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U.S. Department of Health and Human Services

Enforcement Report - Week of April 2, 2014

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Product Type Product Description Code Info Classification Reason for Recall Recalling Firm
Devices OASIS Medical Vidaurri LASIK Flap Irrigator, Product Specification 4036V. The Vidaurri LASIK Flap Irrigator is a 16g x 1/2'' stainless steel cannula with two 25g x 9/16'' tip extensions. There are eight .25mm ports (four per tip). Product Specification 4036V Lot D1201AD Lot D0702A Y Lot D0802J Lot D09028 Lot D0103V Lot D0303S Lot D1203AH Lot D0104AC Lot D0304AQ Lot D0504AG Lot D0105AV Lot D0205J Lot D0305AH Lot D03058D Lot D0605AE Lot D0705Y Lot D0805A8 Class II "Please be aware that this is not a new recall. The firm has taken action; but, due to administrative issues additional products are now being classified by the agency".Foreign deposit present on the surface of the Vidaurri LASIK Flap Irrigators Oasis Medical Inc
Devices OASIS Medical Vidaurri LASIK Flap Irrigator, Sterilized, Product Specification 8065403604 Dual Tip Irrigator 8 Ports The Dual tip Irrigator 8 Ports is placed into a vacuum formed plastic tray and a Tyvek lid is heat-sealed onto the tray. The heat-sealed tray is placed into a Tyvek pouch, heat-sealed and sterilized. After sterilization, 10 pouches are loaded into a carton, the carton is labeled and heat-shrink wrapped. Product Specification 8065403604 Lot D0304S Lot D0405A Y Lot D05058H Class II "Please be aware that this is not a new recall. This recall was initially classified in 2005 (Z-1595-05). The firm has taken action; but, due to administrative issues this product is now being classified by the Agency".Foreign deposit present on the surface of the Vidaurri LASIK Flap Irrigators. Oasis Medical Inc
Devices OASIS Medical Vidaurri LASIK Flap Irrigator, Non-sterilized Bulk, Product Specification MK-036V, LASIK Flap Irrigator (Vidaurri) The MK-03V cannula is placed into a vacuum formed plastic tray and a blank Tyvek lid is heat-sealed onto the tray. The heat-sealed tray is placed into a Tyvek pouch, heat-sealed and placed into a polybag. The polybag is sealed and labeled. Typically there are 100 pouches per polybag. Product Specification MK-036V Lot D0305Y Class II "Please be aware that this is not a new recall. This recall was initially classified in 2005 (Z-1595-05). The firm has taken action; but, due to administrative issues this product is now being classified by the Agency".Foreign deposit present on the surface of the Vidaurri LASIK Flap Irrigators. Oasis Medical Inc
Devices OASIS Medical Vidaurri LASIK Flap Irrigator, Non-sterilized Bulk, Product Specification B-4036V-NS, LASIK Flap Irrigator (Vidaurri) The -B4036V-NS cannula is placed into a vacuum formed plastic tray and a Tyvek lid is heat-sealed onto the tray. The heat-sealed tray is placed into a polybag. The polybag is sealed and labeled. Typically there are 100 trays per polybag. Product Specification 8-4036V-NS Lot D060488 Lot D0804T Lot D0904A Lot D1004AV Lot D12048X Class II "Please be aware that this is not a new recall. This recall was initially classified in 2005 (Z-1595-05). The firm has taken action; but, due to administrative issues this product is now being classified by the Agency".Foreign deposit present on the surface of the Vidaurri LASIK Flap Irrigators. Oasis Medical Inc
Biologics Red Blood Cells Leukocytes Reduced 16KP02714 Class III Blood product,which was out of controlled storage for an indeterminable length of time, was distributed. American National Red Cross (The)
Biologics Red Blood Cells Leukocytes Reduced 16KJ35036 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 Leukocytes Reduced 16KJ35036 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 16KJ35036 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 50E40490 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 Leukocytes Reduced 50V09551; 50V09552; 50V09556; 50V09559; 50V09560; 50V09561; 50V09562; 50V09563; 50V09566; 50V09570; 50V09571; 50V09572; 50V09573; 50V09574; 50V09575; 50V09576 Class III Blood products, collected using trip scales for which the daily QC was not documented, were distributed. American National Red Cross (The)
Biologics Red Blood Cells Leukocytes Reduced 50LC29458; 50LC29460; 50LC29464; 50LC29466; 50LC29467; 50LC29471; 50LC29474; 50LC29475; 50LC29476; 50LC29477; 50LC29478; 50LC29479; 50LC29480; 50LC29482; 50LC29485; 50LC29487; 50LC29488; 50LC29490 Class III Blood products, collected using trip scales for which the daily QC was not documented, were distributed. American National Red Cross (The)
Biologics Platelets Pheresis Leukocytes Reduced Irradiated 103332673 Class II Blood product, which was possibly contaminated with Propionibacterium acnes, was distributed. Blood Systems, Inc.
Biologics Source Plasma 40900748636; 40900733901 ;40900905179; 40900912627; 40900833187; 40900764257; 40900702857; 40900774922; 40900820044; 40900484458; 40900492546; 40900617994; 40900525539; 40900547391; 40900616473; 40900530442; 40900416295; 40900446320; 40900587895; 40900569080; 40900224103; 40900288350; 40900315072; 40900280009; 40900291200; 40900245192; 40900367040; 40900383569; 40900381352; 40900165502; 40900181334; 40900118095; 40900088543; 40900090467; 40900077810; 40900072912; 40900039821; 40900053199; 40900033075; 40900033895; 40900021437; 40900021437. Class II Blood products, collected from donors whose physical exams were not adequately performed, were distributed. CSL Plasma, Inc.
