| 14 Oct 2014 | St Jude Medical, 10F Fast-Cath Trio" Hemostasis Introducer, REF # 406308, Sterile EO. The Fast-Cath Trio" Hemostasis Introducer consists of the following components: Port hemostasis adapter (3), Sheath (10F Cath-Lock"), dilator (10F) and 0.038 guidewire. See product labeling for diagram of contents. | St Jude Medical | Device | Class II | 1 |
| 14 Oct 2014 | Hapi Pudding, 3-pack, net wt. 8.46oz, UPC 11152 13417, JFC item #13417 | J F C International Inc | Food | Class I | 1 |
| 10 Oct 2014 | MethylPREDNISolone Tablets, USP, 4 mg, 100 unit dose blisters, Packaged and Distributed by: American Health Packaging, Columbus, OH ---- Carton of 100 NDC 68084-149-01, Individual Dose NDC 68084-149-11 | American Health Packaging | Drug | Class III | 1 |
| 8 Oct 2014 | Box Label: 3 mm Cueva Electrode Kit, Sterile EO, Rx Only, REF. CNE1-3KDINX . Pouch labels: Each kit contains 3 pouches. 3 mm Cueva Electrode CNE-3X, Cueva Electrode Applicator Wand CNE-100X, Cueva Electrode Leadwire CNE-LW-2DINX. Box Label: 2 mm Cueva Electrode Kit, Sterile EO, Rx Only, REF. CNE1-2KDINX . Pouch… | Ad-Tech Medical Instrument Corporation | Device | Class II | 1 |
| 8 Oct 2014 | Lotte European Waffle, Net Wt. 40g, 160g UPC 8801062518111, 8801062518135 (69443) | Lotte International America Corp (LA Branch) | Food | Class I | 1 |
| 7 Oct 2014 | The Persona Tibial Articular Surface Inserter is a sterilizable instrument intended for use in multiple total knee arthroplasty procedures. Per the Persona Surgical technique, the Persona Tibial Articular Inserter is used to seat the articular surface implant onto the tibial baseplate. | Zimmer, Inc. | Device | Class II | 1 |
| 7 Oct 2014 | Mortara Surveyor S12 and Surveyor S19 Patient Monitors. Product Usage: They are indicated for use in adult & pediatric patient populations. They facilitate the monitoring of: Non-invasive blood pressure (NIBP), Impedance respiration, Invasive blood pressure (P1-P4), Temperature, Functional arterial oxygen… (69467) | Mortara Instrument, Inc | Device | Class II | 1 |
| 7 Oct 2014 | ZEE Aspirin 325mg - 24 tablets in single dose packets, OTC, Manufactured for ZEE Medical Inc., Irvine,CA 92606 by ULTRA Tab Laboratories, Inc. Highland, NY 12528 (69538) | Zee Medical Products Inc | Drug | Class II | 1 |
| 6 Oct 2014 | Bumble Bee Premium Albacore Tuna in Water, Net Wt. 2.5oz, UPC 8660024011, 8660024031, 5763800424. Bumble Bee Premium Albacore Tuna In Water, Net Wt. 5oz, UPC 8660024016; UPC 8660024051, 5763800425. | Bumble Bee Foods LLC | Food | Class II | 9 |
| 3 Oct 2014 | Philips IntelliVue Monitors with software revisions J.21.03, J.21.19. Model Product MP5 M8105A; MP5SC M8105AS; MP5T M8105AT; MP5 Upgrade M8105AU ; MP5SC Upgrade 866327 The monitors are intended to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults,… | Philips Medical Systems, Inc. | Device | Class II | 2 |
| 3 Oct 2014 | Ketorolac Tromethamine INJECTION, USP, 30 mg per mL, a) 1 mL vial (NDC 25021-701-01) b) 2 mL vial (NDC 25021-701-02), Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195 | Sagent Pharmaceuticals Inc | Drug | Class II | 1 |
| 2 Oct 2014 | DePuy Synthes Radiolucent Retractor, part number 387.580, lot number 3620715 | Synthes, Inc. | Device | Class II | 1 |
| 2 Oct 2014 | Hydrocortisone Butyrate Cream 0.1%, Net Wt. 15 gm tubes, Rx only, Manufactured for: Rouses Point Pharmaceuticals, LLC Cranford, NJ 07016 By: Ferndale Laboratories, Inc. Ferndale, MI 48220 --- NDC 43478-270-15 | Valeant Pharmaceuticals International | Drug | Class III | 2 |
| 1 Oct 2014 | Continuum Acetabular System Trabecular Metal Shell with Multi Holes, Porous 68mm, Prosthesis, Hip, Semi-Constrained, Metal/Polymer | Zimmer, Inc. | Device | Class II | 1 |
| 1 Oct 2014 | Hydromorphone Hydrochloride Injection, USP, 10 mg/mL, Rx only, packaged in a) 1 mL Single-dose Vial (NDC 0703-0110-01), packaged in 10 x 1 mL Single-dose Vials per carton (NDC 0703-0110-03); Mfd By: Hospira Inc., Lake Forest, IL 60045; Mfd For: Teva Parenteral Medicines, Inc., Irvine, CA 92618; and b) 1 mL… | Hospira Inc. | Drug | Class II | 1 |
| 1 Oct 2014 | HYDROXYPROGESTERONE CAPROATE 250 MG/ML (IN SESAME OIL), Rx Only 4 mL INJECTABLE IM USE. Manufactured by Avella Specialty Pharmacy, Phoenix, AZ 85085. (69405) | Avella of Deer Valley, Inc. | Drug | Class II | 1 |
| 1 Oct 2014 | Kupiec Rice Cakes with Dark Chocolate, 3.1 oz (90g), 6 cakes packaged in white foil with a photo image of the rice cake on the front of the packaging. Sold to retail locations with 16 packages per case. (69398) | Markpol Distributors Inc. | Food | Class I | 1 |
| 30 Sep 2014 | Symmetric Total Knee Femoral Components Product Usage: Symmetric Total Knee Femoral Component is intended for use with Signal Medical Corp. Total Knee System for cemented use INA Total Knee Replacement. The femoral component is made of cobalt chromium alloy (ASTM F75). | Signal Medical Corporation | Device | Class II | 1 |
| 30 Sep 2014 | StarMedTec LightTrail¿ Reusable Fibers, 365 um; Material/Part Number: 6453 | Boston Scientific Corporation | Device | Class II | 3 |
| 30 Sep 2014 | Truvada (200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate) tablets, 30 count bottles, Rx only, Manufactured for Gilead Sciences, Inc. Foster City, CA 94404, NDC 61958-0701-1 | Gilead Sciences, Inc. | Drug | Class III | 1 |
| 30 Sep 2014 | Outer Carton labeled in part as: Multiple Organics Certified 100% Organic Mango Fillets Net Weight 20 Lbs. (9.07 kgs) In 5 X 4 Lb. bags Product of Mexico Certified Organic by QAI www.multipleorganics.com USDA Organic Inner plastic bag labeled in part as: Organic Mango Filets Net Weight 5Lbs (2.26 kgs) Product of… (69390) | Multiple Organics, Inc. | Food | Class II | 1 |
| 29 Sep 2014 | DOPamine Hydrochloride and 5% Dextrose INJ, USP, 200 mg per 250 mL, Rx Only, Baxter USA, NDC 0338-1005-02. | Baxter Healthcare Corp. | Drug | Class II | 1 |
| 26 Sep 2014 | Black Mamba Suture Passer. The Biomet Sports Medicine Mamba instruments are utilized to aid in passing suture through soft tissue. The Mamba Needle is designed for use with the Mamba Suture Passer. The needles are sterile, disposable, and for single-patient use only. | Biomet, Inc. | Device | Class II | 3 |
| 26 Sep 2014 | Bystolic (nebivolol) tablets, 20 mg/tablet, packaged as 7 tablets/bottle/carton, and 12 bottles/trays, Professional Sample, Rx only, Forest Pharmaceuticals, Inc., St. Louis, MO. --- NDC 0456-1420-07 | Forest Pharmaceuticals Inc | Drug | Class II | 1 |
| 26 Sep 2014 | Wild Caught Seared Ahi Tuna Seasoned with Cracked Black Pepper and Garlic, manufactured by Lagniappe Louisiana Foods, Inc.-Instructions say to keep frozen. (69383) | Anova Food, Llc | Food | Class I | 1 |
| 26 Sep 2014 | next by Nature brand DARK CHOCOLATE CHERRIES, NET WT. 3 Oz (85 g), UPC 817582252006 --- Produced by Tropical Valley Foods PO Box 2994 Plattsburgh, NY 12901 (69396) | Tropical Valley Foods, Inc. | Food | Class II | 1 |
| 24 Sep 2014 | Discovery Elbow Humeral Trial Product Usage: Biomet manufactures a variety of elbow joint replacement prostheses intended for primary and revision joint arthoplasty for use in cemented applications. Elbow joint replacement components include humeral and ulnar components, and in some instances, hinge components. | Biomet, Inc. | Device | Class II | 1 |
| 24 Sep 2014 | Biosense Webster's Reprocessed SOUNDSTAR¿ eco Diagnostic Ultrasound Catheters, Catalog Nos: M-5723-115, Model Number BIO10438577. | STERILMED, INC. | Device | Class II | 1 |
| 24 Sep 2014 | Nettle Leaf powder Gross Wt: 55.5 Lbs. Net Wt: 55.0 Lbs. This material is being sold for further processing, and for Manufacturing use only. Distributed by Whole Herb Company (69355) | Whole Herb Company | Food | Class I | 1 |
| 23 Sep 2014 | ArcPoint Labs 5 Panel Dip Drug Screen, Part No. APD-5M. The ArcPoint Labs Dip Drug Screen Dip Card is a one-step immunoassay for the qualitative detection of multiple drugs and drug metabolites in human urine. | Ameditech Inc | Device | Class II | 3 |
| 23 Sep 2014 | Microseal Augmented (20 degrees) Liner, acetabular liner component made from UHMW polyethylene (ASTM F648). Sizes 36x52x20; and 36x50x20. Device is intended for use with Whiteside Biomechanics, Inc./Signal Medical Corporation Micro-Seal Shell in an uncemented Total Hip Replacement. | Signal Medical Corporation | Device | Class II | 1 |
| 23 Sep 2014 | Golden Corral MEATLOAF MIX #18028, Keep Frozen, Net Weight: 20 Lbs. (4 - 5 Lb. Bags), FOR INSTITUTIONAL USE ONLY, Manufactured Exclusively for GC Corporation, Raleigh, NC 27612 | Processed Foods, Inc.- Custom Foods | Food | Class III | 6 |
| 19 Sep 2014 | External power supply adaptors that accompany Clinitek Status+ The Clinitek Status systems is a urine analyzer. | Siemens Healthcare Diagnostics, Inc | Device | Class II | 3 |
| 19 Sep 2014 | GE Healthcare Carescape Patient Data Module | GE Healthcare, LLC | Device | Class II | 1 |
| 19 Sep 2014 | MaxLock Extreme Mod-Foot Concave Reamer; Individually packaged in a 3 x 4 bag and heat sealed with label on the outside. Used during procedures to clear away bone and cartilage within the desired implant area. | Orthohelix Surgical Designs Inc | Device | Class II | 1 |
| 19 Sep 2014 | Straumann Bone Level Tapered Implant 04.1 mm RC, SLActive¿ 8mm, Roxolid¿, Loxim Article Number: 021 .5308 Dental implants are intended for surgical placement in maxillary and/or mandibular arches to provide support for prosthetic restorations in edentulous or partially edentulous patients. Dental implants are for… | Straumann USA, LLC | Device | Class II | 1 |
| 19 Sep 2014 | IMMULITE /IMMULITE 1000 Systems COR Cortisol, REF/Catalog Number LKC01, SMN 10381388, IVD. For in vitro diagnostic use with the IMMULITE 1000 Systems Analyzers for the quantitative measurement measurement of cortisol (hydrocortisone, Compound F) in serum, as an aid in the clinical assessment of adrenal status. | Siemens Healthcare Diagnostics | Device | Class II | 1 |
| 19 Sep 2014 | Mars Chocolate North America Milk Chocolate M & M's Net Wt. 3.40 oz packed in a brown, 3 inch x 6.5 inch cardboard box 12 Theater boxes per case Distributed by Mars Snackfoods US LLC., Hackettstown, NJ 07840-1503 UPC 40000294764 | Mars Chocolate North America | Food | Class II | 1 |
| 19 Sep 2014 | President's Choice- PC Organics brand Original Stoned Wheat Crackers, 200 g UPC: 0 60383 70928 0 (69310) | Venus Wafers Inc. | Food | Class II | 1 |
| 18 Sep 2014 | Covidien Medi-Trace Cadence and Kendall Adult Multi-Function Defibrillation Electrodes, Radiotransparent Part Number: 22660R | Covidien LLC | Device | Class I | 6 |
| 18 Sep 2014 | Multi-Lumen Central Venous Catheterization Kit | Arrow International Inc | Device | Class II | 1 |
| 18 Sep 2014 | V.A.C. GranuFoam Silver Large Dressing is barrier to bacterial penetration and may help reduce infection. Featuring SensaT.R.A.C. Technology REF M8275099/10 STERILE Single Use only Latex Free Rx Only. | KCI USA, Inc. | Device | Class II | 1 |
| 18 Sep 2014 | EndoWrist Stapler 45 instrument for the da Vinci Si System Model Number: IS3000 Product Usage: For use with da Vinci Si System. The Intuitive Surgical Endoscopic Instrument Control System is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and… | Intuitive Surgical, Inc. | Device | Class II | 1 |
| 18 Sep 2014 | Siemens Mammomat Inspiration mammography systems. The Mammomat Inspiration system is intended for mammography exams, screening, diagnosis, and stereotactic biopsies under the supervision of medical professionals. Mammographic images can be interpreted by either hard copy film or soft copy workstation. | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 18 Sep 2014 | E-Z- GAS II EFFERVESCENT GRANULES Antacid/Antiflatulent ,4 g (0.14 oz), 50 -count box, Rx Only, Manufactured in USA for E-Z EM, Inc. Lake Success, NY 11042 by Tower Laboratories LTD Centerbrook, CT 06409 NDC 10361-793-01 | Bracco Diagnostic Inc | Drug | Class III | 1 |
| 17 Sep 2014 | EndoWrist One Vessel Sealer used in conjunction with the da Vinci Si Surgical System IS3000. The Endo Wrist One Vessel Sealer is a bipolar electrosurgical instrument for use with the da Vinci Si Surgical System and the ERBE VIO 300 D electrosurgical generator. It is intended for grasping and blunt dissection of… | Intuitive Surgical, Inc. | Device | Class II | 1 |
| 17 Sep 2014 | Compress Face Reamer Product Usage: Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement, tumor resections, revision of previously failed total joint arthroplasty, and trauma. | Biomet, Inc. | Device | Class II | 1 |
| 17 Sep 2014 | Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Product Usage: Boston Scientific cardiac resynchronization therapy defibrillators (CRT-Ds) are indicated… | Boston Scientific CRM Corp | Device | Class II | 2 |
| 17 Sep 2014 | Esprit V1000 and V200 Ventilators, Model No. V1000 and V200; and the 3rd Generation Power Supply Repair Part (RP)Kits Microprocessor-controlled, electrically powered mechanical ventilators intended for use by qualified medical personnel to provide continuous or intermittent ventilator support for adult, pediatric and… | Respironics California Inc | Device | Class I | 1 |
| 17 Sep 2014 | Protocol 10% NBF Product Usage: 10% NBF is used to store and fixate tissue prior to grossing and histological examination. It is a primary fixative that prevents autolysis (degradation) of tissue. | Richard-Allan Scientific Company | Device | Class I | 7 |
| 17 Sep 2014 | Xarelto (rivaroxaban) Tablets 15 mg per tablet, 5 count bottle, Rx Only, Manufactured by: JOLLC, Gurabo, PR 00778 NDC 50458-578-99 (69302) | Janssen Ortho L.L.C. | Drug | Class II | 1 |
| 17 Sep 2014 | naturebox cranberry macaroon granola net wt. 3.75 oz (106g) naturebox.com Back label incorrectly has nutrition and ingredients for cherry berry granola labeled in part as: Ingredients: Whole grain oats, brown sugar, dried cranberries (cranberries, sugar, sunflower oil) almonds, coconut, pecans, dried cherries… | NatureBox, Inc. | Food | Class II | 1 |
| 16 Sep 2014 | ZOLL Pro-padz Sterile Multi-Function Electrodes (MFE) Part Number: 8900-4012 Product Usage: These MFE Electrodes are used in connection with ZOLL Defibrillators for Adult patients. These disposable single use MFEs are processed through Gamma Radiation to a SAL of 10-6 per International/ National Standards, EN ISO… | Bio-Detek, Inc. | Device | Class II | 4 |
| 16 Sep 2014 | Su Cocina brand Pan Molido (Plain Bread Crumbs). Product is packaged in 8 oz. bags. The UPC is 6 79790 05912 5. The Label is read in parts: "***SU COCINA***Plain Bread Crumbs***INGREDIENTS: Bread Crumbs*** DOMINGUEZ FOODS OF WASHINGTON*** P.O. Box 506, Zillah, Washington 98953***509-829-6089***". (69264) | Dominguez Foods of Washington, Inc. | Food | Class I | 1 |
| 15 Sep 2014 | AC Powered adjustable bed frame. AC powered adjustable bed frame used in nursing facilities. | Primus Medical LLC | Device | Class II | 1 |
| 15 Sep 2014 | Siemens ADVIA Centaur¿ Systems HBc Total (HBcT), Reagent. For In Vitro Diagnostic Use Catalog Number: 07566733 Siemens Material Number: 10309508 The ADVIA Centaur HBc Total assay is an in vitro diagnostic test for the qualitative determination of total antibodies to the core antigen of the hepatitis B virus (HBc… | Siemens Healthcare Diagnostics, Inc | Device | Class II | 2 |
| 15 Sep 2014 | ASK-05501-AFH1, Lot Number 23F13K0969 Anesthesia Conduction Catheter, Epidural Anesthesia Kit | Arrow International Inc | Device | Class II | 1 |
| 15 Sep 2014 | Codman EDS 3 Drainage System with Ventricular Catheter (External Drainage System) Catalog Number: 82-1730 Indicated for draining cerebrospinal fluid (CFS) and other fluids of similar physical characteristics as a means of reducing intracranial pressure and CSF volume when the insertion of a permanent, internal shunt… | Codman & Shurtleff, Inc. | Device | Class II | 3 |
| 15 Sep 2014 | TOPIRAMATE Tablets 200 mg, 60 Tablet Bottles, Rx Only. Manufactured by Cadila Healthcare Ltd. Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ USA 08534. NDC 68382-141-14. | Zydus Pharmaceuticals USA Inc | Drug | Class II | 1 |
| 15 Sep 2014 | Tarceva (erlotinib) Tablets, 150 mg, 30 count bottle, Rx only, Manufactured by: Kremers Urban Pharmaceuticals Inc. Seymour, IN 47274 NDC 50242-064-01 | Astellas Pharma US Inc | Drug | Class II | 1 |
| 15 Sep 2014 | Assured Aspirin Enteric Safety Coated Tablets, 81 mg, Adult Low Strength, Pain Reliever (NSAID), 60-count bottle, Distributed by Greenbrier International, Inc., Chesapeake, VA 23320 UPC 639277018328. (69248) | Individual firm, name withheld | Drug | Class II | 1 |
| 15 Sep 2014 | CREON (pancrelipase) Delayed-Release Capsules, Lipase 24,000 USP Units, 250 Capsule Bottles, Rx Only. Marketed by: AbbVie Inc., North Chicago, IL 60064, Product of Germany. NDC 0032-1224-07. | AbbVie Inc | Drug | Class II | 1 |
| 15 Sep 2014 | Fresh Finds ground black pepper Net Wt. 3.53 oz (100g) Distributed by: Big Lots Stores, Inc. P.O. Box 28523 Columbus, OH 43228-0523 Packed in the USA UPC 411010982901 packaged in plastic jars; 12 jars per case | Gel Spice Co, Inc. | Food | Class I | 1 |
| 12 Sep 2014 | Omni Micro-electrode/reference electrode for cobas b221 analyzer. The Roche Diagnostics Omni S Analyzer is a fully automated critical care analyzer intended to be used for the measurement of pH, PCO2, PO2, sodium, potassium, ionized calcium, chloride, hematocrit, glucose, lactate, urea/BUN, total hemoglobin, oxygen… | Roche Diagnostics Operations, Inc. | Device | Class III | 1 |
| 12 Sep 2014 | Amiodarone HCl Injection, 450 mg/9 mL (50 mg per mL), 9 mL Single-Use Vial, Rx only, Manufactured for Mylan Institutional, LLC, Rockford, IL 61103, NDC 67457-153-09. | Mckesson | Drug | Class II | 1 |
| 12 Sep 2014 | CST Roma Tomatoes Whole Roma 1/25# Origin: USA Keep Refrigerated UPC: 40000356942 Taylor Farms, Pacific, Tracy, CA 95376 | Taylor Farms Pacific Inc. (MacArthur Facility) | Food | Class I | 2 |
| 12 Sep 2014 | 2/24 ounce clear plastic bags of 3/8 inch diced Roma tomatoes. These bags are in a cardboard carton. The bags and carton have a yellow label that reads in part: Boskovich Farms, Inc Costco Deli Dept. 63 ***QUINOA SALAD KIT Item # 624843 CONTENTS: (2) QUINIA MIX *** (2) Diced Roma *** NET WT: 23.96 LBS . | Boskovich Farms, Inc | Food | Class I | 2 |
| 11 Sep 2014 | The Ingenuity CT, Ingenuity Core, and Ingenuity Core128 scanners are Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment,… | Philips Medical Systems (Cleveland) Inc | Device | Class II | 1 |
| 11 Sep 2014 | ASSEMBLY, PATIENT SIDE CART, PS4000 used with the da Vinci Xi Surgical System. Product Usage: The Intuitive Surgical Endoscope Instrument Control System (da Vinci Surgical System, Model IS4000) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt… | Intuitive Surgical, Inc. | Device | Class II | 1 |
| 11 Sep 2014 | MethylPREDNISolone TABLETS, USP 4 mg, a) 100 count bottles (NDC 0603-4593-21) and b) 21 count blister pack (NDC 0603-4593-15), Rx only, Mfg for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811 | Qualitest Pharmaceuticals | Drug | Class III | 1 |
| 11 Sep 2014 | Roma Tomatoes, 25lbs. case (69225) | Expo Fresh L.L.C | Food | Class I | 1 |
| 10 Sep 2014 | Frozen battered onion rings packaged in 40 oz plastic bags, 6/case under the following private labels: (1) Imperial Sysco 3/8" Battered Onion Rings, Distributed by Sysco Corporation, Houston, Texas 77077-2099, Product no.: 41010044, and UPC code: 074865 84822 0; and (2) KickStarts Batter Dipt Onion Rings, Net Wt. 40… | McCain Foods USA | Food | Class II | 2 |
| 9 Sep 2014 | Persona The Personalized Knee System 2.5 mm Female Screw 48 mm Length Sterile Qty-2. Sterilized using irradiation, single use. | Zimmer, Inc. | Device | Class II | 1 |
| 9 Sep 2014 | Buprenorphine Hydrochloride Injection, CIII, 0.3 mg base/mL ,1 mL, 10 Carpuject Sterile Cartridge Units with Luer Lock, Slim-Paks, F Intramuscular or Intravenous Use, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-2012-32 | Hospira Inc. | Drug | Class II | 1 |
| 8 Sep 2014 | Philips Expression MR200 MRI Patient Monitoring System Model 866120 | Invivo Corporation | Device | Class II | 1 |
| 8 Sep 2014 | Hudson RCI¿ Pediatric Anesthesia Breathing Circuits, Single Patient Use, Rx Only, Product Usage: To administer medical gases to a patient during anesthesia. It provides both an inhalation and exhalation route and may include a connector, adaptor, and Ypiece. | Teleflex Medical | Device | Class I | 1 |
| 8 Sep 2014 | VITROS 4600 Chemistry System (VITROS 5,1 FS System family member), System Product Code 6802445. The VITROS 4600 Chemistry System is intended for use in the in vitro quantitative measurement of a variety of analytes of clinical interest, using both VITROS Chemistry Products Slides (colorimetric endpoint, rate,… | Ortho-Clinical Diagnostics | Device | Class II | 2 |
| 8 Sep 2014 | Potassium Chloride Injection, 10 mEq per 100 mL, Highly Concentrated (100 mEq/L), 100 mL Sterile single dose container bags, Rx only, Baxter USA, product code 2B0826, NDC 0338-0709-48. | Baxter Healthcare Corp | Drug | Class II | 1 |
| 8 Sep 2014 | Natural Blue Diamond Almonds Artisan Nut-Thins crafted with brown rice, almonds & Chia Seeds Wheat & Gluten free Net wt. 4.25 oz. Box. (120.5g) Cracker Snacks UPC: 41570 10938 Best Before Dates: AUG 06 15 and AUG 07 15 Manufactured for: Blue Diamond Growers 1802 C St. Sacramento, CA 95811 | Blue Diamond Growers | Food | Class II | 1 |
| 5 Sep 2014 | GE Healthcare Precision 500D, Classical R&F System. Product Usage: The Precision 500D R&F X-ray System is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic examinations, including general R&F and Pediatric examinations. | GE Healthcare, LLC | Device | Class II | 1 |
| 5 Sep 2014 | Philips Expression MR200 MRI Patient Monitoring System | Invivo Corporation | Device | Class II | 1 |
| 5 Sep 2014 | Frozen jalapeno bagels sold under the Maple Leaf Bakery brand in three different sizes: 3 oz. (64 bagels/case), 4 oz. (78 bagels/case), and 4.5 oz. (72 bagels/case) (69183) | Wholesome Harvest Baking, Inc. | Food | Class II | 1 |
| 5 Sep 2014 | Publix brand Jalapeno Bagels, sold in self service bins and counter sales. | Publix Super Markets, Inc. | Food | Class II | 1 |
| 5 Sep 2014 | Plum Organics Little Cremes: Organic Rice Milk Snacks; Super Greens: Kale, Apple and Sweet Potato; Net Wt. 1 oz. (28 grams) 8 CT. USDA Organic; Dairy Free. Ingredients: ORGANIC SWEET POTATO PUREE, ORGANIC APPLE PUREE, ORGANIC RICE MILK (ORGANIC BROWN RICE, WATER), ORGANIC EVAPORATED CANE SYRUP, ORGANIC TAPIOCA… | Plum, Inc. | Food | Class II | 3 |
| 5 Sep 2014 | Twix Unwrapped Bites 7.0 oz. distributed by Mars chocolate na, llc Hackettstown, NJ 07840-1503 USA UPC 040000484325 contained in a Metallized-golden stand up pouch (SUP) package 5 pouches per carton, 2 cartons per case | Mars Chocolate North America | Food | Class I | 1 |
| 3 Sep 2014 | SPECTRUM Pump, Model No. 35700BAX. Intended to be used for the controlled administration of intravenous fluids. | Baxter Healthcare Corp. | Device | Class II | 1 |
| 3 Sep 2014 | RECLAIM Distal Reamer Extension Non Sterile REF 2975-00-500 Intended as an attachment device to the distal reamers to allow the surgeon to clear soft tissue while reaming the distal femoral canal. | DePuy Orthopaedics, Inc. | Device | Class II | 1 |
| 2 Sep 2014 | DePuy Synthes TI Vectra Plates: TI Vectra-One" Plate 2 Level / 34 mm part 04.613.184 3337672 TI Vectra" Plate 3 Level / 57 mm part 04.613.257 lot 3693878 TI Vectra" Plate 4 Level / 64 mm part 04.613.364 lot 8143905 | Synthes, Inc. | Device | Class II | 1 |
| 2 Sep 2014 | Siemens Ysio Max system The Ysio Max is a radiographic system used in hospitals, clinics, and medical practices. Ysio Max enables radiographic and tomographic exposures of the whole body including: skull, chest, abdomen, and extremities and may be used on pediatric, adult and bariatric patients. It can also be used… | Siemens Medical Solutions USA, Inc | Device | Class II | 4 |
| 2 Sep 2014 | The Aeroneb Professional Nebulizer System is a portable medical device for multiple patient use that is intended to aerosolize physician-prescribed solutions for inhalation to patients on and off ventilation or other positive pressure breathing assistance. The Aeroneb Professional Nebulizer System is suitable for use… | Aerogen Ltd. | Device | Class II | 4 |
| 2 Sep 2014 | Tullia's Italian Meatless Pasta Sauce, packaged in a 16 oz. (436g) and 32 oz. (872g) glass jars with one-piece metal closures. The 32 oz. (872g) glass jar has the UPC 7 48863 64322 3. The 16 oz (436g) glass jar has the UPC 7 48863 64321 6. (69168) | Individual firm, name withheld | Food | Class II | 1 |
| 30 Aug 2014 | Supreme brand Colossal Crab Meat, 16 oz; Premium Pasteurized Crab Meat. Product of Thailand. Distributed by Supreme Lobster and Seafood Company, Villa Park, IL 60181 | Supreme Distributors, Inc. | Food | Class II | 10 |
| 29 Aug 2014 | Dako Autostainer Link 48 with software version Dako Link 4.0.3, Model No. AS480 Product Usage: For in vitro diagnostic use. The Dako Autostainer Link 48 is an automated slide processing system compatible with reagents for the staining of paraffin-embedded and frozen tissue sections, cytospins, cell smears and fine… | Dako North America Inc. | Device | Class II | 1 |
| 29 Aug 2014 | Individually 2/3 oz. slices of American cheese product individually wrapped in transparent plastic an packaged in 12 oz. and 16 oz.. packages, and 4 lb. cartons under the Kraft brand name. Cases of 12 oz. packages include 48 packages per case. Cases of 16 oz. packages include either 12 or 36 packages per case. Cases… | Kraft Heinz Foods | Food | Class III | 1 |
| 29 Aug 2014 | 4C GRATED CHEESE HOMESTYLE 100% NATURAL PARMESAN, NET WT. 6 OZ. (170g) glass jars, UPC Number:0-41387-32790-8. Manufactured by 4C FOOD CORP., BROOKLYN, NY 11208. Product of USA. (69143) | 4 C Foods, Corp. | Food | Class I | 1 |
| 29 Aug 2014 | Chinese Style Noodles, 10lbs./bx (69167) | Phoenix Produce & Noodle Company, LLC. | Food | Class II | 1 |
| 29 Aug 2014 | soft caramel balls coated in chocolate in orange plastic bag with labeling: palmer Creepy Peepers Chocolaty Coated Soft Caramel Filled Eyeballs NET WT 9 OZ Creepy Peepers Lot/Code Date: 066113 UPC 00041269503734 MANUFACTURED ON EQUIPMENT WHICH PROCESSES WHEAT, PEANUT BUTTER AND ALMONDS Inside plastic bag: Foil… (69190) | R.M. Palmer Company | Food | Class II | 1 |
| 29 Aug 2014 | Papetti's Table Ready Refrigerated pre-cooked scrambled eggs with butter flavor. Keep refrigerated 33 - 40 degrees F. Packaged in 12- 1.85 pound bags with Net Wt. 22.2 lbs (10.06 kg). Product code: 46025-85877. UPC Code: 1 07 46025 85877 2. | Michael Foods, Inc. | Food | Class II | 2 |
| 28 Aug 2014 | eFilm Workstation 4.0 and 4.0.1. eFilm Workstation is one of the components of a PACS (Picture Archiving and Communications System). Product Usage: eFilm Workstation is a software application that is used for viewing medical images. eFilm Workstation receives digital images and data from various sources (including… | Merge Healthcare, Inc. | Device | Class II | 1 |
| 28 Aug 2014 | Bionector Needleless connector. Bionector is a multi-purpose catheter accessory; a closed needle-less system permitting blood sampling, intermit ant injection and continuous infusion of fluids or medications to patients in a hospital or homecare situation. | Vygon Corporation | Device | Class II | 1 |
| 28 Aug 2014 | Dimension Vista¿ Mass CKMB Isoenzyme Calibrator (MMB CAL) an in vitro diagnostic product for the calibration of Creatine Kinase MB Isoenzyme (MMB) method on the Dimension Vista¿ System. | Siemens Healthcare Diagnostics, Inc. | Device | Class II | 1 |
| 28 Aug 2014 | Oxycodone and Acetaminophen Tablets USP 10 mg/325 mg 100 count bottles Rx Only. Manufactured by Norwich Pharmaceuticals Inc., Norwich, NY 13185 USA; Distributed by Alvogen Inc, Pine Brook NJ 07058 USA. | Alvogen, Inc | Drug | Class II | 1 |
| 28 Aug 2014 | Hostess Frosted Bagged Donettes, 11.25 oz | Hostess Brands LLC | Food | Class II | 6 |
| 27 Aug 2014 | The Ysio Systems with software version VC10 The Ysio enables radiographic and tomographic exposures of the whole Body including: skull, chest, abdomen, and extremities and may be used on pediatric, adult and bariatric patients. | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 27 Aug 2014 | Charnley PN Retract & Handle, REF 962004000, Non-Sterile-DuPuy International Ltd. The Charnley Pin Retractor and Handle Set is used to facilitate the insertion and extraction of two pins into and out of bone in the incision area, thereby holding the incision soft tissue open during the surgical procedure. | DePuy Orthopaedics, Inc. | Device | Class II | 1 |
| 27 Aug 2014 | McKesson Cardiology" Hemo intended for complete physiological/hemodynamic monitoring, clinical data acquisition, medical image and data processing, and analytical assessment. | Mckesson Information Solutions LLC | Device | Class II | 1 |
| 27 Aug 2014 | GYRUS ACMI, REF 3345 -Everest BiCOAG MOLly Forceps 5mm/45cm REF 3345PK - PKS MOLly Forceps 5mm/45cm REF 3640 -Everest BiCOAG Macro Jaw Forceps 5mm/45cm REF 3640PK- PKS Macro Jaw Forceps 5mm/45cm REF 3844- Everest BiCOAG LP Scissors 5mm/45cm REF 910010PK- PKS MOLly Forceps 5mm/45cm Single-use, sterile devices intended… | Gyrus Medical, Inc | Device | Class II | 1 |
| 27 Aug 2014 | Justright Surgical, JustRight 5mm Stapler, REF JR-ST25-2.0, Sterile, EO, Rx Only, JR-ST25-2.0 product is packaged in cases of 6. The JustRight 5mm Stapler is intended for use in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection, and creation of anastomosis. | Justright Surgical, LLC | Device | Class II | 2 |
| 26 Aug 2014 | Spacelabs Medical Patient Monitor is a Physiological, Patient monitor With Arrhythmia Detection or Alarms. The Models are 91367, 91369, 91370, 91387, and 91393 are sold with Perioperative Mode (option D), which includes Start case/End case functionality, Upgrade Kit 040-1548-00. Spacelabs Healthcare patient monitors,… | Spacelabs Healthcare Inc | Device | Class II | 1 |
| 25 Aug 2014 | BioFlo PICC with ENDEXO Technology Maximal Barrier Nursing Kit, 3F-55 cm, UPN Product No. H965750231, REF/Catalog No. 75-023, STERILE --- Intended for short or long term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications,… | Navilyst Medical, Inc | Device | Class II | 12 |
| 25 Aug 2014 | Basil Pesto Pasta packaged in a non-flex plastic tub, net wt 8 oz. A green sticker is placed on the lid of the package which contains the lot code. Product is refrigerated (69151) | TJs Place | Food | Class I | 1 |
| 25 Aug 2014 | La Orocovena, Pound Cake Queso, NET WT. 2 OZ. (56.7 grams) (69120) | Individual firm, name withheld | Food | Class I | 1 |
| 22 Aug 2014 | Suction canisters labels as follows: 1) DeRoyal(R) SUCTION CANISTER, 1000cc, SEMI-RIGID, REF 71-6510, NON-STERILE, Rx Only. 2) NOVAPLUS(TM) SUCTION CANISTER, 1000 cc, SEMI-RIGID, Cat. No. V71-6510, NON-STERILE, Rx Only general hospital | DeRoyal Industries Inc | Device | Class II | 2 |
| 21 Aug 2014 | UniCel 600/800 Access Immunoassay Systems are in vitro diagnostic devices used for the quantitative, semi-quantitative, or qualitative determination of various analytes concentrations found in human body fluids. The cables and kits are used in UniCel DxI 600, 800 instruments, and are distributed to Beckman and… | Beckman Coulter Inc. | Device | Class II | 1 |
| 21 Aug 2014 | Condensed Skim Milk in bulk tanker (approximately 40,000 pounds per tanker load) | Dairy Farmers of America | Food | Class III | 3 |
| 20 Aug 2014 | VITROS Chemistry Products PHYT (Phenytoin) Slides, REF/Product Code 829 8671, IVD. For in vitro diagnostic use only. VITROS Chemistry Products PHYT Slides quantitatively measure phenytoin (PHYT) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated… | Ortho-Clinical Diagnostics | Device | Class II | 1 |
| 19 Aug 2014 | ADVIA Centaur Immunoassay System (including refurbished units), This system is intended for professional use in a laboratory environment only. Tests performed using this system are intended for in vitro diagnostic use. As with all diagnostic tests, a definitive clinical diagnosis should not be based on the results of… | Siemens Healthcare Diagnostics | Device | Class II | 2 |
| 19 Aug 2014 | STAT 2 Flow Controller; 80" (203 cm) Appx 14.8 mL, 20 Drop Primary Set w/2 Clave, STAT 2 Flow Controller, Rotating Luer, Item No. 011-C9801. Product Usage: IV Administration sets are intended for the infusion and withdrawal of fluids. The devices are provided sterile. | ICU Medical, Inc. | Device | Class I | 4 |
| 19 Aug 2014 | Garden Fresh Egg Salad, Code #2022, Net Wt. 5 lbs. (2.268 Kg) UPC 11596-52022 | Garden-Fresh Foods, Inc. | Food | Class I | 1 |
| 18 Aug 2014 | Siemens Dimension Vista¿ CHEM 1 CAL, lot 3GM081. The CHEM 1 CAL is an in vitro diagnostic product for the calibration of Calcium (CA), Cholesterol (CHOL), Creatinine (CREA), Glucose (GLU), Lactic Acid (LA), Magnesium (MG), Thyroxine (T4), Thyroxine Uptake (TU), Blood Urea Nitrogen (BUN), and Uric Acid (UA) methods on… | Siemens Healthcare Diagnostics, Inc. | Device | Class II | 1 |
| 15 Aug 2014 | LAP-BAND AP SYSTEM AP Large with Access Port, Allergan, LAP-BAND AP SYSTEM Access Port I. Product was distributed for both the AP Large and AP Standard sizes. The LAP-BAND System is indicated for weight reduction for patients with obesity, with a Body Mass Index (BMI) of at least 40 kg/m2 or a BMI of at least 30… (69132) | Apollo Endosurgery Inc | Device | Class II | 1 |
| 15 Aug 2014 | Array LaserLink, Manufactured by Lumenis, The Array" LaserLink" is a laser system accessory intended for use in the treatment of ocular pathology. " For the Posterior Segment, the Array" LaserLink" is indicated for use in Retinal Photocoagulation and Panretinal Photocoagulation of Vascular and Structural… | Lumenis, Inc. | Device | Class II | 1 |
| 15 Aug 2014 | Roots, Original Hummus, Net Wt. 8oz (227 g), and 16oz (454 g), Gluten-Free Vegan, UPC: 860971000009, and 723175787629, 166 W. Haywood St., Asheville, NC 2801, RootsFood.com. This product is packaged in 8 oz. and 16 oz. non-flexible plastic tubs. | Roots Organic Gourmet | Food | Class II | 9 |
| 14 Aug 2014 | Biomedix SELEC-3 I.V. Administration Set. Individually sealed into a Tyvek¿ and LDPE/PET pouch. Secondary packaging includes 48 pouched units per box/case. STERILE (69249) | Biomedix, Inc. | Device | Class II | 1 |
| 13 Aug 2014 | Vapotherm Precision Flow, Disposable Patient Circuit PF-DPC-High. For use with the Precision Flow system Precision Flow" is intended for use to add warm moisture to breathing gases from an external source for administration to a neonate/infant, pediatric and adult patients in the hospital, sub-acute institutions, and… | Vapotherm, Inc. | Device | Class II | 8 |
| 13 Aug 2014 | RENASYS EZ Negative Pressure Wound Therapy (NPWT) System (RENASYS EZ) for patients who would benefit from a suction device particulary as the device may promote wound healing. | Smith & Nephew, Inc. | Device | Class II | 1 |
| 13 Aug 2014 | METOCLOPRAMIDE ORAL SOLUTION, USP 5 mg/5 mL, (present as the hydrochloride), 10 mL cups, Rx only. Manufactured by VistaPharm Inc., Largo, FL 33771. NDC 66689-031-01. | VistaPharm, Inc. | Drug | Class II | 1 |
| 12 Aug 2014 | eXpertDC intraoral x-ray, models: eXpert DC, NA, 75 Inch reach; eXpert DC, NA, 65 Inch reach; eXpert DC, CN, 55 Inch reach; eXpert DC, WW, 75 Inch reach; eXpert DC, WW, 65 Inch reach; eXpert DC, WW, 55 Inch reach; OEM Arm Assembly w/o cables; Assy, Articulated Arm & Tubehead, eDC; and Assy, Articulated Arm &… (69064) | Gendex Corp | Device | Class II | 1 |
| 11 Aug 2014 | ABX PENTRA Magnesium RTU Reagent, Part No. A11A01646 Product Usage: ABX PENTRA Magnesium RTU reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of magnesium in human serum and plasma based on a photometric test using xylidyl blue. Magnesium measurements are used in… | Horiba Instruments, Inc dba Horiba Medical | Device | Class II | 1 |
| 11 Aug 2014 | ENVOY 500 AST Reagent Kit, reference Model/Catalog 55255, for Envoy 500. Intended Use of the Product: Envoy 500 AST Reagent is for the quantitative in vitro diagnostic determination of aspartate aminotransferase (AST) in human serum and plasma using the Envoy 500 Chemistry System. Aspartate aminotransferase (AST)… | ELITech Clinical Systems SAS | Device | Class III | 1 |
| 11 Aug 2014 | Tradiciones' Andinas Purple Corn Drink Chicha Morada, Net Wt: 33,81 Fl. oz. (1 Lt.), Distributed by: JP Trading and Global Imports LLc, Newark, NJ 07102 (973) 242-3143, Toll free (888) 606 PERU, NDC 854219002795 (69172) | JP Trading and Global Imports LLC | Food | Class II | 1 |
| 8 Aug 2014 | The Rejuvenator Chamber manufactured by Baro-Therapies, Inc. Product Usage: Indicated for relief from general aches and pains brought on by changes in the weather. (69053) | Baro-Therapies, Inc | Device | Class II | 1 |
| 8 Aug 2014 | CareFusion EnVe and ReVel Ventilators. The EnVe/ ReVel Ventilator is designed for use on patients who require respiratory support or mechanical ventilation and weigh a minimum of 5 kg (11 lbs.). It is suitable for service in hospital, transport and homecare as a source of continuous or intermittent positive pressure… (69020) | CareFusion 203, Inc. | Device | Class I | 1 |
| 8 Aug 2014 | Philips Healthcare Integris Allura 15 -12 Fluoroscopy x ray system | Philips Medical Systems, Inc. | