| 21 Sep 2012 | Asahi KASEI, REXEED(TM)- 15 SX, HEMODIALYZER dialysis filter | Asahi Kasei Medical Co., Ltd., Okatomi Plant | Device | Class II | 7 |
| 12 Sep 2012 | Pramipexole Dihydrochloride Tablets, 0.25 mg, 90-count tablets per bottle, Rx only, Manufactured in India by Sandoz Private Ltd., for Sandoz Inc., Princeton, NJ 08540, NDC 0781- 5249-92, | Sandoz Incorporated | Drug | Class III | 2 |
| 4 Sep 2012 | Bard Ventralight ST Mesh. - Ellipse 8" x 10" (20.3 cm x 25.4 cm) Product Code 5954810. The Bard Ventralight ST Mesh is a dual-component (absorbable and nonabsorbable) sterile prosthesis. The device classification name is "Mesh, Surgical, Polymeric." It is in tented for use in the reconstruction of soft tissue… | Davol, Inc., Subs. C. R. Bard, Inc. | Device | Class II | 2 |
| 4 Sep 2012 | Enalapril Maleate Tablet, USP 5mg 30 Tablet bottle, Rx, Apace Packaging LLC, Ft. Run, KY 42133, NDC 15338-211-30 | Apace KY LLC | Drug | Class III | 1 |
| 31 Aug 2012 | Somersaults Crunchy Nuggets baked with sunflower seed and toasted grains. Pacific Sea Salt Flavor, Net Wt. 6 oz. UPC 8-98403 00201-7; | Somersault Snack Co., LLC | Food | Class I | 1 |
| 30 Aug 2012 | Guardian II Hemostasis Valve, Model 8210 and Guardian II NC Hemostasis Valve, Model FH102. Intended to maintain hemostasis during the use of diagnostic/interventional devices. The device is indicated for maintaining a seal around diagnostic/interventional devices with outside diameters up to 8.0F (2.67 mm or 0.105")… | Vascular Solutions, Inc. | Device | Class II | 1 |
| 30 Aug 2012 | Tropical Salsa Product is labeled in part: "***FRESH***Garden Highway***Fresh Party Favorites!***PERISHABLE***KEEP REFRIGERATED***Tropical Salsa***Net Wt. 11 oz (312 g)***Best if Sold By***Renaissance Food Group LLC***Rancho Cordova, CA 95670***1-888-4 -HWYFUN***www.gardenhighway.com***" | World Food LLC. | Food | Class I | 3 |
| 30 Aug 2012 | Mango Spears: 1) Delish Mango Spears Net Wt. 5 oz. (142 g) Enjoy by: 8/28/2012 and before Prepared for Walgreens Inc. Deerfield, Illinois 60015 Distributed by Walgreens UPC 0 49022 53700 2; Delish Mango Spears 1 lb .(454 g) UPC 0 49022 58823 3 2) Mango Spears Best if Sold By: 08/28/12 and before 16 oz (1 lb)… | Individual firm, name withheld | Food | Class I | 13 |
| 30 Aug 2012 | Fresh Tropical Fruit Mix has the Item # 027-01480, and the UPC is 0 45009 01480 1. Haggen Label reads in part "HAGGAEN'S ORIGINAL *** Tropical Mixed Fruit *** Ingredients: Fresh Pineapple, Papaya, Mango & Kiwi ***Distributed with Pride by: Haggen, Inc., Bellingham, WA *** Net Weight 8 oz. ( 227 g.)***". | Triple B Corporation - Charlie's Produce | Food | Class I | 6 |
| 28 Aug 2012 | Empty Evacuated Container 250 mL and 1000 mL. Empty Evacuated containers are used for mixing compatible medications or blood collections. | Hospira Inc. | Device | Class II | 1 |
| 28 Aug 2012 | The Brilliance CT 16 System Product Usage: The Brilliance 16 is a Whole Body Computed Tomography X-ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. | Philips Medical Systems (Cleveland) Inc | Device | Class III | 1 |
| 28 Aug 2012 | Sekisui Spectrolyse PAI-1, In-Vitro Diagnostic for Quantitative determination of Plasminogen Activator Inhibitor Type- 1 (PAI-1) activity in human plasma. Catalog Number: 101201 For the determination of Plasminogen Activator Inhibitor Type 1 (PAI-1) activity in human plasma. The test is for in Citro diagnostic use. | Sekisui Diagnostics Llc | Device | Class II | 1 |
| 27 Aug 2012 | Ultraview SL 91493 Integrated Module Housing. PCIS patient monitors is intended to sound various alarm tones that are generated by the specific PCIS patient parameter modules. Each patient parameter module determines (a) when an alarm condition is violated; (b) the alarm priority (i.e. high, medium or low); (c) alarm… | Spacelabs Healthcare, Llc | Device | Class II | 1 |
| 27 Aug 2012 | Friendly's Sundae Nut Football Limited Edition, 48 oz. carton UPC :0-29839-00530-7 | Friendly Ice Cream Corp. | Food | Class II | 3 |
| 26 Aug 2012 | Fresh Express Hearts of Romaine Crunchy and Sweet 100% Hearts of Romaine Lettuce. 10 oz. plastic bag UPC 71279 26102. Fresh Express, Salinas, CA. | Fresh Express Incorporated | Food | Class I | 1 |
| 24 Aug 2012 | Volcano brand Intravascular Ultrasound, Volcano s5/s5i Family Software Version 3.2.1 or 3.2.2, Models/Part Numbers: 435-0607.01, 435-0607.04, 435-0602.01, 435-0602.02; Product is manufactured and distributed by Volcano Corporation, Rancho Cordova, CA. Medical device for use in imaging of histology. | Volcano Corporation | Device | Class II | 1 |
| 24 Aug 2012 | MX 16-slice CT Scanner System, models 728131 and 728132. The MX 16-slice CT Scanner System can be used as a whole body computed tomography X-ray system. | Philips Medical Systems (Cleveland) Inc | Device | Class II | 1 |
| 23 Aug 2012 | "SAFEWAY farms White Sliced Mushrooms***DISTRIBUTED BY SAFEWAY INC.***PLEASATON, CA***PRODUCT OF CANADA***NET WT 8 OZ (227g)" UPC 0 21130 28443 6 | Safeway Inc | Food | Class I | 1 |
| 23 Aug 2012 | Naturally Fresh Salad Toppings, Roasted & Glazed Pecan Pieces, Net weight 3.5 oz, Distributed by: Naturally Fresh, Atlanta, GA (62992) | Naturally Fresh Inc. | Food | Class I | 1 |
| 23 Aug 2012 | Dole Mushroom, packaged in a retail package, net wt. 8 oz. The UPC is 0 33383 67600 5. | United Salad Company | Food | Class I | 1 |
| 22 Aug 2012 | 12/14 TAPER HIGH OFFSET NECK USE WITH SMITH & NEPHEW STEMS AND 12/14 FEMORAL COMPONENTS ONLY CO-CR, REF 71352112, Smith & Nephew, Inc. Memphis, TN 38116 USA. USE WITH SMITH & NEPHEW STEMS AND 12/14 FEMORAL COMPONENTS. | Smith & Nephew Inc | Device | Class II | 1 |
| 22 Aug 2012 | S-Rom¿ Total Hip System Poly Liner Packaging: The insert is placed into an inner foil pouch and vacuum sealed; a ring is placed into a Tyvek/PET pouch and sealed; the foil pouch and Tyvek/PET pouch are placed into a nylon outer pouch and sealed. This is then placed into a folding carton, labeled, and shrink-wrapped.… | DePuy Orthopaedics, Inc. | Device | Class II | 1 |
| 22 Aug 2012 | Dole Italian Blend; Romaine, Radicchio; 10 oz plastic bag (283g); UPC:7143000819. Dole, Monterey, CA 93942. | Dole Fresh Vegetables Inc | Food | Class I | 1 |
| 22 Aug 2012 | Spence & Co Ltd brand 8oz Smoked Salmon Trim | Spence & Co., Ltd. | Food | Class I | 2 |
| 21 Aug 2012 | Siemens Mobilett Mira. Mobile X-Ray System. | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 21 Aug 2012 | Red Vines Black Licorice Twists; No preservatives and Always Fat Free Packaged in the following configurations: One Pound Pac: Red and white Plastic bag with a window to display licorice twists. UPC 0 41364 00283 5; 5 oz Black Licorice Tray Pack; UPC 4136451277 and 4136450277; 7 oz Black Licorice Laydown Bag: UPC… | American Licorice Co | Food | Class II | 3 |
