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U.S. Department of Health and Human Services

Enforcement Report - Week of January 23, 2013

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Product Type Product Description Code Info Classification Reason for Recall Recalling Firm
Biologics Blood and Blood Products for reprocessing 2284245; 2285158 Class III Blood products, collected from a donor who was not asked follow-up questions regarding increased risk for vCJD, were distributed. Penrose-St Franc Health Services Blood Bank
Biologics Red Blood Cells Leukocytes Reduced Plasma Frozen 04FF62346, 04FF62348, 04FF62357, 04FF62358, 04FF62362, 04FF62364, 04FF62373, 04FF62376, 04FF62386, 04FF62389, 04FF62393, 04FF62402, 04FF62403, 04FF62405, 04FF62407, 04FF62412, 04FF62419, 04FF62421, 04FF62424, 04FF62426, 04FF62525, 04FF62530, 04FJ19204, 04FJ19228, 04FJ19233, 04FJ19236, 04FJ19245, 04FJ19247, 04FJ19253, 04FJ19263, 04FJ19270, 04FJ19272, 04FJ19277, 04FJ19281, 04FJ19284, 04FJ19295, 04FJ19297, 04FJ19303, 04FJ19312, 04FJ19317, 04FJ19324, 04FJ19333, 04FJ19337, 04FJ19488, 04FJ19500, 04FJ19505, 04FJ19507, 04FJ19591, Class II Blood products, collected from donors, whose suitability to donate was not adequately determined, were distributed ARC Blood Services, New England Region
Biologics Red Blood Cells Rejuvenated Irradiated 04FJ19207, 04FJ19217, 04FJ19220, 04FJ19224. 04FJ19230, 04FJ19476,04FJ19487, 04FJ19595, 04FJ19601 Class II Blood products, collected from donors, whose suitability to donate was not adequately determined, were distributed ARC Blood Services, New England Region
Biologics Plasma Frozen 04FF62362,04FF62364,04FJ19247,04FJ19324 Class II Blood products, collected from donors, whose suitability to donate was not adequately determined, were distributed ARC Blood Services, New England Region
Biologics Blood and Blood Products for Reprocessing 04FF62350, 04FF62352, 04FF62357, 04FF62358, 04FF62376, 04FF62386,04FF62396, 04FF62405, 04FF62407,04FF62421, 04FF62424, 04FJ19204, 04FJ19228, 04FJ19230, 04FJ19233, 04FJ19245, 04FJ19270, 04FJ19272,04FJ19277. 04FJ19284, 04FJ19295, 04FJ19317, 04FJ19333, 04FJ19495 04FJ19500, 04FJ19504, 04FJ19507 Class III Blood products, collected from donors, whose suitability to donate was not adequately determined, were distributed ARC Blood Services, New England Region
Biologics Red Blood Cells Leukocytes Reduced 09FN91160 Class II Blood product, collected from a donor who reported travel to a malarial endemic area, was distributed. American National Red Cross (The)
Biologics Red Blood Cells 1970058 Class II Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. LifeServe Blood Center
Biologics Blood and Blood Products for Reprocessing 1970058 Class II Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. LifeServe Blood Center
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced 1959203;1959203 Class II Blood products, collected from a donor who reported travel to a malarial endemic area, were distributed. LifeServe Blood Center
Biologics Red Blood Cells 11FM49562 Class II Blood product, positive for the S-antigen but labeled as S-antigen negative, was distributed. American Red Cross Blood Services
Biologics Platelets Pheresis Leukocytes Reduced 011LF20539 Class II Blood product, with platelet yield that exceeded the manufacturer's limit for the product to be stored in one bag, was distributed. American Red Cross Blood Services
Biologics Red Blood Cells LX44682 Class II Blood product, collected from a donor who reported travel to a malarial endemic area, was distributed. LifeServe Blood Center
Biologics Red Blood Cells Leukocytes Reduced Irradiated 49GN54061 Class II Blood product, labeled with an incorrect expiration date, was distributed. Baylor University Medical Center - Transfusion Service Center
Biologics Red Blood Cells Leukocytes Reduced 009FE12874; 09FQ21836 Class II Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. American National Red Cross (The)
Biologics Platelets Pheresis Leukocytes Reduced 009GZ05786; 009GZ06597 Class II Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. American National Red Cross (The)
Biologics Blood and Blood Products for Reprocessing 009FE12874; 09FQ21836 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 4066720 Class II Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed. University of Texas Medical Branch at Galveston (The)
Biologics Platelets Pheresis Leukocytes Reduced W045007915604 Class II Blood product, which was possibly contaminated with Propionibacterium species, was distributed. Community Blood Center Of Gtr KC
Biologics Platelets Pheresis Leukocytes Reduced W045007915029 Part 1 ;W045007915029 Part 2 Class II Blood products, which were possibly contaminated with Propionibacterium species, were distributed. Community Blood Center Of Gtr KC
Biologics Blood and Blood Products for Reprocessing 21GV34559; 21KV00196; 21KV00328. Class III Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. American National Red Cross
Biologics Red Blood Cells Leukocytes Reduced 21GV34559; 21KV00196; 21KV00328. Class II Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. American National Red Cross
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced W045008007317 Part A ;W045008007317 Part B Class II Blood products, which failed to meet the minimum specification for product volume, were distributed Community Blood Center Of Gtr KC
Biologics Red Blood Cells Leukocytes Reduced 21KM96454 Class II Blood product, collected from a donor who reported post donation illness, was distributed. American National Red Cross
Biologics Source Plasma 08IMOB1579; 08IMOA6642; 08IMOA3960 Class III Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed. BioLife Plasma Services LP
Biologics Platelets Pheresis Leukocytes Reduced Irradiated 21KT41666; 21KT41666 Class II Blood products, labeled as leukoreduced without the assurance that they met the criteria for leukoreduced products, were distributed. American National Red Cross
Biologics Red Blood Cells Leukocytes Reduced 011GT77158; 011FX17525 Class II Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. American Red Cross Blood Services
Biologics Plasma Frozen 011GT77158 Class II Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. American Red Cross Blood Services
Biologics Blood and Blood Products for Reprocessing 011FX17525 Class III Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. American Red Cross Blood Services
Biologics Platelets Pheresis Leukocytes Reduced Irradiated 21FP45176 Class II Blood products, labeled as leukoreduced without the assurance that they met the criteria for leukoreduced products, were distributed. American National Red Cross
Biologics Platelets Pheresis Leukocytes Reduced 21FP45176 Class II Blood products, labeled as leukoreduced without the assurance that they met the criteria for leukoreduced products, were distributed. American National Red Cross
Biologics Red Blood Cells Leukocytes Reduced 011FZ82900 Class II Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. American Red Cross Blood Services
Biologics Blood and Blood Products for Reprocessing 011FZ82900 Class III Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. American Red Cross Blood Services
Biologics Source Plasma LZ090296; LZ089770 Class II Blood products, collected from a donor who did not have a complete physical examination, were distributed. Interstate Blood Bank Inc Mo
Biologics Red Blood Cells Leukocytes Reduced 21LZ09600 Class II Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. American National Red Cross (The)
Biologics Cryoprecipitated AHF 21LZ09600 Class II Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. American National Red Cross (The)
Biologics Blood and Blood Products for Reprocessing 21LZ09600 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 21LZ02870; 21LZ07089; 21LZ10267; 21LZ14250. Class II Blood products, collected from a donor who reported travel to a malarial endemic area, were distributed. American National Red Cross
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced 21LQ32862, 21LQ32862 Class II Blood product, collected from a donor with an unacceptably low hemoglobin, was distributed. American National Red Cross (The)
Biologics Red Blood Cells Leukocytes Reduced 011GG65599 Class II Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. American Red Cross Blood Services
Biologics Cryoprecipitated AHF 011GG65599 Class II Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. American Red Cross Blood Services
Biologics Blood and Blood Products for Reprocessing 011GG65599 Class III Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. American Red Cross Blood Services
Biologics Red Blood Cells Leukocytes Reduced 21FV31979 Class II Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. American National Red Cross (The)
Biologics Blood and Blood Products for Reprocessing 21FV31979 Class III Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. American National Red Cross (The)
Drugs CABERGOLINE Tablets, 0.5 mg, RX only, 8 count bottles, Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960 NDC 0093-5420-88 Lot number 6A007046V, exp 07/12 Class III Impurities/Degradation Products: This lot of product will not meet the impurity specification over shelf life Teva Pharmaceuticals USA, Inc.