Devices Siemens Artis Q and Artis Q biplane systems Product Usage: Interventional Fluoroscopic X-ray model numbers 10848280, 10848281, 10848282, and 10848283. Class II There exists the possibility that during clinical operation, a breakdown of the x-ray tube could result in loss of x-ray imaging for the Artis Q and Artis Q biplane systems with a flat detector as 40 HDR (large 30x40). Siemens Medical Solutions USA, Inc
Devices Drill Template and the Saw Guide for the Ulna Osteotomy System. Intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragments, including osteopenic bone in the ulna. Part Nos. 03.111.900 through 03.111.905, with Lot Nos. 779372, 2638601, 7769386, 2638603, 7836420, 7772531, 2638604, 7836422, 7772538, 2638605, 7836423, 7915554, 7772543, 7772542, 7872775, 8400287, 7772554, 7772555, and 8229040. Class II The Drill Template and the Saw Guide for the Ulna Osteotomy System may exhibit jamming, bending, or breaking of the screw connecting the Saw Guide to the Drill Template or jamming, bending, or breaking of the K-wire during fixation of the Drill Template. Synthes, Inc.
Food Bonduelle USA Inc (Oakfield) BEANS GREEN CUT GRADED, Net weight: 1,480 lbs (bulk form in Totes), Keep frozen. Item # 1103805, Lot # A0002813 Class III Bonduelle North America has recalled bulk totes of Cut and Whole Green Beans due to the presense of filth. Bonduelle USA Inc
Food Bonduelle USA Inc (Oakfield) BEANS GREEN WHOLE GRADED, Net weight: 1,100 lbs (bulk form in Totes), Keep frozen. Item # 1103905, Lot #'s: A0002962, A0003047 Class III Bonduelle North America has recalled bulk totes of Cut and Whole Green Beans due to the presense of filth Bonduelle USA Inc
Food Chicken Soup for the Soul Thai-Style Chicken Broth, 32 oz. (2 lb., 907 g. paperboard carton. Distributed by Chicken Soup For The Soul Foods, LLC, Stamford, CT 06902-7532 UPC: 8 19239 01021 2. All lot codes Class II Product contains undeclared wheat Chicken Soup For The Soul Food
Biologics Platelets Pheresis Leukocytes Reduced Irradiated W202013807120; Class II Blood products, labeled leukoreduced without the assurance that they met the criteria for leukoreduced products, were distributed. American Red Cross Greater Alleghenies Region
Biologics Platelets Pheresis Leukocytes Reduced W2020138071301; W2020138071302; W202013807158; Class II Blood products, labeled leukoreduced without the assurance that they met the criteria for leukoreduced products, were distributed. American Red Cross Greater Alleghenies Region
Biologics Source Plasma 3740398610; 3740396742; Class II Blood products, collected from a donor who received a tattoo within 12 months of donating, were distributed. Talecris Plasma Resources, Inc.
Biologics Fresh Frozen Plasma W227712350078; Class II Blood product, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed. Mid-South Regional Blood Center
Biologics Red Blood Cells Leukocytes Reduced W035212147740Z; 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 W035212147740Z; Class III Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. Carter BloodCare
Food New Horizon Cuisine Chicken Demi-Glace Xpress, packaged in 16-oz. plastic cups (6/case) and New Horizon Cuisine Chicken Demi-Glace packaged in 16-lb. (2-gal.) buckets. The firm name on the label is New Horizon Cuisine, Ankeny, IA. Lot numbers 1062, 1065, and 1068 Class III Product was manufactured using chicken that was reported to be spoiled by another government agency. New Horizon Cuisine
Drugs DermOtic Oil (fluocinolone acetonide) 0.01% Ear Drops, 20 mL bottle, Rx only Manufactured and Distributed by: Hill Dermaceuticals, Inc. Sanford, Florida 32773 NDC 28105-160-20 12H028B exp. 01/14 Class III Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing. Hill Dermaceuticals, Inc.
Drugs Derma-Smoothe/FS fluocinolone acetonide 0.01% Topical Oil (Scalp Oil), 4 fl. oz., Rx only. Manufactured and Distributed by: Hill Dermaceuticals, Inc. Sanford, Florida 32773 NDC 28105-149-04 12J030C exp. 03/14, 12L041C exp. 05/14 Class III Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing. Hill Dermaceuticals, Inc.
Drugs Derma-Smoothe/FS fluocinolone acetonide 0.01% Topical Oil (Body Oil) 4 fl. oz., Rx only Manufactured and Distributed by: Hill Dermaceuticals, Inc. Sanford, Florida 32773 NDC 28105-150-04 13D010A exp. 10/14. Class III Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing. Hill Dermaceuticals, Inc.
Drugs ROYAL PHARMACEUTICALS Derma-Smoothe/FS fluocinolone acetonide 0.01% Topical Oil (Body Oil) 4 fl. oz., Rx only Manufactured by: Hill Dermaceuticals, Inc. for: Royal Pharmaceuticals NDC 68791-101-04 13E013A exp. 11/14. Class III Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing. Hill Dermaceuticals, Inc.
Drugs ROYAL PHARMACEUTICALS Derma-Smoothe/FS fluocinolone acetonide 0.01% (Scalp Oil), 4 fl.oz., Rx only Manufactured by: Hill Dermaceuticals for: Royal Pharmaceuticals NDC 68791-102-04 13E014A exp. 11/14, 13F02C exp 12/14. Class III Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing. Hill Dermaceuticals, Inc.