| 18 Aug 2012 | Tanimura & Antle Romaine Lettuce (Laitue Romaine) in plastic bag Wrapped Single Head Romaine marked Field Packed for Freshness.. Distributed by Tanimura & Antle, Salinas, CA. (62910) | Individual firm, name withheld | Food | Class I | 1 |
| 17 Aug 2012 | Octopus 101 Perimeter; PeriTrend Software Analysis A perimeter is a device intended to determine the extent of the peripheral visual field of a patient. The device projects light on various points of a curved surface, and the patient indicates whether he or she sees the light. | Haag-Streit USA Inc | Device | Class II | 1 |
| 17 Aug 2012 | Highline Mushrooms Sliced, white mushrooms 8 oz. (62374) | Ciolino Wholesale Produce, Inc. | Food | Class I | 1 |
| 17 Aug 2012 | ProBalance Protein To Go(TM), Milk Chocolate Shake, Dietary Supplement, Net Wt 2.5 fl oz (Responsible firm on labeling: Pro Balance LLC, 4070 Tampa Road, Oldsmar, FL 34677) | Protica, Inc | Food | Class II | 4 |
| 16 Aug 2012 | GE Healthcare, Innova 2121IQ, Innova 3131IQ Cardiovascular X-ray imaging systems. K060259: The Innova 3131IQ (3131-IQ) and 2121 IQ (2121-IQ) biplane systems are indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally,… | GE Healthcare, LLC | Device | Class II | 1 |
| 16 Aug 2012 | Zoll X Series Defibrillator/Pacemaker/Monitor Product Usage: The product is used by qualified medical personnel for the purpose of converting ventricular fibrillation to sinus rhythm or other cardiac rhythms capable of producing hemodynamically significant heart beats. In addition, the product may be used in… | ZOLL Medical Corporation | Device | Class II | 1 |
| 16 Aug 2012 | Markets of Meijer, fresh Grillers, Mushrooms with Rosemary, 10 oz, Ingredients: Mushrooms, Rosemary, Product of Canada, Keep Refrigerated, Pre-heat grill or over to 450 F... Cook 15-20 minutes in oven/BBQ or 4-5 minutes in microwave... | Pure Hothouse Foods Inc. | Food | Class I | 3 |
| 16 Aug 2012 | Meijer Brand Mushrooms, imported from The Netherlands Stems & Pieces, DR WT 4-oz and 8-oz sizes/Net Wt. 6.5-oz and 13.25-oz, UPC 7-1373337545-0 and UPC 7-1373337544-3 | Meijer Distribution, Inc | Food | Class III | 1 |
| 16 Aug 2012 | Whole Cantaloupe. Both unlabeled and labeled "MIDWEST BEST" PRODUCE INC. HOMEGROWN CANTALOUPE #4319 PRODUCT OF THE USA (62963) | Chamberlain Farms Inc. | Food | Class I | 1 |
| 15 Aug 2012 | Philips SureSigns VSi/VS2+ patient monitors Model Part Numbers VSi/ 863275, 863276, 863277, VS2+ 863278, 863279. The SureSigns VS2+ vital signs monitor is for monitoring, recording and alarming of multiple physiological parameters of adults, pediatrics, and neonates in healthcare environments. Additionally, the… | Philips Healthcare Inc. | Device | Class II | 1 |
| 15 Aug 2012 | 0.9% Sodium Chloride Injection, USP, Pre-Filled Flush Solution, 3 mL in 12 mL Single Use Syringe, Rx only, List no. 1078-33, made in Nashville, TN, manufactured for Hospira, Inc., Lake Forest, IL 60045 USA. Flush syringe. | Amsino Medical USA | Device | Class III | 2 |
| 15 Aug 2012 | Capex Shampoo (fluocinolone acetonide), Topical Shampoo, 0.01%, Rx only, For Topical Use Only, 4 fl oz in a 6 oz bottle, Marketed by: Galderma Laboratories, LP, Fort Worth, TX, Mfd. by: Hill Dermaceuticals, Inc., Sanford, FL --- NDC 0299-5500-04, (62803) | Galderma Laboratories, L.P. | Drug | Class III | 1 |
| 15 Aug 2012 | Wegman's Tomato Basil with Orzo Soup 16 oz retail cup Product Code: 85653 | Blount Seafood Corporation | Food | Class II | 4 |
| 14 Aug 2012 | Philips DigitalDiagnost Systems with M Cabinet Model: 712025 Stationary radiographic system, digital-Universal RAD Applications | Philips Healthcare Inc. | Device | Class II | 1 |
| 14 Aug 2012 | JUGGERKNOT IN¿GUIDE PUNCH, 2.9MM. The JuggerKnot 2.9mm In-Guide Punch is intended to be used to prepare a 2.9mm hole into bone in which the JuggerKnot 2.9mm Suture Anchor is to be placed. The JuggerKnot 2.9mm Suture Anchor is intended to be used to attach soft tissue to bone. | Biomet, Inc. | Device | Class II | 1 |
| 14 Aug 2012 | Varian brand Clinac, Trilogy, Novalis Tx, Unique, linear accelerators; Model Number: H14, H18, H29, Reference/FSCA Identifier: CP-08881; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA. 1) The Varian Low Energy Linear Accelerator is indicated for precision radiotherapy for… | Varian Medical Systems, Inc. Oncology Systems | Device | Class II | 1 |
| 14 Aug 2012 | Pico de Gallo salsa, 2 lbs pouch, packaged in a case of 5/2 lbs. Product labeling reads in part:" REAL MEX FOODS ITEM # 15102 "MILD" PICO DE GALLO*** PACK SIZE: 5/2 LBS. NET WEIGHT: 10 LBS Real Mex Foods 3305 Vernon Ave. Vernon, Ca 90058***". | Real Mex Foods | Food | Class I | 2 |
| 14 Aug 2012 | Organic Pinenuts. 5lb bag: Organic Pine nuts packed into plastic bag with a twist tie with a White stick on label with hand written product description. 27.5lb bag: Organic Pine nuts inside of a plastic bag with a white stick on label with typed product description. | Honey Heaven Wholesale, Inc. | Food | Class I | 1 |
| 13 Aug 2012 | Blueberry Crisp CLIF Bars, 12 pack boxes, UPC: 7-22252-30260-1 | Clif Bar And Company | Food | Class II | 2 |
| 13 Aug 2012 | Fresh Mahi Mahi Fillets,10 lb Styrofoam case, labeled in part: "***Mahi Fillets S/ON Costa Rica Wild****KEEP AT 38 OR BELOW Keep refrigerated***ATLANTIC FISHERIES 8195 NW 67TH ST MIAMI FLORIDA 33166***TEL***FAX 305-594-4301***PACK U.S.A. (62888) | Atlantic Fisheries | Food | Class II | 1 |
| 13 Aug 2012 | intraKID Lot 658 with a Best By date of 12/12, 33 oz and 2 oz bottles (62872) | Drucker Labs LP | Food | Class II | 1 |
| 10 Aug 2012 | Capsule Neuron Docking Station, a component in the DataCaptor Connectivity System Catalog Number DC-NU-DS-CK The Capsule Neuron Docking Station is a component in the DataCaptor Connectivity System. The Capsule Neuron Docking Station provides connection for the Capsule Neuron UMPC which is a bedside device that… (62844) | Capsule Tech Inc. | Device | Class II | 1 |
| 10 Aug 2012 | QKC1692E The QKC1692E Quick Connect device connects endoscopes to the sterilization tray for C1220E liquid chemical sterilization processor. | Steris Corporation | Device | Class II | 1 |
| 9 Aug 2012 | AmeriWater MRO Dialysis RO+ System, AmeriWater 1303 Stanley Avenue, Dayton, OH 45404 (800) 535-5585 www.AMERIWATER.com. The AmeriWater MRO Portable Reverse Osmosis Systems are water treatment systems intended for use in hemodialysis applications. They are designed to pre-treat and purify potable water for use in… (62891) | AmeriWater Inc | Device | Class II | 1 |
| 9 Aug 2012 | 3DKnee e+ Tibial Insert - HXLPE-VE, Sterile, Material: Highly cross linked vitamin E PE, Sz 2/9mm. The insert is intended to more closely match the kinematics of the knee, allowing some rotation along the medial condyle and increased congruency along lateral condyle. This insert is to be used along with the other… | Encore Medical, Lp | Device | Class II | 1 |
| 9 Aug 2012 | Tip Cover for 8mm Monopolar Curved Scissors (Hot Shears)Accessory, Disposable, 8mm MCS, Box of 10. The intended use of the Tip Cover Accessory is to provide dielectric insulation over a section of the Monopolar Curved Scissor instrument so that RF energy is only available at the scissor blades. The Monopolar Curved… | Intuitive Surgical, Inc. | Device | Class II | 1 |
| 9 Aug 2012 | Omnilife Science Apex Knee System Modular Tibia Augment, Size 1 x 4mm Ref: KC-54010. The Apex Knee System is intended for use as a primary or revision total knee replacement. | Omni Life Science | Device | Class II | 6 |
| 9 Aug 2012 | Integra CRW Precision Arc (CRWPRECISE), CRW Arc System (CRWASL), HRAIM Head Ring Assembly with Intubation Mounts The CRW stereotactic system is used in conjunction with the HRAIM head ring is a target-centered system that can be configured to be CT-only or CTIMR compatible. The CRW stereotactic system is a… | Integra LifeSciences Corporation | Device | Class II | 2 |
| 9 Aug 2012 | Jaffe Bros. brand, Pine nuts, raw and shelled. Packaged in plastic bag. Labeling reads in part:"Jaffe Bros.***Organically Grown Raw, Shelled Pine Nuts This product was packaged on shared equipment that also processes Peanuts***Distributed by Jaffe Bros., Inc. P.O.Box 636 Valley Center, CA 92082***". (62829) | Jaffe Brothers | Food | Class II | 1 |
| 9 Aug 2012 | Watermelon, labeled IT'S WATERMELON TIME!, Produce of USA, Seedless, #4032. (62980) | Tunnel Farms | Food | Class II | 1 |
| 8 Aug 2012 | Nature's Harvest, pine nuts, Net WT 3 oz (85 g), Distributed by Amport Foods, 550 Kasota Ave, SE., Minneapolis, MN 55414, 3 00 71725 72753 4. Case Label Stock No. 5640 8/3 oz Nature's Harvest, Pine Nuts Best by: 12-28-12 363x1E1, 3 00 71725 72753 5. Amport Foods Bags: Amport Foods, Pine Nuts, Net WT 4 0 z (113 g), 0… | American Importing Co, Inc | Food | Class II | 1 |
| 8 Aug 2012 | Aussie-Style Lucky Country Soft Licorice in 1.5 lb. bags. The product is packaged 1.5lb x 18 bags per tray. (62795) | Lucky Country, Inc. | Food | Class II | 1 |
| 8 Aug 2012 | Yogurt Parfait Strawberry, Net weight 9 oz. (225 g), UPC 0 20728 70004 4. Product contains yogurt and strawberry filling and one cup of granola, packaged in a clear container, and granola is in the inner container. The product is labeled in part: '***YOGURT PARFAIT STRAWBERRY***9oz (225g)***Distributed by PACIFIC… (62788) | Shin Shin Foods, Inc. | Food | Class II | 1 |
| 8 Aug 2012 | Crown Program BK Fresh Apple Slices, 2 oz On or before August 13; no upc code | Missa Bay, LLC | Food | Class I | 29 |
| 7 Aug 2012 | 16 Fr HemoStar XK Long-Term Hemodialysis Catheter, implanted Standard kit containing an AirGuard introducer. The device is used for patients requiring hemodialysis. The HemoStar XK catheter is made of radio-opaque polyurethane and allows for flow rates as high as 500 ml/min during hemodialysis treatment. | Bard Access Systems | Device | Class III | 1 |
| 7 Aug 2012 | ADVIA Centaur Prolactin Assay: ADVIA Centaur Calibrator B Catalog Number. Prolactin:110757 and 110758: US:Calibrator B 00652707 (6 pack) or 00649625 (2 pack ) OUS: 2 pack REF: 00650577 and Ref: 00654130 (6 pack) Product Usage: ADVIA Centaur CP Prolactin assay: For in vitro diagnostic use in the quantitative… | Siemens Healthcare Diagnostics, Inc | Device | Class III | 2 |
| 7 Aug 2012 | Bissinger's Campfire S'Mores Salt Caramels, packaged in 1.8-oz. boxes, 5 pieces per box, 12 boxes per display case, UPC 846107012788. The firm name on the label is Bissinger's Handcrafted Chocolatier, St. Louis, MO. (62754) | Karl Bissinger Inc | Food | Class II | 1 |
| 7 Aug 2012 | Meal Replacement product is labeled in part: "***The Perfect Shake***All of the Best***None of the Rest***foru***Dietary supplement***Net wt. 20 oz (1 lb 4 oz) (564 g)***A well balanced blend of old-world plant nutrition.***What's in The Perfect Shake supplement? All of the best, and none of the rest, in amounts that… (62960) | Atlas Operations, Inc. | Food | Class II | 1 |
| 6 Aug 2012 | Precise Digital Accelerator Delivery of radiation to defined target volumes | Elekta, Inc. | Device | Class II | 1 |
| 6 Aug 2012 | Crispy Punjabi Cookies, By TWI Foods, Net Wt. 800g/1.76 lb, Manufactured by TWI Foods, Inc. 1-866-9-CRISPY, www.crispyjustbaked.com, UPC 627265001520, Product of Canada. (62846) | Singh And Singh Distributors Inc. | Food | Class I | 1 |
| 5 Aug 2012 | Dippin' Stix Sliced Apples & Caramel with Peanuts | Reichel Foods, Inc | Food | Class I | 2 |
| 3 Aug 2012 | Newport HT70 and HT70 Plus Ventilators, Model Number: HT70 and HT70 Plus. Product Usage: The HT70 ventilator system is intended to provide continuous or intermittent positive pressure mechanical ventilatory support for the care of individuals who require mechanical ventilation through invasive or non-invasive… | Newport Medical Instruments Inc | Device | Class I | 1 |
| 3 Aug 2012 | Instrumentation Laboratory ACL TOP (Base) PN 0000280000 ACL TOP is a bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems… | Instrumentation Laboratory Co. | Device | Class II | 6 |
| 3 Aug 2012 | HALO Flex Energy Generators Manufactured by B¿RRX Medical (now Covidien) 540 Oakmead Parkway Sunnyvale, CA 95085. The HALO Flex Energy Generator is indicated for use for the coagulation of soft tissue. The HALO Flex System is indicated for use in the coagulation of bleeding and non-bleeding sites in the… | Covidien LLC | Device | Class II | 1 |
| 3 Aug 2012 | Propofol Injectable Emulsion, 1%, 1 g/100 mL (10 mg/mL), 100 ml Single patient infusion vial, Rx only, Hospira, Inc. Lake Forest, IL 60045 USA, NDC 0409-4699-24 | Hospira Inc. | Drug | Class II | 1 |
| 3 Aug 2012 | Crispy Punjabi Cookies, By TWI Foods, Net Wt. 800g/1.76 lb, Manufactured by TWI Foods, Inc. 1-866-9-CRISPY, www.crispyjustbaked.com, UPC 627265001520, Product of Canada. (62849) | Indian Foods & Spices, LLC | Food | Class I | 1 |
| 2 Aug 2012 | 100 ft roll of tubing inside a cardboard box. Medical devices are sealed into the tubes prior to ethylene oxide sterilization. Tube maintains sterility of the enclosed medical devices until opened. | Steris Corporation | Device | Class III | 1 |
| 2 Aug 2012 | PHADIA Varelisa Cardiolipin IgM Cardiolipin autoantibody immunological test system (IgM class antibodies) | Phadia US Inc | Device | Class III | 1 |
