| 16 May 2017 | Ventolin HFA (albuterol sulfate) Inhalation, 90 mcg per actuation, 200 Metered Inhalations, Net Wt. 18 g inhalers, Rx only, GlaxoSmithKline, Research Triangle Park, NC 27709, NDC 0173-0682-20. | GlaxoSmithKline, LLC | Drug | Class II | 1 |
| 16 May 2017 | SAMI'S BAKERY, MILLET & FLAX, CHOCOLATE CHIP COOKIE, Packed by: Sami's Pita Bakery Inc., Tampa, FL Event 77317 | Sami's Pita Bakery, Inc. | Food | Class II | 1 |
| 15 May 2017 | Fluconazole Injection, USP, 200 mg/100 mL (2mg/mL), 100 mL Single-Dose Intravia Container bag, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, Product Code 2J1446, NDC 0338-6046-48 | Baxter Healthcare Corporation | Drug | Class II | 2 |
| 12 May 2017 | MesaLabs Conductivity Standard Solution, 14 mS/cm, 32 ounces (950 ml). Product No. : 02.0027, 020510 (carton of 6 of 02.0027). Polyethylene bottle Conductivity/TDS Calibrator solutions are a secondary standard solution used for the calibration of conductivity/TDS cells together with conductivity/TDS measurement… | Mesa Laboratories, Inc. | Device | Class II | 1 |
| 12 May 2017 | Chef Luca's Italian Gluten Free Foods Lasagna Al Forno Baked Cheese Lasagna, 15 oz . frozen UPC Code: 85573103116 Event 77298 | Italian Gluten Free Foods CL | Food | Class I | 1 |
| 11 May 2017 | Normed General Instruments 503004541: Werber Countersink Cannulated for micro CBS Screws, AO 503004341: Werber Countersink Cannulated for micro CBS Screws, round-shaft The Countersink is an instrument which is used over the guide wire to prepare for adequate space in the cortical bone rim to sink the screw head in to… | Zimmer Gmbh | Device | Class II | 1 |
| 9 May 2017 | Benzonatate capsules, 200 mg, 100-count bottle, Rx only, Manufactured by: Strides Shasun Limited Bangaluru -560076 India, Distributed by Strides Pharma Inc East Brunswick, NJ 08816, NDC 64380-713-06 | Strides Pharma INC | Drug | Class III | 1 |
| 8 May 2017 | HYDROCORTISONE LOTION, USP, 2.5%, 2 FL OZ (59 mL) bottle, Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811, NDC 0603-7785-52. | Vintage Pharmaceuticals LLC, DBA Qualitest Pharmaceuticals | Drug | Class III | 1 |
| 8 May 2017 | Sugar Crackers 400g (14.1oz) x 12 packets per carton/case, UPC 9556184 500023 Event 77233 | U-Can Food Trading Inc | Food | Class II | 1 |
| 8 May 2017 | Schiff Move Free Advanced Plus MSM & Vitamin D3 with Glucosamine + Chondroitin, 80 Coated Tablets, Dietary Supplement, Product item number: 20525-11873 Event 77231 | RB Manufacturing LLC | Food | Class III | 1 |
| 5 May 2017 | Opteryx Variable Rescue Screw, Part #CP2214, UDI: *+M711CP22140/$$801716012*. Packaged in heat-sealed plastic bag. Product Usage: 4.5mm x 14mm Anterior Cervical Plate System Variable Rescue Screw. The Opteryx Cervical Plate System is intended as a temporary fixation device used for correction and stabilization of… | Innovasis, Inc | Device | Class II | 1 |
| 5 May 2017 | Wegmans Wegmans Family Pack Potato Salad, Net Wt. 48 OZ; Ingredients: Pasta Shells***Water, Cucumbers, Feta Cheese...ect; Allergens: Contains Milk and Wheat; Distributed By: Wegmans Food Markets, Inc., Rochester, NY 14603; Sell By: 5/7/17 3379-4; UPC: 7789024678 | ASK Foods Inc | Food | Class I | 1 |
| 2 May 2017 | Legacy Full Contour Laboratory Abutment: 3.5mmD Platform/5.5mmD | Implant Direct Sybron Manufacturing, LLC | Device | Class II | 1 |
| 2 May 2017 | Arietta 70 Ultrasound System Intended for use by trained personnel (doctor, sonographer. etc.) for the diagnostic Ultrasound evaluation. | Hitachi Medical Systems America Inc | Device | Class II | 1 |
| 2 May 2017 | Herbal Tea Variety 120 ml/pouch, 40 pouches/case Event 77173 | U S Deer Antlers Export & Import | Food | Class I | 1 |
| 2 May 2017 | Bean Sprout 10 lbs. bag, 10lb box, 12/12oz, 20/15oz, 24/1.5 lbs., 5lbs. bag, 3lb tray Event 77174 | Fuji Natural Foods, Inc. | Food | Class II | 1 |
| 2 May 2017 | Nutty INFUSIONS Roasted Cashew Butter, NET WT. 10 OZ (284 g) | HVF Inc. d.b.a Huson Valley Farms | Food | Class I | 2 |
| 1 May 2017 | Yellowfin Tuna Hilo Cubes, Random cut. 15 lb. cases. (1 x 15 lb. bags per case) Brand name: Reel Fresh UPC: 664183001454 Ingredients: Frozen tuna and carbon monoxide (to promote color retention). Product of Indonesia, Wild Caught Event 77184 | Tropic Fish Hawaii, LLC | Food | Class I | 1 |
| 1 May 2017 | Protein Bar 14 bars/box, Net Wt. 19.74oz (560g) Each shipping carton contains 12 boxes Event 77179 | Herbalife International Of America Inc | Food | Class III | 1 |
| 28 Apr 2017 | NexGen Offset Stem Extension, sizes 14mm and 17mm For use in total arthroplasty. | Zimmer Biomet, Inc. | Device | Class II | 1 |
| 28 Apr 2017 | Buprenorphine HCI Injection, 0.3 mg/mL, 1 mL Single Dose Vial (NDC 42023-179-01), packaged in 1 mL x 5 Single Dose Vials per carton (NDC 42023-179-05), Rx Only, Distributed by: Par Pharmaceuticals Companies, Inc., Spring Valley, NY 10977. | PAR Sterile Products LLC | Drug | Class II | 1 |
| 28 Apr 2017 | Frozen Wild Shrimp Burgers, Wild Grill Foods brand, net wt. 12 oz. Each package contains 4/ 3 oz. pieces. UPC 8 94067 00248 6. The 12 oz. package label is read in parts: "***SHRIMP BURGERS***WILD GRILL***Net WT WT. 12 OZ.***Distributed by Wild Grill Foods***INGREDIENTS: Shrimp, Cod and or Pollock, Butter, Gluten Free… Event 77158 | Unisea Inc. | Food | Class II | 1 |
| 27 Apr 2017 | Organic Veda brand Ginger Powder, 24 jars, Net Wt. 16 oz. (454 grams) Event 77151 | Lords Organics Llc | Food | Class I | 1 |
| 26 Apr 2017 | Hoffmann LRF Safety Clip (Bone Transport Strut), 14 x 12 x 5 mm, REF 4933-0-401, NDC (01)07613327131475(10)V07241 Product Usage: Intended for fixation of fractures, joint contractures, fusions, limb lengthening, deformity correction, and bone and soft tissue reconstruction in pediatric patients and adults. | Stryker Howmedica Osteonics Corp. | Device | Class II | 1 |
| 26 Apr 2017 | Wegman's O'’Brien Hash Browns, frozen packages, net wt. 28 oz. UPC 07789036523. | McCain Foods USA | Food | Class II | 1 |
| 26 Apr 2017 | Dip Trio Mix Homemade Gourmet Dip Mix Net Wt. 2.9 oz. Distributed by: Phoenix Food, LLC. Canton, TX 75103 www.homemadegourmet.com Event 77142 | Phoenix Food, LLC | Food | Class I | 1 |
| 26 Apr 2017 | ARTISAN-STYLE PIZZA DOUGH BALL distributed under the following sizes and Product Codes: (a) 12 OZ ARTISAN-STYLE PIZZA DOUGH BALL, RICH'S label, Product Code 11268, UPC 0 00 49800 11268 1, NET CASE WT: 12.2 KG (27 LB), UNIT NET WT: 340 G (12G), COUNT: 36; (b) 18 OZ ARTISAN-STYLE PIZZA DOUGH BALL, Product Code 11269,… | Rich Products Corp | Food | Class II | 3 |
| 25 Apr 2017 | ETEST ETP32 (Ertapenem) Ref. 531640, 531600, blister packaging ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria (Only 531640 was distributed in the United States) | BioMerieux SA | Device | Class II | 1 |