Drugs ROYAL PHARMACEUTICALS DermOtic Oil fluocinolone acetonide 0.01% (Ear Drops), 20 ml, Rx only Manufactured by: Hill Dermaceuticalsfor: Royal Pharmaceuticals NDC 68791-103-20 13F015B exp. 12/14, 13G023B exp. 01/15 Class III Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing. Hill Dermaceuticals, Inc.
Drugs SETON PHARMACEUTICALS Fluocinolone acetonide 0.01% Topical Oil (Scalp Oil), 4 fl.oz., Rx only Manufactured by: Hill Dermaceuticals, Inc. For: Seton Pharmaceuticals NDC 13925-507-04 13F015C exp. 12/14. Class III Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing. Hill Dermaceuticals, Inc.
Drugs SETON PHARMACEUTICALS Fluocinolone Acetonide 0.01% Topical Oil (Body Oil), 4 fl.oz., Rx only Manufactured by: Hill Dermaceuticals, Inc. For: Seton Pharmaceuticals NDC 13925-506-04 13F016A exp. 12/14. Class III Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing. Hill Dermaceuticals, Inc.
Drugs SETON PHARMACEUTICALS Fluocinolone Acetonide 0.01% Oil EAR DROPS, 20 ml, Rx only Manufactured by: Hill Dermaceuticals, Inc. For: Seton Pharmaceuticals NDC 13925-508-20 13F017B exp. 12/14, 13F020B exp 12/14 Class III Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing. Hill Dermaceuticals, Inc.
Food Thickened Water Pudding Thick 32 oz. (944ml) Phase 3 Ingredients: Pasteurized Filtered Water, Cellulose Gum Fibre, Potassium Sorbate. 3310133 Best By Date: 11/06/2015 Class II NUTRA Balance Pre-Thickened Water was found to contain mold. Nutra Balance Products
Food Thickened Water Nectar Thick 32 oz. (944ml) Phase 1 Ingredients: Pasteurized Filtered Water, Cellulose Gum Fibre, Potassium Sorbate, Citric Acid. 3310133 Best By Date: 11/06/2015 Best By Date: 07/30/2015 Best By Date: 05/02/2015 Class II NUTRA Balance Thickened Water Nectar Thick was found by the FDA to contain mold. In addition, Thickened Water Pudding thick was sampled by Nutra Balance Products and it subsequently tested positive for Enterobacter sp. and Xanthomonas sp. Nutra Balance Products
Biologics Red Blood Cells Leukocytes Reduced W088413545499; Class II Blood product, collected from a donor who reported travel to a malarial endemic area, was distributed. Blood Bank Of Hawaii
Biologics Red Blood Cells W036808185457; Class II Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. OneBlood, Inc.
Biologics Blood and Blood Products for Reprocessing W036808185457; Class III Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. OneBlood, Inc.
Biologics Blood and Blood Products for Reprocessing 3881200; Class II Blood product, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed. OneBlood, Inc.
Devices i-STAT G3+ Cartridge pH, pCO2 and pO2 measurements are used in the diagnosis, monitoring and treatment of respiratory disturbances and metabolic and respiratory based acid-based disturbances. List number 03P78-25 :Lot number N13183 Class II Abbott Point of Care has determined that some individual patient results generated with the i-STAT G3+ cartridge lot N13183 have the potential to exhibit incorrectly elevated PCO2 and depressed pH results. Abbott Point Of Care Inc.
Biologics Source Plasma 41205422321; 41205387140; 41205353899; Class II Blood products, collected from a donor who received a tattoo within 12 months of donating, were distributed. Csl Plasma, Inc.
Biologics Red Blood Cells Leukocytes Reduced W069113101516; Class II Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. Mississippi Blood Services Inc.
Biologics Blood and Blood Products for Reprocessing W069113101516; Class III Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. Mississippi Blood Services Inc.
Biologics Red Blood Cells 1444044; 1619813; Class II Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. OneBlood, Inc.
Biologics Cryoprecipitated AHF 1619813; Class II Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. OneBlood, Inc.
Biologics Platelets 1619813; Class II Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. OneBlood, Inc.
