 2. Win Schuler in 10 lb. pail with snap on lid (01498) Sell by Date before 3/20/2015 Class I Various Peanut butters, cheese spreads, cold pack cheese, salsa, cheese balls/logs have the potential to be contaminated with Listeria monocytogenes. Parkers Farm Inc
Food Swiss Almond Cold Pack Cheese sold under the following sizes and brands: 1. Parkers Farm or Parkers label in 8 ounce (14005), 13.5 ounce (17005) cups with snap on lid; 5 lb. (52244) and 10 lb. (53244) pail with snap on lid; 2. Amish Classic in 8 ounce cup with snap on lid (AC14005). 3. Block & Barrel in 5.5 lb. pail with snap on lid (2388270). 4. Bucky Badger in 8 oz. (31711) cups with snap on lid. 5. Central Markets in 8 oz cups with snap on lid (27058). 6. Cobblestone Market in 5 lb. pail pails with snap on lid (42703). 7. Dierks Waukesha in 5 lb. pail with snap on lid (52242). Sell by Date before 3/20/2015 Class I Various Peanut butters, cheese spreads, cold pack cheese, salsa, cheese balls/logs have the potential to be contaminated with Listeria monocytogenes. Parkers Farm Inc
Food Horseradish Cold Pack Cheese sold under the following sizes and brands: 1. Parkers Farm or Parkers label in 8 ounce (13006), 14 ounce (17006), 16 ounce (17006UL) cups with snap on lid; 5 lb. (41550) and 10 lb. (42550 pail with snap on lid; 2. Amish Classic in 8 ounce cup with snap on lid (AC13006). 3. Block & Barrel in 5.5 lb. pail with snap on lid (2593424). 4. Bucky Badger in 12 oz. (51311) cups with snap on lid. 5. Central Markets in 8 oz cups with snap on lid (27055). 6. Cobblestone Market in 5 lb. pail pails with snap on lid (42603). 7. Dierks Waukesha in 5 lb. pail with snap on lid (41552). Sell by Date before 3/20/2015 Class I Various Peanut butters, cheese spreads, cold pack cheese, salsa, cheese balls/logs have the potential to be contaminated with Listeria monocytogenes. Parkers Farm Inc
Food Bacon Cold Pack Cheese sold under the following sizes and brands: 1. Parkers Farm or Parkers label in 8 ounce (14002) and 14 ounce (17002) cups with snap on lid; 5 lb. Cheeseball Base - Bacon (14441) and 10 lb. (61760) pail with snap on lid; 2. Bucky Badger in 8 oz. (31611) and 14 oz. (41611) cups with snap on lid. Sell by Date before 3/20/2015 Class I Various Peanut butters, cheese spreads, cold pack cheese, salsa, cheese balls/logs have the potential to be contaminated with Listeria monocytogenes. Parkers Farm Inc
Food Swiss & Cheddar Cold Pack Cheese sold under the following sizes and brands: Parkers Farm or Parkers label in 8 ounce (13012) cups with snap on lid; and 10 lb. (81774) pail with snap on lid; Sell by Date before 3/20/2015 Class I Various Peanut butters, cheese spreads, cold pack cheese, salsa, cheese balls/logs have the potential to be contaminated with Listeria monocytogenes. Parkers Farm Inc
Food Onion Cheddar Cold Pack Cheese sold under the following sizes and brands: Parkers Farm or Parkers label in 8 ounce (14003) cups with snap on lid; Sell by Date before 3/20/2015 Class I Various Peanut butters, cheese spreads, cold pack cheese, salsa, cheese balls/logs have the potential to be contaminated with Listeria monocytogenes. Parkers Farm Inc
Food Cheddar Ranch Cheeseball Base Cold Pack Cheese sold under the following sizes and brands: Parkers Farm or Parkers label in 5 lb. (12221) pail with snap on lid. Sell by Date before 3/20/2015 Class I Various Peanut butters, cheese spreads, cold pack cheese, salsa, cheese balls/logs have the potential to be contaminated with Listeria monocytogenes. Parkers Farm Inc
Food Green Onion Cheeseball Base Cold Pack Cheese sold under the following sizes and brands: Parkers Farm or Parkers label in 5 lb. (13331) pail with snap on lid; Sell by Date before 3/20/2015 Class I Various Peanut butters, cheese spreads, cold pack cheese, salsa, cheese balls/logs have the potential to be contaminated with Listeria monocytogenes. Parkers Farm Inc
