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U.S. Department of Health and Human Services

Enforcement Report - Week of June 18, 2014

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Product Type Product Description Code Info Classification Reason for Recall Recalling Firm
Biologics Source Plasma 3390027291, 3390026997, 3390034901, 3390034613, 3390034177, 3390033892, 3390033469, 3390033180, 3390032797, 3390032529, 3390032271, 3390031693, 3390031410, 3390031031, 3390029276, 3390028939, 3390028671, 3390012919, 3390012722, 3390030301, 3390029888, 3390029304, 3390028888, 3390028585, 3390028144, 3390027839, 3390027478, 3390027200, 3390026795, 3390026532, 3390026022, 3390025464, 3390025215, 3390024882, 3390024316, 3390024051, 3390023876, 3390023612, 3390023015, 3390022664, 3390022459, 3390022147, 3390021905, 3390021626, 3390019372, 3390019174, 3390018812, 3390018481, 3390018240, 3390017846, 3390017612, 3390017216, 3390016985, 3390016654, 3390016420, 3390016106, 3390015849, 3390015489, 3390015259, 3390014959, 3390014685, 3390014384, 3390014163, 3390013933, 3390013733, 3390013439, 3390013224, 3390012946, 3390012751, 3390012496, 3390012103, 3390011903, 3390011682, 3390011462, 3390011210, 3390010971, 3390010750, 3390003006, 3390002682, 3390002337, 3390002045, 3390021152, 3390020917, 3390020618, 3390020404, 3390020051, 3390019867, 3390019539, 3390018923, 3390018752, 3390018194, 3390017706, 3390017561, 3390017127, 3390016973, 3390016583, 3390016403, 3390016009, 3390015815, 3390015402, 3390015217, 3390014798, 3390014667, 3390014308, 3390019301, 3390018546, 3390018197, 3390017940, 3390017520, 3390017318, 3390016944, 3390016722, 3390016374, 3390016162, 3390036116, 3390031303, 3390031155, 3390029200, 3390029014, 3390036586, 3390036446, 3390007066, 3390004328, 3390004253, 3390003906, 3390003853, 3390003481, 3390003270, 3390003136, 3390001924, 3390001865, 3390001651, 3390001566, 3390014569, 3390014401, 3390026741, 3390026095, 3390025709, 3390025082, 3390024857, 3390024485, 3390024287, 3390023891, 3390023238, 3390022907, 3390022358, 3390022127, 3390021606, 3390021266, 3390020711, 3390020484, 3390020126, 3390019573, 3390019354, 3390019028, 3390018815, 3390018493, 3390018259, 3390017879, 3390017618, 3390021969, 3390021741, 3390021435, 3390021243, 3390020890, 3390020690, 3390020350, 3390020113, 3390019558, 3390019214, 3390019006, 3390018674, 3390018458, 3390018090, 3390017832, 3390017442, 3390017212, 3390016872, 3390016640, 3390016305, 3390016086, 3390015487, 3390015110, 3390014918, 3390014571, 3390014398, 3390014067, 3390013927, 3390013722, 3390013545, 3390013207, 3390012955, 3390012738, 3390013995, 3390013471, 3390013180, 3390013010, 3390009581, 3390008723, 3390008521, 3390007959, 3390007784, 3390031592, 3390031279, 3390030572, 3390000462, 3390000207, 3390008676, 3390008321, 3390007988, 3390007742, 3390006452, 3390006151, 3390005812, 3390005552, 3390005379, 3390033489, 3390032843, 3390032470, 3390031999, 3390026996, 3390026612, 3390026388, 3390026014, 3390025744, 3390025366, 3390025123, 3390024760, 3390024521, 3390024169, 3390023928, 3390023650, 3390022104, 3390021885, 3390021557, 3390021370, 3390021042, 3390020824, 3390020502, 3390020281, 3390017016, 3390016786, 3390016441, 3390016234, 3390014703, 3390014493, 3390014174, 3390014006, 3390015699, 3390015340, 3390014217, 3390014041, 3390013727, 3390013538, 3390013216, 3390012962, 3390032851, 3390032598, 3390032307, 3390031899, 3390031424, 3390001169, 3390001070, 3390036430, 3390035900, 3390034548, 3390033581, 3390033129, 3390032883, 3390032483, 3390032321, 3390032036, 3390031335, 3390031146, 3390029914, 3390029726, 3390029227, 3390028524, 3390028243, 3390027786, 3390027531, 3390027084, 3390026866, 3390026441, 3390026213, 3390025809, 3390025577, 3390025112, 3390024609, 3390024012, 3390023739, 3390023383, 3390022838, 3390022414, 3390022217, 3390021850, 3390021670, 3390021134, 3390020559, 3390020037, 3390019772, 3390019501, 3390019208, 3390018939, 3390018673, 3390018413, 3390018079, 3390017722 Class II Blood products, collected from donors for whom donor suitability was not adequately determined, were distributed. Talecris Plasma Resources, Inc.
Devices Cordis EMPIRA RX PTCA Dilatation Catheter Catalog # 85R30300S For cardiovascular use. Catalog # 85R30300S LOT # CE0001447 exp date: 2014-08 Class II Dilatation catheters could exhibit radial versus axial tears should they burst during inflation. Cordis Corporation
Devices Philips IntellVue Info Center iX 866023; PIIC iX Upgrade 866024; IntellVue Server iX Upgrade 866026; PIIC Classic Upgrade 866117 Patient Physiological Monitor. All iX versions with A.01 software Class II If a customer creates customized trend scales in the trend review tile and the iX or primary server reboots for any reason, the iX(s) will enter a reboot loop. If one iX reboots, the issue will impact only those patients monitored on that device. If the primary server reboots, all patients across all iX devices will be impacted. Philips Healthcare Inc.
Veterinary BARF World Brand Juicy Chicken Recipe 12 patties packed into a 6 lb bag. UPC 3752800101 Distributed by: BARF World Inc. 3840 Blackhawk Road, Suite 100 Danville, CA 94506 Lot T220, S220 Use by 8/7/13. Class I Product was manufactured on the same equipment as product that tested positive for Salmonella by the Minnesota Dept of Public Health. BARF World Inc
Veterinary BARF World Brand Juicy Lamb Recipe 12 patties packed into a 6 lb bag. UPC 3752800104 Distributed by: BARF World, Inc. 3840 Blackhawk Road, Suite 100 Danville, CA 94506 Lot S220 Use by 8/7/13. Class I Product was manufactured on the same equipment as product that tested positive for Salmonella by the Minnesota Dept of Public Health. BARF World Inc
Veterinary BARF World Brand Juicy Combination Recipe 12 patties packed into a 6 lb bag. UPC 3752800106 Distributed by: BARF World, Inc. 3840 Blackhawk Road, Suite 100 Danville, CA 94506 Lot S220 Use by 8/7/13. Class I Product was manufactured on the same equipment as product that tested positive for Salmonella by the Minnesota Dept of Public Health. BARF World Inc
Veterinary BARF World Brand Variety Pack; 12 patties packed into a 6 lb bag- one each of Chicken, Beef, Lamb, Combination. No UPC - contains individual UPC for each variety. Distributed by: BARF World, Inc. 3840 Blackhawk Road, Suite 100 Danville, CA 94506 Lot S220 Use by 8/7/13. Class I Product was manufactured on the same equipment as product that tested positive for Salmonella by the Minnesota Dept of Public Health. BARF World Inc
Devices Leica Ceiling Mount MSF-1 for use with M841 and M501 operating microscopes. Article Number 10446781 utilizes a supply voltage of 230 V. Article Number 10446782 utilizes a supply voltage of 110 V. Intended to be used for improving the visibility of objects through magnification and illumination. Leica Ceiling Mount MSF-1; Article Numbers: 10446781, 10446782 Class II The ceiling mount supplier encountered an event in which the drive screw in the motor unit, which lifts and lowers the lower lift arm, broke. As a result, the lift arm fell down approx. 60 cm (23.6 inches). Leica Microsystems, Inc.