Biologics Source Plasma 0300487938; 0300488345; 0300489002; 0300489570; 0300490435; 0300490684; 0300491382; 0300491737; 0300492711; 0300493807; 0300494158; 0300495122; 0300495417; 0300496174; 0300496553; 0300497384; 0300498402; 0300498745; 0300499952; 0300500251; 0300501085; 0300501524; 0300502548; Class III Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. Biomat USA Inc
Devices AXIOM Artis Systems Product usage: Artis zee is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Model nos. 7412807, 7727717, 7728392 with serial numbers: 35020, 34999,35098 35113 35042 35061 35064 35073 35014 35069 35053 35055 35056 35054 35008 35057 35044 35018 35097 35108 35046 35048 35050 35045 35004 35019 46004 46005 40000 40009 40011 40006 40007 40010 44016 44005 44011 Class II Certain units of the AXIOM Artis Systems are using a flat detector cooling unit with inappropriate connectors that may possibly leak, causing a system failure and possible drop out of the gantry system. Siemens Medical Solutions USA, Inc
Devices PowerPort® Slim Implantable Port, indicated for patient therapies requiring repeated access to the vascular system. Product Codes: 1716000, 1716070 Lot Numbers: REXA1302, REXA1350, REXB1160 Class II Bard Access Systems, Inc. has notified customers of a labeling discrepancy involving PowerPort® Slim Implantable Port 1716000, 1716070 in which the label states that the implantable port contains silicone suture plugs, however approximately 23% of the units contained in the affected lots have a PowerPort® Slim titanium implantable port without silicone suture plugs. Bard Access Systems
Devices AMS BUN UREA NITROGEN For the In vitro quantitative determination of Urea Nitrogen in serum Quantitative determination of Bun in serum. Model Numbers: 40072, 40146, 81046. Lot codes: 131083, 131084, 131085, 131086, 131087, 131088, 131089, 1310810, 1310811, 1310812, 1310813, 1310814, 1310815, 141081. Class II Marketing the devices outside 510(k) requirements AMS Diagnostics, LLC
Devices AMS URIC ACID For the In vitro quantitative determination of Uric Acid in serum Quantitative determination of Uric Acid in serum. Model Numbers: 40147, 80147. Lot codes: 131253, 131254, 131255. Class II Marketing the devices outside 510(k) requirements AMS Diagnostics, LLC
Devices AMS AST For the In vitro quantitative determination of AST in serum Quantitative determination of AST in serum. Model Numbers: 40072, 40146, 80146. Lot codes: 131083, 131084, 131085, 131086, 131087, 131088, 131089, 1310810, 1310811, 1310812, 1310813, 1310814, 1310815, 141081. Class II Marketing the devices outside 510(k) requirements AMS Diagnostics, LLC
Food FAIRWAY brand CONDIMENT GRILLING SAUCE, NET WT 12 oz (340 g), UPC 7 58940 70609 3 -- Distributed By: Fairway Group Central Services LLC New York, New York 10027 --- The product is packaged in a glass bottle, 12 bottles per case. Lot 340 GRSC with a "use by" date of 03/08/2014, and Lot 357 GRSC with a "use by" date 03/25/2014 (located on side of glass bottle) Class II The Grilling Sauce contains undeclared fish (anchovies), a a sub-ingredient in the Worcestershire Sauce ingredient used in making the product. Wolfgang B. Gourmet Foods, Inc.
Food Kinnikinnick Original Homestyle Waffles 210 g/7.4 oz Cardboard Box UPC 620133001981 BB 20131209, 20131231, BB 2014 0126, 2014 AL15, 2014 JN24, 2014 JL29 Class I Undeclared milk World Pure Foods Wholesalers, Inc.
Food Kinnikinnick Cinnamon & Brown Sugar Homestyle Waffles 210 g/7.4 oz Cardboard Box UPC 620133001981 BB 20140127, 2014 MA28, 2014JN25 Class I Undeclared milk World Pure Foods Wholesalers, Inc.
Food Kinnikinnick Panko Style Bread Crumbs-Weight: 350g/12.5oz Cardboard Box UPC 62013360015 3 BB 20140209, 20140119, 20140211, 2014MR30, 2014 JN02, 2014JL23, 20131230 Class I Undeclared milk World Pure Foods Wholesalers, Inc.
Devices Single Analyte DAU Calibrator (5 mL) Norbuprenorphine: Cutoff Calibrator; IVD - for in vitro diagnostic use only; Lin-Zhi International Sunnyvale, CA The Norbuprenorphine Drug of Abuse (DAU) cutoff Calibrator is used for qualitative and semi-qualitative calibration of the Lin-Zhi Internal, Inc. Buprenorphine (BUP) enzyme Immunoassay (REF # A53684) on the Synchron Clinical Analyzer Product catalog number: A68827; Lots 1308006, 1308131, Expiry: March 28, 2015. Class III Customer reported that the Synchron NBUP cutoff calibrator (10 ng/mL) could not be qualified through quality control testing. The cutoff calibrator was recovering at a concentration close to the NBUP Control Level 1 (7 ng/mL). Lin-Zhi International Inc
Devices DICOM Export Format for Sum Dose with Velocity v3.0.0. A stand-alone software product that provides the oncology care specialists (physicians, physicists, dosimetrists, etc.) a means for comparison of medical imaging data from multiple DICOM conformant imaging modality sources. It allows the display, annotating, volume rendering, registration and fusing of medical images as an aid during use by diagnostic radiology, oncology, radiation therapy planning and other medical specialties. VelocityAIS 3.0.0 Class II An anomaly was detected such that, under certain conditions, a summed dose created by Velocity replaces the calculated dose from an approved plan in Eclipse when importing the dose from Velocity. Velocity Medical Solutions, LLC
Food L-Citrulline, bulk product, 25 kg Lot number 121109 Class I The recall was initiated due to an adverse event report from a consignee and the discovery of a compound other than L-Citrulline in at least one drum. Axel Chemicals
Food my essentials brand sour cream, NET WT. 24 OZ. (680g), UPC 7 25439 10546 0 --- Firm on label: DISTRIBUTED BY DZA BRANDS, LLC 2110 Executive Drive, Salisbury, NC 28147 --- The sour cream is packed in a plastic container. APR 05 14 (ink jetted onto the lip of the lid on each container) Class II HP Hood LLC received one complaint of a foreign object in sour cream product with APR 05 14 code. The object was subsequently identified to be part of a metal bolt from a filling machine. HP Hood LLC
Devices D-10" Hemoglobin Testing System, Model number: 220-0220 Manufactured by: Bio-Rad Laboratories, Inc. 4000 Alfred Nobel Drive Hercules, CA 94545 The D-10 Hemoglobin Testing System is a single module designed for hemoglobin analysis in mid-volume laboratories. The D-10 is a fully integrated system for sample dilution, processing and analysis of hemoglobin, designed for use with specific Bio-Rad reagent kits. The D-10 incorporates the use of a dedicated software system for instrument control, data collection and analysis. Model number: 220-0220 Class II On a rare occasion the D-10 software might generate an extra result by duplicating the result form the previous sample and the Sample ID/Injection number from the next sample. Bio-Rad Laboratories, Inc.