| 25 Apr 2017 | StatLock IV Premium Catheter Stabilization Device, product code IV0570. sterile. Packaging: packaged as single units in tyvek to film pouches, the product is distributed in cartons containing 25 devices and cases containing 250 devices. | Bard Access Systems Inc. | Device | Class II | 1 |
| 25 Apr 2017 | I.Q.F Chopped Spinach, Del Mar Foods Product Corp; 35 lb. Net Weight. brown case fiber with polyliner Del Mar Food Products; Watsonville, CA 95077 Event 77149 | Del Mar Food Products Corp. | Food | Class I | 1 |
| 25 Apr 2017 | Label reads in part "***Full Tilt Ice Cream Fudge Brownie Swirl Vegan***one pint***Ingredients: Coconut Milk (coconut milk, water, citric acid), organic evaporated cane juice, bownie bits (flour, sugar, cocoa powder, non-aluminum baking powder, salt, vanilla extract, coconut oil.), fudge (cocoa powder, unsweetened… Event 77133 | Name withheld | Food | Class II | 1 |
| 25 Apr 2017 | Whole Foods Market Cold Pressed Juice, Apple; 16 FL. Oz. (1 pt) 473 mL. Keep refrigerated - Enjoy within 5 days of opening. UPC 8 13377 02154 3 Event 77157 | Name withheld | Food | Class I | 1 |
| 24 Apr 2017 | Brennen Skin Graft Mesher. Surgical instrument designed to expand skin grafts' | Molnlycke Health Care, Inc | Device | Class II | 1 |
| 24 Apr 2017 | Philips V60 Ventilators, Material No. 850008, 1053613, 1053614, 1053615, 1053616, 1053617, 1076715, 1076716, 1076717, DU1053617, U1053617. Old Material No. 850008, 989805628251, 989805612101, 989805613391, 989805613661, 989805611761, 989805627411, 989805627431, 989805627441, 989805616411, 989805636631. | Respironics California Inc | Device | Class I | 1 |
| 24 Apr 2017 | UniCel DxH 800 Coulter Cellular Analysis System, Catalog No. 629029, B24465, B24802, B66445, B68304, B63322. | Beckman Coulter Inc. | Device | Class II | 2 |
| 24 Apr 2017 | Microalbumin Reagent, Catalog No. 475100, Product Labeling A18520AL MA reagent, when used in conjunction with UniCel DxC 600/800 System(s) and SYNCHRON Systems MA Calibrator, is intended for quantitative determination of Albumin concentration in human urine | Beckman Coulter Inc. | Device | Class II | 1 |
| 24 Apr 2017 | Clozapine Tablets USP, 25 mg, 100-count bottle (NDC 0093-4359-01), 500- count bottle (NDC 0093-4359-05), 100 Unit Dose Blisters per carton (NDC 0093-4359-93), Individual Blister Pack (NDC 0093-4359-19), Rx Only, Manufactured By: Teva Pharmaceutical Industries Ltd., Jerusalem, 9777600, Israel | Teva Pharmaceuticals USA | Drug | Class II | 1 |
| 24 Apr 2017 | Farming Fish brand Organic Basil Pesto with Watercress, was packaged in 8.5 oz. plastic deli containers. UPC 7 23175 33586 8. The label is read in parts: "***100% Organic Basil Pesto with Watercress *** 8.5oz***Ingredients: ALL ORGANIC Basil, Watercress, Sunflower Seed Oil, Sunflower Seeds, Garlic, Lemon Juice, Sea… Event 77130 | Name withheld | Food | Class I | 1 |
| 23 Apr 2017 | Linear Straight Broach Handle (Rasp Handle) (Greatbatch Part # 510397; DJO Surgical Inc., # 803-03-159) and EZ Clean" Linear Broach Handle Greatbatch Part # T11824, DJO Surgical Inc. # 803-03-059). | Greatbatch Medical | Device | Class II | 1 |
| 21 Apr 2017 | PE CONNECTOR 3/8 STRAIGHT 20/BX, Sterile, Single use, Product Usage: Catheter Connector/Accessory | Teleflex Medical | Device | Class II | 4 |
| 21 Apr 2017 | Jackson-Pratt Hemaduct Cardiothoracic Silicone Round Drain,19FR. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain is a radio-opaque section of tubing which… | Cardinal Health 200, LLC | Device | Class II | 20 |
| 21 Apr 2017 | Infant 25% DEXTROSE Injection, USP, 2.5 g (250 mg/mL), 10 mL Unit of Use Single-dose Syringe per carton, Rx only, Hospira Inc., Lake Forest, IL 60045, NDC 0409-1775-10 | Hospira Inc. | Drug | Class I | 1 |
| 21 Apr 2017 | Organic Cocoa-Dusted Chocolate Ginger, packaged and distributed in 5 lbs. bulk bag. Product was later offered to consumers in a self-serve bulk bin at retail store. The label is read in parts: "***Organic Cocoa-Dusted Chocolate Ginger***Made with Fair Trade 70% Dark Chocolate***Ingredients: Dark… | Hummingbird Wholesale | Food | Class I | 1 |
| 21 Apr 2017 | Jalapeño Flavored Lays Kettle Cooked potato chips and Jalapeño Flavored Miss Vickies Kettle Cooked potato chips in the following unit sizes: 1.75 oz, 2.75 oz, 8 oz, 13.5 oz, 2.125 oz, 6.5 oz, 0.85 oz, 1.375 oz, 2.25 oz, and 1.375 oz | Frito-Lay, Inc | Food | Class I | 6 |
| 21 Apr 2017 | Soylent 1.8 Powder , 7 x 15oz pouches, SKU: 1WK-V108 Event 77093 | Rosa Foods HQ | Food | Class I | 1 |
| 21 Apr 2017 | Roundy's Southern Style Diced Hash Browns, frozen, net wt. 32 oz per package, UPC 0 01115 05501 9. Harris Teeter Southern Style Diced Hash Browns, frozen, net wt. 32 oz per package, UPC 0 07203 64902 0. | McCain Foods USA | Food | Class II | 1 |
| 20 Apr 2017 | Microfil Composite Instruments are packaged in an unsealed plastic sleeve, which is then placed in a cardboard box. Microfil Composite Instruments are intended to be sterilized by the dentist prior to each use. It is used for composite restoration development. The thin paddles shape light-cured composites. Paddles… Event 76963 | Almore International Inc | Device | Class II | 1 |
| 20 Apr 2017 | 10-1335M - SpF-XL IIB 2/DM Implantable Stimulator. Indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels. | EBI Patient Care, Inc. | Device | Class I | 2 |
| 20 Apr 2017 | VORTRAN Automatic Resuscitator, VARPlus; Model PTE-5002; Qty: 10 each Anesthesiology: This device is to be used by properly trained personnel to deliver emergency, short term, constant flow, pressure cycled ventilatory support. | Vortran Medical Technology 1, Inc | Device | Class II | 2 |
| 20 Apr 2017 | IC-Green (indocyanine green for injection, USP), 25 mg, packaged in a kit containing six vials of 25 mg lyophilized powder, Rx only, Manufactured by: Akorn, Inc., NDC 17478-701-02 | Akorn, Inc. | Drug | Class III | 1 |
| 19 Apr 2017 | White OR Towels, X-Ray Detectable, Sterile, 4 Towels per/pk; 20pk/Cs. Intended for packing and absorption externally or within patient wounds in various procedures or surgical cases. | Medical Action Industries Inc | Device | Class II | 2 |
| 19 Apr 2017 | ARIES System and ARIES M1 System | Luminex Corporation | Device | Class II | 1 |
| 19 Apr 2017 | Shield and Protect Moisture Barrier Cream, 1.1% Clotrimazole, Net Weight 4 oz - 115 g Anti-Fungal, Gentell, Inc., Bristol, PA NDC 61554-232-40 | Gentell, Inc | Drug | Class II | 1 |
| 18 Apr 2017 | Children's Cetirizine Hydrochloride Chewable Tablets, 5 mg, 30-count bottle, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol - 389 350, Gujarat, India; Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 47335-343-83. | Sun Pharmaceutical Industries, Inc. | Drug | Class III | 1 |