Devices Leica Ceiling Mount MS-1F & MC-1F for use with the M500 N operating microscope. Article Number 10446657 utilizes a supply voltage of 110 V. Article Number 10446658 utilizes a supply voltage of 220 V. Intended to be used for improving the visibility of objects through magnification and illumination. Leica Ceiling Mounts MS-1F, MC-1F; Article Numbers: 10446657, 10446658 Class II The ceiling mount supplier encountered an event in which the drive screw in the motor unit, which lifts and lowers the lower lift arm, broke. As a result, the lift arm fell down approx. 60 cm (23.6 inches). Leica Microsystems, Inc.
Veterinary Bailey's Choice 100% Chicken Treat, Net wt. 5oz, Made in Waleska, GA . Lot numbers: Jun 2 2013, Jun 3, 2013, Jun 15, 2013, Jul 8, 2013 and Jul 11, 2013 Class I Possible Salmonella contamination. Bailey's Choice
Veterinary Bailey's Choice 100% Chicken Breast Treat, Made in Waleska, GA Lot number: Jun 4, 2013 Class I Possible Salmonella contamination. Bailey's Choice
Veterinary Bailey's Choice 100% Teriyaki Chicken Treat, Made in Waleska, GA Lot number: 132881 Class I Possible Salmonella contamination. Bailey's Choice
Drugs vitaliKOR Ready When You Are, Fast Acting Formula Dietary Supplement capsules, 40 count bottle, Distributed by Vitality Research Labs, LLC, Las Vegas, NV 89148. LOT K58Q Exp 01/16 LOT F50Q Exp 07/16 Class I Marketed Without an Approved NDA/ANDA: FDA sampling found undeclared vardenafil and tadalafil in vitaliKOR capsules Vitality Research Labs LLC
Drugs REDUCE WEIGHT FRUTA PLANTA Capsules, 400 mg, supplied in 30 count boxes, distributed by MyNicKnaxs, LLC., Deltona, FL ALL LOTS Class I Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceutical ingredient: Phenolphthalein. MyNicNaxs, Inc.
Drugs JIANFEIJINDAN Activity Girl Capsules, 400 mg, supplied in 30 count boxes, distributed by MyNicKnaxs, LLC, Deltona, FL ALL LOTS Class I Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared ingredient: N-di-desmethylsibutramine, an analog of sibutramine MyNicNaxs, Inc.
Drugs Fruta BIO 400 mg capsules, supplied in 30 count boxes, distributed by MyNicKnaxs, LLC, Deltona, FL ALL LOTS Class I Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceutical ingredients: Sibutramine and Phenolphthalein . MyNicNaxs, Inc.
Drugs Super Fat Burning Bomb Capsules, 400 mg, supplied in 30 count boxes, distributed by MyNicKnaxs, LLC, Deltona, FL ALL LOTS Class I Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceutical ingredients: Phenolphthalein and N-desmethylsibutramine MyNicNaxs, Inc.
Drugs Pill for weight reduction, (Japanese Chinese Formula from Japan Hokkaido Cangye Pharmacy Co, Ltd) 400 mg, supplied in 40 count boxes, distributed by MyNicKnaxs, LLC, Deltona, FL ALL LOTS Class I Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceutical ingredient: Phenolphthalein MyNicNaxs, Inc.
Drugs SlimEasy Herbs Capsule, 400 mg, supplied in 30 count boxes, distributed by MyNicKnaxs, LLC, Deltona, FL ALL LOTS Class I Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceutical ingredient: sibutramine and N-desmethylsibutramine MyNicNaxs, Inc.
Drugs Meizi Evolution Soft Gel Capsules, supplied in 30 count bottles, distributed by MyNicKnaxs, LLC, Deltona, FL ALL LOTS Class I Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceutical ingredient: N-desmethylsibutramine, benzylsibutramine, and sibutramine MyNicNaxs, Inc.
Drugs Slim Xtreme Weight loss capsules, 500 mg, supplied in 30 count bottles, Another product from Globe All Wellness, LLC Hollywood, FL 33020, distributed by MyNicKnaxs, LLC Deltona, FL ALL LOTS Class I Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceutical ingredient: N-desmethylsibutramine, benzylsibutramine, and sibutramine MyNicNaxs, Inc.
Drugs Magic Slim capsules, supplied in 60 count bottles, distributed by MyNicKnaxs, LLC, Deltona, FL ALL LOTS Class I Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceutical ingredients: N-desmethylsibutramine, benzylsibutramine, and sibutramine MyNicNaxs, Inc.
Drugs Meizitang Strong Version Botanical Slimming, Soft Gel Capsules, 650 mg, supplied in 30 count bottles, distributed by MyNicKnaxs, LLC, Deltona, FL ALL LOTS Class I Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceutical ingredients: N-desmethylsibutramine, benzylsibutramine, and sibutramine MyNicNaxs, Inc.
Drugs Venlafaxine HCl Extended-Release Capsules, 150 mg, 90-count Unit of Use bottles, Rx only, Distributed by: Greenstone LLC, Peapack, NJ 07977, NDC 59762-0182-2, UPC 3 59762-0182-2 9. V130014, Exp 08/15 Class I Presence of Foreign Tablets/Capsules: A Pharmacist reported a foreign capsule with markings (TKN 250) and identified as a Tikosyn (dofetilide) capsule in a lot of Effexor XR 150 mg capsules that was packaged in the same packaging campaign as this Venlafaxine HCl lot. Greenstone Llc
Food Harry & David; WILD 'N SPICY; DOS QUESOS DIP; NET WT 1 lb.; (453g);Mild; in glass jars; MADE FOR HARRY AND DAVID, MEDFORD OR, HARRYANDDAVID.COM; 800-547-3033 Lot codes 10204 Class II Undeclared Wheat due to a supplier's inadvertent use of a wheat product instead of whey in preparing the cheese pre-mix for the recalling firm. Fischer & Wieser Specialty Foods
Food Harry & David; WILD 'N SPICY; JALAPENO TOMATO CHEESE DIP; NET WT 1 lb.; (453g);Medium; in glass jars; MADE FOR HARRY AND DAVID, MEDFORD, OR, HARRYANDDAVID.COM; 800-547-3033 Lot code 10364 Class II Undeclared Wheat due to a supplier's inadvertent use of a wheat product instead of whey in preparing the cheese premix for the recalling firm. Fischer & Wieser Specialty Foods
Drugs Bella Vi INSANE Bee Pollen Dietary Supplement Capsules, 60 count bottles, www.BellaViProducts.com, distributed by Pure Edge Nutrition, LLC, Toms River, NJ lot # 201303 EXP: 14/03/07 Class I Marketed without an Approved NDA/ANDA; product was found to contain undeclared sibutramine & phenolphthalein Pure Edge Nutrition
Drugs Bella Vi BTrim MAX Dietary Supplement capsules, 60 count bottles, www.BellaViProducts.com, distributed by Pure Edge Nutrition, LLC, Toms River, NJ lot # BTX13 EXP: 2015/08/15 Class I Marketed without an Approved NDA/ANDA; product was found to contain undeclared sibutramine & phenolphthalein Pure Edge Nutrition
Drugs Bella Vi BTrim ULTIMATE BOOST Dietary Supplement capsules, 30 count bottles, www.BellaViProducts.com, distributed by Pure Edge Nutrition, LLC, Toms River, NJ lot # BTRM3452 EXP: 2015/07/03 Class I Marketed without an Approved NDA/ANDA; product was found to contain undeclared sibutramine & phenolphthalein Pure Edge Nutrition
Drugs Bella Vi eXtreme ACCELERATOR Dietary Supplement Capsules, 30 count bottles, www.BellaViProducts.com, distributed by Pure Edge Nutrition, LLC, Toms River, NJ lot # BTRX7654 EXP: 2015/07/08 Class I Marketed without an Approved NDA/ANDA; product was found to contain undeclared sibutramine & phenolphthalein Pure Edge Nutrition
Drugs Bella Vi INSANE AMP'D Dietary Supplement capsules, 60 count bottles, www.BellaViProducts.com, distributed by Pure Edge Nutrition, LLC, Toms River, NJ lot # VINA2013 EXP: 2015/06/12 Class I Marketed without an Approved NDA/ANDA; product was found to contain undeclared sibutramine & phenolphthalein Pure Edge Nutrition
Drugs Bella Vi AMP'D UP Advanced Weight Loss Dietary Supplement capsules, 60 count bottles, www.BellaViProducts.com, distributed by Pure Edge Nutrition, LLC, Toms River, NJ lot # AU2013AB EXP: 2015/05/20 and lot #BVAU813 EXP: 2015/08/12 Class I Marketed without an Approved NDA/ANDA; product was found to contain undeclared sibutramine & phenolphthalein Pure Edge Nutrition