Food Frozen Ice Cake (Watermelon), 17.98 oz, 6 retail units/carton, UPC 8 801062 443055 Lot codes: 13.05.01F2 and 13.07.17F2 13.05.01F2 - This code date was printed on the retail units contained within Entry #EJA-5046135-1 (November) 13.07.17F2 - This code date was printed on the retail units contained within Entry #EJA-5045319-2 (October) Class I Jin Sun Mi International is recalling watermelon ice bar product because it contains undeclared peanuts. JIN SUN MI INTERNATIONAL INC
Devices Spacelabs Healthcare G2 Clinical Access Mislabeled CDs for PN: 063-1829-11 Rev A and Update Kit, PN: 040-1565-10. Used for installing ICS G2 Clinical Access software onto hospital personal computers. Two G2 Clinical Access CD part numbers are affected: PN: 063-1829-11 Rev A and Update Kit, PN: 040-1565-10. Serial numbers distributed in the US: "040-1565-10" and "063-1829-11". Serial number distributed outside the US: "063-1829-11". Class II Spacelabs has voluntarily recalled G2 Clinical Access Software CD because the programs installed on the Clinical Access CD are incorrect and it will prevent the customer from installing Clinical Access. Spacelabs Healthcare, Llc
Devices HeartMate II Implant Kit with Pocket Controller; with sealed grafts (NAm) with sealed grafts (EU) Product Usage: HeartMate II is a mechanical device that circulates blood throughout the body when the heart is too weak to pump blood adequately on its own. Catalog number 106015 (NAm) 106016 - EU all serial numbers Class I Discovery of serious injuries and deaths associated with the process of changing from a primary System controller to their back-up System controller in patients using the Pocket System controller model. Thoratec Corporation
Devices HeartMate II System Controller Product Usage: HeartMate II is a mechanical device that circulates blood throughout the body when the heart is too weak to pump blood adequately on its own. It is sometimes called a a heart pump or VAD. HeartMate II is a small implantable LVAD. HeartMate II attaches to the heart and is designed to assist or take over the pumping function of the patients left ventricle, the main pumping chamber of the heart. Catalog number 106762 (NAm) 106017 - EU all serial numbers Class I Discovery of serious injuries and deaths associated with the process of changing from a primary System controller to their back-up System controller in patients using the Pocket System controller model. Thoratec Corporation
Devices Heart Mate II Pocket Controllers removed from packaging Product Usage: HeartMate II is a mechanical device that circulates blood throughout the body when the heart is too weak to pump blood adequately on its own. Catalog number 105109 (found on side of unit) all serial numbers Class I Discovery of serious injuries and deaths associated with the process of changing from a primary System controller to their back-up System controller in patients using the Pocket System controller model. Thoratec Corporation
Devices HeartMate II LVAD Pump and Pock Controller Kit; Product Usage: HeartMate II is a mechanical device that circulates blood throughout the body when the heart is too weak to pump blood adequately on its own. Catalog number 107801 all serial numbers Class I Discovery of serious injuries and deaths associated with the process of changing from a primary System controller to their back-up System controller in patients using the Pocket System controller model. Thoratec Corporation
Devices FIBERNET Embolic Protection System: Recommended Vessel Diameter 3.5 0 5.0 mm, Maximum Guidewire Diameter: 0.014 in ( 0.36 mm) Rx only, Sterile; Manufactured in: Invatec S.P.A., 25030 Roncadelle, Italy; Manufacturer: Medtronic Inc. Minneapolis, MN 55432. The FiberNet Embolic Protection System is indicated for use as a guidewire and emboli protection system to capture and remove embolic material (thrombus/debris) produced while performing percutaneous transluminal interventional procedures in carotid arteries in high surgical risk patients with reference vessel diameters of 3.5 mm to 7.0 mm. US Model Number FBC350500190, lot number 1E029174; Internation Model number FBN350500190; lot 1E012912. Class II Medtronic is recalling a specific subset of lot numbers of the FIBERNET Embolic Protection System (EPS) where the yellow polyimide tube on the FIBERNET EPS was not removed from the FIBERNET EPS during the manufacturing process and subsequently may remain on the FIBERNET EPS. Medtronic Vascular, Inc.
Devices FIBERNET Embolic Protection System: Recommended Vessel Diameter 5.0 -6.0 mm, Maximum Guidewire Diameter: 0.014 in (0.36mm) Rx only, Sterile; Manufactured in: Invatec S.P.A., 25030 Roncadelle, Italy; Manufacturer: Medtronic Inc. Minneapolis, MN 55432. The FiberNet Embolic Protection System is indicated for use as a guidewire and emboli protection system to capture and remove embolic material (thrombus/debris) produced while performing percutaneous transluminal interventional procedures in carotid arteries in high surgical risk patients with reference vessel diameters of 3.5 mm to 7.0 mm. US Model Number FBC 500600190, lot number 1E029176; International Model Number FBN500600190, lot number 1E012914. Class II Medtronic is recalling a specific subset of lot numbers of the FIBERNET Embolic Protection System (EPS) where the yellow polyimide tube on the FIBERNET EPS was not removed from the FIBERNET EPS during the manufacturing process and subsequently may remain on the FIBERNET EPS. Medtronic Vascular, Inc.