Drugs I-C Drops, Eye Cleansing Agent, 15 ml ASN/Maxam P.O. Box 1277 Hood River, OR 97031 N/A Class II Lack of Assurance of Sterility: The product is being recalled because the product label does not state sterile in accordance with 21 CFR Part 200.50(a)(1), Ophthalmic Preparations and Dispensers, and it is not in compliance with 21 CFR Part 349, Ophthalmic Drug Products for Over-The-Counter Use. James G. Cole, Inc.
Devices DePuy Spine EXPEDIUM Offset Torque Wrench Product Code 2797-29-510 The device is intended for use during the final tightening of an Expedium Offset Spinal Construct. All lots Class II A component within the handle of the Expedium Offset Torque Wrench is prematurely wearing, potentially resulting in the instrument recording torque values outside of the specification. DePuy Spine, Inc.
Veterinary AvoDerm Natural Lamb Meal Brown Rice Adult Dog Formula, 26 lb. Packaged in plastic bag with plastic liner. Product Code/SKU/Material # 1000065074, UPC Code 0 5290702043 8, Best before dates of 28 Aug 2013, 29 Aug 2013, 30 Aug 2013. Class I The firm recalled because the product has the potential to be contaminated with Salmonella. Breeders Choice Pet Foods Inc
Devices Vycor Medical ViewSite Brain Access System 17mm/ 11mm / 5cm Device***STERILE*** Product Usage: The Vycor Viewsite Brain Access System (VBAS) has been designed to serve as a self-retaining retractor system for brain tissue. It is comprised of an introducer and a working channel port that are secured by a spring-loaded latch. Each device allows for the gentle retraction of tissue, visualization of the surgical site and for the smooth manipulation of introduced instruments. The range of device sizes (width and length) provides various working channel sizes. Model # TC171105 Lot # VM83450 Class I Vycor Medical recalled their VBAS (Vycor Viewsite Brain Access System) because an unidentified black fiber was found on the device. Vycor Medical, Inc.
Devices Computed Tomography X-Ray System Brilliance Workspace Portal, Model #728269 Philips Medical Systems, Highland Heights, OH. The Brilliance Workspace Portal is a component of the Computed Tomography X-Ray System that is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. The portal (together with the scanner) provides image processing and display through software applications that process, analyze, display, quantify and interpret medical images/data. Model #728269; Serial #s: 79906, 79921, 79927, 79937, 80007, 80026, 80031, 80040, 80058, 80062, 80066, 80069, 80087, 80110, 80121, 80155, 80167, 80168, 80169, 80174, 80192, 80193, 80195, 80201, 80208, 80209, 80219, 80227, 80228, 80230, 80252, 80258, 80266, 80280, 80289, 80293, 80294, 80315, 80322, 80328, 80333, 80340, 80341, 80348, 80360, 80375, 80385, 80387, 80394, 80398, 80416, 80421, 80422, 80429, 80447, 80451, 80460, 80474, 80482, 80484, 80485, 80492, 80497, 80505, 80516, 80578, 80585, 80591, 80629, 80646, 80658, 80681, 80704, 80709, 80711, 80720, 80723, 80743, 80749, 80751, 80831, 80835, 80866, 80878, 80908, 80909, 80911, 80914, 80916, 80930, 80931, 80944, 80974, 80992, 80999, 81023, 81025, 81034, 81045, 81071, 81099, 81101, 81107, 81117, 81126, 81136, 95382 & 95592. Class II Philips was notified that when performing post processing with the Brilliance Workspace Portal platform with software versions 2.6.1.4, the coronary arteries in the rendered image are segmented automatically. However, the center line is not extracted or highlighted upon hovering and making it impossible to activate the vessel and choose the appropriate name (label) from the drop-down menu. Philips Medical Systems (Cleveland) Inc
Biologics Red Blood Cells Leukocytes Reduced W036511025390 Class II Blood product, collected from a donor who emigrated from an area considered endemic for malaria, was distributed. LifeShare Blood Centers
Veterinary Nature's Recipe, Oven Baked Biscuits with Real Chicken, Made with sweet potatoes, oats, flaxseed., 19 ounces; UPC: 30521 51549 UPC: 30521 51549 Lot code: 2199TP; Best by: 10/11/13 Lot code: 2200TP; Best by: 10/12/13 Class I Product may be contaminated with Salmonella. Del Monte Corp
Veterinary Pet Bird Feed- Sleek and Sassy are sold under multiple names. Products with UPCs are listed below. Garden Conure has the following UPCs: 0-1253111602-0; 0-1253111604-4; 0-1253111620-4; 0-1253111640-2; Garden Large Hookbill has the following UPCs: 0-1253113102-3; 0-1253113104-7; 0-1253113120-7; 0-1253113140-5; Garden Large Hookbill No Sunflower has the following UPCs: 0-1253113202-0; 0-1253113204-4; 0-1253113220-4; 0-1253113240-2; Garden Parrot has the UPCs: 0-1253112103-1; 0-1253112125-3; Nutty Garden Grain has the UPCS: 0-1253115502-9; 0-1253115504-3; 0-1253115520-3; 0-1253115540-1; Garden Macaw has the UPCs: 0-1253115602-6; 0-1253115604-0; 0-1253115620-0; 0-1253115640-8; Garden Complete Pellet has the UPCs: 0-1253115702-3; 0-1253115704-7; 0-1253115720-7; 0-1253115740-5; Fruit Veggie Nut Treat has the UPCs: 0-1253114302-6; 0-1253114304-0; 0-1253114320-0; 0-1253114316-3; 0-1253114332-3; No expiration dates on packages. Product has lot code 01148 through 01241 (it is interpreted as: 11 is for manufacturing year 2011, and 48 is week 48 of 2011). Class I Pet bird food and small animal pet foods are recalled due to a potential to be contaminated with Salmonella. Wildwood Seeds
Veterinary Small Pet Animal Food is sold under Sleek and Sassy brand. Product are packaged from 2 lb., 4 lb., 20 lb., to 40 lb in polysynth bag. Garden Small Animal has the following UPCs: 0-1253113902-9; 0-1253113904-3; 0-1253113920-3; 0-1253113940-1; No expiration dates on packages. Product has lot code 01148 through 01241 (it is interpreted as: 11 is for manufacturing year 2011, and 48 is week 48 of 2011). Class I Pet bird food and small animal pet foods are recalled due to a potential to be contaminated with Salmonella. Wildwood Seeds
Veterinary Garden Guinea Pig/Rabbit diet is sold under Sleek and Sassy brand. Product is packaged from 2 lb., 4 lb., 20 lb., to 40 lb in polysynth bag. Garden Guinea Pig/Rabbit has UPC is 0-1253113502-1. No expiration dates on packages. Product has lot code 01148 through 01241 (it is interpreted as: 11 is for manufacturing year 2011, and 48 is week 48 of 2011). Class I Pet bird food and small animal pet foods are recalled due to a potential to be contaminated with Salmonella. Wildwood Seeds
Veterinary Fortified feeds are sold under Sleek and Sassy brand. Different products with UPCs are listed below. Fortified Large Hookbill with the UPCs: 0-1253111402-6; 0-1253111404-0; 0-1253111420-0; 0-1253111440-8; Fortified Large Hookbill No Sunflower with the UPCs: 0-1253111502-3; 0-1253111504-7; 0-1253111520-7; 0-1253111540-5; Fortified Parrot with the UPCs: 0-1253113003-3; 0-1253113025-5; Fortifed Small Animal with the UPCs: 0-1253112902-0; 0-1253112904-4; 0-1253112920-4; 0-1253112940-2; No expiration dates on packages. Product has lot code 01148 through 01241 (it is interpreted as: 11 is for manufacturing year 2011, and 48 is week 48 of 2011). Class I Pet bird food and small animal pet foods are recalled due to a potential to be contaminated with Salmonella. Wildwood Seeds
Veterinary WILD WINGS, CERTIFIED ORGANIC, PREMIUM ORGANIC BLEND, PREMIUM SEED FOR BIRDS, Net wt. 80 oz (5 lbs) (2.27 kg), HBD INTERNATIONAL, 7108 CROSSROADS BLVD., SUITE 325 BRENTWOOD, TN 37027, 615.221.9890 800.346.0269 POM9512WL2201A4 Class I Product was manufactured with peanuts recalled by Sunland due to the potential for salmonella contamination. HBD International
Veterinary Charlee Bear Protein Crunch Bars, 84% Chicken Recipe with Sweet Potatoes, 5.5 oz, UPC Code 8710890001. Lot # 20112 Class I Charlee Bear Products, a division of Wixon, Inc., is voluntarily recalling certain lots of its Charlee Bear Protein Crunch Treats because they have the potential to be contaminated with Salmonella. Wixon, Inc.