| 2 Aug 2012 | Sterile Empty Vial and Injector (30mL PCA vial), Rx only, One/List No. 6021-03, Hospira, Inc., Lake Forest, IL 60045. For use with a compatible Hospira PCA pump set with injector and a compatible Hospira infusion device. | Hospira, Inc. | Device | Class II | 1 |
| 1 Aug 2012 | The SYSTEM 1E Liquid Sterilant Processing System. The SYSTEM 1E Liquid Sterilant Processing System is intended for the liquid chemical sterilization of manually cleaned immersible and reusable critical and semi-critical heat sensitive medical devices, including endoscopes and their accessories. | Steris Corporation | Device | Class II | 1 |
| 1 Aug 2012 | DGPHP RFA High-Power Single Use Grounding Pads and Cool-Tip RFA Electrode Kits (containing DGPHP RFA High-Power single use grounding pads) The product is used during ablation surgical procedures. | Nellcor Puritan Bennett Inc. (dba Covidien LP) | Device | Class II | 1 |
| 1 Aug 2012 | "Tres Monjitas***Pineapple and guava beverage***Distribuido por Vaquer¿a Tres Monjitas Inc***" Package sizes: gallons, 1/2 gallons, quarts, 14 oz and 8 oz. (62789) | Vaqueria Tres Monjitas, Inc. | Food | Class I | 1 |
| 31 Jul 2012 | V60 Ventilator, Continuous Ventilator, Model# V60, PN 1056490 Product Usage: The V60 Ventilator is an assist Ventilator and is intended to augment patient breathing. It is intended for spontaneously breathing individuals who require mechanical ventilation: patients with respiratory failure, respiratory insufficiency,… | Respironics California Inc | Device | Class I | 1 |
| 31 Jul 2012 | Jakes Spice Drop, Jake's Jelly Spice Drops 3oz, 4.5oz, 5oz, 6oz and 7oz packages Distributed by Jake's Liberty Packaging Oak Park, MI 48237 248-747-2223 (62730) | Four Brothers Packaging Corporation | Food | Class II | 1 |
| 30 Jul 2012 | CLIF Bar Brand Coconut Chocolate Chip CLIF Bars, 6-pack boxes, UPC: 7-22252-66030-5 Product is manufactured by Harlan Bakeries in Indianapolis, IN. | Clif Bar And Company | Food | Class III | 2 |
| 30 Jul 2012 | Amy's Brand Pizza Pesto Made with Organic Vegetables & Basil in 7 oz; ; 13.5 oz; Sku# 42272-00104 Product is processed and packaged by Amys Kitchen, White City, Oregon | Amy'S Kitchen | Food | Class I | 2 |
| 28 Jul 2012 | Whole Fresh Cantaloupe, PLU# 4319, Burch Farms, Faison, NC 28341. On 8/2/2012 the recall was expanded to include cantaloupes labeled, Cottle Strawberry, Inc., #4319, Faison, NC. (Cottle Farms is not involved in this recall). | Burch Farms | Food | Class I | 2 |
| 27 Jul 2012 | TxRx Knee 15 Coil 3T. For use in conjunction with magnetic resonance scanners to produce diagnostic images of the knee that can be interpreted by a trained physician. (62949) | Quality Electrodynamics LLC | Device | Class II | 1 |
| 27 Jul 2012 | Multileaf Collimator To be used for single or multiple fractions, delivered as static and/or dynamic beams of radiation, in all areas of the body where such treatment is indicated. | Elekta, Inc. | Device | Class II | 1 |
| 27 Jul 2012 | The Bio-Rad MONOLISA Anti-HBs EIA is for In Vitro Diagnostic Use and it has the catalog number 25220. It is a qualitative and quantitative enzyme immunoassay for the detection of antibody for hepatitis B surface antigen in human serum and EDTA or citrated plasma. The Bio-Rad MONOLISA Anti-HBs EIA is a qualitative and… | Bio-Rad Laboratories | Device | Class II | 1 |
| 27 Jul 2012 | Eco-Dent Sparkling Clean Mint Ultimate Essential MouthCare, Natural Daily Rinse and Oral Wound Cleanser/Oral Debriding Agent, 8 fl oz (237 mL) bottle, Alcohol Free, Dist By: Eco Dent, 1100 Lakes Dr., Silver Lake, WI 53170 USA, UPC Code: 00037541 (62756) | Capco Custom Packaging Inc | Drug | Class II | 1 |
| 27 Jul 2012 | Oasis Age Essential (cetylpyridinium chloride) Mouthwash, 0.06%, 473 mL (16 fl oz) bottle, Oasis Consumer Healthcare LLC, 812 Huron Road, Cleveland, Ohio 44115, UPC 8 51076 00300 2. (62761) | Natural Essentials Inc | Drug | Class III | 1 |
| 27 Jul 2012 | Fresh Select Brussels Sprouts, 6x8oz, 9x12oz. Item # 22986, 22707, UPC 0 11110 91610 5, 7 09351 32222 8. | Apio, Inc. DBA Apio Fresh LLC | Food | Class II | 3 |
| 27 Jul 2012 | GREEN CHILE CHICKEN ENCHILADAS 12 OZ | Busch's, Inc. - Central Production Facility | Food | Class I | 12 |
| 27 Jul 2012 | The product listed below is prepared at Whole Foods Market and distributed in their retail chef's case or on the self-service bar. It was not sold labeled. BABY SHRIMP SALAD | Ron Stockman Whole Foods | Food | Class I | 31 |
| 27 Jul 2012 | Finest Traditions Smokey Baked Beans, 8 lbs.,10 733147 10456 6, 16 oz., 7 33147 00161 5, 8 lbs., 10 733147 10231 9; | Garden-Fresh Foods, Inc. | Food | Class I | 94 |
| 26 Jul 2012 | Ventolin HFA (albuterol sulfate) Inhalation Aerosol 90 mcg per actuation, 200 Metered Inhalations, FOR ORAL INHALATION ONLY - For use with Ventolin HFA actuator only. Net. wt. 18 g Rx only, GlaxoSmithKline, Reasearch Triangle Park, NC 27709 NDC 0173-0682-20 (62799) | GlaxoSmithKline Inc | Drug | Class II | 1 |
| 26 Jul 2012 | Trader Jose's, Mild Salsa, 16 ounce (1 lb) 454g), in clear rigid plastic containers with snap on lids. | Simmering Soups Inc. | Food | Class I | 2 |
| 26 Jul 2012 | UNH Stir Fry: 5 lbs ply bag Broccoli. Bock Choy. Spanish Onions (1" x 1" cut). Celery Packed by: fresh Ideas Co., 18 Bunker Hill Industrial Park, Boston, MA 02129 Item # 00137 | Fresh Ideas Inc. | Food | Class I | 13 |
| 26 Jul 2012 | Carob Raw Powder Distributed by San Francisco Herb and Natural Food Co. Fremont, Ca. | San Francisco Herb & Natural Food Company | Food | Class II | 28 |
| 25 Jul 2012 | Siemens ADVIA Centaur Multi-Diluent 1 - Used for automated dilutions for the ADVIA Centaur BNP and TSH3 Ultra assays when on-board the ADVIA Centaur or ADVIA Centaur XP systems. Catalog Numbers: 2 Pack REF 07907174 (110312) 6 Pack REF 07293184 (110313). Used for automated dilutions for the ADVIA Centaur BNP and TSH3… | Siemens Healthcare Diagnostics, Inc | Device | Class II | 1 |
| 25 Jul 2012 | Aesculap S4 Element 4.5mm Polyaxial Screws (ST240T, ST241T, ST242T, ST243T, ST244T, and ST245T). The S4 Spinal System is intended for anterior/anterolateral and posterior, non-cervical pedicle and non-pedicle fixation. Fixation is limited to skeletally mature patients and is intended to be used as an adjunct to… | Aesculap Implant Systems LLC | Device | Class II | 1 |
| 24 Jul 2012 | Capintec Captus 3000 Thyroid Uptake System Nuclear uptake probe intended to be used by trained Nuclear Medicine Technologists to perform thyroid uptake procedures, which consist of the measurement of organ uptake and circulating radioactivity. | Capintec Inc | Device | Class II | 1 |
| 23 Jul 2012 | VersaTREK Windows Software, Version 5.4.3 is a component of the VersaTrek System. The Software CD will be individually packaged using a standard CD plastic case and placed into a standard CD mailer The VersaTREK System is for cultivating and recovering microorganisms, especially bacteria and yeasts, from blood and… (62757) | Trek Diagnostic Systems | Device | Class III | 1 |
| 23 Jul 2012 | Cisco brand HealthPresence, version 2.1; Model/Catalog Number: CHP-ENTPRSYR2.I-K9; Product is manufactured and distributed by Cisco Systems, Inc. San Jose, CA Cisco HealthPresence, version 2 is intended for remote consultation of patients with a healthcare provider. Cisco HealthPresence enables remote collaboration… (62770) | Cisco Systems Inc | Device | Class II | 1 |
| 23 Jul 2012 | Mercaptopurine Tablets, USP, 50 mg, 30 Tablets (3 x 10) unit dose blisters per carton, Rx only, Packaged by American Health Packaging, 2550-A John Glenn Avenue, Columbus, OH 43217, barcode 6808432511; Carton labeling Dist by: Par Pharmaceutical Companies, Inc., Spring Valley, NY 10977, NDC 68084-325-21. | American Health Packaging | Drug | Class II | 1 |
| 23 Jul 2012 | 6" Club Sandwich, 8" Club Sandwich, Club Sandwich Triangle, and Wide Wedge Club Sandwich | Rita's Fine Food, Inc. Dba Da Vinci's | Food | Class II | 12 |
| 20 Jul 2012 | CASS-CLAY, Ice Cream, Artificially Flavored MAPLE NUT, One Gallon (3.78 L), 0 70422 03404 4 HORNBACHERS, MAPLE NUT, Ice Cream, HALF GALLON(1.89 L), 0 41130 21666 4 COLUMBIA VALLEY FARMS, MAPLE NUT, 62438, 3 GALLON(11.34L), 0 41493 62438 0 | Cass Clay Creamery AMPI Fargo Division | Food | Class I | 29 |
| 18 Jul 2012 | syngo Imaging XS. Radiological image processing system. | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 18 Jul 2012 | syngo.plaza, Model number 10592457. Intended use: radiological image processing system. | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 17 Jul 2012 | Thai Farmer Brand Preserved Star Gooseberry, NET WT 7.0 OZ. Packaged 30 per case. Product labeling reads in part:"***THAI FARMER BRAND PRESERVED STAR GOOSEBERRY*** DISTRIBUTED BY: T.F. FOODS, INC. PARAMOUNT, CA 90723***NET WT. 7.0 OZ***PRODUCT OF THAILAND***". (62920) | T.F. Foods Incorporated | Food | Class II | 1 |
| 15 Jul 2012 | Enduramesh Corpectomy Spacer System Product Usage: The Enduramesh is a vertebral body replacement system intended for use in the thoracic and lumbar spine (T1-S1) to replace a collapsed, damaged or unstable vertebral body due to tumor or trauma/fracture. The device is intended for use with either allograft or… (62926) | Lucero Medical LLC | Device | Class II | 1 |
| 13 Jul 2012 | CosMedix Serious Protection, Natural SPF 28 Sunscreen, 3.3 fl.oz/100mL (100 g), Distributed by CosMedix, LLC, Atlanta, GA --- Also labeled as RESULTS RX, Serious Protection Rx, SPF 28 Sunscreen, Net Wt. 4oz/120g. (62779) | Island Kinetics dba Covalence | Drug | Class II | 1 |
| 10 Jul 2012 | Optima XR220amx Mobile general purpose radiographic imaging of the human head and body. | GE Healthcare, LLC | Device | Class II | 2 |
| 3 Jul 2012 | Verify¿ Bowie-Dick Test Card, Model #S3098, Steris Biological Operations, 9325 Pinecone Drive, Mentor, OH 44060 The Verify Bowie-Dick Test Card consists of a card printed on one side with bars of chemical indicator ink. On the opposite side of the card, space is provided for critical cycle information to be recorded.… | Steris Corporation | Device | Class II | 1 |
| 2 Jul 2012 | Frozen Pangasius Fish, brand name T&T, in the following sizes: a. IQF 15 lbs bulk carton: 3/5 oz, 5/7 oz, 7/9 oz, 9/11 oz b. 11lbs x 2 per carton: 8/10 oz and 10 oz/up c. 2lbs x 5 per carton: 2/3 oz d. 15lbs carton: 2/3 oz Product labeling reads in part:" T&T SWAI ROSE ROLL(Pangasius hypophtalmus)***FARM-RAISED… (62762) | Nha Trang Seafoods, Inc | Food | Class III | 1 |
| 29 Jun 2012 | Bard Foley procedural trays packaged in breather bags. The product is packaged ten units in each shipper box, and are sold sterile for single use. Used to catheterize patients. The finished trays are sold in Tyvek breather bags. (62774) | C.R. Bard, Inc., Urological Division | Device | Class II | 1 |
| 29 Jun 2012 | BD FACS 7-color Setup beads BD Biosciences, San Jose, CA 95131. BD FACS 7 color Setup Beads are for in vitro diagnostic use on BD FACSCanto or BD FACSCanto II systems. The beads are run with BD FACSCanto clinical software. This system provides application specific setup, including automated compensation and cytometer… | BD Biosciences, Systems & Reagents | Device | Class II | 1 |
| 27 Jun 2012 | Carboplatin Injection, 10 mg/mL, 45 mL Multi-Dose Vial, Rx only, antineoplastic/cytotoxic agent; Manufactured for Hospira, Inc., Lake Forest, IL 60045, Product of Australia, NDC 61703-339-50 (Hospira label), NDC 61703-360-50 (Novoplus label) | Hospira Inc. | Drug | Class II | 4 |
| 25 Jun 2012 | Frozen tiny oyster meat I.Q.F. , 40x8oz (20lbs/case); | Interstate Seafood Inc | Food | Class II | 3 |
| 20 Jun 2012 | Philips HeartStart MRx monitor/defibrillators Models: M3535A and M3536A, M3536J, M3536M, M3536MC, M3536M1, M3536M2, M3536M3, M3536M4, M3536M5, M3536M6 The Heartstart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained… | Philips Healthcare Inc. | Device | Class II | 1 |
| 20 Jun 2012 | Little Remedies For Tummys, Stimulant Laxative (sennosides) Drops, 1 FL OZ (30 mL), Dist. by Medtech Products Inc., Irvington, NY 10533, UPC 7 56184 12071 2. | Medtech Products, Inc. | Drug | Class II | 1 |
| 19 Jun 2012 | STERRAD 100S Cassette, Batch # 12A077. The STERRAD 100S and STERRAD NX sterilizations systems are low-temperature general purpose sterilizers used to sterilize heat and moisture sensitive reusable medical devices. The sterilant used is hydrogen peroxide supplied in cassette form as a separate accessory. The STERRAD… | Advanced Sterilization Products | Device | Class III | 2 |
| 14 Jun 2012 | The 2.7mm Drilling Guide is a reusable instrument used in conjunction with a drill to prepare oriented holes in bone for insertion of a Standard Surfix¿ Locking Screw with plates for the Tiblaxis, Uni-CP, Advansys MLP and Advansys DLP compression plate systems. The Drilling Guides are initially supplied to users in… (62728) | Integra Life Sci. | Device | Class II | 1 |
| 14 Jun 2012 | ZEE Antiseptic Wipes, First Aid Antiseptic, Benzalkonium chloride 0.133% (effective concentration), over the counter; supplied in 10 (item 2633), 50 (items 0204 and 02040 [sold in Canada only]) and 100 (item 0271) wipes per box distributed by ZEE MEDICAL, INC., Irvine, CA | Dukal Corp. | Drug | Class II | 2 |
| 11 Jun 2012 | Sterile Distraction Screws of 3 different sizes: 12mm, 14mm and 16mm sold under TSI, 3COR, DB Surgical, and American Surgical Products brands and Sterile XL Screws of 7 different sizes: 90mm, 100mm, 110mm, 120mm, 130mm, 140mm, 150mm sold under TSI brand Sterile Distraction Screws are intended for the distraction in… | Tedan Surgical Innovations Llc | Device | Class II | 1 |