Food Smoked Cheddar Cold Pack Cheese sold under the following sizes and brands: Parkers Farm or Parkers label in 8 ounce (13004) cups with snap on lid; Sell by Date before 3/20/2015 Class I Various Peanut butters, cheese spreads, cold pack cheese, salsa, cheese balls/logs have the potential to be contaminated with Listeria monocytogenes. Parkers Farm Inc
Food Garlic Cold Pack Cheese sold under the following sizes and brands: 1. Parkers Farm or Parkers label in 8 ounce (13008) cups with snap on lid; 10 lb. (11269) pail with snap on lid; 2. Bucky Badger in 8 oz. (31811) and 14 oz. (41811) cups with snap on lid. Sell by Date before 3/20/2015 Class I Various Peanut butters, cheese spreads, cold pack cheese, salsa, cheese balls/logs have the potential to be contaminated with Listeria monocytogenes. Parkers Farm Inc
Food Jalapeno Cold Pack Cheese sold under the following sizes and brands: 1. Parkers Farm or Parkers label in 10 lb. pail (91347) with snap on lid; 5 lb. Cheeseball Base - Jalapeno (15551) pail with snap on lid; 2. Bucky Badger in 8 oz. (31911) and 14 oz. (41911) cups with snap on lid. Sell by Date before 3/20/2015 Class I Various Peanut butters, cheese spreads, cold pack cheese, salsa, cheese balls/logs have the potential to be contaminated with Listeria monocytogenes. Parkers Farm Inc
Food Sharp Cheddar & Port Wine Cold Pack Cheese sold under the following sizes and brands: Aldi label in 14 oz. (112699 / #7742) cup with snap on lid. Sell by Date before 3/20/2015 Class I Various Peanut butters, cheese spreads, cold pack cheese, salsa, cheese balls/logs have the potential to be contaminated with Listeria monocytogenes. Parkers Farm Inc
Food Spicy Beer Cheese Spread sold under the following sizes and brands: Parkers Farm or Parkers label in 5 lb. (01508) pails with snap on lid, Say Cheez Beer cheese - spicy (17050) in 14 oz. cups with snap on lid Sell by Date before 3/20/2015 Class I Various Peanut butters, cheese spreads, cold pack cheese, salsa, cheese balls/logs have the potential to be contaminated with Listeria monocytogenes. Parkers Farm Inc
Food Pimento Cheese Spread sold under the following sizes and brands: 1. Parkers Farm or Parkers label in 12 ounce (20100) cup with snap on lid; 2. Block & Barrel in 4 lb. pail with snap on lid (2382588). 3. HYTOP label in 12 ounce (952549) and 20 ounce (952556) cups with snap on lid. Sell by Date before 9/20/2014 Class I Various Peanut butters, cheese spreads, cold pack cheese, salsa, cheese balls/logs have the potential to be contaminated with Listeria monocytogenes. Parkers Farm Inc
Food Bacon Cheese Spread sold under the following sizes and brands: Bucky Badger label in 12 ounce (51611) cups with snap on lids. Sell by Date before 9/20/2014 Class I Various Peanut butters, cheese spreads, cold pack cheese, salsa, cheese balls/logs have the potential to be contaminated with Listeria monocytogenes. Parkers Farm Inc
Food Garlic Cheese Spread sold under the following sizes and brands: Bucky Badger label in 12 ounce (51811) cups with snap on lids. Sell by Date before 9/20/2014 Class I Various Peanut butters, cheese spreads, cold pack cheese, salsa, cheese balls/logs have the potential to be contaminated with Listeria monocytogenes. Parkers Farm Inc
Food Jalapeno Nacho Dip sold under the following sizes and brands: Parkers Farm or Parkers label in 12 ounce (20200) cups with snap on lids. Sell by Date before 9/20/2014 Class I Various Peanut butters, cheese spreads, cold pack cheese, salsa, cheese balls/logs have the potential to be contaminated with Listeria monocytogenes. Parkers Farm Inc
Food Restaurant Bar Cheese sold under the following sizes and brands: Parkers Farm or Parkers label in 5 lb. (21811) pails with snap on lids. Sell by Date before 9/20/2014 Class I Various Peanut butters, cheese spreads, cold pack cheese, salsa, cheese balls/logs have the potential to be contaminated with Listeria monocytogenes. Parkers Farm Inc