Veterinary Charlee Bear Protein Crunch Bars, 84% Chicken Recipe with Carrots, 5.5 oz, UPC Code 8710890000. Lot # 19812, 19912, 20012, 20212. Class I Charlee Bear Products, a division of Wixon, Inc., is voluntarily recalling certain lots of its Charlee Bear Protein Crunch Treats because they have the potential to be contaminated with Salmonella. Wixon, Inc.
Food Grandma's Peanut Butter Sandwich Creme Cookies, Net WT. 3.025 oz, Frito-Lay, Inc. Plano, TX 75024 GRANDMA'S Peanut Butter Sandwich Creme cookies have a sell-by date of March 12, 2013 or earlier and UPC code of 28400-00153. Class I The firm is recalling GRANDMA'S Peanut Butter Sandwich Creme cookies and GRANDMA'S Peanut Butter Mini Sandwich Creme cookies because they contain undeclared milk and egg. Frito Lay, Inc
Food Grandma's Peanut Butter Mini Sandwich Creme Cookies, Net WT. 1.71 oz, Frito-Lay, Inc. Plano, TX 75024 GRANDMA'S Peanut Butter Mini Sandwich Creme cookies have a sell-by date of May 21, 2013 or earlier and UPC code of 28400-00901. The sell-by date is located on the front of the package. Class I The firm is recalling GRANDMA'S Peanut Butter Sandwich Creme cookies and GRANDMA'S Peanut Butter Mini Sandwich Creme cookies because they contain undeclared milk and egg. Frito Lay, Inc
Devices Bausch and Lomb 27G sterile cannula packed in the Bausch and Lomb Amvisc 1.2% Sodium Hyaluronate ( Model 59051, 59081, 59051L, 59081L) and Amvisc Plus 1.6% Sodium Hyaluronate (Model 60081, 60051, 60051L, 60081L) ophthalmic viscosurgical device. The 27G disposable cannula is attached to the syringe standard luer fitting to deliver the Amvis or Amvis Plus during use as a surgical aid in opthalmic anterior or posterior segment procedures. B100003G B100015A B100015D B100023A B100023B B100023C B100023D B100023E B100039D B100039F B100046A B100046B B100046C B100058A B100069A B110027D B110028C B110048A B110048D B110056A B120011D B120016A D100008B D100009A D100011A D100011B D100011C D100016B D100016C D100022A D100022B D100022C D100022D D100026A D100026C D100026D D100026E D100030A D100030B D100030C D100035A D100035C D100035D D100043A D100043B D100043C D100044B D100044C D100044D D100044E D100045A D100045B D100045C D100059A D100059B D100059C D100060A D100060B D100061A D100061B D100080A D100081A D100081AS D110015A D110015B D110016A D110045A D110046A D110047A D110070A D110071A D110072A D110090A D110090B D110091A D110092A D110108A D110108B D110108BR D120015A D120015B D120027A D120028A D120029A D120029B D120038B D120039A D120068A D120068B 023632 023633 023639 023640 023647 023801 023811 023863 023886 023897 023920 023933 023972 024022 024025 024028 024257 024323 024436 C10003B E090105A D090095B D090096A D090096C D090097C D090097D Amvisc 1.2% Sodium Hyaluronate ( Model 59051, 59081, 59051L, 59081L) Amvisc Plus 1.6% Sodium Hyaluronate (Model 60081, 60051, 60051L, 60081L) Class I Some disposable cannulas (with 4-digit lot numbers) provided with the Amvisc or Amvisc Plus OVD are not properly engaging to the Luer-Lock on the Amvisc and Amvisc Plus sterile glass syringes. The cannulas may leak viscoelastic material or detach from the syringe during injection. In rare incidents, detachment has resulted in serious patient injury. Bausch and Lomb, Incorporated
Devices Fresenius GranuFlo Dry Acid Concentrate For Bicarbonate Dialysis 2.0 K 2.5 Ca 1 Mg 16.5 GAL Catalog Number: OFD2251-3B Product Usage: GranuFlo is indicated in the treatment of acute and chronic renal failure during the hemodialysis treatment. Lot Numbers: 12NXGF001, 12NXGF003, 12NXGF006, 12NXGF007, 12NXGF013,, 12NXGF015, 12NXGF016, 12NXGF017, 12PXGF001, 12PXGF003, 12PXGF005, 12PXGF007, 12PXGF009, 12PXGF012, 12PXGF013, 12PXGF015, 12PXGF016 Class III GranuFlo Dry Acid Concentrate may show discoloration Fresenius Medical Care Holdings, Inc.
Devices Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 2.0K 2.0 Ca 1Mg .16.5GAL Catalog Number: OFD2201-3B Product Usage: GranuFlo is indicated in the treatment of acute and chronic renal failure during the hemodialysis treatment. Lot Numbers:12NXGF004, 12NXGF008, 12PXGF010, 12PXGF014 Class III GranuFlo Dry Acid Concentrate may show discoloration Fresenius Medical Care Holdings, Inc.
Devices Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 3.0K 2.5 Ca 1Mg .16.5GAL Catalog Number: OFD3251-3B Product Usage: GranuFlo is indicated in the treatment of acute and chronic renal failure during the hemodialysis treatment. Lot Numbers:12NXGF002, 12NXGF014, 12PXGF006, Class III GranuFlo Dry Acid Concentrate may show discoloration Fresenius Medical Care Holdings, Inc.
Devices Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 2.0K 2.25 Ca 1Mg .16.5GAL Catalog Number: OFD2231-3B Product Usage: GranuFlo is indicated in the treatment of acute and chronic renal failure during the hemodialysis treatment. Lot Numbers:12NXGF005, 12NXGF019, 12PXGF008 Class III GranuFlo Dry Acid Concentrate may show discoloration Fresenius Medical Care Holdings, Inc.
Devices Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 1.0K 2.0 Ca 1Mg .16.5GAL Catalog Number: OFD1201-3B Product Usage: GranuFlo is indicated in the treatment of acute and chronic renal failure during the hemodialysis treatment. Lot Number:12NXGF009 Class III GranuFlo Dry Acid Concentrate may show discoloration Fresenius Medical Care Holdings, Inc.