| 10 Jun 2012 | Flavored cheddar cheese, vacuum packed in weights ranging from 0.25-0.50 pounds, labeled and batch coded by firm. Cheese labeled in part: "Medium Cheddar Red Pepper with Onion & Garlic Pasteurized whole milk, salt, culture, vegetable rennet, spices. r-BST free.***GOLDEN GLEN CREAMERY 15098 Field Road Bow, WA… (62282) | Vauxner-USA, LLC | Food | Class I | 1 |
| 7 Jun 2012 | Siemens Stratus(R) CS Acute Care(TM) D-dimer Calibrator (DDM CalPak) lots 502058002 and 501318002 The Stratus(R) CS Acute Care(TM) D-dimer Calibrator (DDMR CalPak), Catalog No. CDDMR-C is an in-vitro diagnostic product intended to be used for the calibration of the Stratus(R) CS Acute Care(TM) D-dimer )DDMR) method | Siemens Healthcare Diagnostics, Inc. | Device | Class III | 1 |
| 6 Jun 2012 | ABL80 FLEX (with FLEX software) and ABL80 FLEX CO-OX (with CO-OX software) - pH Blood Gas and Electrolytes Analyzer System. Intended Use The ABL80 FLEX (with FLEX software) and ABL80 FLEX CO-OX (with CO-OX software) are portable, automated analyzers that measure pH, blood gases, electrolytes, glucose and oximetry… (60514) | Sendx Medical Inc | Device | Class II | 1 |
| 6 Jun 2012 | Spacelabs Ultraview DM3 Monitor Model Number: 91330-NT The Ultraview DM3 Monitor is indicated for use by health care professionals for monitoring patient vital signs. The Ultraview DM3 Monitor is intended for monitoring, recording, and alarming basic vital signs on adult and pediatric patients. Monitored parameters… (62939) | Zoe Medical Incorporated | Device | Class II | 1 |
| 5 Jun 2012 | Humphrey Candy Kisses, 4 oz. individually wrapped and contained in a clear plastic bag, UPC Code 81084 00002. Bags are packed 40 to a case. | The Humphrey Popcorn Co | Food | Class II | 2 |
| 1 Jun 2012 | CIDEX OPA, High Level Disinfectant Solution, Glutaraldehyde-free (0.55% ortho-phthaladehyde) solution. The CIDEX OPA solution is intended for automated and manual cleaning and disinfection. | Advanced Sterilization Products | Device | Class II | 1 |
| 31 May 2012 | Low Profile Abutment, Non-Hexed Castable Cylinder Model LPCCC1. Product is labeled in part: "***REF LPCCC1***Low profile Abutment Hexed Castable Cylinder***Cylinder; Cylindre; Zylinder; Cilindro; Cilindro; Cilindro***RX only***NON STERILE***Caution: Law prohibits dispensing without prescription***Consult instructions… | Biomet 3i, LLC | Device | Class II | 1 |
| 29 May 2012 | Acrobat 3000 (AC3000) Spring Arm as support arm for iLED operating lights, TRUMPF Medizinsysteme GmbH + Co KG 82178 Puchheim. The TRUMPF surgical lights are intended to locally illuminate an operating or examination area of the patients body with a high intensity light. | Trumpf Medical Systems, Inc. | Device | Class II | 1 |
| 29 May 2012 | TRESTLE LUXE¿ Anterior Cervical Plating System, Product code KWQ. 510(k) K102820. The TRESTLE LUXE Anterior Cervical Plating System is a temporary device used to stabilize the cervical spine during bone fusion development. Device implants include a range of plate sizes and bone screws to provide the versatility… | Alphatec Spine, Inc. | Device | Class II | 1 |
| 29 May 2012 | syngo(R) Lab Data Manager and syngo(R) Lab Process Manager, all versions. This device is classified as a data calculator and processing module for use with In-vitro diagnostic devices. It also provides work flow management as well as remote instrument control to multiple interfaced instruments. | Siemens Healthcare Diagnostics, Inc. | Device | Class II | 1 |
| 25 May 2012 | Nitre powder. Brand "Selected Product", 4oz plastic bags, UPC 0 45027 97918 2. (61944) | Hocean Inc | Food | Class I | 1 |
| 22 May 2012 | BD GeneOhm MRSA ACP Assay Catalog #441637, box 48 tests labeled in part***GeneOhm Sciences Canada, Inc., 2555 boul, du Parc-Technologique, Quebec, QC, Canada G1P 4S5*** BD GeneOhm MRSA ACP Assay is a qualitative in vitro diagnostic test for the direct detection of methicillin-resistant Staphylococcus aureus (MRSA)… | Becton Dickinson & Co. | Device | Class II | 5 |
| 9 May 2012 | Brand name: RayStation. Generic name: Treatment Planning System. Software version and build numbers are 2.5.0.144 and 2.5.1.89. Product lifetime is 5 years. RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters… | RAYSEARCH LABORATORIES AB | Device | Class II | 1 |
| 8 May 2012 | ON-Q pump with ONDEMAND bolus button, ON-Q C-bloc with ONDEMAND; ON-Q C-bloc with Select a Flow and ONDEMAND Model/Reference #: 7000180, 7000181, 7000182, 7000367, 7000397, CB003, CB005, CB006, P400X1-7+5/60, P400X2-14+5/30, P400X5+5/60, and PMB01. Part Numbers: 101347100, 101347300, 101347400, 101360200, 101368400,… (62769) | I-Flow Corporation | Device | Class I | 1 |
| 7 May 2012 | V Series Patient Monitors; Mindray DS USA, Inc. Product Usage: The V Series Monitor is intended for intra hospital use under the direct supervision of a licensed healthcare practitioner. The indications for Use for the V Series include the monitoring of the following human physiological parameters: ECG waveform… | Mindray DS USA, Inc. d.b.a. Mindray North America | Device | Class II | 1 |
| 7 May 2012 | AquaRoyale Oyster IQF Packed By Dai One Food.Co., LTD. Packed For: Sunny Seafoods, Inc. 11 Sunflower Avenue, Paramus, NJ 07652. USA NET WT.: 20 LBS (40/8oz) ICSSL No. KR-8-SP | Sunny Seafoods Inc | Food | Class II | 3 |
| 30 Apr 2012 | Siemens Mobilett Mira mobile x-ray system Product Usage: Mobile x-ray system | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 30 Apr 2012 | Siemens Uroskop Access. Fluoroscopic, image intensified x-ray system | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 30 Apr 2012 | SunFresh Natural Fruit & Nut, Distributed by: Sunfresh Natural, LLC. Passaic, NJ 07055. Please visit us at: www.sunfreshnatural.com. 6 ounce and 10 ounce packages (Net wt.). (62913) | SUNFRESH NATURAL LLC. | Food | Class II | 1 |
| 23 Apr 2012 | Amplilink (AL) Software 3.2.3 for use with COBAS AMPLICOR, CAP/CA, COBAS TaqMan,and COBAS AmpliPrep/COBAS TaqMan. The software can be used with a Laboratory Information System. | Roche Molecular Systems, Inc. | Device | Class II | 1 |
| 16 Apr 2012 | Multihance Multipack (gadobenate dimeglumine) injection, 529 mg/mL, Pharmacy Bulk Package - Not for Direct Infusion, For Intravenous Use, Rx only, a) 50 mL Single Dose Vial, b) 100 mL Single Dose Vial, Manufactured for: Bracco Diagnostics Inc. Princeton, NJ 08543 by Nycomed GmbH, 78224 Singen (Germany), NDC a)… | Bracco Diagnostics Inc | Drug | Class II | 1 |