| 18 Apr 2017 | 5-MTHF *10ML* MDV 5MG/ML INJ, Injection, 5mg/mL, Rx only, 10mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy | Key Pharmacy and Compounding Center | Drug | Class II | 79 |
| 18 Apr 2017 | RALEY'S MUESLI CHOCOLATE CURLCRUNCH CEREAL; 12 oz. box - foil bag inside paper box. UPC: 46567-02266;Product Distributed by Raley's, West Sacramento, CA;Product of Switzerland | Name withheld | Food | Class II | 3 |
| 17 Apr 2017 | Allergy Relief Diphenhydramine HCl 25 mg, Antihistamine, Dye-Free, 24 Softgels, distributed under the following labels: (a) TopCare Allergy Relief, DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELK GROVE VILLAGE, IL 60007, NDC 36800-483-24, UPC 0-36800-39134-5; (b) Rexall Since 1903 Allergy Relief, PACKAGED FOR DOLGENCORP,… Event 77007 | P & L Development, LLC | Drug | Class III | 1 |
| 17 Apr 2017 | Zinc Oxide Paste 25%, 500 g, For Prescription Compounding, Fagron Inc.2400 Pilot Knob Rd, St. Paul, MN 55120m NDC 51522-0694-5. | Fagron, Inc | Drug | Class III | 1 |
| 17 Apr 2017 | Moondance desserts gluten free Chocolate Chip Cookie Bar 12 oz (340g) UPC 36211 68096 9 | Moondance Heavenly Desserts, LLC | Food | Class II | 2 |
| 15 Apr 2017 | Lemongrass Satay, Net: 9oz (265gr), 12units/case and 1/2 gallon, 6 units/case | TP Food Processing Inc. | Food | Class II | 2 |
| 15 Apr 2017 | Decorated (sugared) holiday cookies sold in the shape of purple eggs, pink bunnies or yellow chicks. These cookies were sold in the self service cookie display. | Whole Foods Market | Food | Class I | 2 |
| 14 Apr 2017 | Spacelabs Healthcare Arkon Anesthesia Delivery System is intended for use in the hospital environment and operating room. Absorber Adapter Assembly Service Kit, part number: 050-9045-00. Absorber Adapter Assembly, part number: 650-1648-01. Arkon Absorber Canister Carrier, part number: 380-0916-01. | Del Mar Reynolds Medical, Ltd. | Device | Class II | 1 |
| 14 Apr 2017 | CSI, Orbital Atherectomy System (OAS) Saline Infusion Pump, Rx only, Part Number: 7-10014, Model Number: SIP-3000. | Cardiovascular Systems Inc | Device | Class II | 1 |
| 14 Apr 2017 | Kemps YO2 Frozen Yogurt Mudslide, One Pint, UPC 41483-04121 | Kemps, LLC | Food | Class II | 13 |
| 13 Apr 2017 | Medtronic PAK NEEDLE BEVELED AND TROCAR TIPS, REF 8670009, QTY 1 EA, STERILE R, Rx only | Medtronic Sofamor Danek USA Inc | Device | Class II | 1 |
| 13 Apr 2017 | Cobalt HV Bone Cement Cobalt MV Bone Cement Cobalt HV Bone Cement With Gentamicin | Zimmer Biomet, Inc. | Device | Class II | 1 |
| 13 Apr 2017 | Access BR Monitor, Part No. 387620 | Beckman Coulter Inc. | Device | Class II | 1 |
| 13 Apr 2017 | Hyland's Baby Teething Tablets [Calcarea Phosporica 6X HPUS, Chamomilla 6X HPUS, Coffea Cruda 6X HPUS, Belladonna 12X HPUS (0.0000000000003% alkaloids, calculated)] Quick-Dissolving Tablets, packaged in a) 40-count bottles (NDC 54973-3127-3) (UPC 3 54973 31273 9); b) 135-count bottles (NDC 54973-3127-1) (UPCs 3 54973… | Standard Homeopathic Company | Drug | Class I | 2 |
| 13 Apr 2017 | 7-ELEVEN CAESAR SIDE SALAD 3 oz. packaged in clear plastic container | Del Monte Fresh Produce N.A., Inc. HQ | Food | Class I | 1 |
| 13 Apr 2017 | Beyond Beef Feisty Crumble Vegan Gluten-free Non-GMO Weight: 10 lbs. (2) 5 lb. bags UPC: 10852629004412 KEEP FROZEN 111 Main Street El Segundo, CA 90245 866-756-4112 customer@beyondmeat.com www.beyondmeat.com; Beyond Meat Beyond Beef Crumbles Feisty Net WT 11oz (312g) KEEP FROZEN Plant Based Protein Crumbles UPC:… Event 77017 | BEYOND MEAT | Food | Class I | 1 |
| 12 Apr 2017 | Omega Incline Platform Lift | Savaria Concord Lifts, Inc. | Device | Class II | 1 |
| 12 Apr 2017 | Savaria SL-1000 Stairlift | Savaria Concord Lifts, Inc. | Device | Class II | 1 |
| 12 Apr 2017 | Bone Dowell Harvest Tubes | Zimmer Biomet, Inc. | Device | Class II | 1 |
| 12 Apr 2017 | 5.5mm Diameter x 500mm CoCr Straight Rod, Model number X077-0420. The product is packaged in plastic bags with one piece per bag. Product Usage: The 5.5mm dia. X 500 mm CoCr Straight Rod is an accessory to the Fortex Pedicle Screw System. It is a straight rod connected between two or more pedicle screws to create a… | XTANT MEDICAL INC | Device | Class II | 1 |
| 12 Apr 2017 | The Savaria Stairfriend is a Residential, commercial, indoor, stair lift for curved stairs. | Savaria Concord Lifts, Inc. | Device | Class II | 1 |
| 12 Apr 2017 | AXIOM Sensis, Computer, Diagnostic, Programmable. Intended to be used as a diagnostic and administrative tool supporting hemodynamic cardiac catheterizations and/or intracardiac electrophysiology studies. | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 12 Apr 2017 | Amplia MRI Quad CRT-0 SureScan Claria MRI Quad CRT-D SureScan Compia MRI Quad CRT-D SureScan | Medtronic Inc., Cardiac Rhythm and Heart Failure | Device | Class II | 1 |
| 12 Apr 2017 | SENSATION PLUS 8Fr. 50cc Intra-Aortic Balloon Catheter with Insertion Kit & STATLOCK Product Code/Part Number: 0684-00-0576-01U is a cardiac assist device which support the heart's left ventricle by increasing coronary perfusion and reducing the work of the left ventricle. | Datascope Corporation | Device | Class II | 1 |
| 11 Apr 2017 | OVATIO Models: VR 6250, DR 6550, CRT 6750. Product Usage: OVATIO VR 6250, OVATIO DR 6550, PARADYM VR 8250, PARADYM DR 8550, PARADYM RF VR 9250, PARADYM RF DR 9550, INTENSIA VR 124 and INTENSIA DR 154 are indicated for use in patients who are at high risk of sudden cardiac death due to ventricular tachyarrhythmias and… | Sorin Group Italia SRL - CRF | Device | Class II | 3 |
| 11 Apr 2017 | Biomet Microfixation TraumaOne System Surgical Tray - Model # 46-1600 | Biomet Microfixation, LLC | Device | Class II | 1 |
| 11 Apr 2017 | The Bakery Peanut Butter Chocolate Chunk Cookies, Net Wt. 14 oz. (396g), packaged in a clear plastic clam shell, UPC 0 78742 06652 3, Distributed by: Wal-Mart Stores, Inc. Bentonville, AR 72716 Event 77027 | Name withheld | Food | Class I | 1 |
| 11 Apr 2017 | H.E. B. brand Pomegranate Infused Cranberries COVERED IN Dark Chocolate, NET WT. 8 OZ. (227g), UPC CODE 041220985883 Event 76990 | Nassau Candy | Food | Class I | 1 |
| 10 Apr 2017 | RAPIDPoint 500 Blood Gas Analyzer with v2.4 software for professional use in a point-of-care or laboratory environment. This system tests blood gases, electrolytes, metabolites, total hemoglobin, and hemoglobin derivatives in arterial, venous, and capillary whole blood samples. Siemens SMN numbers: 10492730,… | Siemens Healthcare Diagnostics Inc | Device | Class II | 1 |
| 10 Apr 2017 | Proton therapy system -Proteus 235 aka Proteus Plus. A medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation. | Ion Beam Applications S.A. | Device | Class II | 1 |
| 10 Apr 2017 | CooperSurgical lnflatoball Latex Rubber Pessary sold as an individual unit and also part of the lnflatoball Pessary Kit. Product Usage: The lnflatoball Pessary is a single-patient use pessary manufactured from natural latex rubber and is used for treating cystocele and/or rectocele associated with procidentia or… | CooperSurgical, Inc. | Device | Class II | 1 |
| 10 Apr 2017 | CytoGuard Closed Luer Connector, Intravenous access 2 cartons of 50 units each (100 units per case) | B Braun Medical Inc | Device | Class II | 1 |
| 10 Apr 2017 | Tropicana 100% JUICE, orange juice From Concentrate with Other Natural Flavors, 24-10 FL OZ (296 mL) BOTTLES, (TOTAL 240 FL OZ (1.8 GAL) 7L), UPC 48500 75823, Tropicana Manufacturing Company, Inc., Bradenton, Florida 34206 USA Event 77028 | Quaker Oats Co | Food | Class II | 1 |
| 10 Apr 2017 | Vertical Pharmaceuticals OB Complete with DHA Prenatal Multivitamin, 60 softgels Rx Only, Manufactured for: Vertical Pharmaceuticals, LLC Sayreville, NJ 08872 UPC 368025049603 Event 77059 | Vertical Pharmaceuticals, Inc. | Food | Class II | 1 |
| 10 Apr 2017 | Hand Crafted, LG Paleteria, La Granja, Mango Flavored Ice cream, Wt. 4 oz., in clear flexible plastic wrap. Event 77058 | La Granja Inc | Food | Class I | 1 |
| 8 Apr 2017 | Whole Foods single-serve Organic Vanilla Yogurt parfait cups with Strawberries and Granola, Various weights PLU 58260 | Whole Food Market | Food | Class I | 1 |
| 7 Apr 2017 | Desoximetasone Ointment USP, 0.25%, 15 g tubes, Rx Only, Teligent Pharma, Inc. Buena. New Jersey 08310 NDC 52565-030-15 Event 77061 | Teligent, Inc. | Drug | Class III | 1 |
| 7 Apr 2017 | JAP001 Jalapeno Powder, 44 lbs., cardboard carton with internal polybag Event 77010 | Henry-Broch Co | Food | Class I | 1 |
| 6 Apr 2017 | 01.4mm x 457mm (18in) K-Wire, Threaded Blunt, Ref 9080B-18T, Qty: 1 per pack, Material: SS 316L, Full Temper, per ASTM F138, Amendia, 1755 West Oak Parkway, Marietta, GA 30062 Guide Wires are used to establish a pathway into the bony pedicle to place implants during spinal surgery | Amendia, Inc | Device | Class II | 1 |
| 6 Apr 2017 | Methylprednisolone Acetate 40 mg/mL, Lidocaine HCl 10 mg/mL, 10 mL Multi-Dose Vial For Injection, Rx Only, Isomeric Pharmacy Solutions, 2401 Foothill Drive, SLC, UT 84109, Part # 1010, barcode 3 70285 10101 4. | Isomeric Pharmacy Solution, LLC | Drug | Class II | 7 |
| 6 Apr 2017 | Estriol, For Prescription Compounding, packaged in a) 1 G bottle (NDC: 51552-1392-1), b) 5 G bottle (NDC: 51552-1392-2), c) 25 G bottle (NDC: 51552-1392-3), d) 100 G bottle (NDC: 51552-1392-5), RX only, Distributed by Fagron, Inc. 2400 Pilot Knob Rd, St. Paul, MN 55120 Tel. 1-(800) 423-6967 Also packaged as: Estriol… | Fagron, Inc | Drug | Class II | 2 |
| 6 Apr 2017 | Precooked, chilled, Fresh Jumbo Lump Crabmeat, 1 lb, packaged in plastic container with plastic lid. King Crab and Seafood De Venezuela, product of Venezuela. | Seafarers Inc. | Food | Class I | 3 |
| 5 Apr 2017 | DOLPHIN INFLATION DEVICE CALIBER INFLATION DEVICE; Catalog Number: CL3030- 018SNA- 018SND 0185NA 0185ND; INTERNAL CODE NUMBER: 0185TR- 0185NA- 018SND 0185NA 0185ND | PEROUSE MEDICAL | Device | Class II | 1 |
| 5 Apr 2017 | The JETSTREAM is a rotational atherectomy catheter system designed for use in debulking and treating vascular disease in the peripheral vasculature. The System includes multiple distal ports located at the catheter tip, which are designed to provide independent infusion and aspiration functions for the active removal… | Boston Scientific Corporation | Device | Class II | 1 |
| 5 Apr 2017 | SoftPort Easy-Load Lens Delivery System Model: EZ-28V Is used for the folding and delivering of the LI61AO, LI61AOV, or LI61SE 3-piece lens into the eye. The SofPort Easy-Load Lens Delivery System consists of a syringe shaped body and tip with a plunger, drawer, and haptic puller. It is a sterile, disposable plastic… | Bausch & Lomb Surgical, Inc. | Device | Class II | 1 |
| 5 Apr 2017 | ADVIA Centaur Systems Insulin Calibrator; Test Code: Calibrator IRI; Catalog Number: 04618899 | Siemens Healthcare Diagnostics, Inc | Device | Class II | 2 |
| 5 Apr 2017 | Cedeira Octopus in Oil Spiced Piquant, Net Weight 4.4oz (125g) Event 76823 | Malgor & Co., Inc. | Food | Class II | 1 |
| 5 Apr 2017 | Organic Marketside Spring Mix, net Wt. 5 oz. (142g) packed in rigid plastic container, UPC code 6 8113132897 5. | Fresh Express Incorpated | Food | Class II | 1 |
| 5 Apr 2017 | Oberlander Bakery Gluten Free Brand “Chocolate Kokosh Cake Net Wt. 16 oz. Manufactured by: Orthodox Baking Co. Inc. Belleville, NJ 07109, UPC 43711 18093 7 Event 76960 | Oberlander Baking Co | Food | Class I | 1 |
| 3 Apr 2017 | Mederi Stretta Catheter and Accessory Kit, Sterile For Use with the MEDERI MDRF1 GENERATOR ONLY. Used in the treatment of gastroesophageal reflux disease (GERD). REF 175-5580 Event 76972 | Mederi Therapeutics, Inc | Device | Class II | 1 |
| 3 Apr 2017 | Second generation neoBLUE LED Phototherapy Light (neoBLUE 2) sold between 2003 and 2008. Catalog Part Number 010066. Top Assembly Part Numbers: 040906, 040904, 040756, 040758, 040658, 040680. Product Usage: Device is used to provide treatment for neonatal hyperbilirubinemia. | Natus Medical Incorporated | Device | Class II | 1 |
| 3 Apr 2017 | AQUIOS CL Flow Cytometer, Ref no. B30166, Software Versions 2.0 and 2.0.1 Product Usage: The AQUIOS CL Flow Cytometer is intended for use with in vitro diagnostic flow cytometric applications using up to four fluorescent detection channels using a blue (488 nm) laser, two light scatter detection channels and… | Beckman Coulter Inc. | Device | Class II | 1 |
| 3 Apr 2017 | Lactate Reagent (LACT 2 x 50), Catalog No. A95550 Intended for the quantitative determination of Lactate concentration in human plasma and cerebrospinal fluid (CSF). | Beckman Coulter Inc. | Device | Class II | 7 |
| 3 Apr 2017 | Refresh Tears (Carboxymethylcellulose Sodium Solution) 0.5%, Lubricant Eye Drops, Sterile packaged as 1) two 15 mL bottles, USPC Code 784190442214, 2) 4x15 mL and one 5 mL bonus bottles, USPC Code 069886941746, Distributed by Cell Distributors, Union, NJ Event 76861 | Cell Distributors | Drug | Class II | 1 |
| 3 Apr 2017 | Season's Choice Garden Fresh Sweet Peas, Net Wt 16 oz (1lb) 454g, Keep Frozen. UPC 41498-164294. | Lakeside Foods, Inc | Food | Class II | 1 |
| 1 Apr 2017 | Healon, Part No. 10290953, 10295210, 10200011, 10200012, 10201012, 10203012, 10213012, 10223012, 10290701, 10294751, 10295701 | Abbott Medical Optics Inc. (AMO) | Device | Class II | 6 |
| 1 Apr 2017 | GERMAN CHOCOLATE KB KILLER BROWNIE 3x35 CT NET WT 36 LBS (16.33 kg) CONTAINS: Milk, Nuts: Pecans, Soy, Wheat UPC 10858061005321. Item #483-2016 | Killer Brownie Distributing LLC | Food | Class I | 4 |
| 31 Mar 2017 | Menu Del Sol Beans and Cheese Burritos, UPC 45230-05601, 8 units/case, 32oz (2lb) Event 76904 | SIGMA FOODS INC | Food | Class I | 1 |
| 31 Mar 2017 | Great Value Bread and Butter Chips 24 Fl Oz. Distributed by: Wal-Mart Stores, Inc., Bentonville, AR 72716 UPC 078742145990 | Pinnacle Foods, LLC | Food | Class II | 1 |
| 31 Mar 2017 | Reser's Fine Foods, American Classics Macaroni Salad, Net Wt 1 lb. (454 g) UPC 7117.19007, packaged in 16 oz plastic tubs, 12 per case. Reser's Fine Foods, Inc. Beaverton, OR 97006. | Reser's Fine Foods, Inc. | Food | Class I | 1 |
| 31 Mar 2017 | Premium Hunt's Chili Kit, Total NET WT 44.8 OZ (2.80 LB) 1.27kg; Directions: 1) Cook and stir meat in saucepan over medium-high 7 minutes or until done; drain. 2) Stir in all remaining ingredients; simmer 10 minutes, stirring occasionally. Con Agra Foods, P.O BOX 3768, Dept. Hunts, Omaha, NE 68103-0768 USA | ConAgra Foods Inc | Food | Class II | 1 |
| 30 Mar 2017 | 18L6 HD transducer on the ACUSON S Family ultrasound systems with software versions VD10A or VD10C; Model numbers: 18L6 HD transducer – 10041227 & 10789400 S1000 – 10441701 S2000 – 10041461 S2000 (Refurb) - 10440017 S3000 – 10441730 Radiology: The ultrasound imaging systems are intended for the following… | Siemens Medical Solutions USA, Inc. | Device | Class II | 1 |
| 30 Mar 2017 | Newport Medical HT70 and HT70- Plus Ventilators, Rx Only Product Usage: The Newport HT70 family of ventilators 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 interfaces.… | Newport Medical Instruments Inc | Device | Class I | 1 |
| 30 Mar 2017 | AMO 25GA Vitrectomy Cutter (Model Number NGP0025) and AMO 20GA Vitrectomy Cutter and Irrigation Sleeve (Model Number NGP0020) Used with the AMO Whitestar Signature System. For ophthalmic use. | Abbott Medical Optics Inc. (AMO) | Device | Class II | 1 |
| 30 Mar 2017 | HeartMate II LVAS with Pocket Controller; 107801 - HMII PUMP & POCKET CTRL ONLY UDI:00813024011286 Intended to provide hemodynamic support in patients with end-stage, refractory left ventricular heart failure; intended for use inside or outside the hospital. | Thoratec Corporation | Device | Class I | 3 |
| 30 Mar 2017 | Dressing Knee/Shldr, P/N 02328 Product Usage: These products are sterile dressings used as an insulation barrier between the Polar Care cold therapy pad and the skin. Sterile dressings are typically applied in a non-sterile environment after post-op and on occasion may be applied in a sterile environment. Breg has… | Breg Inc | Device | Class II | 8 |
| 30 Mar 2017 | RENOVATION, RADIAL OSTEOTOME BLADE, SIZE 10, REF 71369310, STERILE R, QTY: (1) | Smith & Nephew, Inc. | Device | Class II | 12 |
| 30 Mar 2017 | Pollock Fillet is frozen block, packed in waxed coated fiber block liners. Each frozen block weighs 7.45 KG. There are 3 blocks packaged in a fiber master carton that has a poly box liner. The master case is a brown carton with blue print that has the brand "Alaska Brands" on the case and has a poly liner. This… | GAS LLC, LLC - Golden Alaska M/V | Food | Class II | 2 |
| 30 Mar 2017 | Life Rising Formulas SHT Chest Relief, 54 Capsules; Manufactured for: Nature's Health (USA) Chicago, IL 60616 Event 76913 | Ton Shen Health Inc | Food | Class I | 1 |
| 30 Mar 2017 | Econo, Estilo Pulpo al Ajillo, Octopus Style with Garlic Flavor, Net Wt. 4oz (115g) | Supermercado Econo Inc. E | Food | Class II | 3 |
| 29 Mar 2017 | Medi-Therm Hyper/Hypothermia System, MTA7900 | Stryker Medical Division of Stryker Corporation | Device | Class II | 1 |
| 29 Mar 2017 | 10.0 Grams Chili Spice Blend in packets Event 76903 | Arro Corporation | Food | Class II | 1 |
| 28 Mar 2017 | GP161R; ELAN 4 1-RING DIAMOND BURR COARSE D2.0; GP162R; ELAN 4 1-RING DIAMOND BURR+ COARSE D2.0; GP163R; ELAN 4 1-RING DIAMOND BURR COARSE D2,3; GP164R; ELAN 4 1-RING DIAMOND BURR+ COARSE D2,3; GP165R; ELAN 4 1-RING DIAMOND BURR COARSE D3,0; GP166R; ELAN 4 1-RING DIAMOND BURR+ COARSE D3,0; GP167R; ELAN 4 1-RING… | Aesculap Implant Systems LLC | Device | Class II | 3 |
| 28 Mar 2017 | MR GHIATAS Beaded Breast Localization Wire, Product Code: 477201, 479201 Product Usage: The GHIATAS Beaded Breast Localization Wire consists of an introducer needle and asemi-rigid localization wire that are intended for use during breast lesion surgery as a guidefor the surgeon to follow in the excision of the… | Bard Peripheral Vascular Inc | Device | Class II | 1 |
| 28 Mar 2017 | hCG Body Shaper, Highly Purified Human Chorionic Gonadotrophin 5000 IU, Colloidal Silver B12, Stabilizers/Excipients, Not For Medical Use, Must Be Refrigerated, Distributed by HCG Body Shaper, St. Peters, MO Event 76680 | Name withheld | Drug | Class II | 1 |
| 28 Mar 2017 | PrednisoLONE Oral Solution USP, 15 mg/5mL, alcohol content: 5%(v/v) 240 mL bottle, Rx Only, Manufactured in Canada By: CONTRACT PHARMACEUTICALS LIMITED CANADA, Ontario, Canada, L5N 6L6, Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960, NDC 0093-6118-87 | Teva Pharmaceuticals USA | Drug | Class III | 1 |
| 28 Mar 2017 | LaBri's Body Health Atomic, 60 capsules Event 76858 | Name withheld | Drug | Class I | 1 |
| 28 Mar 2017 | Apple Cider with Potassium Sorbate, packed under the following labels: RUDY'S BLEND APPLE CIDER; 1 GAL. (3.78L), UPC: 8 56005 00344 3; RUDY'S BLEND APPLE CIDER, 1/2 GAL (1.89L), 8 56005 00434 6; FRESHLY PRESSED APPLE CIDER Carlson Orchards Harvard, Mass, 1/2 GAL (1.89L), 8 56005 00323 8; FRESHLY PRESSED APPLE CIDER… | Bevovations, LLC dba New England Apple Products Company | Food | Class II | 2 |
| 28 Mar 2017 | Clancy’s Snack Combo Pack 20 x 1 oz; Each 20 oz selling unit contains 4 x 1 oz bags of Original Potato Chips, 4 x 1 oz bags of Sour Cream & Onion Potato Chips, 4 x 1 oz bags of Barbecue Potato Chips, 3 x 1 oz bags of Nacho Tortilla Chips, 3 x 1 oz bags of Ranch Tortilla Chips, and 2 x 1 oz bags of Cheese Curls. Large… Event 76923 | Name withheld | Food | Class I | 1 |
| 28 Mar 2017 | Safeguard Flour product code 5122286 packaged in 50 lb bags Event 76888 | Ardent Mills Llc Usa | Food | Class II | 1 |
| 27 Mar 2017 | Mentor Smooth Round SPECTRUM Post- Operatively Adjustable Saline Breast Implant, Product Code: 350-1490, UDI/GTIN: 00081317002048 | Mentor Texas, LP. | Device | Class II | 1 |
| 27 Mar 2017 | Whole Foods Market Made Right Here 6pk Banana Choc Chip Muffins, 6 pack. Net Wt. 1 lb 1 oz. | Whole Food Market | Food | Class I | 1 |
| 27 Mar 2017 | Chili Seasoning 50 lbs INGREDIENTS: Chili Pepper, Minced Onion, Wheat Flour***CONTAINS: WHEAT spicetec FLAVORS & SEASONINGS 195 Alexandra Way Carol Stream, IL 60188 (630) 582-5608 | Givaudan Flavours Corp | Food | Class II | 11 |
| 24 Mar 2017 | Anthrex Bio-SwiveLock SP Vented, 5.5mm x 24.5 mm, Self-Punching | Arthrex, Inc. | Device | Class II | 6 |
| 24 Mar 2017 | Blood Agar (TSA w/ 5% Sheep Blood) Plate, For In Vitro Diagnostic Use, Remel, Lenexa, KS 66215 Product Usage: Blood Agar is a solid medium recommended for use in qualitative procedures for the cultivation of a wide variety of microorganisms and visualization of hemolytic reactions. | Remel Inc | Device | Class II | 1 |
| 24 Mar 2017 | Dale Medical Stabilock Endotracheal Tube Holder Product # 270 The Dale Stabilock Endotracheal Tube Bolder 270 is a 2 piece device consisting of an adhesive base, Dale product number 273, that attaches to the patient's skin and a cushioned neckband with tube channel that attaches with hook & loop closures. The 270 is… | Dale Medical Products, Inc. | Device | Class II | 2 |
| 24 Mar 2017 | WECK Visistat 35R Disposable Skin Stapler, Ref 528135, Rx Only, Sterile EO, Visistat is indicated for the external skin closure of lacerations on the outer layer of the dermis for a wide range of general, thoracic, obstetric, gynecological, orthopedic, cardiovascular, urological, and plastic surgical procedures | Teleflex Medical | Device | Class II | 1 |
| 23 Mar 2017 | 1 mL Medallion Syringe. Catalog Numbers: 701989001, K01-05197P, MSS011-YP, K01-07946P, MSS011, MSS011-LB, MSS011-R, MSS011-Y, MSS011P, MSS011-LBP, MSS011-DG, K08-02926AP, K01-07742P, K10-05457P. | Merit Medical Systems, Inc. | Device | Class II | 1 |
| 23 Mar 2017 | Sysmex, Automated Hematology Analyzer XN Series, Sysmex Corporation, 1-5-1 Wakinohama-Kaigandori, Chuo-ku, Kobe 651-0073 Japan | Sysmex America Inc | Device | Class II | 1 |
| 23 Mar 2017 | MYPROTEIN, MYPRE V2(TM) Net Wt. 17.6 Oz (1.1 lb) /500g, Blue Raspberry, preworkout, 500g, THE HUT GROUP(R), 1350 Cedar Grove Park, Shepherdsville, KY, UPC 5 065104 570111 | Armada Nutrition | Food | Class II | 7 |
| 22 Mar 2017 | PERI-LOC VOLAR DISTAL RADIUS - RIGHT 3H STD HEAD LOCKING PLATE, 62 MM LENGTH, SST PLATE, REF 71823114, QTY: (1) NON-STERILE, Rx only, Smith & nephew, Inc., Memphis TN 38116 | Smith & Nephew, Inc. | Device | Class II | 1 |
| 22 Mar 2017 | Regenerex Patella RGX 3 PEG SER A PATELLA 28MM RGX 3 PEG SER A PATELLA 31MM RGX 3 PEG SER A PATELLA 34MM RGX 3 PEG SER A PATELLA 37MM Product Usage: The Regenerex Series A Patella can be used for any non-cemented resurfaced 3-peg patella application within the Vanguard Complete Knee System. 1. Painful and disabled… | Zimmer Biomet, Inc. | Device | Class II | 1 |
| 22 Mar 2017 | Wingman 35 Crossing Catheter, 65cm, Model Numbers: WGM35065US WGM35065CE WGM35090US WGM35090CE WGM35135US WGM35135CE Event 76821 | ReFlow Medical | Device | Class I | 1 |
| 22 Mar 2017 | NC Trek RX Coronary Dilatation Catheter, Part No. 1012448-06, 1012448-08, 1012448-12, 1012448-15, 1012448-20, 1012449-06, 1012449-08, 1012449-12, 1012449-15, 1012449-20, 1012449-25, 1012450-06, 1012450-08, 1012450-12, 1012450-15, 1012450-20, 1012451-06, 1012451-08, 1012451-12, 1012451-15, 1012451-20, 1012451-25,… | Name withheld | Device | Class I | 3 |
| 22 Mar 2017 | Isopto Carpine (pilocarpine hydrochloride opthalmic solution) 4%, packaged in 15 mL bottle, Rx only, Manufactured by: Alcon Laboratories, Inc. Fort Worth Texas 76134 USA NDC 0998-0206-15 | Novartis Pharmaceuticals Corp. | Drug | Class III | 2 |
| 22 Mar 2017 | Olanzapine Tablets, 2.5 mg, 1000-count bottles, Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India, NDC 62756-551-18. | Sun Pharmaceutical Industries, Inc. | Drug | Class III | 4 |
| 21 Mar 2017 | Sample probes associated with: cobas 6000 Series System, cobas 8000 Modular Analyzer Series, cobas c 311 analyzer cobas c 501/502 cobas c 701/702 cobas 8000 ISE Product Usage: The cobas 6000 series is a fully automated, random-access, software-controlled system for immunoassay and photometric analysis intended for… | Roche Diagnostics Corporation | Device | Class II | 1 |
| 20 Mar 2017 | ROHO HIGH PROFILE Single Compartment Cushion with Sensor Ready Technology and ROHO MID PROFILE Single Compartment Cushion with Sensor Ready Technology. Event 76836 | Roho Inc. | Device | Class II | 1 |
| 18 Mar 2017 | Raisin Bread, Valley Bakery, Rock Valley, IA, 1 count. UPC 290104404006, packaged in clear plastic bags | Valley Bakery Wholesalers Inc | Food | Class I | 27 |
| 17 Mar 2017 | GIZA Vertebral Body Replacement Event 76852 | Eden Spine Europe SA | Device | Class II | 1 |
| 17 Mar 2017 | Pressure Injectable Arrowg+ard Blue Plus Multi-Lumen Central Venous Catheterization Kit. Permits venous access to central circulation by way of subclavian, jugular and femoral veins. The ARROWg+ard technology is intended to provide protection against catheter-related bloodstream infections (CRBSIs). It is not… | Arrow International Inc | Device | Class II | 1 |
| 17 Mar 2017 | Fluocinonide Cream UPS, 0.05% (Emulsified Base), packaged in 60 g tube, Rx only, Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada, Dist. by Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-1254-3 | Taro Pharmaceuticals U.S.A., Inc. | Drug | Class III | 1 |
| 17 Mar 2017 | Nabelsi Thyme (also known on invoices as Zatar) 450g retail (24 packages per wholesale case) 4.5kg retail (2 bags per wholesale case) Cardboard box wholesale case, retail packages flexible plastic Event 76993 | Aroma Imports Inc | Food | Class I | 1 |
| 17 Mar 2017 | 40/50 ct/kg (21/25 ct/lb) Farm Raised Head-On Shrimps, Keep Frozen, Must be fully cooked before serving. 1.02 kg, 2.24 lb. Packed by: Global Marketing Ent Inc, Chicago, IL 60616 Event 76827 | Global Marketing Enterprises, Inc. | Food | Class II | 1 |
| 15 Mar 2017 | Shandon Rapid Chrome Kwik-Diff Kit Part Number: 9990700 Shandon Rapid Chrome Kwik-Diff Reagent #3 Part Number 9990707 Shandon Rapid Chrome Kwik-Diff Kit, Part Number 9990700 is sold as a kit in 500ml bottles. Shandon Rapid Chrome Kwik-Diff Kit, Part Number 9990707 is sold as a reagent in a 4L bottle. Intended for use… | Richard-Allan Scientific Company | Device | Class II | 1 |
| 14 Mar 2017 | Accu-Chek Connect Diabetes Management App versions 2.0.0, 2.0.1 and 2.1.0 for iOS and Android Product Usage: This is a digital product available for download direct to customers from the Apple App Store and the Google Play Store. The total number of downloads is not available. The number of unique users for each… | Roche Diabetes Care, Inc. | Device | Class II | 1 |
| 13 Mar 2017 | Sulfamethoxazole and Trimethoprim Oral Suspension, USP 200 mg / 40 mg per 5 mL , Grape Flavor, Rx Only, 16 fl oz. (473 mL), HI-TECH PHARMACAL CO., INIC, Amityville, NY 11701, NDC 50383-824-16 | Akorn Inc | Drug | Class II | 1 |
| 12 Mar 2017 | EpiPen 2-Pak (Epinephrine) Auto-Injectors 0.3 mg, Rx only, Manufactured for Mylan Specialty L.P., Morgantown WV 26505 by Meridian Medical Technologies, Inc., Columbia, MD 21046, a Pfizer company; NDC 49502-500-02 ---- ALSO LABELED OUTSIDE THE US AS ---- Epipen Auto-Injector 0.3 mg -Bright Stock labeled for multiple… | Meridian Medical Technologies a Pfizer Company | Drug | Class I | 2 |
| 10 Mar 2017 | Stryker PROFESS Registration Kit. The Stryker PROFESS Registration Kit is a member of the Navigation portfolio and is used as an intraoperative guidance system to enable intranasal and sinus computer-assisted surgery. The system is comprised of PROFESS Registration Stickers, a PROFESS Patient Tracker, and a PROFESS… | Stryker Instruments Div. of Stryker Corporation | Device | Class II | 1 |
| 10 Mar 2017 | HeartWare Ventricular Assist System (HVAD) Pump Driveline Splice Kit Product Usage: Is intended to repair the driveline cable once an electrical break has been identified. These repairs are limited to the portion of the driveline that is outside the patient boundary (exit side). | Heartware | Device | Class I | 1 |
| 8 Mar 2017 | Sonesta S2; Article numbers: 525-S2-110V and 525¿¿S2-220V Event 77075 | Sonesta Medical Ab | Device | Class II | 1 |
| 8 Mar 2017 | enGen (TM) Laboratory Automation Systems using all TCAutomation(TM) Software Versions with the InOut Communication Interface, IVD | Ortho-Clinical Diagnostics | Device | Class II | 1 |
| 7 Mar 2017 | uNion Cervical Plate System Product Usage: The uNion Cervical Plate System is intended for anterior fixation of the cervical spine (C2 to Ti). The system is to be used to provide stabilization of the anterior cervical spine as an adjunct to fusion for the treatment of degenerative disc disease (defined as neck pain… | Ulrich Medical USA Inc | Device | Class II | 1 |
| 7 Mar 2017 | Trigal Sorullitos de Maiz (Corn Sticks), Peso Neto (Net Weight) 10oz (283.5g), Manufacturado Por: Pastry Foods, Inc., Calle Elver #932, 1 Ext. Country Club, Rio Piedras, PR | Pastry Food Products Inc. | Food | Class II | 2 |
| 3 Mar 2017 | Goya Octopus in Garlic Sauce, Pulpo al Ajillo, NET WT./PESO NETO 4 oz. (113g), PRODUCT OF SPAIN "WILD FISH", GOYA FOODS, INC., Secaucus N.J. 07096. | Tradewind Foods de Puerto Rico Inc. | Food | Class II | 5 |
| 28 Feb 2017 | Stryker SmartLife Large Aseptic Housing (7126-120-000) | Stryker Instruments Div. of Stryker Corporation | Device | Class II | 1 |
| 23 Feb 2017 | Ziehm Imaging solo FD Mobile Fluoroscopic C-arm | Ziehm Imaging Inc | Device | Class II | 1 |
| 22 Feb 2017 | Bupivacaine HCl in 0.9% Sodium Chloride all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054 | Advanced Pharma Inc. | Drug | Class II | 60 |
| 21 Feb 2017 | VITROS Chemistry Products VANC Reagent, REF/Product Code 680 1709, Unique Identifier No. 10758750006731, Rx ONLY, IVD --- Ortho Clinical Diagnostics - USA -- Ortho-Clinical Diagnostics Pencoed, CF35 5PZ, UK ---- The VITROS VANC reagent is for ORTHO Clinical Diagnostics manufactured by Siemens. The VANC product has a… | Ortho-Clinical Diagnostics | Device | Class II | 1 |
| 16 Feb 2017 | Optic Splash (naphazoline hydrochloride) Eye Drops, packaged in 0.5 FL OZ (15mL) bottles, Manufactured by SATO Pharmaceuticals CO., LTD. 1-5-27 Motoakasaka Minato-Ku Tokyo, Japan, NDC 49873-501-01. | Sato Pharmaceutical Inc. | Drug | Class II | 3 |
| 14 Feb 2017 | Amish Creamery Butter Cheese Sold under the following brand names: Amish Classic 6 lb & 15 ib and Guggisberg 15 ib Distributed by: Guggisberg Cheese, 5060 S.R. 557, Millersburg, OH 44654 | Guggisberg Cheese Inc | Food | Class I | 9 |
| 10 Feb 2017 | Olympus ENDOEYE HD II Video Telescopes Models: WA50040A Endoeye HD II, 10 mm, 0 deg., autoclavable; WA50042A Endoeye HD II, 10 mm, 30 deg., autoclavable; repair cable 10mm 0/30 deg., part number W7100603 | Olympus Corporation of the Americas | Device | Class II | 1 |
| 9 Feb 2017 | ViperWire Advance with Flextip Peripheral Atherectomy Guide Wire, Part Number: 7-10026-01,Model Number: VPR-GW-FT14. Product Usage: The Stealth 360 Orbital PAD System and the Diamondback 360 Peripheral Orbital Atherectomy System are percutaneous orbital atherectomy systems indicated for use as therapy in patients… | Cardiovascular Systems Inc | Device | Class II | 1 |
| 5 Feb 2017 | Colby cheese. All affected product private labeled for other companies. Brands: Guggisberg; Dutch Farms; Meijer; Amish Classics; Lipari Old Tyme; Laubscher; Walnut Creek; Copperwood; Dietz & Watson; Banquet; Product packaged as: 6lb deli horns (4 diameter x 13 long cylinder) 2 or 4 per case; 15lb long horns (6… | Deutsch Kase Haus, LLC | Food | Class I | 13 |
| 3 Feb 2017 | HeartWare HVAD System Controller The HeartWare Ventricular Assist System (VAS is indicated for use as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure. The HeartWare Ventricular Assist System (VAS) is designed for in-hospital and… | Heartware | Device | Class I | 1 |
| 3 Feb 2017 | CORFLO, PEG Adaptor Repair Kit with ENFit Connectors, Size: 12FR (4mm); Product Usage: CORFLO PEG Tubes are intended for delivery of enteral nutrition, water and medications into the stomach. The PEG adapter is the connection point between the tubing and the feeding set/syringe. The adapter is designed as a… | CORPAK MedSystems, Inc. | Device | Class II | 3 |
| 31 Jan 2017 | MiniMed 620G and MiniMed 640G Insulin Pumps with Software Version 2.6 and below are affected. Catalog Numbers for these insulin pumps are MMT-1510, MMT-1710, MMT-1711, MMT-1712. | Medtronic Inc. | Device | Class II | 1 |
| 30 Jan 2017 | Tarina Fe 1/20 (Norethindrone Acetate and Ethinyl Estradiol Tablets, USP and Ferrous Fumarate Tablets), 1 blister pack containing 28 tablets (NDC 50102-128-01), packaged in 3 pouches, each pouch contains one blister pack of 28 tablets (NDC 50102-128-03), Rx only, Manufactured for: Afaxys, Inc., Charleston, SC 29403,… | Mylan Pharmaceuticals Inc. | Drug | Class III | 2 |
| 19 Jan 2017 | Fresh Mozzarella; No brand name. Shipped in 30 lb. plastic bucket Event 76984 | Farmo Foods, Inc. | Food | Class II | 1 |
| 14 Jan 2017 | MEDHOT MTI 2000 THERMAL IMAGING SYSTEM - TotalVision software with Elevated Body Temperature Screening module, for use as a medical diagnostic purposes as part of a telethermographic system utilizing FLIR cameras, Models A615sc and A315sc. Cameras are private labeled as MAX Basic, MAX 76 and MAX 307. Event 76622 | Med-Hot Thermal Imaging, Inc. | Device | Class II | 1 |
| 11 Jan 2017 | Trail's End Chicago Cubs Sweet and Savory Collection Trail's End Chicago Cubs Chocolate Lover's Collection Trail's End Chicago Blackhawks Collection Tin Snack mixes containing: Chocolate Caramel Corn; Chocolate Pretzels; White Chocolate Pretzels; White Cheddar Popcorn; Butter Toffee Caramel Corn. Tins contain 3-4,… Event 76926 | Weaver Popcorn Co. | Food | Class II | 1 |
| 5 Jan 2017 | Fluconazole Tablets, USP, 100 mg, 100-count Unit Dose carton, Rx only, Manufactured by Dr. Reddy's Laboratories Limited, Bachupally - 500 090 INDIA, Distributed by MAJOR PHARMACEUTICALS, 31778 Enterprise Dr., Livonia, MI 48150 USA, NDC 0904-6500-61 | The Harvard Drug Group | Drug | Class II | 2 |
| 4 Jan 2017 | Donepezil HCl tablets, 10mg, packaged in 10x10 blister packs per carton (100 Unit Dose) container, Rx only, Manufactured by Sandoz, Inc., 506 Carnegie Center, Suite 400, Princeton, NJ 08805, Distributed by: McKesson Packaging Services, 7101 Weddington Rd, Concord, NC 28027, NDC 63739-678-10 | Mckesson Packaging Services | Drug | Class III | 1 |
| 1 Jan 2017 | Ceftriaxone TX 32 US S30, Ref 412302 and Ceftriaxone TX 32 US F100, Ref 507058 ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic ba | BioMerieux SA | Device | Class II | 1 |
| 27 Dec 2016 | Aripiprazole Tablets, 2 mg, 30 count unit dose box, Rx only, Manufactured by Apotex Inc., Toronto, Ontario, Canada, Distributed by Major Pharmaceuticals, Livonia, MI NDC 0904-6509-04 | The Harvard Drug Group | Drug | Class III | 1 |
| 23 Dec 2016 | BD FlowSmart Set MiniMed Pro-set Rx Only Distributed by Medtronic MiniMed Inc. 8006464633 8185765555 Legal Manufacturer Becton, Dickinson and Company USA BD Medical-Diabetes Care Becton Dickinson France SAS | Becton Dickinson & Company | Device | Class II | 1 |
| 14 Dec 2016 | 16 mm Distraction Pin, Titanium, Qty: 1 per pack; STERILE; Manufactured for: Medline Industries, Inc., Mundelein, IL 60060 USA Distraction Pin is designed for Anterior Cervical Fusion Procedures. Use with vertebral body distraction instruments. It is intended as a temporary fixation screw utilized during cervical… | MEDLINE INDUSTRIES INC | Device | Class II | 5 |
| 12 Dec 2016 | Rabeprazole Sodium Delayed Release Tablets, 20 mg, a) 30-count bottle (NDC 65162-0724-03), b) 90-count bottle (NDC 65162-0724-09), Rx Only, Manufactured by Amneal Pharmaceuticals Pvt. Ltd., Ahmedabad INDIA 382220, Distributed by Amneal Pharmaceuticals, Bridgewater, NJ 08807 | Amneal Pharmaceuticals LLC | Drug | Class II | 1 |
| 12 Dec 2016 | Source Naturals Dietary Supplement Vitamin D-3; Bioactive Form for Bone and Immune Health 2000 IU per serving, 500% DV. Other ingredients: Vegetable Glycerin, Deionized water, citric acid, Natural orange flavor and lemon essential oil. Use 5 drops once daily in a drink. Packed in glass bottles in the following sizes:… | Threshold Enterprises Ltd | Food | Class II | 1 |
| 9 Dec 2016 | Macaroni & Cheese microwaveable cups sold under the following brands: 1. Big Win Original Macaroni & Cheese Dinner, UPC 11822-58403. 2. Cheese Club express mac Macaroni Cheese Dinner, UPC 41498-17167, 3. Great Value Macaroni & Cheese Dinner, UPC 78742-08249. | Treehouse Foods | Food | Class II | 1 |
| 17 Nov 2016 | SmartSite Add-On Bag Access Device, Model No. 10013365 | CareFusion 303, Inc. | Device | Class II | 1 |
| 6 Oct 2016 | 14cm QD Angle Attachment Product Usage: Product attachment | The Anspach Effort, Inc. | Device | Class II | 103 |
| 1 Sep 2016 | Mozobil (plerixafor injection) 24mg/1.2mL (20mg/mL), For Single Use Only, Rx Only, Manufactured by: Genzyme Corporation 500 Kendall Street, Cambridge, MA 02412 USA NDC: 0024-5862-01 | Sanofi-Aventis U.S. LLC | Drug | Class III | 1 |
| 25 Jul 2016 | Slow Roasted Ham & Swiss Breakfast Sandwich, Fully Cooked/Keep Frozen/Perishable Net Wt 5.6 oz (159 g) MANUFACTURED EXCLUSIVELY FOR STARBUCKS COFFEE COMPANY SEATTLE, WA 98134 UPC 7 62111 10495 1 Event 77180 | SK Food Group Groveport | Food | Class I | 1 |
| 7 Jul 2016 | The TM Ardis Interbody System implant is a convex, straight TLIF or PLIF device for interbody fusion of the anterior column of the spine. TM Ardis is designed for fusing the adjacent bony surfaces and may be used to replace a disc at one or two contiguous levels in L2-S1. The superior and inferior surfaces of the… | Zimmer Trabecular Metal Technology, Inc. | Device | Class III | 1 |
| 22 Jun 2016 | Alprazolam Extended-release Tablets, USP, 1 mg, 60-count bottle, Rx Only, Manufactured and Distributed by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A., NDC 0378-5022-91 | Mylan Pharmaceuticals Inc. | Drug | Class II | 1 |
| 13 Apr 2016 | Merge Cardio software. The firm name on the label is Merge Healthcare, Hartland, WI. Intended to be used to acquire, store, print, transfer, and archive clinical information. | Merge Healthcare, Inc. | Device | Class II | 1 |
| 6 Nov 2015 | Destination Renal Guiding Sheath Intended for the introduction of interventional and diagnostic devices into the human vasculature. | Terumo Medical Corporation | Device | Class II | 1 |
| 5 Aug 2015 | SurFlo IV Catheter | Terumo Medical Corporation | Device | Class II | 1 |
| 30 Mar 2015 | Schiller AG ISA CO2 Sensor (AKA: PhaseIn Unit), Merge Part Number HW-HEMO-00001. The PhaseIn Unit is an optional accessory (sold separately) to the Merge Hemo Patient Data Module (PDM). The PDM is a major component of the Merge Hemo system. | Merge Healthcare, Inc. | Device | Class II | 1 |
| 27 Mar 2015 | BBL Trypticase Soy Agar with 5% Sheep Blood (TSA II) and Chocolate II Agar (GC II Agar with Hemoglobin and IsoVitaleX) – I Plate Product Usage: Testing - Trypticase Soy Agar with 5% Sheep Blood is used for the growth of fastidious organisms and for the visualization of hemolytic reactions. Chocolate II Agar is an… | Becton Dickinson & Co. | Device | Class III | 1 |
| 23 Feb 2015 | Mobius3D Product Usage: Mobius3D software is used for quality assurance and treatment plan verification in radiation therapy. It calculates radiation dose three-dimensionally in a representation of a patient or a phantom. The calculation is based on read-in treatment plans that are initially calculated by a treatment… Event 77177 | Mobius Medical Systems, LP | Device | Class II | 1 |
| 29 Nov 2014 | Magellan Diagnostics LeadCare Ultra Blood Analyzer Part Number: 80-0010 | Magellan Diagnostics, Inc. | Device | Class I | 2 |
| 15 May 2014 | Pointe Scientific Chemistry Controls Level I and II LEVl: Amber glass vial w/PP white plastic cap. LEV2: Amber glass vial w/PP black plastic cap. | Medtest Holdings, Inc. | Device | Class III | 1 |
| 15 Feb 2012 | Pointe Scientific Hitachi AST Reagent R1 : PE plastic bottle w/PP plastic cap. R2: PE plastic bottle w /PP plastic cap. Product Usage: Two Part Chemistry Reagent For the quantitative determination of Aspartate Aminotransferase (ASl) in human serum on Hitachi analyzers. | Medtest Holdings, Inc. | Device | Class III | 1 |
| 6 Oct 2011 | Navitrack System - OS Knee Universal, Orthopedic Stereotaxic Instrument CAS Software application intended to assist in the placement of total knee replacement components | Orthosoft, Inc. dba Zimmer CAS | Device | Class II | 1 |
| 9 Jun 2009 | NDI P7 Position Sensor, Stereotaxic Instrument | Orthosoft, Inc. dba Zimmer CAS | Device | Class II | 1 |
| 28 Oct 2008 | Navitrack System - OS Knee Universal, Stereotaxic instrument | Orthosoft, Inc. dba Zimmer CAS | Device | Class II | 1 |
| 20 Jun 2008 | Navitrack System - OS Knee Universal, Orthopedic Stereotaxic Instrument | Orthosoft, Inc. dba Zimmer CAS | Device | Class III | 1 |