Food Sharp Cheddar Cheese Ball and Logs sold under the following sizes and brands: 1. Parkers Farm and Parkers label in 10 ounce logs (40506) and balls (40106) in film overwrap. Sell by Date before 3/20/2015 Class I Various Peanut butters, cheese spreads, cold pack cheese, salsa, cheese balls/logs have the potential to be contaminated with Listeria monocytogenes. Parkers Farm Inc
Food Cheddar Cheese Ball and Logs sold under the following sizes and brands: 1. Aldi label in 10 ounce balls (1087 / #7713) in film overwrap; 2. Win Schuler Original label in 10 ounce balls (55560) and logs (55570) in film overwrap; 3. CP in 8 ounce cheese logs (CH111000) in film overwrap. Sell by Date before 3/20/2015 Class I Various Peanut butters, cheese spreads, cold pack cheese, salsa, cheese balls/logs have the potential to be contaminated with Listeria monocytogenes. Parkers Farm Inc
Food Port Wine Cheese Ball and Logs sold under the following sizes and brands: 1. Parkers Farm and Parkers label in 10 ounce logs (40306) and balls (40606) in film overwrap. Sell by Date before 3/20/2015 Class I Various Peanut butters, cheese spreads, cold pack cheese, salsa, cheese balls/logs have the potential to be contaminated with Listeria monocytogenes. Parkers Farm Inc
Food Ranch Cheese Ball sold under the following sizes and brands: 1. Parkers Farm and Parkers label in 10 ounce balls (40406) in film overwrap. Sell by Date before 3/20/2015 Class I Various Peanut butters, cheese spreads, cold pack cheese, salsa, cheese balls/logs have the potential to be contaminated with Listeria monocytogenes. Parkers Farm Inc
Food Jalapeno Cheese Logs sold under the following sizes and brands: 1. Parkers Farm and Parkers label in 8 ounce logs (12208) in film overwrap. Sell by Date before 3/20/2015 Class I Various Peanut butters, cheese spreads, cold pack cheese, salsa, cheese balls/logs have the potential to be contaminated with Listeria monocytogenes. Parkers Farm Inc
Food Jalapeno Bacon Cheese Ball sold under the following sizes and brands: 1. Parkers Farm and Parkers label in 10 ounce ball (40906) in film overwrap. Sell by Date before 3/20/2015 Class I Various Peanut butters, cheese spreads, cold pack cheese, salsa, cheese balls/logs have the potential to be contaminated with Listeria monocytogenes. Parkers Farm Inc
Food Garlic Cheddar Cheese Logs sold under the following sizes and brands: 1. Parkers Farm and Parkers label in 8 ounce logs (11108) in film overwrap. Sell by Date before 3/20/2015 Class I Various Peanut butters, cheese spreads, cold pack cheese, salsa, cheese balls/logs have the potential to be contaminated with Listeria monocytogenes. Parkers Farm Inc
Food Smokey Bacon Cheese Ball sold under the following sizes and brands: 1. Parkers Farm and Parkers label in 10 ounce ball (40206) in film overwrap. Sell by Date before 3/20/2015 Class I Various Peanut butters, cheese spreads, cold pack cheese, salsa, cheese balls/logs have the potential to be contaminated with Listeria monocytogenes. Parkers Farm Inc
Food Pimento Cheese Ball sold under the following sizes and brands: 1. Parkers Farm and Parkers label in 10 ounce ball (80208) in film overwrap. Sell by Date before 3/20/2015 Class I Various Peanut butters, cheese spreads, cold pack cheese, salsa, cheese balls/logs have the potential to be contaminated with Listeria monocytogenes. Parkers Farm Inc
Food Beer Cheese Ball sold under the following sizes and brands: 1. Parkers Farm and Parkers label in 10 ounce ball (80408) in film overwrap and Say Cheez Beer cheese - Creamy (17051) in 14 oz. cups with snap on lid. Sell by Date before 3/20/2015 Class I Various Peanut butters, cheese spreads, cold pack cheese, salsa, cheese balls/logs have the potential to be contaminated with Listeria monocytogenes. Parkers Farm Inc