| 16 Apr 2012 | Bracco Diagnostics multihance (gadobenate dimeglumine) injection, 529 mg/mL, 20ml, Rx only, Manufactured for: Bracco Diagnostics Inc., Princeton, NJ 08543 USA, NDC 0270-5164-15 | Bracco Diagnostics Inc | Drug | Class III | 1 |
| 6 Apr 2012 | STERIS 5085 and 5085 SRT Surgical Tables, Product Usage: The 5085 is a general surgical table with high patient weight capacity, extended width capability, and lower minimal table top elevation. It accommodates all general surgical procedures including but not limited to, cardiac and vascular, endoscopic, gynecology,… | Steris Corporation | Device | Class II | 1 |
| 3 Apr 2012 | R&S Mexican Food Products, Inc. Tomato/Basil Pressed Tortillas, 1 Dozen. Packaged in sealed flexible plastic bag. (62873) | R & S Mexican Food Products, Inc | Food | Class II | 1 |
| 30 Mar 2012 | Model 324JL On-Board Suction System Intended use: On-board suction system for Ambulance manufacturers. (62736) | Impact Instrumentation, Inc. | Device | Class III | 1 |
| 15 Mar 2012 | Sunquest Laboratory Sunquest Laboratory is intended for use by professionals working in a clinical laboratory. Sunquest Laboratory is intended for use only by professionals who have received extensive training in the use of the software. Sunquest Laboratory is controlled via userdefined security levels, which allow… | Sunquest Information Systems, Inc. | Device | Class II | 1 |
| 9 Mar 2012 | Orasure QuickFlu Rapid A+B Test Manufactured for OraSure Technologies, Inc Bethlehem, PA 18015 USA. The BioSign Flu A + B test is an in vitro rapid qualitative test that detects influenza type A and type B nucleoprotein antigens directly from nasal swab, nasopharyngeal swab and nasal pharyngeal aspirate/wash… | Princeton Biomeditech Corp | Device | Class II | 3 |
| 8 Mar 2012 | BLOM-SINGER indwelling TEP Occluder, catalog IN2004-TO The Blom-Singer Indwelling (TEP(tracheoesophageal Puncture) Occluder is a non-valved silicone prosthesis designed for placement in and maintenance of the TE (tracheoesophageal) puncture following total laryngectomy. The Blom-Singer Indwelling TEP… (62970) | Helix Medical LLC | Device | Class III | 1 |
| 21 Feb 2012 | Toshiba Ultra-Short Magnetic Resonance Imaging System, EXCELART Vantage. MRT-1503/P5-Vantage MRI System. MR imaging. | Toshiba American Medical Systems Inc | Device | Class II | 1 |
| 6 Feb 2012 | CaviCide, Part Numbers: 13-1025, 13-1000, 13-1024, MC-1000. Alternate brands: EnviroCide, part number: 13-3325. Private labeled products of Cavicide: Backscratchers Cavicide, part number: 13-4800. MaxiSpray Plus, part numbers: 13-7400 and 13-7405. pdCARE Surface Disinfectant, part numbers: 13-7525 and 13-7500. Z3… | Metrex Research, LLC. | Device | Class II | 1 |
| 24 Jan 2012 | REF 101-05-20***NOVATION MODULAR DRILL BIT LENGTH: 20mm, DIAMETER 3.2mm***Use with 20mm Screw***STERILE***EXACTECH 2320 NW 56th Court, Gainesville, FL 32653***. To assist the surgeon in the implantation of Novation Hip system components in according to a conventional technique for hemi & total hip arthroplasty.… | Exactech, Inc. | Device | Class II | 6 |
| 20 Jan 2012 | Roundy's Rich Fields Butter Cookies. Product is labeled in part: Side of tin: "***RICH FIELDS*** Butter Cookies***NET WT 12 OZ (340g)***See Bottom Panel for Nutritional Information***" Bottom of tin: "***Nutrition Facts Serving Size 4 Cookies (30g)***INGREDIENTS: Wheat Flour, Sugar, Butter, Eggs, Salt, Soy Lecithin… (62565) | Atico International USA, Inc. | Food | Class II | 1 |
| 5 Jan 2012 | Zilver 518 Vascular Self Expanding Stent The Zilver Vascular Stent is intended for use as an adjunct to percutaneous transluminal angioplasty (PTA) in the treatment of symptomatic disease of iliac arteries up to 100 mm in length with a reference vessel diameter of 5 to 9 mm. Patients should be suitable candidates for… (61451) | Cook Ireland Ltd. | Device | Class II | 1 |
| 3 Jan 2012 | Stewart's Diet Orange N' Cream Soda, 12oz glass bottles (61120) | Individual firm, name withheld | Food | Class II | 1 |
| 22 Dec 2011 | Infinity¿ sampling device, Cytology Brush, United States Endoscopy Group, Inc., 5976 Heisley Road, Mentor, OH 44060 The Infinity sampling device is a disposable cytology brush used to retrieve cytological cell samples in the gastrointestinal tract. | US Endoscopy Group Inc | Device | Class II | 1 |
| 19 Dec 2011 | Eon (Model 3716) IPG is a dual channel; 8-contact receiver designed to be connected to 4, 8, or 16 electrode leads or a lead extension. Product Usage: The Eon and Eon Mini Neurostimulation Systems are indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs including unilateral or… | Advanced Neuromodulation Systems Inc. | Device | Class II | 2 |
| 5 Dec 2011 | Sunquest Laboratory Versions 6.4 and later using Microbiology Result Entry | Sunquest Information Systems, Inc. | Device | Class II | 1 |
| 8 Nov 2011 | ChloraPrep with Tint, HI-Lite Orange, 3 mL Applicator, Patient Preoperative Skin Preparation, External Use Only, Sterile, product code 260415, Carefusion, Leawood, KS 66211, USA | Carefusion 213, Llc | Drug | Class II | 1 |
| 30 Sep 2011 | CMS-8412-R2 Custom Cysto Pack containing 2 oz. bottle of PVP Prep Solution The PV contained in the kit is used in skin prep | Custom Medical Specialties, Inc. | Device | Class II | 4 |
| 30 Sep 2011 | CMS-4501-R1 Custom HSG Tray containing 2 oz. PVP Prep Bottle Product Usage: Usage: The PVP contained in the kit is used in skin prep | Custom Medical Specialties, Inc. | Device | Class I | 12 |
| 19 Aug 2011 | OPTETRAK LOGIC TIBIAL INSERT POSTERIOR STABILIZED***Match Component Colors 6 YELLOW, 11mm, Use with LOGIC Femoral and Tibial Components***REF 02-012-35-6011. There are three product sizes being recalled, 11mm, 13mm, 15mm. All other information is the same. The Optetrak Logic Total Knee System is indicated for use in… | Exactech, Inc. | Device | Class II | 1 |
| 15 Jun 2011 | Azelastine HCl Nasal Solution, 0.1 %, 137 mcg/spray, 30 mL bottle (200 Metered Sprays), Rx only, Mfg by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9, NDC 60505-0833-5. | Apotex Corp. | Drug | Class III | 1 |
| 30 May 2011 | The product affected by this notice is sold under the trade name TomoTherapy SharePlan 1.1 . To determine if the version you are using is affected, bring up the About box in the SharePlan application and check if the build number reported there is 1.3.1.10 . Intended use: t-RayAutoplan is a software that, based on… | RAYSEARCH LABORATORIES AB | Device | Class II | 1 |
| 4 Mar 2011 | Mini-Infuser Model 150XL Single Speed Infusion Pump, an Rx battery operated syringe infusion pump; Product Usage: These product codes includes refurbished units. Intended for the controlled rate delivery of small volume parental fluids as prescribed by a physician. Usage: The Mini-Infuser System is designed for… | Baxter Healthcare Corp. | Device | Class III | 2 |