Drugs Midazolam 0.2 mg/2 mL 0.9% Sodium Chloride syringes, Total dosage: 0.4 mg per 2 mL, Rx Only, Pharmakon Pharmaceuticals, Inc., 14450 Getz Rd, Noblesville, Indiana, NDC 45183-0014-69. Lot #: E1016227C, Exp. 4/21/2014; E0433735C, Exp. 4/20/2014 Class I Superpotent Drug: Product contains twice the stated amount of midazolam. Pharmakon Pharmaceuticals
Biologics Red Blood Cells Leukocytes Reduced W036314102933; Class II Blood product, which was labeled as leukoreduced, but failed the post filtration acceptance criteria for white blood cell count, was distributed. BloodCenter of Wisconsin, Inc
Drugs Pantoprazole Sodium, Delayed-release tablets, USP, 40 mg tablets, 100 (10x10) unit dose packages, Manufactured by Dr. Reddy's Laboratories Limited, India and Distributed by Major Pharmaceuticals, Livonia, MI --- NDC 0904-6235-61 No lot or expiration date is displayed on this carton. Class II Correct Labeled Product Miscart/Mispack: some cartons labeled as Pantoprazole Sodium Delayed-Release may contain correctly labeled blister cards of Lorazepam tablets Legacy Pharmaceutical Packaging
Devices Portex Low Dead Space Connector with Sideport, 3.5mm Product Usage: The connector is used to attach the endotracheal tube to the patient breathing circuit. The low dead space connector minimizes mechanical dead space and subsequent carbon dioxide rebreathing. The connector's sideport permits access for administration of artificial surfactant, airway pressure monitoring, gas sampling, and instillation of sterile saline for airway leakage. Lot or Serial No: 2553426 Class I One lot of 3.0mm sized Connectors, Product Reorder No. 10035-05PS, Lot No. 2553426 were placed in packages labeled as size 3.5mm. Smiths Medical ASD, Inc.
Devices "bluephase style Light probe Pin-point 6>2 mm black***REF # 636 241". Ultraviolet activator for polymerization for use during dental curing. Reference number 636241, all lots Class II Subject of this recall is an accessory to a dental curing light called Bluephase Style. The accessory is a pin point light probe. A stock check revealed broken glass fibers between the connector and the fiber bundle in a large number of these light probes. Ivoclar Vivadent, Inc.
Food El Original pa' ya To Go by hot pandeyuca brand Soft Bread Pan Alinado Lot Codes 001 - 090 Class II During an FDA inspection, it was discovered that the label of several products failed to declare the components ingredients of a butter flavor that included allergens FD&C Yellow #5, FD&C Yellow #6 and FD&C Red #40. Hot Pandeyuca & Company Inc
Food El Original pa' ya To Go by hot pandeyuca brand Cheese Bread Pan de Queso Grande Lot Codes 001 - 090 Class II During an FDA inspection, it was discovered that the label of several products failed to declare the components ingredients of a butter flavor that included allergens FD&C Yellow #5, FD&C Yellow #6 and FD&C Red #40. Hot Pandeyuca & Company Inc
Food El Original pa' ya To Go by hot pandeyuca brand Small Cheese Bread Quesipan Lot Codes 001 - 090 Class II During an FDA inspection, it was discovered that the label of several products failed to declare the components ingredients of a butter flavor that included allergens FD&C Yellow #5, FD&C Yellow #6 and FD&C Red #40. Hot Pandeyuca & Company Inc
Drugs CUBICIN (daptomycin for injection), 500 mg single-use vial, Rx only, Manufactured for: Cubist Pharmaceuticals, Inc., Lexington, MA 02421, NDC 67919-011-01, UPC 3 67919-011-01 6. Lot #: 280453F, Exp 04/16 Class I Presence of Particulate Matter: Customer complaint stating that one vial contained a glass shard. Cubist Pharmaceuticals, Inc.
Biologics Platelets Pheresis Leukocytes Reduced W050911079028 Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. HCSC-Blood Center
Biologics Red Blood Cells Leukocytes Reduced Irradiated W050911075248 Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. HCSC-Blood Center
Biologics Red Blood Cells W050911079014; W050911082588 Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. HCSC-Blood Center
Biologics Fresh Frozen Plasma W050911075248 Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. HCSC-Blood Center
Devices Siemens Healthcare Diagnostics Vista Air Compressor Siemens Healthcare Diagnostics Dimension Vista® System is an in vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of analytes in human body fluids. Dimension Vista® chemical and immunochemical applications use photometric, turbidimetric, chemiluminescence, nephelometric and integrated ion-selective multisensory technology for clinical use. Product Siemens Material Number (SMN) Dimension Vista® 500 Domestic: 10284473 International: 10488224 Dimension Vista® 1500 Domestic: 10444801 International: 10444802 Class II Siemens Healthcare Diagnostics is recalling the Vista Air Compressor replacement part: SMN 10706557 Desc: SKIT Air Compressor Assy,used on the Dimension Vista® 500 and Dimension Vista® 1500 systems because a small number of Vista Air Compressors were miswired, which if installed and powered up, could cause a fire, or become an electrical shock hazard. Siemens Healthcare Diagnostics, Inc.
Devices Tissue-Tek® PARAFORM PROC/EMB/MEDIUM, FORMULA 3 - 8x1Kg. Product Code: 7052. Lot Number: 263922. Class II Sakura Finetek USA, Inc. is conducting a voluntary field corrective action for Tissue-TEK Paraform Processing/embedding Medium Formula3 Paraffin because it was identified that the affected lot has variations in melting temperature. Sakura Finetek USA Inc
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced W035213058097J Class II Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed. Carter BloodCare
Devices Synthes Matrix Mandible Short Cut Plate Cutter Synthes Matrix Mandible Short Cut Plate Cutter is intended for oral, maxillofacial surgery. part number: 03.503.057, lot number 8453237 Class II It was discovered internally that the face of the Synthes Matrix Mandible Short Cut Plate Cutter has the potential for discoloration/corroded material in the affected lot. Synthes, Inc.
Food United Bakery Grissini Parmesan Bread Sticks,; Made with Extra Virgin Olive Oil and Grano Padano Cheese; All Natural, Trans Fat Free; Packaged in 8 oz (227g) and 4.5 oz (128g) containers. Also packaged for Safeway - Safeway Select Parmesan Grissini Breadsticks, 8 oz. (227g) containers. Made in USA Ingredient: Wheat Flour, Water, Unsalted butter, yeast, Extra virgin Olive Oil, Imported Grano Padano Cheese, garlic, sea salt, malted barley, non fat milk, ascorbic acid, natural enzymes. United Bakery, W. Sacramento, CA 4.5 oz container - UPC numbers: 8-91373000762; 8-913730010769 8. oz container - UPC number - 8-91373001026; Safeway UPC - 0-21130-11823 6 Class I Internal label review found egg is an ingredient of Grano Padano Cheese used in Parmesan Bread Sticks, but not declared in product ingredient statement or allergen statement. UB Inc DBA United Bakery & Co
Devices NaturaLyte® Liquid Bicarbonate Concentrate, 6.4 liter bottle to be used with a hemodialysis unit; Part Number: 08-4000-LB. The concentrate is formulated to be used with a three steam hemodialysis machine which is calibrated for acid and bicarbonate concentrates. Lot Number: 14CMLB006 Class III Container cap may contain foreign material- 0.60% - 0.80% Manganese Fresenius Medical Care Holdings, Inc.