Food Mild Salsa sold under the following sizes and brands: 1. Parkers Farm or Parkers label in 16 ounce (51305) container with snap on lid, 32 ounce (10794) and 1 gallon (11600) jug with screw on lid; 2. San Pablo in 16 ounce container with snap on lid (12826). Sell by Date before 7/20/2014 Class II Various Peanut butters, cheese spreads, cold pack cheese, salsa, cheese balls/logs have the potential to be contaminated with Listeria monocytogenes. Parkers Farm Inc
Food Hot Salsa sold under the following sizes and brands: 1. Parkers Farm or Parkers label in 16 ounce (51205) container with snap on lid, 32 ounce (10894) jug with screw on lid; Sell by Date before 7/20/2014 Class II Various Peanut butters, cheese spreads, cold pack cheese, salsa, cheese balls/logs have the potential to be contaminated with Listeria monocytogenes. Parkers Farm Inc
Food Fire Roasted Salsa sold under the following sizes and brands: 1. Parkers Farm or Parkers label in 16 ounce (51605) container with snap on lid, 1 gallon (11900) jug with screw on lid; 2. San Pablo in 1 gallon jug with screw on lid (12827). Sell by Date before 7/20/2014 Class II Various Peanut butters, cheese spreads, cold pack cheese, salsa, cheese balls/logs have the potential to be contaminated with Listeria monocytogenes. Parkers Farm Inc
Food Garlic Salsa sold under the following sizes and brands: 1. Parkers Farm or Parkers label in 16 ounce (51505) container with snap on lid, 32 ounce (41596) jug with screw on lid; Sell by Date before 7/20/2014 Class II Various Peanut butters, cheese spreads, cold pack cheese, salsa, cheese balls/logs have the potential to be contaminated with Listeria monocytogenes. Parkers Farm Inc
Food Black Bean & roasted Chili Salsa sold under the following sizes and brands: 1. Parkers Farm or Parkers label in 32 ounce (80598) jug with screw on lid; Sell by Date before 7/20/2014 Class II Various Peanut butters, cheese spreads, cold pack cheese, salsa, cheese balls/logs have the potential to be contaminated with Listeria monocytogenes. Parkers Farm Inc
Food Peanut Butter sold under the following sizes, brands: Honey CREAMY (55200) Peanut Butter in 16 oz tubs with snap on lid. Sell by Date before 3/20/2015 Class I Various Peanut butters, cheese spreads, cold pack cheese, salsa, cheese balls/logs have the potential to be contaminated with Listeria monocytogenes. Parkers Farm Inc
Food HYTOP Jalapeno Pimento cheese spread in 12 ounce (952754) cups with snap on lid Sell by Date before 3/20/2015 Class I Various Peanut butters, cheese spreads, cold pack cheese, salsa, cheese balls/logs have the potential to be contaminated with Listeria monocytogenes. Parkers Farm Inc
Food Peanut Butter sold under the following sizes, brands: HONEY CRUNCHY (55204) Peanut Butter in 16 oz tubs with snap on lid. Sell by Date before 3/20/2015 Class I Various Peanut butters, cheese spreads, cold pack cheese, salsa, cheese balls/logs have the potential to be contaminated with Listeria monocytogenes. Parkers Farm Inc
Food Peanut Butter sold under the following sizes, brands, and textures: 1. 16 oz tubs with snap on lid (12 tubs in box) Parkers Farm CRUNCHY (55104), 2. 34 oz. tubs with snap on lid (6 tubs in box) Parkers Farm CRUNCHY (55304) Sell by Date before 3/20/2015 Class I Various Peanut butters, cheese spreads, cold pack cheese, salsa, cheese balls/logs have the potential to be contaminated with Listeria monocytogenes. Parkers Farm Inc
Devices FRAXEL DUAL 1550/1927 Laser System, (FRAXEL SR 1500 DUAL Laser System), for dermatological procedures. Model MC-SYS-SR1500-D, Revisions A and B. Class II Solta Medical became aware that obsolete versions of the Laser Treatment Settings card for the Fraxel DUAL 1550/1927 Laser system may have contained incorrect indication for use for treatment of Melasma. Solta Medical, Inc.