Devices Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 2.0K 2,5 Ca 0.75 Mg .16.5GAL Catalog Number: OFD2225-3B Product Usage: GranuFlo is indicated in the treatment of acute and chronic renal failure during the hemodialysis treatment. Lot Numbers:12NXGF011, 12PXGF004 Class III GranuFlo Dry Acid Concentrate may show discoloration Fresenius Medical Care Holdings, Inc.
Devices Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 2.0K 2,5 Ca 0.75Mg .16.5GAL Catalog Number: OFD2223-3B Product Usage: GranuFlo is indicated in the treatment of acute and chronic renal failure during the hemodialysis treatment. Lot Number:12NXGF012 Class III GranuFlo Dry Acid Concentrate may show discoloration Fresenius Medical Care Holdings, Inc.
Devices Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 3.0K 2,0 Ca 1.0Mg .16.5GAL Catalog Number: OFD3201-3B Product Usage: GranuFlo is indicated in the treatment of acute and chronic renal failure during the hemodialysis treatment. Lot Number:12PXGF017 Class III GranuFlo Dry Acid Concentrate may show discoloration Fresenius Medical Care Holdings, Inc.
Devices Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 3.0K 2,5 Ca 0.75Mg .16.5GAL Catalog Number: OFD2325-3B Product Usage: GranuFlo is indicated in the treatment of acute and chronic renal failure during the hemodialysis treatment. Lot Number:12PXGF002 Class III GranuFlo Dry Acid Concentrate may show discoloration Fresenius Medical Care Holdings, Inc.
Devices NEOGRAM AMINO ACIDS AND ACYLCARNITINES TANDEM MASS SPECTROMETRY KIT Product Number: 3026-0030. This kit is intended for the measurement and evaluation of amino acid, free carnitine, and acylcarnitine concentrations from newborn heel prick blood samples dried on filter paper. (Table 1 of Attachment 2) details the analytes measured by the kit. Quantitative analysis of amino acids, free carnitine and acylcarnitines and their relationship with each other is intended to provide analyte concentration profiles that may aid in the screening of newborns for one or more of several metabolic disorders. This kit is to be used for in vitro diagnostic use only, by trained, qualified laboratory personnel. Lot Numbers: 617341, 619236 Class II Truncated V-Bottomed Microplate Wells used in assays contain defective wells. Perkinelmer
Devices NEOBASE NON-DERIVATIZED MSMS KIT Product Number: 3040-001U. This tandem mass spectrometry (MSMS) reagent kit is intended for the measurement and evaluation of amino acids, succinylacetone, free carnitine, and acylcarnitine concentrations from newborn heel prick blood samples dried on filter paper. Quantitative analysis of these analytes ) and their relationship with each other is intended to provide analyte concentration profiles that may aid in screening newborns for metabolic disorders. Lot Numbers: 617253 , 617346, 618494 , 618653, 618764 , 619453 Class II Truncated V-Bottomed Microplate Wells used in assays contain defective wells. Perkinelmer
Devices NEONATAL TOTAL GALACTOSE KIT Product Numbers: 3029-0010, 3029-001B. This kit is intended for the quantitative determination of total galactose (galactose and galactose-1-phosphate) concentrations in blood specimens dried on filter paper as an aid in screening newborns for galactosemia. Lot Numbers: 618201, 619200, 618263 Class II Truncated V-Bottomed Microplate Wells used in assays contain defective wells. Perkinelmer
Devices DBS MICROPLATE, TRUNCATED V-BOTTOMED Product Number: 3033-0010 Lot Numbers: 618609 Class II Truncated V-Bottomed Microplate Wells used in assays contain defective wells. Perkinelmer
Devices Microplate, truncated V-bottomed lots included in the above listed products Product Number: 1380 5465. DBS Microplate is a general purpose 96 well microplate used in the preparation and examination of specimens from the human body. Lot Numbers: 616792 , 617141 , 617980 , 618319, 618664, 618831, 619175 Class II Truncated V-Bottomed Microplate Wells used in assays contain defective wells. Perkinelmer
Devices Brilliance 64 and Ingenuity CT Computed Tomography X-Ray Scanning Systems: Brilliance 64 - Model #728231; and Ingenuity CT - Model # 728326, Distributed By: Philips Healthcare, Cleveland, OH. The Brilliance 64 and Ingenuity CT are Computed Tomography X-Ray Systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient, and equipment supports, components and accessories. Brilliance CT X-RAY System - Model/System Code #728231, Serial Number distributed in the U.S. was: 9654. Ingenuity CT X-Ray System - Model/System Code #728326 - Serial Numbers distributed in the U.S. were: 300018, and 300003. The remaining Serial Numbers distributed overseas were: 91003, 95130, 95157, 95504, and Serial Numbers: 300010, and 300030 . Class II Software anomalies. Philips Medical Systems recalled their Brilliance 64 running software v4.0.0xx516 and their Ingenuity CT running software v4.0.0xx518 due to software issues detected in these CT scanning systems. If these issues were to re-occur they could pose the risk of injury to patients undergoing scans; device users; or device service personnel. Philips Medical Systems (Cleveland) Inc
Food Pastillage (gum paste) Flowers Rose - Pink UPC code: 8 38437 00003 0 Class I Sugar Flowers Plus Inc of Glendale, CA is recalling Cake Decors Pastillage (gum paste) Flowers because of the undeclared use of egg white wash as a glue for the inner petals of flowers. Sugar Flowers Plus
Food Pastillage (gum paste) Flowers Rose - Yellow UPC code: 8 38437 00001 6 Class I Sugar Flowers Plus Inc of Glendale, CA is recalling Cake Decors Pastillage (gum paste) Flowers because of the undeclared use of egg white wash as a glue for the inner petals of flowers. Sugar Flowers Plus
Food Pastillage (gum paste) Flowers Rose - Red UPC code: 8 38437 00002 3 Class I Sugar Flowers Plus Inc of Glendale, CA is recalling Cake Decors Pastillage (gum paste) Flowers because of the undeclared use of egg white wash as a glue for the inner petals of flowers. Sugar Flowers Plus
Food Pastillage (gum paste) Flowers Rose - Blue UPC code: 8 38437 00004 7 Class I Sugar Flowers Plus Inc of Glendale, CA is recalling Cake Decors Pastillage (gum paste) Flowers because of the undeclared use of egg white wash as a glue for the inner petals of flowers. Sugar Flowers Plus
Food Pastillage (gum paste) Flowers Cymbidium - W/M UPC Code: 8 38437 00010 8 Class I Sugar Flowers Plus Inc of Glendale, CA is recalling Cake Decors Pastillage (gum paste) Flowers because of the undeclared use of egg white wash as a glue for the inner petals of flowers. Sugar Flowers Plus
Food Pastillage (gum paste) Flowers Cattleya - W/P UPC code: 8 38437 00011 5 Class I Sugar Flowers Plus Inc of Glendale, CA is recalling Cake Decors Pastillage (gum paste) Flowers because of the undeclared use of egg white wash as a glue for the inner petals of flowers. Sugar Flowers Plus