Devices Maquet PowerLED 700. Product Usage; To provide illumination to the surgical area or the patient. Part number (begins with ALM) and associated serial numbers: ALM568300999 13, 14, 16, 19, 20, 21, 22, 23, 24, 25, 29, 30, 31, 32, 34, 35, 36, 41, 50 ALM568301999 13, 14, 16, 17, 20, 23, 24, 25, 26, 52, 54, 55, 56, 57, 60, 63, 64, 65, 66, 70, 71, 72, 74 ALM568302999 11, 43, 44, 46, 49, 50, 51, 54, 57, 58, 59, 6, 61, 63, 64, 66, 67, 71, 72, 74, 77, 78, 80, 81 ALM568303999 8, 9, 32, 52, 53, 58, 60, 61, 62, 65, 66, 69, 70, 71, 73, 74, 75, 77, 78, 79, 80, 81, 82, 85, 86, 87, 89, 91, 92, 94, 95, 96, 97, 99, 100, 105, 106, 108, 111, 118, 120, 121, 122, 159 ALM568320901 12012, 40015, 40017, 40018, 40019, 40020, 40021, 50010, 50011, 50012, 50013, 50014, 50015, 50016, 50017, 50018, 50019, 50020, 50021, 50022, 50023, 50024, 50025, 50026, 50027, 50028, 50030, 50031, 50032, 50033, 50034, 50035, 50037, 50038, 50039, 50040, 50041, 50042, 50043, 50047, 50048, 50050, 50051, 50052, 50053, 50054, 50055, 50056, 50058, 50059, 50060, 50061, 50064, 50066, 50067, 50068, 50069, 50070, 50071, 50072, 70033, 70034, 70035 ALM568320905 40003, 40004, 40005, 40006, 40007, 40008, 40009, 40010, 40011, 40012, 40013, 40014, 40015, 40016, 50003, 50004, 50005, 50006, 50008, 50009, 50010, 50011, 50012, 50013, 50014, 50015, 50016, 50017, 50018, 50019, 50020, 50021, 60003, 60004, 70001, 70002, 70003, 70004, 70005, 70006, 70007, 70009, 70010, 70011, 70012, 70013, 70014, 70015, 70016, 70017, 70018, 70019, 70020, 70021, 70022, 70024, 70025, 70027, 70028, 70029, 70030, 70031, 70032, 70033, 70034, 70035, 70036, 70037, 70038, 70039, 70040, 70041, 70042, 70043, 70044, 70045, 70046, 70047, 70048, 70049, 70050, 70051, 70052, 70053, 70054, 70055, 70056, 70057, 70058, 70059, 70060, 70061, 70063, 70064, 70066, 70068, 70069 ALM568370900 20017, 20018, 20019, 20020, 20021, 20022, 20023, 20024, 20025, 20026, 20027, 20028, 20029, 20030, 20039, 20040, 20041, 20042, 20043, 20044, 20045, 20046, 20047, 20048, 20049, 20050, 20051, 20052, 20053, 20054, 30038, 30039, 30053, 30054, 40006, 40010, 40012, 40013, 40014, 40015, 40016, 40018, 40019, 40020, 40027, 40028, 40029, 40030, 40031, 40032, 40033, 40034, 50000, 50001, 50004, 50006, 60007, 60008, 60009, 60010, 60012, 60031, 60041, 60042, 60043, 60044, 60046, 60047, 60048 ALM568370901 20024, 20025, 20026, 20027, 20028, 20029, 20030, 20031, 20032, 20033, 20034, 20038, 20039, 20040, 20041, 20042, 20045, 20053, 20054, 20055, 20056, 20057, 20058, 20059, 20060, 20061, 20062, 20064, 20065, 20066, 20067, 20068, 20069, 20070, 32042, 40028, 40033, 40034, 40035, 40036, 40037, 40038, 40045, 50002, 50006, 50008, 50009, 50024, 50035, 50036, 50037, 50039, 50040, 50041, 50042, 50043, 50044, 50045, 50046, 50047, 50048, 60030 ALM568370902 20011, 20015, 20016, 20017, 20018, 20019, 20020, 20021, 20022, 20023, 20024, 20025, 20026, 20027, 20028, 20029, 20030, 20031, 20032, 20033, 20034, 20035, 20036, 20037, 20038, 20039, 20040, 20041, 20042, 20048, 20049, 20050, 20051, 20057, 20058, 20059, 20060, 20061, 20062, 20063, 20064, 20067, 20068, 20069, 20070, 20071, 20072, 20073, 20074, 20075, 20076, 20077, 20078, 20079, 20080, 20083, 20086, 20087, 20089, 20090, 20091, 20094, 20095, 20096, 20098, 20104, 20105, 20106, 20107, 20108, 20109, 20110, 20111, 20112, 20113, 20114, 20115, 20116, 20117, 20118, 20119, 20120, 20121, 20122, 20123, 20124, 20125, 20127, 20132, 20133, 20135, 20136, 20137, 20139, 20140, 20141, 20144, 20151, 20152, 30000, 30051, 30053, 30054, 30062, 30063, 30065, 30066, 30067, 30068, 30078, 30081, 30090, 30091, 30092, 30099, 30107, 30127, 30128, 30130, 30131, 30134, 32164, 40000, 40006, 40007, 40009, 40011, 40012, 40013, 40014, 40015, 40017, 40018, 40019, 40020, 40021, 40023, 40039, 40040, 40041, 40042, 40043, 40044, 40045, 40046, 40047, 40048, 40050, 40051, 40052, 40053, 40054, 40055, 40056, 40057, 40058, 40060, 40064, 40065, 40067, 40078, 40081, 40082, 40083, 40084, 60030, 60031, 60036 ALM568370903 20022, 20023, 20024, 20025, 20026, 20027, 20028, 20029, 20030, 20032, 20033, 20034, 20035, 20036, 20037, 20038, 20039, 20041, 20043, 20044, 20045, 20046, 20047, 20048, 20049, 20050, 20051, 20052, 20053, 20055, 20056, 20057, 20058, 20059, 20066, 20067, 20072, 20073, 20074, 20075, 20076, 20077, 20079, 20080, 20081, 20082, 20084, 20087, 20088, 20089, 20090, 20091, 20092, 20093, 20097, 20098, 20099, 30072, 40025, 50000, 50001, 50002, 50003, 50004, 50006, 50028, 50051, 50052, 50054, 50055, 50057, 50058, 50059, 50060, 60024, 60025, 60026, 60028 ALM568370904 20011, 20013, 20014, 20015, 20016, 20017, 20018, 20019, 20020, 20023, 20024, 20025, 20026, 20027, 20032, 20033, 20034, 20035, 20036, 20037, 20038, 30000, 30001, 30002, 30003, 30004, 30012, 30013, 30014, 30015, 30018, 30019, 30020, 30025, 30026, 30027, 30028, 30029, 30030, 30031, 30032, 30033, 30034, 30035, 30036, 30037, 30038, 30039, 30040, 30041, 30042, 30043, 40011, 40012, 40013, 40014, 40015, 40016, 40017, 40022, 40023, 40024, 40031, 40032, 40033, 40034, 40035, 40036, 50004, 50010, 50011, 50012, 50013, 50014, 50015, 50016, 50017, 50019 ALM568370905 20010, 20016, 20017, 20018, 20019, 20022, 20023, 30027, 40012, 40022, 40023, 40024, 40025, 40027, 40028, 40029, 40031, 40032, 40033, 40037, 40040, 40041, 40047, 40049, 40050, 50005, 50006, 50012, 50015, 50018, 50021, 60007, 60023, 60027, 60030, 60032, 60033 Class II Maquet has identified an issue with the Maquet PowerLED 700 (certain serial numbers). One or several plastic fixation tabs can break, which can cause the ambient light module to partially detach. Maquet Medical Systems USA
Food Raw, frozen, vacuum-packaged rock fish (portions, fillets, and whole fish, various sizes). No code. Class II T. H. Seafood, Inc., is recalling raw, frozen, vacuum packed rockfish due to labeling instructions that do not direct the consumer to "Keep Frozen-Thaw Under Refrigeration" to control the hazard of Clostridium botulinum. T.H. Seafood Inc.