Devices Brilliance CT 16, Brilliance CT 64, Brilliance CT Big Bore Oncology, Brilliance CT Big Bore Radiology, Brilliance iCT, Ingenuity CT, Ingenuity Core, Ingenuity Core 128 and Ingenuity Flex scanners are Computed Tomography X-ray systems. Brilliance CT 16: Model Number: 728246; Serial Number: 5314, 6719, 6726, 6727, 6728, 6729, 6730, 6731, 6732, 6734, 6735, 6736, 6737, 6738, 6744, 6746, 6747, 6748, 6749, 6750, 6751, 6752, 6753, 6754, 6756, 6757, 6758, 6759, 6760, 6761, 6762, 6764, 6767, 6768, 6772, and 50213. Brilliance CT 64: Model Number: 728231; Serial Number: 10805, 10806, 90047, 95880, 95881, 95882, 95885, 95892, 95903, 95907, 95910, 95912, 95913, 95914, 95915, 95918, 95920, 95921, 95922, and 98895. Brilliance CT Big Bore Oncology: Model Number: 728243; Serial Number: 7971, 7977, 7980, 7989, and 7994. Brilliance CT Big Bore Radiology: Model Number: 728244; Serial Number: 7957, 7965, 7979, and 7985. Brilliance iCT: Model Number: 728306; Serial Number: 100477, 100483, 100487, 100489, 100491, 100492, 100494, 100495, 100496, 100500, 100502, 100504, and 100507. Ingenuity CT: Model Number: 728326; Serial Number: 300165 and 333013. Ingenuity Core: Model Number: 728321; Serial Number: 310138, 310142, 310144, 310145, 310149, 310151, 310152, 310153, 310154, 310155, 310158, 310160, 310161, 310162, 310163, 310164, 333013, 333015, and 333017. Ingenuity Core128: Model Number: 728323; Serial Number: 320113, 320114, 320116, 320117, 320118, 320120, 320121, 320122, 320124, 320125, 320128,320129, 320130, 320134, 320137, 320138, 320139, 320140, 320141, 320142, 320143, 320144,320145, 320146, 320147, 320148, 336009, 336010, 336011, 336012, 336013, 336015, 336016, 336018, and 336023. Ingenuity Flex: Model Number: 728317; Serial Number: 345005 Class II Block assembly-lock stop subframe of service latch was not manufactured to engineering specifications from the supplier, causing premature fracture of the threaded rod on the patient support service latch. As a result, the table top can become free floating due to the disengaged service latch in the table top's subframe. Philips Medical Systems (Cleveland) Inc
Food Luna Chocolate Chunk; Whole Nutrition Bar for Women; 15 count box. Clif Bar & Company, Emeryville, CA Individual Bar UPC: 7-22252-10068-9; 15 Count Box UPC: 7-22252-20068-6: Best By Dates of 11NOV14 and 14OCT14. Class II Chocolate Chunk Luna Bars made with macadamia nut butter but macadamia nuts are not included in the ingredient listing or allergen statement. Clif Bar And Company
Food 2521 Cherry Glaze Pop (Flavoring for popcorn) - Paperboard Carton 14022402002, 14022502003, 14022502004 and 14022602005. Class II Flavor concentration is too high Gold Medal Products
Food 327 Ace Cherry Berry Flossugar (Flavoring for cotton candy)- Paperboard Carton 140306A1001 Class II Flavor concentration is too high Gold Medal Products
Food 1031 GA Artifical Cherry Concentrate (Flavoring for shaved ice) - Plastic Gallon 14030610001 Class II Flavor concentration is too high Gold Medal Products
Food 1358 Artificial Cherry Kola (Flavoring for shaved ice)- Plastic Gallon 14030710001 Class II Flavor concentration is too high Gold Medal Products
Food Kellogg's Eggo Buttermilk au babeurre waffles 280g 8ct, UPC 0 64100 23817 6 Ingredients/ Ingredients: Water, Wheat Flour, soybean and palm oil shortening, whole egg, baking powder, sugar, salt milk ingredients, hydrogenated soybean oil, soy lecithin Contains wheat, egg, milk and soy ingredients .... Imported by / Importe par Kellogg Canada Inc. Mississauga, Ontario L4W5S1 Case Label: Kellogg's Eggo Frozen Waffles 64100,12/280 g 23817 Buttermilk Waffles UPC 0 64100 23817 3 2015 FE 13 EJCE Class II There may be small pieces of plastic found in a limited number of Eggo Buttermilk waffles distributed in Canada. Kellogg Company
Food Herring Fillets in Wine Sauce sold under the ELF brand in 12 oz. plastic jars. UPC Code on Cases: 10073302221111. UPC Code on Jars: 73302 12111. Item Number: 005725. Best Before Date: 21 May 14. Lot Number: 03553. Class I Vita Food Products, Inc. of Chicago, Illinois is notifying the public that it is recalling 2,280 individual plastic jars of 12 ounce Elf Herring Fillets in Wine Sauce that actually contains herring fillets in sour cream and therefore contains undeclared milk. Vita Food Products, Inc.
Devices The OEC 9900 Elite mobile fluoroscopy system (image intensified fluoroscopic x-ray) is designed to provide fluoroscopic and spot-film images of the patient during diagnostic surgical and interventional procedure. Examples of clinical application may include cholangiography, endoscopy, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedure. The system may be used for other imaging applications at the physician's discretion. Model Numbers - OEC 9900 Elite Class II GE Healthcare has identified a potential safety issue related to the screws that attach the workstation monitor spring arm to the extension arm on certain OEC 9900 systems, causing the spring arm and monitor to fall forward. GE OEC Medical Systems, Inc
Food "Honey Roasted Peanuts Golden Roast" sold under the Fisher brand and packaged in 14 oz. plastic jars. Best By Date: 5/20/15 N; UPC: 70690 23990; Case Item Code: P27750 Class II Cases containing 12 x 14 oz. plastic jars of Fisher "Honey Roasted Peanuts Dry Roasted" with a "Best By" date of "5/20/15 N" may contain plastic jars that are mislabeled as Fisher "Peanuts Dry Roasted Golden Roast". Dry roasted honey roasted peanuts contain wheat, which is an allergen, and this allergen is not declared on the dry roasted peanut label. John B. Sanfilippo & Son Inc.
Devices Pipeline Embolization Device (PED). Used endovascular treatment of adults with intracranial aneurysms in the internal carotid artery. PED Model/ Lot FA7735014 / 9879718 FA7742512 / 9864827 FA7150035 / 9855921 FA7735016 / 9856429 FA7742518 / 9856431 FA7730010 / 9869991 FA7737514 / 9855933 FA7742518 / 9860762 FA7732514 / 9873854 FA7737516 / 9858010 FA7745014 / 9874111 FA7735014 / 9855265 FA7740016 / 9859214 FA7745016 / 9879736 FA7735014 / 9875267 FA7740016 / 9879180 FA7747514 / 9868888 Class I Potential for the PTFE (polytetrafluoroethylene) coating to delaminate and detach from the delivery wire. Micro Therapeutics Inc, Dba Ev3 Neurovascular
Devices Alligator Retrieval Device (ARD). Used in the peripheral and neurovasculature for foreign body removal. ARD Model/ Lot FA8881040 / 9769118 FA8881030 / 9816048 FA8881040 / 9754682 FA8881050 / 9772283 FA8881040 / 9752800 FA8881030 / 9751662 FA8881030 / 9773525 FA8881020 / 9832735 FA8881040 / 9757667 FA8881020 / 9774620 FA8881030 / 9834039 FA8881040 / 9758530 FA8881020 / 9774620 FA8881030 / 9834039 FA8881030 / 9758532 FA8881030 / 9783730 FA8881020 / 9836553 FA8881050 / 9760946 FA8881040 / 9786013 FA8881030 / 9834039 FA8881030 / 9761690 FA8881040 / 9787928 FA8881050 / 9848544 FA8881020 / 9761692 FA8881030 / 9791385 FA8881030 / 9848543 FA8881030 / 9758532 FA8881040 / 9793305 FA8881030 / 9853152 FA8881040 / 9764206 FA8881030 / 9798648 FA8881030 / 9854769 FA8881040 / 9764206 FA8881030 / 9798648 FA8881030 / 9858153 FA8881040 / 9764212 FA8881050 / 9801041 FA8881030 / 9865759 FA8881030 / 9766949 FA8881020 / 9811215 FA8881050 / 9868025 FA8881030 / 9769117 FA8881030 / 9813908 Class I Potential for the PTFE (polytetrafluoroethylene) coating to delaminate and detach from the delivery wire. Micro Therapeutics Inc, Dba Ev3 Neurovascular
Food OPTIMUM E-1000 IU Gluten Free Dietary Supplement 100 SOFTGELS Product is packaged in a white HDPE bottle with foil cap under the white plastic cap. Bottle contains 100 softgel caps. UPC 0 43292 56291 7. 343230, 343695, 343788, 344603, and 344936. Class II Magno Humphries Laboratories is recalling Vitamin E softgels because the principle display panel states the product contains 1000 IU of Vitamin E however the Supplement Facts label indicated 200 IU of Vitamin E. The supplement actually contains 1000 IU of Vitamin E. Magno Humphries Laboratories, Inc
Food The Kitchen Whole Foods Chipotle Chicken Wrap; Good to Go. Net Weight: 10 oz.. (283 g) individually wrapped sandwich wraps. Distributed by Green Shoots Distribution' So. San Francisco, 94083 Lot code 401090104 with best by date of April 6; UPC: 046319-97076. Class II One production date of Chicken Chipotle Chicken wraps are actually filled with Chicken Caesar mix which contains a fish allergen (anchovies) that are not declared on the label. Whole Foods Market
Devices Terumo Cardiovascular Procedure Kit- X-Coated Pump and Table Pack with FX25RE Catalog Number: 73431 Lot Number: RA-27 Class II Incorrect customer notification label applied to the Tyvek lid of this specific lot of Terumo® Cardiovascular Procedure Kits Terumo Cardiovascular Systems Corp
Food Graeter's Ice Cream Big Scoop COOKIES AND CREAM Ingredients: cream, milk, cane sugar***locust bean gum. Manufactured Under Authority of Graeter's Inc., 1175 Regina Graeter Way Cincinnati, Ohio 45216 022715" 022715 Class II During an inspection on 03/04/2014 by the FDA and the Kentucky State Health Department, the firm was notified that they fail to include the allergens wheat and soy on the label. Tedesco LLC
Devices Edwards Lifesciences Fem-Flex II Arterial and femoral Cannulae, arterial cannula sizes 16, 18 and 20 French, models: FEMII016A, FEMII016AS, FEMII018A, FEMII018AS, FEMII020A, and FEMII020AS. FEMII016A - 59028126, 59049696, 59069370, 59077178, 59090422, 59103195, 59124013, 59138579, 59142234, 59151373, 59176265, 59202398, 59211445, 59218739, 59229566, 59232164, 59240932, 59266788, 59276834, 59312966, 59315604, 59342283, 59369388, 59409771, 59444473, 59468377, 59477867, 59499493, 59504222, 59504265, 59509409, 59551227, 59555094, 59563825, 59563881, 59589947, 59589952, 59609154, 59627646, 59630590, 59635736, 59635737, 59651804, 59662630, 59680124, 59680182, 59684469, 59691508 FEMII016AS - 59047478, 59112421, 59183047, 59229541, 59271782, 59394860, 59463345, 59593794 FEMII018A - 59021243, 59035354, 59043578, 59060761, 59060762, 59062270, 59064759, 59070872, 59079659, 59081681, 59082564, 59092366, 59093899, 59107280, 59114713, 59118388, 59124014, 59126280, 59138577, 59142229, 59142233, 59149665, 59169476, 59173958, 59173973, 59191995, 59210228, 59211444, 59211451, 59218738, 59222629, 59229567, 59235556, 59235558, 59254373, 59261612, 59271772, 59274361, 59299840, 59304350, 59304353, 59315607, 59332980, 59350864, 59379048, 59383856, 59400071, 59437566, 59437567, 59448621, 59458038, 59468821, 59477813, 59477838, 59490065, 59509300, 59509407, 59516176, 59528326, 59546034, 59551226, 59555043, 59555095, 59568507, 59577160, 59581459, 59585855, 59593828, 59604721, 59604722, 59604768, 59615024, 59616140, 59634860, 59634914, 59640034, 59640111, 59645315, 59648786, 59651807, 59651818, 59651905, 59680127, 59680192, 59684473, 59691468, 59691497 FEMII018AS- 59442433, 59551221, 59662385, 59684809 FEMII020A - 59442434, 59444471, 59458044, 59473388, 59477822, 59484137, 59492047, 59509404, 59514153, 59518778, 59523721, 59528327, 59528328, 59551224, 59555098, 59558960, 59572973, 59581458, 59581565, 59585993, 59593791, 59593830, 59599145, 59599177, 59615023, 59616141, 59620333, 59640098, 59641413, 59641415, 59648784, 59651907, 59651909, 59662631, 59670296, 59680176, 59691467, 59702375, FEMII020AS - 59473385, 59555025, 59675123. Class II Potential for separation of dilator tips. Edwards Lifesciences, LLC
Devices Edwards Lifesciences Fem-Flex II Arterial and femoral Cannulae with Duraflo Coating, arterial cannula sizes 16, 18 and 20 French, Models DFEMII016AS, DFEMII018AS, DFEMII020AS, DIIFEMII016A, DIIFEMII018A, and DIIFEMII020A. DFEMII016AS - 59036042, 59213298, 59258406, 59578907; DFEMII018AS - 59176126, 59249371, 59271003, 59369527, 59374074, 59432937, 59468460, 59484133, 59585854, 59589948, 59645287 DFEMII020AS - 59036043, 59113935, 59213299, 59258407, 59320308, 59369528, 59432938, 59468461, 59484119 DIIFEMII016A- 59025196, 59069368, 59115263, 59134580, 59154519, 59218668, 59240886, 59248906, 59304339, 59342282, 59383853, 59409789, 59453487, 59473491, 59491809, 59523710, 59528324, 59555055, 59589915, 59625359, 59645284, 59651762, 59680133, 59691448 DIIFEMII018A - 59030249, 59060764, 59072416, 59093901, 59116037, 59129577, 59149668, 59176262, 59218745, 59240935, 59248907, 59304334, 59337174, 59350865, 59394866, 59431915, 59468375, 59493314, 59528325, 59555040, 59577156, 59599140, 59609142, 59625362, 59651760, 59651808, 59680241 DIIFEMII020A - 59043574, 59069369, 59082560, 59103193, 59124011, 59134578, 59149667, 59176263, 59191993, 59218735, 59229561, 59240934, 59266786, 59299945, 59318926, 59319458, 59337178, 59350871, 59404487, 59437572, 59473387, 59484151, 59516163, 59531221, 59558959, 59563837, 59585992, 59609143, 59620175, 59642447, 59651767, 59651823, 59662388, 59680247. Class II Potential for separation of dilator tips. Edwards Lifesciences, LLC
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