| 19 Jan 2011 | METOCLOPRAMIDE ORAL SOLUTION, USP 5 mg/5 mL, This cup delivers 10 mL, Rx Only, Manufactured by VistaPharm, Inc., Largo FL33771 | VistaPharm, Inc. | Drug | Class III | 1 |
| 31 Dec 2010 | ULTRA Fabric Reinforced Surgical Gown, X-Large, Sterile, Test File. The Kimberly-Clark ULTRA Fabric Reinforced Surgical Gown is a sterile, single use surgical gown intended to protect surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material. | Kimberly-Clark Corporation | Device | Class III | 1 |
| 1 Nov 2010 | Canon Solid State X-ray Imager (Flat Panel/Digital Imager), Digital Radiography, Models CXDI-55C, CXDI-55G and CXDI-70C. These devices are intended to replace radiographic film/screen systems in all general purpose diagnostic procedures. (62828) | Canon Inc. | Device | Class II | 1 |
| 5 Oct 2010 | Sunquest Laboratory LabAccess Results Workstation (LARS) | Sunquest Information Systems, Inc. | Device | Class II | 1 |
| 27 Sep 2010 | Interfaces subject to recall: Medtronic NIM (Nerve Integrity Monitor) 3.0 Patient Interfaces 8253200 (Response) LABELING: Box Label: REF 8253200 x1***NIM-Response 3.0 Patient Interface***Medtronic Xomed, Inc., 6743 Southpoint Drive North Jacksonville, FL 32216-0980 USA***Rx Only***Lot***SN:***" Top of unit is labeled… | Medtronic Xomed, Inc. | Device | Class II | 3 |
| 11 Aug 2010 | Polar Dressing, Knee/MU/Shldr Intelli-Flo-Breg, PN 10630 Used with cold therapy pads to provide insulation barrier between the pad and patient's skin. (58247) | Breg Inc, An Orthofix Company | Device | Class II | 1 |
| 22 Jun 2010 | Kimberly-Clark MIC Safety PEG Kit - Pull Type The Kimberly-Clark MIC PEG Kits - Pull type are Percutaneous Endoscopic gastrostomy (PEG) tubes intended for a non-surgical "pull" endoscopic placement technique. The PEG tube is held in place during use with an external retention disk. | Kimberly-Clark Corporation | Device | Class II | 2 |
| 16 Jun 2010 | Product is labeled in part: "***MEDLINE***Extended PTFE Needle 6.5" (16.51cm) Length***Reorder: ES0016***Contents: 1 Each***SINGLE USE ONLY**latexfree***RX Only***STERILE EO***www.medline.com Manufactured for Medline Industries, Inc. MEDLINE is a registered trademark of Medline Industries, Inc.… | Unimed Surgical Products, Inc. | Device | Class II | 11 |
| 17 Feb 2010 | A mobile, electro-hydraulically operated, fluoroscopic/C-Arm compatible general surgical table. Product Usage: Product provides a flexible, easy-to-use, articulated posturing of a patient for either general, I.A., or specialized surgical procedures. There are movable components and accessories intended for use during… | Steris Corporation | Device | Class II | 1 |
| 8 Dec 2009 | Dietary supplement. Product is labeled as :" Rescue Me***911 Damage Control***brantley living herbal formulas***HERBAL SUPPLEMENT 15 INDIVIDUAL PACKETS 4 VEGAN CAPSULES PER PACKET (2-368mg/2-584mg Each)***DISTRIBUTED EXCLUSIVELY BY: Living Herbal Pharmacy, LLC PO Box 56-2410, Miami, FL 33256-2410***". (62786) | GMP Laboratories of America Inc | Food | Class II | 1 |
| 17 Nov 2009 | CARTO 3 V1.05(FG-5400-00). The CARTO 3 V1.05 System is intended for catheter-based atrial and ventricular mapping. The mapping system allows real-time display of cardiac maps in a number of different formats. Maps may be displayed as cardiac electrical activation maps, cardiac electrical propagation maps, cardiac… | Biosense Webster, Inc. | Device | Class II | 1 |
| 12 Aug 2009 | Safety monitor included with System 8000 Base The Sarns" Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced… | Terumo Cardiovascular Systems Corporation | Device | Class II | 1 |
| 13 Jul 2009 | Whole Body X--ray Scanner This device is indicated as a whole body volume CT system. The system produces volumes of up to 320 axial slices in a single rotation. | Toshiba American Medical Systems Inc | Device | Class II | 1 |
| 22 Jun 2009 | OEC IT3000; IT2500 (EnTrak); IT2500 Plus (EnTrak Plus); IT3500 (InstaTrak); IT3500 Plus (InstaTrak Plus); ConneCTstat; and ConneCTstat Plus picture archiving and communications systems. The systems are an aid to locate anatomical structures during open or percutaneous surgical procedures. It is intended for use in… | GE OEC Medical Systems, Inc | Device | Class I | 1 |
| 16 Jun 2009 | Smith's Old Fashioned Lemon Flavor Iced Tea, pasteurized, packed in 1 gallon (3.78L) containers. The label also reads: 'Smith's The Dairy in the Country' Smith Dairy Products Co. Orrville, OH 44667 * 1-800-776-7076 www.smithdairy.com * 2009 Smith Dairy Products Company Manufactured at Plant # Above Product #193'. (52378) | Smith Dairy Products Co | Food | Class I | 1 |
| 4 Jun 2009 | Apelo Modular Screwdriver labeled in part: "APELO PEDICLE SCREW SYSTEM***Modular Screwdriver***Atlas Spine, Inc.***www.AtlasSpine.com*** 1555 Jupiter Park Drive #4***Jupiter, Florida 33458***561-741-1108***Tissue Sleeve***MFG Date: XX/XX/XXXX***Lot #: XXXX***Weldment***MFG Date: 03/23/2009***Sleeve Assembly***MFG… (62564) | Atlas Spine, Inc. | Device | Class II | 1 |
| 16 Jul 2008 | Various SRI Surgical Disposable Accessory Packs. SRI's Disposable Accessory Packs (also commonly known as convenience kits and custom procedure trays) are an assembly of medical devices packaged together according to the customer specifications, which are then wrapped in a sterilization wrap and sterilized. This… (49060) | SRI Surgical | Device | Class II | 1 |
| 13 May 2008 | EXCELART Vantage, Atlas, and Titan MRI Systems, MRT-1503 and MRT-1504. Imaging of the Whole Body, Fluid Visualization, 2D/3D Imaging, MR Angiography/MR Vascular Imaging, Blood Oxygenation Level Dependent Imaging, Perfusion I Diffusion Imaging, and Proton Spectroscopy. | Toshiba American Medical Systems Inc | Device | Class II | 1 |
| 27 Feb 2008 | Toshiba CT systems, Asteion and Aquilion, that are equipped with a PC based computer, or to those older systems (SGI based) that received an improved table by an upgrade purchase. This device is designed to produce cross-sectional images of a human body by reconstruction of xray transmission data from the same axial… | Toshiba American Medical Systems Inc | Device | Class II | 1 |
| 14 Jun 2007 | Leflunomide tablets, 10 mg, a) 30-count bottle (NDC 60505-2502-1), b) 1000-count bottle (NDC 60505-2502-3), Rx only, Manufactured for Apotex Corp., Weston, Florida 33326 by Apotex Inc., Toronto, Ontario Canada M9L 1T9 | Apotex Corp. | Drug | Class II | 2 |
| 8 Jul 2005 | SUN|DASH RADIUS 252 tanning system; 52 lamps, Ultraviolet Radiation. The device is intended to be used for tanning of the human skin. | JK Products & Services, Inc | Device | Class II | 1 |