Food Pastillage (gum paste) Flowers Gladiolus - A/W UPC ocde: 8 38437 00012 2 Class I Sugar Flowers Plus Inc of Glendale, CA is recalling Cake Decors Pastillage (gum paste) Flowers because of the undeclared use of egg white wash as a glue for the inner petals of flowers. Sugar Flowers Plus
Food Pastillage (gum paste) Flowers Gladiolus - P/BUR UPC code: 8 38437 00013 9 Class I Sugar Flowers Plus Inc of Glendale, CA is recalling Cake Decors Pastillage (gum paste) Flowers because of the undeclared use of egg white wash as a glue for the inner petals of flowers. Sugar Flowers Plus
Food Red Apple Slices 2.4 oz, Item #71746, 20 oz, Item # 71729 14 oz, Item # 71735. Item #71729 is sold under the brand name Sonic UPC 95829 20000. The other two packages are in clear plastic bags. 2 oz Use By 11/30/12 Item #71729, UPC 95829 2000, 2 oz, Use By 12/3/12, Item #71746; & 14 oz, Use By 12/3/12 & 12/6/12 Item # 71735. Class II Possible contamination with Listeria monocytogenes. Fresh Unlimited Inc
Food Sliced Green Apples READY TO EAT 14 oz Innerlock Bag UPC 95829 20042 Use By: 12/3/12, Item #71736 Item #71736, Use By 12/3/2012 and 12/6/2012 Class I Possible contamination with Listeria monocytogenes. Fresh Unlimited Inc
Food Celery Stick 2, 80/2 oz clear plastic bag, Item #70648 USED BY: 11/21/12 Use by 11/21/12 Item# 70648 Class II Possible contamination with Listeria monocytogenes. Fresh Unlimited Inc
Food Carrot coin 1/4 & 80/2oz bag Item #70263 BEST USED BY 11/21/12 TC: 1 317 2359 15:43 Use by 11/21/12 Item# 70263 Class II Possible contamination with Listeria monocytogenes. Fresh Unlimited Inc
Food Red Grapes 80/1.5 oz (3,402g) bag Item #71305 BEST USED BY: 11/21/12 Use by 11/21/12 Item #71305 Class II Possible contamination with Listeria monocytogenes. Fresh Unlimited Inc
Food Pineapple Chunks 80/2 oz (4.536g) bag Item #71607, BEST USED BY: 11/21/12 TC: 1 217 2359 Use by 11/21/12 Class II Possible contamination with Listeria monocytogenes. Fresh Unlimited Inc
Food Red Apples DICED 3/4 & 5/1# (4,536G) bag Item #71707 Ingredients: Apples (Apples, Calcium Ascorbate), BEST USED BY: 11/25/12 TC: 1 317 2359 15:40 PRODUCT OF: USA Use by 11/25/12 Item #71707 Class II Possible contamination with Listeria monocytogenes. Fresh Unlimited Inc
Food Green Pepper Strips 3/8 & 80/2oz (4,536g) bag Item #73032 BEST USED BY: 11/21/12 TC: 1 317 2359 15:45 Use by 11/21/12 Item #73032 Class II Possible contamination with Listeria monocytogenes. Fresh Unlimited Inc
Food Radish Sliced 80/2oz bag Item #74605 BEST USED BY: 11/21/12 TC: 1 317 2359 15:45 Use by 11/21/12 Class II Possible contamination with Listeria monocytogenes. Fresh Unlimited Inc
Food Holiday Fruit Delight Kit 5.1875 lbs (2,353g) INGREDIENTS: APPLES***RED GRAPES, STRAWBERRY GLAZE***MARSHMELLOW***WALNUTS, ALLERGENS: WALNUTS (TREE NUTS) BEST USED BY 11/23/12 TC: 13171319 15:42 Use by 11/23/12 ITEM #74707 Class II Possible contamination with Listeria monocytogenes. Fresh Unlimited Inc
Food Waldorf Salad Kit 5.19lb (2,345g) bag Item #74802 INGREDIENTS: APPLES***MAYONNAISE***CELERY, WALNUTS CONTAINS: SOYBEAN OIL, EGG, TREE NUTS (WALNUTS) BEST USED BY: 11/23/12 TC: 13171319 15:43 Use by 11/23/12 Item #74802 Class II Possible contamination with Listeria monocytogenes. Fresh Unlimited Inc
Food SHREDDED BROCCOLI FRUIT SALAD 6.19# (2,807 g) Ingredients: Broccoli, Cauliflower, Apples, Pears, Cole Slaw Dressing***Cranberry***Raisins CONTAINS: Soybean, egg BEST USED BY: 11/23/12 TC: 13171319 15:59*** Use by 11/23/12 Item #74880 Class II Possible contamination with Listeria monocytogenes. Fresh Unlimited Inc
Food Knorr Pasta Sides Cheesy Bacon Macaroni Net Wt. 3.8 oz, (107 g) Unilever Englewood Cliffs, NJ 07632 USA Made in Canada from domestic and imported ingredients Case SCC 10041000082488 UPC 4100008248 Sept1113BUO Sept1213BUO Class II Knorr Pasta Sides Cheesy Bacon Macaroni may contain soy as a different product mix was inadvertently packaged in the Cheesy Bacon Macaroni pouch. Unilever United States, Inc.
Devices Hoffman LRF Wire Bolt, Catalog number 4933-1-001 through -003. Catalog number 4933-1-001, Lot number Z02804, Z08348, Z08350, Z12549, Z16753. Catalog number 4933-1-002, Lot number Z08351, Z12554, Z16246, Z16752. Catalog number 4933-1-003 Lot Number Z08349, Z09344, Z12551, Z16996. Class II Two complaints have been filed where Hoffman LRF Wires have broken during load bearing application by patients. Stryker Howmedica Osteonics Corp.
Veterinary Plum A+ Single Channel Infusion Pump with Module for Veterinary Use Only; Hospira, Inc., Lake Forest, IL 60045; list number 60529, module 60530-04 List number 60529, serial numbers 14315003, 14315004, 14315005, 14315008, 14315009, 14315011, 14315012, 14315013, 14315014, 14315015, 14315017, 14315018, 14315019, 14315020, 14315022, 14315023, 14315025, 14315026, 14315027, 14315028, 14315029, 14315030, 14315031, 14315034, 14315035, 14315036, 14315037, 14315038, 14315040, 14315041, 14315043, 14315044, 14315045, 14315046, 14315047, 14315048, 14315049, 14315050, 14315051, 14315052, 14315053, 14315054, 14315055, 14315056, 14315057, 14315058, 14315059, 14315061, 14315062, 14315063, 14315064, 14315066, 14315067, 14315069, 14315070, 14315071, 14315072, 14315073, 14315074, 14315075, 14315076, 14315077, 14315078, 14315079, 14315080, 14315081, 14315082, 14315083, 14315084, 14315085, 14315086, 14315087, 14315088, 14315089, 14315090, 14315091, 14315092, 14315093, 14315094, 14315095, 14315096, 14315097, 14315098, 14315099, 14315100, 14315101, 14315103, 14315104, 14315105, 14315106, 14315109, 14315110, 14315111, 14315112, 14315113, 14315114, 14315116, 14315117, 14315118, 14315119, 14315120, 14315121, 14315123, 14315124, 14315125, 14315126, 14315127, 14315128, 14315129, 14315130, 14315131, 14315132, 14315133, 14315134, 14315135, 14315136, 14315137, 14315138, 14315139, 14315140, 14315141, 14315142, 14315143, 14315145, 14315146, 14315147, 14315148, 14315149, 14315150, 14315151, 14315152, 14315153, 14315154, 14315155, 14315156, 14315157, 14315158, 14315159, 14315160, 14315161, 14315162, 14315163, 14315164, 14315165, 14315166, 14315167, 14315168, 14315169, 14315170, 14315171, 14315172, 14315173, 14315174, 14315175, 14315176, 14315177, 14315178, 14315179, 14315180, 14315181, 14315182, 14315183, 14315184, 14315185, 14315186, 14315187, 14315188, 14315189, 14315190, 14315191, 14315192, 14315193, 14315194, 14315195, 14315196, 14315197, 14315198, 14315199, 14315200, 14315201, 14315202, 14315203, 14315204, 14315205, 14315207, 14315208, 14315209, 14315210, 14315211, 14315212, 14315213, 14315214, 14315215, 14315216, 14315217, 14315218, 14315219, 14315220, 14315221, 14315223, 14315224, 14315225, 14315226, 14315227, 14315228, 14315229, 14315230, 14315231, 14315232, 14315233, 14315234, 14315235, 14315236, 14315237, 14315238, 14315239, 14315240, 14315241, 14315242, 14315243, 14315244, 14315245, 14315246, 14315247, 14315248, 14315249, 14315250, 14315251, 14315252, 14315253, 