Food Raw, frozen, vacuum-packaged black cod (portions, fillets, and whole fish, various sizes). No code. Class II T. H. Seafood, Inc., is recalling raw, frozen, vacuum packed black cod due to labeling instructions that do not direct the consumer to "Keep Frozen-Thaw Under Refrigeration" to control the hazard of Clostridium botulinum. T.H. Seafood Inc.
Food Raw, frozen, vacuum-packaged halibut (portions, fillets, and whole fish of various sizes). No code. Class II T. H. Seafood, Inc., is recalling raw, frozen, vacuum packed halibut due to labeling instructions that do not direct the consumer to "Keep Frozen-Thaw Under Refrigeration" to control the hazard of Clostridium botulinum. T.H. Seafood Inc.
Food Raw, frozen, vacuum-packaged salmon (portions, fillets, and whole fish, various sizes). No code. Class II T. H. Seafood, Inc., is recalling raw, frozen, vacuum packed salmon due to labeling instructions that do not direct the consumer to "Keep Frozen-Thaw Under Refrigeration" to control the hazard of Clostridium botulinum. T.H. Seafood Inc.
Biologics Red Blood Cells Leukocytes Reduced W036513065139; Class II Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed. LifeShare Blood Centers
Biologics Red Blood Cells Leukocytes Reduced W036513104300; Class II Blood product, for which documentation of the donor history was incomplete, was distributed. LifeShare Blood Centers
Biologics Blood and Blood Products for Reprocessing W036513104300; Class III Blood product, for which the documentation of the donor history was incomplete, was distributed. LifeShare Blood Centers
Devices Alere Triage® D-Dimer Test PN 98100, Lot W53884B. The Alere Triage® D-Dimer Test is a fluorescence immunoassay to be used with the Alere Triage® Meters for the quantitative determination of cross-linked fibrin degradation products containing D-dimer in EDTA anticoagulated whole blood and plasma specimens. . The Alere Triage® D-Dimer test is intended for use as an aid in the assessment and evaluation of patients suspected of having disseminated intravascular coagulation or thromboembolic events including pulmonary embolism. PN 98100, Lot W53884B. Class II Alere initiated this recall because a limited number of Alere Triage® D-Dimer devices from PN 98100 Lot W53884B were incorrectly manufactured. As a result, when testing patient sample these affected devices will either generate an error code (e.g. E4 error), or they may generate an incorrect result. Alere San Diego, Inc.
Devices HLD Systems Model 610 Washer/High Level Disinfector. Maximum weight of the Model 610 when filled with water is approximately 450 pounds. The dimensions of the system are: Width: 26.5" (67 cm); Depth: 33" (83 cm); Height: 46.5" (118 cm) to top of control panel; 64" (162.6 cm)- height clearance with lid open. Product Usage: Usage: This device washes reusable medical devices and disinfects them with high temperature hot water (pasteurization). The devices are washed with a cleaning solution (containing NaClO (sodium hypochlorite), surfactants, and detergents) to aid in the removal of debris and visible stains. Next, the medical devices and rinsed two times with water. The final, disinfection step uses only hot water at 160 F ± 2 F for 30 minutes. 610601, 610603, 610703, 610704, 610705, 610707, 610708, 610802, 610803, 610804, 610901, 610903, 610904, 610905, 610902, 611001, 611002, 611004, 611102, 611103, 611201, 611202, 611203, 610902L, 611204. First two digits (6 refer to model number 610 for the HLD system Second two digits - two digit year of manufacture Last two digits sequentially numbered as they receive orders. Class II Cenorin LLC is voluntarily recalling HLD Systems Model 610 Washer/High Level Disinfector due to a potential risk of the system not injecting the proper amount of cleaning fluid during the wash cycle and not achieving the desired level of debris reduction. Cenorin, LLC
Devices Armstrong Grommet with wire Otological Ventilation Tube Catalog #: VT-0507-01, Sterilized by Ethylene Oxide, Rx Only. Intended to provide ventilation to the middle ear space through the tympanic membrane. Lot #: 147809 Class II One lot of ventilation tubes have mixed tubes with wire attached to the slanted flange and ventilation tubes with wire attached to the straight flange. This poses no health hazard to the user or patient. Summit Medical, Inc.
Devices enGen (TM) Laboratory Automation System Configured with TCAutomation" Software v3.5 -- For in vitro quantitative measurement of a variety of analytes of clinical interest --- The VITROS 5,1 FS Chemistry System with enGenTM Laboratory Automation System is intended for use in the in vitro quantitative measurement of a variety of analytes of clinical interest, using both VITROS Chemistry Products Slides (colorimetric endpoint, rate, ion-selective electrode, and immunorate methods) and VITROS Chemistry Products MicroTip liquid reagents (spectrophotometric and spectrophotometric immunoassay methods.). ---The enGen (TM) Lab Automation System is a modification to VITROS Analyzers that includes the addition of an automated track sub-system (TCAutomation) for pre-analytical and post-analytical sample and data management. In addition to an Automated Track Sub-system, the enGen (TM) System includes one or more VITROS Chemistry, Immunodiagnostic and/or Integrated Systems (clinical analyzers) as well as a Data Management Subsystem (Middleware), and a Software Configuration (gsb) File. The enGen System is typically interfaced with a Laboratory Information System (LIS) via connectivity facilitated at the Data Management Subsystem level. By using the enGen (TM) Laboratory Automation System as a communication interface between the LIS and the clinical analyzers in the laboratory, the user can manage the workflow to the analyzers and other devices as an integrated system. This eliminates the need for the user to program tests for each sample uniquely on each analyzer. Within the enGen (TM) Laboratory Automation System, the physical routing of samples to the correct location is also automatic. The Buffer Module functions either as a location for samples waiting for results or as a storage area for empty sample tube carriers. When a sample is presented to a clinical analyzer via the Bypass module and is metered for testing, the sample remains on the track system in the Buffer module while waiting for the test results to be generated. If all test results are generated as expected and no additional actions are required, the sample is routed to a designated Exit module where it can be removed from the track system by the user. However, there are certain situations in which a follow-up action (retest of the sample) may be necessary. In these situations, the sample is routed back to a clinical analyzer via the Bypass module to complete the follow-up action. Examples of situations requiring a retest include, but are not limited to: repeat testing when a "No Result"is generated during the initial test event, sample dilution when an out of range result is obtained during the initial test event, and routing to an alternate analyzer when the first analyzer the sample is sent to is unavailable for testing. Once the follow-up sample metering actions are complete, the sample is routed to Buffer module where it remains until testing is complete. Once all test results are obtained the sample is routed to the designated Exit module. enGen (TM) Laboratory Automation Systems configured with TCAutomation" Software version 3.5 Class II Software anomaly: potential buffer timeout issues when using enGen (TM) Laboratory Automation Systems Configured with TCAutomation (TM) Software v3.5. Ortho-Clinical Diagnostics