Devices FIBERNET Embolic Protection System: Recommended Vessel Diameter 6.0 -7.0 mm, Maximum Guidewire Diameter: 0.014 in (0.36mm) Rx only, Sterile; Manufactured in: Invatec S.P.A., 25030 Roncadelle, Italy; Manufacturer: Medtronic Inc. Minneapolis, MN 55432. The FiberNet Embolic Protection System is indicated for use as a guidewire and emboli protection system to capture and remove embolic material (thrombus/debris) produced while performing percutaneous transluminal interventional procedures in carotid arteries in high surgical risk patients with reference vessel diameters of 3.5 mm to 7.0 mm. US Model Number FBC 600700190, lot number 1E029750; International Model Number: FBN600700190: lot numbers 1E012916, 1E017817. Class II Medtronic is recalling a specific subset of lot numbers of the FIBERNET Embolic Protection System (EPS) where the yellow polyimide tube on the FIBERNET EPS was not removed from the FIBERNET EPS during the manufacturing process and subsequently may remain on the FIBERNET EPS. Medtronic Vascular, Inc.
Devices MEVION S250, System, Radiation Therapy, Charged-Particle, Medical used for Proton Radiation Therapy Product Usage: Proton Radiation Therapy S250-0001 Class II Geometric positioning error can occur after a rotational correction has been applied to one or more treatment fields Mevion Medical Systems, Inc.
Food Stage 2 World Baby Thailand; Roasted Pumpkin & Coconut Rice, 3.5 oz. pouch. Product of USA distributed by Plum Inc., Emeryville, CA Best Before 10SEP14 Class II Intermittent damage to the plastic spouts during manufacturing of two varieties of Plum products on two production dates may cause plastic fragments to break loose and cause a potential choking hazard. Plum Inc
Food Stage 2 World Baby ; Zucchini & Spinach with Pasta Marinara; 3.5 oz. pouch. Product of USA distributed by Plum Inc., Emeryville, CA Best Before 09SEP14 Class II Intermittent damage to the plastic spouts during manufacturing of two varieties of Plum products on two product dates may cause plastic fragments to break loose and cause a potential choking hazard. Plum Inc
Food UNCLE BEN's(R) READY RICE(R) Original Enriched Long Grain White Rice, 8.8 oz. (250g), UPC 054800 031764 Best Before Date 12/14 MADE IN CANADA 351GBBFP [1L, 2L, 3L, 1R, 2R, 3R] Class II Voluntary recall was initiated after identifying a number of packages with punctures on the back of the package that led to spoilage (off odors and appearance). Mars Food US
Food Golden Natural Fruit Island Net Wt. 25.00 oz Product of Crown Food North Bergen, NJ 07047 Packed by: Crown Food/North Bergen 07047 USA UPC 098346021032 Sell by Date 11/19/14 Class I NYSDAM analysis has revealed the presence of undeclared sulfites and undeclared FD&C Yellow #6 in Golden Natural Brand "Fruit Island". Crown Food Distributors Inc
Devices Ovation Prime Abdominal Stent Graft System; Manufacturer: TriVascular, Inc. 3910 Brickway Blvd. Santa Rosa, CA 95403 The TriVascular Ovation Prime Abdominal Stent Graft System is an endovascular device delivered via a small diameter catheter to treat abdominal aortic aneurysms (AAAs). The stent graft is designed to reline the diseased vasculature, providing an endovascular blood conduit for isolating the aneurysm from the high pressure flow of blood, thereby reducing the risk of rupture. The stent graft is a modular configuration comprised of an aortic body section, iliac limbs, and iliac extensions as required. All codes Class II Communication to European physician users of the Ovation Prime Abdominal Stent Graft system to notify them of changes to Instructions for Use. Trivascular, Inc
Devices Weck® Vista", Universal Laparoscopic Port, Size 5/10mmx100mm, Product Usage: An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. Product Code: 405910, Lot Number: 01G1200242, 01G1200341, 01J1200100, 01J1200378, 01J1200461, 01K1200266, 01K1200171, 01L1200182, 01A1300139, 01B1300050, 01D1300318, 01E1300217, and 01E1300432. Class II Complaints were received of leakage of insufflation gas through the device, which can cause difficulty or delay in the completion of laparoscopic surgical procedures. Teleflex Medical
Devices 10mm Weck® Vista" Cannula-only, Teleflex Medical, Product Usage: An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. Product Code: 405912, Lot Number: 01J1200462, 01K1200129, 01K1200377, 01K1200596, 01K1200611, 01L1200369, 01A1300106, 01E1300218, 01E1300311, 01F1300135, and 01F1300079. Class II Complaints were received of leakage of insufflation gas through the device, which can cause difficulty or delay in the completion of laparoscopic surgical procedures. Teleflex Medical
Devices 5/10 mm Weck®, Vista" Optical Bladeless Laparoscopic Access Port, Product Usage: An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. Product Code: 405933, Lot Numbers: 01L1200353, and 01F1300080. Class II Complaints were received of leakage of insufflation gas through the device, which can cause difficulty or delay in the completion of laparoscopic surgical procedures. Teleflex Medical
Devices 5/10 mm Weck®, Vista" Universal Cannula, Teleflex Medical, Product Usage: An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. Product Code: 410944, Lot Numbers: 01K1200601, 01K1200623, 01L1200355, 01L1200378, 01A1300203, 01D1300412, 01J1200241, 01K1200066, 01K1200622 Class II Complaints were received of leakage of insufflation gas through the device, which can cause difficulty or delay in the completion of laparoscopic surgical procedures. Teleflex Medical
Devices Weck® Vista" Universal Laparoscopic Port, Size 5/10/12mmx100mm, Product Usage: An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. Product Code: 40591213, Lot Numbers: 01J1200416, 01K1200612, 01L1200160, 01A1300418, 01A1300427, 01E1300056, 01E1300052, 01E1300055 Class II Complaints were received of leakage of insufflation gas through the device, which can cause difficulty or delay in the completion of laparoscopic surgical procedures. Teleflex Medical
Devices Weck® Vista" Universal Laparoscopic Port, Size 5/10/12mmx125mm, Product Usage: An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. Product Code: 405910C, Lot Numbers: 01G1200243, 01J1200226, 01L1200368, 01A1300177, 01D1300107, 01E1300140, 01E1300435. Class II Complaints were received of leakage of insufflation gas through the device, which can cause difficulty or delay in the completion of laparoscopic surgical procedures. Teleflex Medical
Devices 12mm Weck® Vista" Cannula-only, Teleflex Medical, Product Usage: An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. Product Code: 405910R, Lot Numbers: 01J1200009, 01J1200234, 01J1200380, 01K1200142, 01M1200251, 01A1300140, 01A1300376, 01A1300419, 01A1300370, 01A1300179, 01A1300419, 01A1300373. Class II Complaints were received of leakage of insufflation gas through the device, which can cause difficulty or delay in the completion of laparoscopic surgical procedures. Teleflex Medical
Devices 5/10/12 mm Weck® Vista" Optical Bladeless Laparoscopic Access Port, Product Usage: An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. Product Code: 405910RC, Lot Numbers: 01J1200010, 01J1200242, 01K1200070, 01A1300141, 01B1300052, and 01D1300319. Class II Complaints were received of leakage of insufflation gas through the device, which can cause difficulty or delay in the completion of laparoscopic surgical procedures. Teleflex Medical
Devices 5/10/12 mm Weck® Vista" Universal Cannula, Product Usage: An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. Product Code: 405912C, Lot Numbers: 01J1200384, 01K1200725, 01L1200352, and 01B1300009. Class II Complaints were received of leakage of insufflation gas through the device, which can cause difficulty or delay in the completion of laparoscopic surgical procedures. Teleflex Medical
Devices 5/10/12MM X 100MM Weck® Vista" UNIVERSAL CONE OPEN ACCESS, Product Usage: An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. Product Code: 405912R, Lot Numbers: 01H1200064, 01K1200378, 01K1200621, 01L1200370, 01M1200071, 01M1200252, 01A1300170, 01A1300201, 01A1300420, 01A1300545, and 01F1300136. Class II Complaints were received of leakage of insufflation gas through the device, which can cause difficulty or delay in the completion of laparoscopic surgical procedures. Teleflex Medical
Devices 5/10 Weck® Vista" Universal Balloon Open Access Port - Standard Length (70mm), Product Usage: An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. Product Code: 405912RC, Lot Numbers: 01G1200244, 01M1200020, 01M1200068, 01A1300546, and 01A1300559. Class II Complaints were received of leakage of insufflation gas through the device, which can cause difficulty or delay in the completion of laparoscopic surgical procedures. Teleflex Medical
Devices 5/10 Weck® Vista" Universal Balloon Open Access Port - Long Length (100mm), Product Usage: An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. Product Code: 410944L, Lot Numbers: 01J1200219, 01K1200067, 01K1200600, 01L1200056, 01L1200354, and 01A1300202. Class II Complaints were received of leakage of insufflation gas through the device, which can cause difficulty or delay in the completion of laparoscopic surgical procedures. Teleflex Medical
Devices 5/10 Weck® Vista" Universal Balloon Open Access Port  Short Length (53mm), Product Usage: An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. Product Code: 410944S, Lot Numbers: 01J1200460, 01K1200619, 01L1200515, and 01E1300137. Class II Complaints were received of leakage of insufflation gas through the device, which can cause difficulty or delay in the completion of laparoscopic surgical procedures. Teleflex Medical
Devices 5/10/12 Weck® Vista" Universal Balloon Open Access Port  Standard Length (70mm), Product Usage: An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. Product Code: 410944S, Lot Numbers: 01J1200460, 01K1200619, 01L1200515, and 01E1300137. Class II Complaints were received of leakage of insufflation gas through the device, which can cause difficulty or delay in the completion of laparoscopic surgical procedures. Teleflex Medical
Devices 5/10/12 Weck® Vista" Universal Balloon Open Access Port  Long Length (100mm), Product Usage: An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. Product Code: 412944L, Lot Numbers: 01J1200231, 01K1200597, 01K1200618, 01K1200728, 01A1300178, 01D1300316, 01E1300310, and 01E1300436. Class II Complaints were received of leakage of insufflation gas through the device, which can cause difficulty or delay in the completion of laparoscopic surgical procedures. Teleflex Medical
Devices Morph AccessPro Steerable Introducer; 6F Introducer, 45 cm working length Single use only. BioCardia, Inc. San Carlos, CA 94070 BioCardia Morph AccessPro is intended to provide a pathway through medical instruments cush as balloon dilation catheters, guidewires or other therapeutic devices that may be introduced into the peripheral vasculature. Catalog number MAP645 - Lot numbers: 1037 1048 1055 1059 1069 1073 1074 1079 1092 1095 1115 1118 1121 1125 1128 1130 1134 1147 1155 1164 1168 1169 1173 1177 1184 1190 Class II Firm discovered the potential for particulates in the inner lumen of Morph Access Pro Steerable Introducer, which could result in am embolic event. Biocardia, Inc.
Devices Morph AccessPro Steerable Introducer; 6F Introducer, 90 cm working length: Single use only. BioCardia, Inc. San Carlos, CA 94070 BioCardia Morph AccessPro is intended to provide a pathway through medical instruments cush as balloon dilation catheters, guidewires or other therapeutic devices that may be introduced into the peripheral vasculature. Catalog number MAP690 -lot numbers: 1051 1063 1083 1106 1119 1137 1138 1140 1146 1148 1151 1154 1160 1162 1183 1186 Class II Firm discovered the potential for particulates in the inner lumen of Morph Access Pro Steerable Introducer, which could result in am embolic event. Biocardia, Inc.
Devices Suture, Non-absorbable, Synthetic, Polyamide, Sterile, Rx only, Product Usage: Non-absorbable polyamide surgical suture is a non-absorbable, sterile, flexible thread prepared from long-chain aliphatic polymers Nylon 6 and Nylon 6,6 and is indicated for use in soft tissue approximation. Product Code: 1154654, Lot number: 02K0801212 Class II The products are being recalled because they did not meet minimum needle attachment strength requirements. Teleflex Medical
Devices Sutures, Non-absorbable, Synthetic, Polyethylene, Sterile, Rx only, Product Usage: Non-absorbable poly(ethylene terephthalate) surgical suture is a multifilament, non-absorbable, sterile, flexible thread prepared from fibers of high molecular weight, long-chain, linear polyesters having recurrent aromatic rings as an integral component and is indicated for use in soft tissue approximation. Product Code: 0100019-507, Lot number: 02F1301128;  ...
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Class II The products are being recalled because they did not meet minimum needle attachment strength requirements. Teleflex Medical
Devices Sutures, Non-absorbable, Synthetic, Polypropylene, Sterile, Rx only, Product Usage: Non-absorbable polypropylene surgical suture is a monofilament, Non-absorbable, sterile, flexible thread prepared from long-chain polyolefin polymer known as polypropylene and is indicated for use in soft tissue approximation. Product Code: 833-123, Lot numbers: 02A0902858, 02D0900775, 02G1003092, 02H1100535, 02H1100536, & 02K1102309; Product Code: 833-124, Lot numbers: 02A1200503, 02B1101450 & 02C0903400; Product Code: 02D0900010, 02D0900103, 02D1003285, 02D1003286 & 02F1302321; Product Code: 02G1000045, 02G1300348, 02G1301122, 02H1100494, & 02L0803407; Product Code: 02L1100009, 02M1002289, 02M1101933 & 02F1302322; 833-213, Lot number: 02H1100687; Product Code:  ...
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Class II The products are being recalled because they did not meet minimum needle attachment strength requirements. Teleflex Medical
Devices Sutures, Absorbable, Synthetic, Polyglycolic Acid, Sterile, Rx only, Product Usage: Non-absorbable polypropylene surgical suture is a monofilament, Non-absorbable, sterile, flexible thread prepared from long-chain polyolefin polymer known as polypropylene and is indicated for use in soft tissue approximation. Product Code: BON100, Lot numbers: 02H1302839, 02J1101705, 02D1101137, and 02F1103013. Class II The products are being recalled because they did not meet minimum needle attachment strength requirements. Teleflex Medical
Devices Sutures, Non-absorbable, Steel, Monofilament and Multifilament, Sterile, Rx only, Product Usage: A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or Ushaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system. Product Code: X-4981M4, Lot number: 02J0800451 Class II The products are being recalled because they did not meet minimum needle attachment strength requirements. Teleflex Medical
Devices Sutures, Non-absorbable, Silk, Sterile, Rx only, Product Usage: Natural non-absorbable silk surgical suture is a non-absorbable, sterile, flexible multifilament thread composed of an organic protein called fibroin. This protein is derived from the domesticated species Bombyx mori (B. mori) of the family Bombycidae. Natural non-absorbable silk surgical suture is indicated for use in soft tissue approximation. Natural non-absorbable silk surgical suture meets the United States Pharmacopeia (U.S.P.) monograph requirements for Non-absorbable Surgical Suture (class I). Natural non-absorbable silk surgical suture may be braided or twisted; it may be provided uncoated or coated; and it may be undyed or dyed with an FDA listed color additive. Product Code: X-6371M5, Lot numbers: 02E0801603 Class II The products are being recalled because they did not meet minimum needle attachment strength requirements. Teleflex Medical
Food Italian blend Salad (Romaine Lettuce and Radicchio) packaged under the following brand names: Dole Italian Blend, (UPC 7143000819); Fresh Selections Italian Style Blend (Kroger) (UPC 1111091045); Little Salad Bar Italian Salad, (UPC 4149811014); Marketside Italian Style Salad, (Wal Mart) (UPC 8113102780) 10 oz. bags (283 g) Dole Fresh Vegetables Monterey, CA 93942 A058201A, A058201B, Best By March 12, 2014. Class I Canadian Food Inspection Agency tested a random sample of bagged Italian Blend which tested positive for Listeria Monocytogenes. Dole Fresh Vegetables Inc
Food Cookin' Cajun (TM) Acadiana Style Etouffee Seasoning Blend, UPC 898851004 all product distributed 03/10/2012 - 03/10/2014 Class II Product is labeled as containing flour, but contains wheat flour which is not declared on the label. Creole Delicacies Kitchens Inc
Food Sausage & Egg English Muffin, Good and Fresh brand, 4.1 oz, packaged in clear plastic wrap. UPC 855173005204. Sell Thru 03/15/14 11:59 pm Class II Ready to eat breakfast sandwich was assembled with raw suasage meat. Flying Food Group LLC
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