14315254, 14315255, 14315256, 14315257, 14315258, 14315259, 14315260, 14315261, 14315262, 14315263, 14315264, 14315265, 14315266, 14315267, 14315268, 14315269, 14315270, 14315271, 14315272, 14315273, 14315274, 14315275, 14315276, 14315277, 14315278, 14315279, 14315280, 14315281, 14315282, 14315283, 14315284, 14315285, 14315286, 14315287, 14315288, 14315289, 14315290, 14315291, 14315293, 14315294, 14315295, 14315296, 14315297, 14315298, 14315299, 14315300, 14315301, 14315302, 14315303, 14315304, 14315305, 14315306, 14315307, 14315308, 14315309, 14315310, 14315311, 14315312, 14315313, 14315314, 14315315, 14315316, 14315317, 14315318, 14315319, 14315320, 14315321, 14315322, 14315323, 14315324, 14315325, 14315326, 14315327, 14315328, 14315329, 14315330, 14315331, 14315332, 14315333, 14315334, 14315335, 14315336, 14315337, 14315338, 14315339, 14315340, 14315341, 14315342, 14315343, 14315344, 14315345, 14315346, 14315347, 14315348, 14315349, 14315350, 14315351, 14315352, 14315353, 14315354, 14315355, 14315356, 14315357, 14315358, 14315359, 14315360, 14315361, 14315362, 14315363, 14315364, 14315365, 14315366, 14315367, 14315368, 14315369, 14315370, 14315371, 14315372, 14315373, 14315374, 14315375, 14315376, 14315377, 14315378, 14315379, 14315380, 14315381, 14315382, 14315383, 14315384, 14315385, 14315386, 14315387, 14315388, 14315389, 14315390, 14315391, 14315392, 14315393, 14315394, 14315395, 14315396, 14315397, 14315398, 14315399, 14315400, 14315401, 14315402, 14315403, 14315404, 14315405, 14315406, 14315407, 14315408, 14315409, 14315410, 14315411, 14315412, 14315413, 14315414, 14315415, 14315416, 14315417, 14315418, 14315419, 14315420, 14315421, 14315422, 14315423, 14315424, 14315425, 14315426, 14315427, 14315428, 14315429, 14315430, 14315431, 14315432, 14315433, 14315434, 14315435, 14315436, 14315437, 14315438, 14315439, 14315440, 14315441, 14315442, 14315443, 14315444, 14315445, 14315446, 14315447, 14315448, 14315449, 14315450, 14315451, 14315452, 14315453, 14315454, 14315455, 14315456, 14315457, 14315458, 14315459, 14315460, 14315461, 14315462, 14315463, 14315464, 14315465, 14315466, 14315467, 14315468, 14315469, 14315470, 14315471, 14315472, 14315473, 14315474, 14315475, 14315476, 14315477, 14315478, 14315479, 14315480, 14315481, 14315482, 14315483, 14315484, 14315485, 14315486, 14315487, 14315488, 14315489, 14315490, 14315491 Class II The volume control knob on some Plum A+ infusers (located on the back of the infuser) may not function as described in the System Operating Manual - the direction for Loud and Quiet may be reversed. The manual indicates a clockwise rotation of the knob decreases the volume; however, on some of the devices the alarm volume increases when the knob is turned clockwise. Hospira Inc.
Food Cold-smoked salmon in vacuum plastic bags that are partially clear and partially colored black, white, gold and pink, labeled in part: front panel: ***NATHAN'S TRADITIONAL DELICATESSEN NOVA SALMON CLASSIC SMOKED***NET WT 3 OZ (85g)*** back panel: ***NATHAN'S TRADITIONAL DELICATESSEN NOVA SALMON CLASSIC SMOKED***This salmon can be frozen for up to 45 days. Thaw under refrigeration. Once opened, keep refrigerated and be sure to enjoy within five days. Keep refrigerated at 38F or below.***0 73030 80368 2***INGREDIENTS: ATLANTIC SALMON (COLOR ADDED), SALT, SUGAR, PRESERVATIVES (SODIUM BENZOATE, SODIUM ERYTHORBATE, SODIUM NITRITE), FD&C YELLOW #5, YELLOW #6, RED #40, BLUE #1, AND NATURAL HARDWOOD SMOKE. DISTRIBUTED BY OCEAN BEAUTY SEAFOODS LLC, SEATTLE, WA 98119 WWW.OCEANBEAUTY.COM FARM RAISED PRODUCT OF CHILE A white stick-on label, affixed to the top left hand corner of the back panel, reads: top line: M228208 middle line left to right: 07 09 285 12 14 09 and bottom line: 10632 Pack Date: 285 UPC: 0 73030 80368 2; Class I Ocean Beauty Seafood's sample was found positive for Listeria monocytogenes. Ocean Beauty Seafoods, LLC
Food Cold-smoked salmon in vacuum plastic that are partially clear and partially colored blue, yellow, white, labeled in part: front panel: ***Lascco BRAND SLICED SMOKED NOVA SALMON NET WT 4 OZ (113g) PERISHABLE. KEEP REFRIGERATED AT 38F OR COLDER. back panel: ***Lascco BRAND SLICED SMOKED NOVA SALMON***0 72840 01751 7***INGREDIENTS: ATLANTIC SALMON (COLOR ADDED), SALT, SUGAR, PRESERVATIVES (SODIUM BENZOATE, SODIUM ERYTHORBATE, SODIUM NITRITE), FD&C YELLOW #5, YELLOW #6, RED #40, BLUE #1, AND NATURAL HARDWOOD SMOKE. DISTRIBUTED BY OCEAN BEAUTY SEAFOODS LLC, SEATTLE, WA 98119 WWW.OCEANBEAUTY.COM FARM RAISED PRODUCT OF CHILE A white stick-on label, affixed to the top left hand corner of the back panel, reads: top line: M228208 middle line left to right: 07 09 285 12 14 09 and bottom line: 10632 Pack Date: 285 UPC: 0 72840 01757 7 Class I Ocean Beauty Seafood's sample was found positive for Listeria monocytogenes. Ocean Beauty Seafoods, LLC
Devices Spacelabs Smart Disclosure System, Model 92810, is an integrated component of the Intesys Clinical Suite (ICS) G2, Version 4.03. The Smart Disclosure product collects patient waveforms, alarms, vital signs, and 12-lead reports. A 24-hour waveform acquisition is standard, with an upgrade option to 72 hours. The product provides basic trends in both tabular and graphical format, along with a retrospective ECG analysis. The analysis may be defined by patient, and the data may be presented in multiple formats, including a rhythm, a histogram, and a summary view. Standard reports are available from Smart Disclosure, including saved events, disclosure, trends, histogram, and summary. The Spacelabs Smart Disclosure System, Model 92810 is indicated for use in clinical situations where there is a need for review of physiological waveform information and alarm events up to 72 hours after the fact. Smart Disclosure is also indicated in those situations where a retrospective analysis of monitoring patients' ECG waveform data, that can be annotated and edited, is desired. The intended use of the Spacelabs Smart Disclosure is to interface with the Spacelabs monitoring network, providing the user with a means of recalling waveform information and performing retrospective analysis. The most recent 72 hours of monitored patient ECG waveform data can be analyzed, with each analysis limited to 24 hours or less. ICS G2 Smart Disclosure Model 92810, Version 4.03. There are no serial numbers. Class II Displaying or printing of an incorrect waveform for the time indicated in the printout or display in the Spacelabs Healthcare Intesys Clinical Suite (ICS) G2, Version 4.03, Clinical Access portion of Smart Disclosure, Model 92810. Spacelabs Healthcare, Llc
Food Marketside, Chunky Bleu Cheese Dressing, Net Wt. 14 fl. oz (414)mL, Manufactured For Marketside, a division of Wal-Mart Stores, Inc., Bentonville, AR 72716. Lot code 81H09062; Best By 01/04/13; UPC 6 81131 02900 1 Class II Undeclared Allergen: Dairy Naturally Fresh Inc.