Devices enGen (TM) Laboratory Automation Systems (enGen) with TCAutomation (TM) -- For in vitro quantitative measurement of a variety of analytes of clinical interest; for pre-analytical and post-analytical sample and data management. --- Background: The enGen (TM) Lab Automation System is a modification to VITROS Analyzers that includes the addition of an automated track sub-system (TCAutomation) for pre-analytical and post-analytical sample and data management. In addition to an Automated Track Sub-system, the enGen (TM) System includes one or more VITROS Chemistry, Immunodiagnostic and/or Integrated Systems (clinical analyzers) as well as a Data Management Subsystem (Middleware), and a Software Configuration (gsb) File. The enGen System is typically interfaced with a Laboratory Information System (LIS) via connectivity facilitated at the Data Management Subsystem level. The Bypass Module is an analyzer specific module that interfaces clinical analyzers to the enGen System and allows for aspirating patient samples directly from the clinical analyzers. A sample tube carrier sensor in the Bypass Module is used to detect sample tube carriers as they leave the metering location of the Bypass. If a tube carrier is not detected within a defined period of time (6.4 seconds) the next sample to be metered may not advance for processing. TCA Software versions 2.6 , 3.2 and 3.5 configured with Bypass Modules for ADVIA Centaur (R), Abbott Architect (TM), VITROS (R) and/or Tosoh AIA (R) Systems Class II Software anomaly: potential for delay in the reporting of patient sample test results when using enGen (TM) Laboratory Automation Systems with TCAutomation (TM) Software v2.6, v3.2 and v3.5. Ortho-Clinical Diagnostics
Devices VITROS 4600 Chemistry System, Product Code/Catalog Number 6802445 for in vitro diagnostic use. Software Version 3.0 and lower; Serial Numbers J46000108 through J46000403 Class II Potential for biased results when a Multiple Window (MW) code is associated with results generated by the VITROS 4600 Chemistry System, the VITROS 5600 Integrated System and the VITROS 5,1 Chemistry System. MW codes may be associated with results from any of the following VITROS Chemistry Products using multiple point (multipoint) rate measurements. The MicroSlide assays that could be affected are VITROS ALT, ALKP, AST, CHE, CK, GGT and LDH Ortho-Clinical Diagnostics
Devices VITROS 5600 Integrated System, Product Code/Catalog Number 6802413 for in vitro diagnostic use. Software Version 3.0 and lower; Serial Numbers J56000110 through J56001912 Class II Potential for biased results when a Multiple Window (MW) code is associated with results generated by the VITROS 4600 Chemistry System, the VITROS 5600 Integrated System and the VITROS 5,1 Chemistry System. MW codes may be associated with results from any of the following VITROS Chemistry Products using multiple point (multipoint) rate measurements. The MicroSlide assays that could be affected are VITROS ALT, ALKP, AST, CHE, CK, GGT and LDH Ortho-Clinical Diagnostics
Devices VITROS 5,1 FS Chemistry System and VITROS 5,1 FS Refurbished, Product Codes/Catalog Numbers 6801375, 6801890 for in vitro diagnostic use. Software Version 2.7 and below; VITROS 5,1 FS Chemistry System Serial Numbers: J34000102 through J34002323; VITROS 5,1 FS Chemistry System Refurbished Serial Numbers:  34000337,  34001840,  34000316,  34001389, 34001317,  34000538,  34000552,  34000360,  34000451,  34000833,   34001572,  34000193,  34001633,  34000851,  34001345,  34001396, 34001809,  34001897,  34001240,  34001612,  34001311,  34000212, 34001472,  34001172,  34001390,  34000557,  34000893,  34001297, 34001378,  34001218,  34000318,  34000596,  34000497,  34000495, 34000529,  34000478,  34001569,  34001243,  34001504,  34000947, 34001422,  34000805,  34000631,  34001248,  34001251,  34000601, 34001274,  34001668,  34001850,  34001379,  34000133,  34000642, 34001626. Class II Potential for biased results when a Multiple Window (MW) code is associated with results generated by the VITROS 4600 Chemistry System, the VITROS 5600 Integrated System and the VITROS 5,1 Chemistry System. MW codes may be associated with results from any of the following VITROS Chemistry Products using multiple point (multipoint) rate measurements. The MicroSlide assays that could be affected are VITROS ALT, ALKP, AST, CHE, CK, GGT and LDH Ortho-Clinical Diagnostics
Devices Boston Scientific, NovaGold High Performance Guidewire, Rx only, Sterilized using ethylene oxide, UPN M00552010 and M00552000, Manufactured by NeoMetrics Inc, 2605 Fernbrook Lane Suite J, Plymouth, MN 55447. The NovaGold Guidewire is intended for use in selective cannulation of the biliary ducts including the common bile, pancreatic, cystic, right and left hepatic ducts, and to aid in the placement of diagnostic and therapeutic devices during endoscopic procedures. MO26343, MO26345, MO26724, MO27402, MO26342, MO26344, MO26731, MO27401, MO27660, MO27901, MO27659, MO27820, MO27899 Class II Neo Metrics, Inc. is recalling NovaGold Guidewire because the tip may uncoil and / detach more frequently than anticipated. There have been no reports of illness or injury. NEO METRICS, INC.
Food Poco Pac Salad Dressing, Distributed by Diamond Crystal Brands, Inc., Savannah, GA 31405, and packaged in single serve packets of 9 or 12 grams (g) of product. Product is packed as follows: 500 ct-9g (Product Code: 86251), 200ct-9g (Product Code: 86242) and 200 ct-12g (Product Code: 86228). Product Code: 86251, Lot numbers: D009E, D022E, D027E, D030E, D031E, D037E, D038E, D048E, D056E, D057E, D058E, D093E, D105E, D136D, D150D, D156D, D162D, D163D, D171D, D172D, D178D, D190D, D193D, D199D, D204D, D213D, D220D, D224D, D227D, D228D, D229D, D234D, D235D, D241D, D248D, D249D, D252D, D254D, D255D, D266D, D267D, D274D, D275D, D281D, D282D, D295D, D298D, D302D, D315D, D316D, D318D, D322D, D329D, D338D, D339D, D344D, D345D, D361D; Product Code: 86242, Lot number: D022E, D037E, D065E, D105E, D169D, D171D, D184D, D189D, D193D, D199D, D203D, D204D, D220D, D233D, D234D, D240D, D256D, D269D, D274D, D280D, D283D, D294D, D315D, D329D, D331D, D351D, D358D, D360D; Product Code: 86228, Lot numbers: D009E, D022E, D027E, D038E, D048E, D058E, D136D, D162D, D184D, D193D, D199D, D204D, D220D, D224D, D227D, D228D, D235D, D241D, D248D, D249D, D254D, D266D, D267D, D280D, D283D, D298D, D315D, D316D, D322D, D329D, D345D, D346D. Class I Undeclared Allergen: Egg Diamond Crystal Brands, Inc.
Devices Ultrasonic Transducer Kits For use with the Access Family of Immunoassay Systems*. *The Access Family of Immunoassay Systems includes the Access 2, UniCel DxI 800 and UniCel DxI 600, UniCel DxC 600i, and the UniCel DxC 880i, UniCel DxC 860i, UniCel DxC 680i, and UniCel DxC 660i systems. Access 2 Immunoassay Systems, Catalog Number: 81600N. UniCel DxI 600 Access Immunoassay Systems, Catalog Numbers: A30260 and A71460. UniCel DxI 800 Access Immunoassay Systems, Catalog Numbers: 973100 and A71456. UniCel DxC 600i SYNCHRON Access Clinical Systems, Catalog Number: A25640. Catalog numbers for these systems are included in the respective DxI 600 and DxI 800 model numbers: UniCel DxC 660i SYNCHRON Access Clinical Systems, UniCel DxC 680i SYNCHRON Access Clinical Systems, UniCel DxC 860i SYNCHRON Access Clinical Systems, UniCel DxC 880i SYNCHRON Access Clinical Systems. Class II Beckman Coulter is initiating a field action for the Access Family of Immunoassay Systems because some Ultrasonic Transducer Kits were potentially assembled with incorrect mounting screws. Beckman Coulter Inc.
Devices BioDerm Liberty 3.0 External Male Catheter Specialty Type with integral collection chamber (Component: SKIN-PREP Protective wipes). The recalled wipes are used on intact skin for applying skin protectant to the glands for control of male incontinence with an external, non-invasive and nonsterile device. Lot Codes: Range from U24401 through U29801; Model Numbers: 23046, 23036, 21046, 21036. 21026 and 21006. Class II On 06/08/2011, BioDerm, Inc. issued a voluntary recall of a component skin wipes for the BioDerm Liberty 3.0 External male Catheter, BioDerm Liberty Pouch Clean & Dry External Male Catheter and BioDerm Safe n' Dry. This component (wipes) were initially manufacturer by Smith & Nephew and recalled due to a potential bacterial contamination. BioDerm, Inc.
Devices BioDerm Liberty Pouch Clean & Dry External Male Catheter Specialty Type with integral collection chamber (Component: SKIN-PREP Protective wipes). The recalled wipes are used on intact skin for applying skin protectant to the glands for control of male incontinence with an external, non-invasive and nonsterile device. Lot Codes: Range from U24401 through U29801; Model Numbers: 23046, 23036, 21046, 21036. 21026 and 21006. Class II On 06/08/2011, BioDerm, Inc. issued a voluntary recall of a component skin wipes for the BioDerm Liberty 3.0 External male Catheter, BioDerm Liberty Pouch Clean & Dry External Male Catheter and BioDerm Safe n' Dry. This component (wipes) were initially manufacturer by Smith & Nephew and recalled due to a potential bacterial contamination. BioDerm, Inc.
Devices BioDerm Safe n' Dry 21006 (Component: SKIN-PREP Protective wipes). The recalled wipes are used on intact skin for applying skin protectant to the glands for control of male incontinence with an external, non-invasive and nonsterile device. Lot Codes: Range from U24401 through U29801; Model Numbers: 23046, 23036, 21046, 21036. 21026 and 21006. Class II On 06/08/2011, BioDerm, Inc. issued a voluntary recall of a component (Smith and Nephew skin wipes) used in the BioDerm Liberty 3.0 External Male Catheter, BioDerm Liberty Pouch Clean & Dry External Male Catheter and BioDerm Safe n' Dry. Potential bacterial contamination of Smith and Nephew skin wipes by one of their contract manufacturers. BioDerm, Inc.
Devices Cooper Surgical TAMPA CATHETER 5 French 33 cm. Intended for Hysterosonography. Model Number: 61-2005 Lot 141525 Class II Sterility of the device may be compromised due to unsealed pouch CooperSurgical, Inc.
Food Marzipan - Pink, Orange and Green; Packed in 1 lb, (16 oz.) plastic containers and and 10.5 lb. 4.76 kg) pails. Ingredient: Sugar, almonds, potassium sorbate, oil of bitter almonds. Mandelin: California Almonds and Almond Pastes, Wasco California 93280 Codes: 1 Lb. packages: 2234, 91469FY; 10.5 lb packages: 133, 233, 336, 390, 509, 878, 995, 1071, 1608, 1617, 1634, 1677, 1691, 2529, 91276, 91714, 91755, 91786, 91113YF, and 91276YF Class II Undeclared Yellow #5 & 6 in Marzipan (Pink, Green, Orange). Mandelin Inc
Cosmetics KLM Hand & Body Moisturizing Lotion with oatmeal, aloe, and vitamin E sold in 800 mL bags, 1000 mL bottles, and 1 gallon bottles. Manufactured in the USA in a LEED Silver certified facility Kutol Products Co. Cincinnati, OH 45241. The product was also distributed under the Dominant 4 Protection brand name in Australia in 750 mL bags. 1 gallon - Kutol Catalog # 6207, Lot (L) 13020804; 800 mL bag - Kutol Catalog # 6265, Lot (L) 13062710; 1000 mL bottle - Kutol Catalog # 66236, Lot (L) 13062710; Dominant 750 mL bag - Kutol Catalog # 6226, Dominant Catalog # 15248, Lot (L) 13062710. Class II Product has been found to contain Pseudomonas aeruginosa and Pseudomonas putida. Kutol Products Co
Devices Stryker 0.5mm Round Fluted Bur Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant, Craniotomy, Vertebral Fusion and Fixation and Craniosynostosis. Part Number 5820-10-5, Lot Number 13354017 Class II There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments. Stryker Instruments Div. of Stryker Corporation
Devices Stryker 1.0mm Round Fluted Bur Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant, Craniotomy, Vertebral Fusion and Fixation and Craniosynostosis. Part Number 5820-10-10, Lot Number 14005017 Class II There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments. Stryker Instruments Div. of Stryker Corporation
Devices Stryker 2.0mm Round Fluted Bur Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant, Craniotomy, Vertebral Fusion and Fixation and Craniosynostosis. Part Number 5820-10-20, Lot Numbers 13347017,14010017 Class II There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments. Stryker Instruments Div. of Stryker Corporation
Devices Stryker 4.0mm Round Fluted Bur Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant, Craniotomy, Vertebral Fusion and Fixation and Craniosynostosis. Part Number 5820-10-40, Lot Numbers 13344017 Class II There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments. Stryker Instruments Div. of Stryker Corporation
Devices Stryker 6.0mm Round Fluted Bur Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant, Craniotomy, Vertebral Fusion and Fixation and Craniosynostosis. Part Number 5820-10-60, Lot Numbers 13343017 Class II There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments. Stryker Instruments Div. of Stryker Corporation
Devices Stryker 3.0mm Round Fluted Bur Soft Touch Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant, Craniotomy, Vertebral Fusion and Fixation and Craniosynostosis. Part Number 5820-10-130, Lot Numbers 13346017, 13346027 Class II There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments. Stryker Instruments Div. of Stryker Corporation
Devices Stryker 5.5mm Round Fluted Bur Soft Touch Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant, Craniotomy, Vertebral Fusion and Fixation and Craniosynostosis. Part Number 5820-10-155, Lot Number 13346017 Class II There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments. Stryker Instruments Div. of Stryker Corporation
Devices Stryker 3.0mm Round Fluted Bur Aggressive Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant, Craniotomy, Vertebral Fusion and Fixation and Craniosynostosis. Part Number 5820-10-230, Lot Number 13343017 Class II There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments. Stryker Instruments Div. of Stryker Corporation
Devices Stryker 4.5mm Round Fluted Bur Aggressive Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant, Craniotomy, Vertebral Fusion and Fixation and Craniosynostosis. Part Number 5820-10-245, Lot Number 13350017 Class II There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments. Stryker Instruments Div. of Stryker Corporation
Devices Stryker 5.0mm Round Fluted Bur Aggressive Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant, Craniotomy, Vertebral Fusion and Fixation and Craniosynostosis. Part Number 5820-10-250, Lot Numbers 13336017, 13339017, 13340017, 13344017 Class II There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments. Stryker Instruments Div. of Stryker Corporation
Devices Stryker 5.5mm Round Fluted Bur Aggressive Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant, Craniotomy, Vertebral Fusion and Fixation and Craniosynostosis. Part Number 5820-10-255, Lot Numbers 13354017, 14013017 Class II There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments. Stryker Instruments Div. of Stryker Corporation
Devices Stryker 6.0mm Round Fluted Bur Aggressive Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant, Craniotomy, Vertebral Fusion and Fixation and Craniosynostosis. Part Number 5820-10-260, Lot Numbers 13346017 Class II There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments. Stryker Instruments Div. of Stryker Corporation
Devices Stryker 2.0mm Tapered Round Elite Bur Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant, Craniotomy, Vertebral Fusion and Fixation and Craniosynostosis. Part Number 5820-10-320, Lot Numbers 14009017 Class II There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments. Stryker Instruments Div. of Stryker Corporation
Devices Stryker 3.5mm Zyphr Elite Round Fluted Bur Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant, Craniotomy, Vertebral Fusion and Fixation and Craniosynostosis. Part Number 5820-10-635, Lot Numbers 13354017 Class II There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments. Stryker Instruments Div. of Stryker Corporation
Devices Stryker 5.0mm Zyphr Elite Round Fluted Bur Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant, Craniotomy, Vertebral Fusion and Fixation and Craniosynostosis. Part Number 5820-10-650, Lot Number 14005027 Class II There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments. Stryker Instruments Div. of Stryker Corporation
Devices Stryker 6.0mm Zyphr Elite Round Fluted Bur Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant, Craniotomy, Vertebral Fusion and Fixation and Craniosynostosis. Part Number 5820-10-660, Lot Number 13352017 Class II There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments. Stryker Instruments Div. of Stryker Corporation
Devices Stryker 2.0mm Zyphr Elite Round Fluted Bur Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant, Craniotomy, Vertebral Fusion and Fixation and Craniosynostosis. Part Number 5820-10-920, Lot Number 13344017 Class II There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments. Stryker Instruments Div. of Stryker Corporation
Devices Stryker 5.0mm Egg Bur Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant, Craniotomy, Vertebral Fusion and Fixation and Craniosynostosis. Part Number 5820-15-50, Lot Number 13343017 Class II There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments. Stryker Instruments Div. of Stryker Corporation
Devices Stryker 6.0mm Egg Bur Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant, Craniotomy, Vertebral Fusion and Fixation and Craniosynostosis. Part Number 5820-15-60, Lot Number 14002017 Class II There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments. Stryker Instruments Div. of Stryker Corporation
Devices Stryker 5.0mm Barrel Bur Sterile Part Number 5820-17-50, Lot Number 13345017 Class II There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments. Stryker Instruments Div. of Stryker Corporation
Devices Stryker 5.0mm Acorn Bur Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant, Craniotomy, Vertebral Fusion and Fixation and Craniosynostosis. Part Number 5820-30-50, Lot Number 13347017 Class II There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments. Stryker Instruments Div. of Stryker Corporation
Devices Stryker 6.0mm Acorn Bur Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant, Craniotomy, Vertebral Fusion and Fixation and Craniosynostosis. Part Number 5820-30-60, Lot Number 13353017 Class II There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments. Stryker Instruments Div. of Stryker Corporation
Devices Lindemann Drill Short, 1.6mm Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant, Craniotomy, Vertebral Fusion and Fixation and Craniosynostosis. Part Number 5820-102-16, Lot Number 14006017 Class II There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments. Stryker Instruments Div. of Stryker Corporation
Devices Stryker 1.3mm Wire Pass Drill Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant, Craniotomy, Vertebral Fusion and Fixation and Craniosynostosis. Part Number 5820-103-13, Lot Number 14004017 Class II There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments. Stryker Instruments Div. of Stryker Corporation
Devices Stryker 1.5mm Wire Pass Drill Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant, Craniotomy, Vertebral Fusion and Fixation and Craniosynostosis. Part Number 5820-103-15, Lot Number 14004017 Class II There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments. Stryker Instruments Div. of Stryker Corporation
Devices Stryker 2.5mm x 3.6mm Neuro Drill Soft Touch Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant, Craniotomy, Vertebral Fusion and Fixation and Craniosynostosis. Part Number 5820-107-25, Lot Number 13346017 Class II There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments. Stryker Instruments Div. of Stryker Corporation
Devices Stryker 3.0mm x 3.8mm Neuro Drill Soft Touch Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant, Craniotomy, Vertebral Fusion and Fixation and Craniosynostosis. Part Number 5820-107-30, Lot Number 13351017, 14007017 Class II There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments. Stryker Instruments Div. of Stryker Corporation
Devices Stryker 4.0mm x 5.1mm Neuro Drill Soft Touch Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant, Craniotomy, Vertebral Fusion and Fixation and Craniosynostosis. Part Number 5820-107-40, Lot Number 13339017 Class II There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments. Stryker Instruments Div. of Stryker Corporation
Devices Stryker 3.0mm x 3.8mm Neuro Drill Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant, Craniotomy, Vertebral Fusion and Fixation and Craniosynostosis. Part Number 5820-107-430, Lot Number 13350017 Class II There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments. Stryker Instruments Div. of Stryker Corporation
Devices Stryker 3.0mm x 3.8mm Precision Neuro Drill Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant, Craniotomy, Vertebral Fusion and Fixation and Craniosynostosis. Part Number 5820-107-530, Lot Number 13332017, 13332027, 13332037, 13333017, 13333027, 13334017, 13334027, 13336017, 13336027, 13346017, 13347017, 13347027, 13347037, 14017017 Class II There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments. Stryker Instruments Div. of Stryker Corporation
Devices Stryker 5.0mm Barrel Bur Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant, Craniotomy, Vertebral Fusion and Fixation and Craniosynostosis. Part Number 5820-017-050S1, Lot Number 14015017 Class II There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments. Stryker Instruments Div. of Stryker Corporation
Devices Stryker 3.0mm x 3.8mm Neuro Drill Less Aggressive Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant, Craniotomy, Vertebral Fusion and Fixation and Craniosynostosis. Part Number 5820-107-430S1, Lot Number 14003017,14005017 Class II There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments. Stryker Instruments Div. of Stryker Corporation
Devices Taut Operative Cholangiogram Catheter, 4.5FR (1.5mm) x 76cm To facilitate the introduction of contrast media into the biliary ducts to obtain a cholangiogram during laparoscopic or open cholecystectomy. Product Code 18400, Lot No. 01A1400037 Class II Several complaints were received for the metal support tube missing from the cholangiogram catheter. Teleflex Medical
Food La Terra Fina All Natural Spinach & Kale Dip and Spread; Made with Greek Yogurt; Net Wt. 10 oz. (.625 lb) 284 g UPC 6 40410 51350 1; La Terra Fina, Union City, CA. Item number: 4303501; Lot 20140421, Expiration Date: 5/31/2014; Lot 20140428, Expiration Date: 6/14/2014. Lot 20140505, Expiration Date: 6/6/2014 Class III Ingredient statement for one lot of Greek Yogurt Spinach Kale dip contains the ingredient statement for spinach dip. La Terra Fina Inc.
Devices IntelliVue MX40 Wearable Patient Monitor in use with the Philips IntelliVue Information Center iX (PIIC iX); 865350, 865351, 865352 Serial numbers within the following ranges that have the MX40 interfaces: 00700001 - US01443745 and US014Z1301 - US014Z1431 Class II IntelliVue MX40 (part numbers 865350, 865352) with software revisions B.00 or B.01 may not resume alarming when the alarms are paused and the pause timer ends. Philips Medical Systems, Inc.
Devices RUSCH Easy Cath Coude Kit, 10 FR, Rx Only, Sterile, Distributed by: Teleflex Medical, Research Triangle Park, NC 27708. A tubular device that is inserted through the urethera and is used to pass fluids to or from urinary tracts. Product Code: ECK103, Lot number: 02A1402484 Class II Product was packaged with a straight catheter rather than the correct coude (curved) catheter. Teleflex Medical
Devices Horizon Medical Imaging Horizon Medical Imaging is a medical image and information management application that is intended to receive transmit, store, retrieve, display, print and process digital medical images, digital medical video, and associated medical information from various medical imaging systems. HMI 4.6.1, HMI 5.0 (Service Pack 1: Service Pack 5; Service Pack 7; Service Pack 8), HMI 11.0 (11.0.3; 11.0.4; 11.0.5; 11.0.6; 11.0.6 FR EXP2; 11.0.7; 11.0.8), HMI 11.5 (11.5.1; 11.5.2), HMI 11.6, HMI 11.7, HMI 11.8, HIM 11.9, McKesson Radiology 12.0 Class II Firm received a complaint that an unreported study performed that day could not be opened from the archive. Mckesson Medical Immaging
Drugs Dr. Reddy's Metoprolol Succinate Extended Release Tablets, USP 25 mg. 100-count bottle, Rx only, Manufactured By: Dr. Reddy's Laboratories Limited, Batchupally - 500 090 India. NDC55111-466-01 Lot # C206578 Exp. 05/14 Lot # C207415 Exp. 06/14 Class II Failed Dissolution Specifications: Failure of dissolution test observed at the 18 month time point. Dr. Reddy's Laboratories, Inc.
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