Food Nautifish Frozen Cooked Lobster Meat. CKL 12 X 11.3 oz. Metal Cans. 12 items/case. Keep Frozen. Dates of Manufacture: 10/5/12, 11/4/12, 11/5/12, 11/6/12, 11/7/12. Date Codes: 12 309 to 12 312, Lot #50979 R, Product #12834. Date Code: 12 279. Lot #48213 R, Product number: 12834 Class I This product was found with Listeria monocytogenes through laboratory analysis. Cap Sur Mer, Inc.
Food Apollo Frozen Cooked Lobster Meat. BCKL Lobster Meat 6X2 lb, plastic bags, 6 individual items per case, keep frozen Date of Manufacture: 10/05/12; Lot # 11244 Class I The product or a previous product from this date code was found with Listeria monocytogenes through laboratory analysis. Cap Sur Mer, Inc.
Food Captain Homard Frozen Cooked Lobster Meat. Broken Tail Meat, 6X2 lb, plastic bags, 6 individual items per case. Keep Frozen. Date of Manufacture: 10/05/12, 11/05/12, 11/06/12, 11/07/12. Date Code: 12 279: #48293 R; #16046; 12 310, 12 311, 12 312 Lot# 50028 R Class I The product or a previous product from this date code was found with Listeria monocytogenes through laboratory analysis. Cap Sur Mer, Inc.
Food Frozen Cooked Lobster Tail Meat. Nautifish. 2 lb plastic bags, 6 items/case. Keep Frozen Date of Manufacture: 10/05/12. Date Code 12 279; Product Number: 339538 Class I The product or a previous product from this date code was found with Listeria monocytogenes through laboratory analysis. Cap Sur Mer, Inc.
Food Frozen Cooked Lobster Meat. Salad Meat 6 X 2 lb. plastic bags, 6 individual items per case. Captain Homard and Apollo. Keep Frozen Date of Manufacture: 11/04/12, 11/05/12, 11/06/12, 11/07/12; Date Code: 12 309 - 12 312; Lot #50019 and 50432R for Captain Homard; Lot #50020 for Appolo Product #15721 Class I This product was found with Listeria monocytogenes through laboratory analysis. Cap Sur Mer, Inc.
Food Frozen Cooked Lobster Meat. TCK Nautifish 6 X 2 lbs. Plastic Bags, 6 individual per case. Keep Frozen Date of Manufacture: 11/05/12, 11/06/12; Date Code: 12 310 - 12 311. Lot #50022 R, Product # 339 703 Class I The product or a previous product from this date code was found with Listeria monocytogenes through laboratory analysis. Cap Sur Mer, Inc.
Drugs Perindopril Erbumine Tablets, 8mg, 100 Tablets per Bottle, Rx Only, Boehringer Ingelheim, Roxane Laboratories Inc., Columbus, OH 43216, NDC 0054-0112-25. Lot #160017A, Exp 04/2013. Class III Impurities/Degradation Products: Out of Specification results found for impurity B, identified as the drug's metabolite. Boehringer Ingelheim Roxane Inc
Drugs Prednisone tablets, USP, 10mg, Rx Only, Units of Use, NDC: a) 45802-303-67, 48-count Cartons, b) 45802-303-21, 21-count Cartons, Manufactured by: West-Ward Pharmaceutical Corporation, Eastown, NJ 07724, Distributed by: Perrigo, Allegan, MI 49040. Lot #s: a) 2DV1238, Exp10/13; 2CV0623, 2CV0625, Exp 11/13; b) 2DV1239, Exp 10/13; 2CV0627, Exp 11/13 Class II Presence of Foreign Substance(s); Perrigo has been notified of a recall by the manufacturer of this product, West-Ward Pharmaceuticals. This is a sub-recall due to tablets contaminated with trace amounts of food-grade lubricant, as well as stainless steel inclusions L. Perrigo Co.
Food Candy Canes, Peppermint Flavor, 5 oz boxes, packed 12 individually candy canes/box, and labeled in part ***Distributed by Greenbriar International, Inc., Chesapeake, VA 23320, MADE IN CHINA*** Batch number: YT-0112003 01880-001 120521 01880-001 120605 Class II Candy product may contain metal and/or plastic pieces embedded in the candy. Dollar Tree Distribution, Inc.
Food Candy Canes, Cherry Flavor, 5 oz boxes, packed 12 candy canes/box, and labeled in part ***Distributed by Greenbriar International, Inc., Chesapeake, VA 23320, MADE IN CHINA*** Batch number: 01880-001 120504 Class II Candy product may contain metal and/or plastic pieces embedded in the candy. Dollar Tree Distribution, Inc.
Food JOEY'S GOURMET LEMON CAKE; NET WT 3 oz. (85 g); UPC 026104613403; Joey's Fine Foods, Inc., Newark, NJ 07104; 973-482-1400 All lots Class II Product contains undeclared FD&C Yellow #5. Local Baking, Co, Inc. T/A Joey's Fine Foods
Devices Sarns flexible arterial cannula, 6.7 mm (20Fr) OD with 3/8 in. connector, suture ring, 9.5 in (24 cm) long The Sarns High Flow Aortic Arch Cannula and Sarns Flexible Arterial Cannulae are indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery Lot number: 0677286 and Catalog number: 13010. Class II Flexible Arterial Cannula and High-Flow Aortic Arch Cannula connectors were identified to contain flash on the exterior of the cannula connector that exceeded established specifications. Because the flash has the potential to detach in the operative field, TCVS has decided to remove all affected lots that were manufactured with the affected connector part. Terumo Cardiovascular Systems Corporation
Devices Sarns flexible arterial cannula, 7.3 mm (22 Fr) OD with 3/8in connector, suture ring, 9.5in (24 cm) long The Sarns High Flow Aortic Arch Cannula and Sarns Flexible Arterial Cannulae are indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery Lot number: 0677284 and Catalog number: 13020 Class II Flexible Arterial Cannula and High-Flow Aortic Arch Cannula connectors were identified to contain flash on the exterior of the cannula connector that exceeded established specifications. Because the flash has the potential to detach in the operative field, TCVS has decided to remove all affected lots that were manufactured with the affected connector part. Terumo Cardiovascular Systems Corporation
Devices Sarns flexible arterial cannula, 8.0 mm (24 Fr) with 3/8in connector, suture ring, 9.5in (24 cm) long The Sarns High Flow Aortic Arch Cannula and Sarns Flexible Arterial Cannulae are indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery Lot number: 067728 and 0681074 and Catalog number: 13030 Class II Flexible Arterial Cannula and High-Flow Aortic Arch Cannula connectors were identified to contain flash on the exterior of the cannula connector that exceeded established specifications. Because the flash has the potential to detach in the operative field, TCVS has decided to remove all affected lots that were manufactured with the affected connector part. Terumo Cardiovascular Systems Corporation
Devices Sarns high-flow aortic arch cannula, 5.2 mm (16 Fr) OD with 3/8in connector, 7.5in (19 cm) long The Sarns High Flow Aortic Arch Cannula and Sarns Flexible Arterial Cannulae are indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery Lot number: 0677294, 0680693, 0682187 and Catalog number: 12315 Class II Flexible Arterial Cannula and High-Flow Aortic Arch Cannula connectors were identified to contain flash on the exterior of the cannula connector that exceeded established specifications. Because the flash has the potential to detach in the operative field, TCVS has decided to remove all affected lots that were manufactured with the affected connector part. Terumo Cardiovascular Systems Corporation
Devices Sarns high-flow aortic arch cannula, 6.5 mm (20 Fr) OD with 3/8in connector, 11in (28 cm) long The Sarns High Flow Aortic Arch Cannula and Sarns Flexible Arterial Cannulae are indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery Lot number: 0680122, 0680751and Catalog number: 12325 Class II Flexible Arterial Cannula and High-Flow Aortic Arch Cannula connectors were identified to contain flash on the exterior of the cannula connector that exceeded established specifications. Because the flash has the potential to detach in the operative field, TCVS has decided to remove all affected lots that were manufactured with the affected connector part. Terumo Cardiovascular Systems Corporation
Devices Sarns high-flow aortic arch cannula, 6.5 mm (20 Fr) OD with 3/8in connector, 11in (28 cm) long, with X coating surface The Sarns High Flow Aortic Arch Cannula and Sarns Flexible Arterial Cannulae are indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery Lot number: 0677299 and Catalog number: 12325X Class II Flexible Arterial Cannula and High-Flow Aortic Arch Cannula connectors were identified to contain flash on the exterior of the cannula connector that exceeded established specifications. Because the flash has the potential to detach in the operative field, TCVS has decided to remove all affected lots that were manufactured with the affected connector part. Terumo Cardiovascular Systems Corporation
Food Yangsheng Eggs Preserved Duck Eggs Content 6 pcs Net Wt: approx 12.69 oz (360g) S&M (USA) Enterprise Corp Rm3 8/F., Yuexiu Bldg., 160-174 Lockhart Road, Wan Chai, HK Distributed by : S & M Int'l Inc 100 Pulaski ST., Bayonne NJ 07002 Product of China UPC 6949682803551 Lot YS12-02A Class II Preserved Duck Eggs do not meet pH standard of 10 for boiled/preserved eggs. S & M International Inc
Food Somersault brand Cinnamon Crunch. Crunchy nuggets baked with sunflower seeds and toasted grains. Sunflower seed snack. .5 oz, 1 oz., 2 oz., 6 oz., and 16 oz. Cinnamon Crunch 12ct; 6oz. Case Code10-8-98403-002-27-4;Product Code 8-98403-002-27-7; Sell By: 8/30/2013 or earlier Cinnamon Crunch 16ct; 2oz.Case Code10-8-98403-002-27-4; Product Code8-98403-002-27-7; Sell By: 8/30/2013 or earlier Cinnamon Crunch 100ct; 0.5oz., Case Code10-8-98403-002-24-3; Product Code 8-98403-002-24-6; Sell By: 8/30/2013 or earlier Cinnamon Crunch 36ct; 1oz.Case Code10-8-98403-002-23-6; Product Code 8-98403-002-22-2; Sell By: 8/30/2013 or earlier, Cinnamon Crunch 50ct; 1oz., Case Code 10-8-98403-002-22-9; Product Code 8-98403-002-22-2; Sell By: 8/30/2013 or earlier Cinnamon Crunch Bulk 8ct; 16oz. (for samples only, no case and product code)Sell By: 8/30/2013 or earlier Shipper 36ct; 1oz. SS CC, Case Code10-8-98403-002-26-7; Product Code 8-98403-002-22-2; Sell By: 8/30/2013 or earlier Class I During ingredient review for kosher certification, the firm discovered that the finished product package did not bear a milk allergen declaration, although a flavor ingredient was found to contain milk Somersault Snack Co., LLC
Devices Q-Plus T Powered Laser Surgical Instrument Nd:YAG 1064 nm and 532 nm: Treatment of vascular lesions and pigmented lesions; Hair and tattoo removal; The incision, excision, ablation, vaporization of soft tissue for general dermatology. Ruby 694nm: Cutting, vaporization and ablation of soft tissue; Tattoo removal; Treatment of benign pigmented lesions. All codes and devices are applicable. Class II Quanta System S.p.A, Italy, is notifying U.S. consignees that their website contained promotional materials for products distributed in the U.S. which did not specify that some of the claims made therein were not meant to apply to the U.S. distributed devices. Quanta System, S.p.A.
Devices Eterna Giovinezza System, Powered Laser Surgical Instrument. Permanent hair reduction; Photocoagulation of dermatological vascular lesions; Photothermolysis of blood vessels (treatment of facial and leg veins); Treatment of benign pigmented lesions; Inflammatory acne All codes and devices are applicable. Class II Quanta System S.p.A, Italy, is notifying U.S. consignees that their website contained promotional materials for products distributed in the U.S. which did not specify that some of the claims made therein were not meant to apply to the U.S. distributed devices. Quanta System, S.p.A.
Devices Ultrawave II EX 1320/ Ultrawave III EX 1320 Powered Laser Surgical Instrument. Nd:YAG 1064 nm: Coagulation and hemostasis of benign vascular lesions (e.g. port wine stains, hemangiomas, warts, telangiectasia, rosacea, venus lake, leg and spider veins, scars, straie and psoriasis; Treatment of benign pigmented lesions to reduce lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments; Treatment of facial wrinkles (e.g. periocular and periorbital); Removal of unwanted hair, for the stable longterm, or permanent, hair reduction, including Fitzpatrick IVI and suntanned skin types; For the treatment of pseudofolliculitis barbae (PFB); Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar; For use on all skin types (Fitzpatrick IVI) including tanned skin. Alexandrite 755 nm: Coagulation and hemostasis of vascular lesions and the removal and permanent reduction of unwanted hair in Fitzpatrick skin types 1VI, including suntanned skin types; Pigmented lesions; Wrinkles. Nd: YAG 1320 nm: General surgery and dermatology for the incision, excision, ablation, vaporization, coagulation and hemostasis of soft tissue; Treatment of periorbital and periocular wrinkles, fine lines and wrinkles, treatment of back acne and atrophic acne scars. IPL: Permanent hair reduction; Photocoagulation of dermatological vascular lesion (i.e. face telangiectasia); Photothermolysis of blood vessels (treatment of facial and leg veins); Treatment of benign pigmented lesions. All codes and devices are applicable. Class II Quanta System S.p.A, Italy, is notifying U.S. consignees that their website contained promotional materials for products distributed in the U.S. which did not specify that some of the claims made therein were not meant to apply to the U.S. distributed devices. Quanta System, S.p.A.
Food Woodstock All Natural Tamari Almonds, 7.5 OZ in a gusseted re-sealable poly bag. Best By: 10/24/13 Lot: 12298 UPC# 0-42563-00838-3 Class I Undeclared soy ingredient on mislabeled back panel. While the Tamari Almonds contain soy, the ingredient statement does not include soy. In addition, the nutrition facts and UPC# are incorrect which corresponds to another almond product. People who have an allergy or severe sensitivity to soy run the risk of serious or life-threatening allergic reaction if they consume this product. Woodstock Farms
Drugs Divalproex Sodium Delayed-Release Tablets, USP, 500 mg Valproic Acid Activity, 100-count tablets per bottle, Rx only, Manufactured by Upsher-Smith Laboratories, Inc., Minneapolis, MN 55447, NDC 0245-0182-11. Lot #: 310162, Exp 09/14 Class III Labeling: Label Error On Declared Strength; Some bottles of product were missing the color-coded strength on the primary display panel of the label. Upsher Smith Laboratories, Inc.
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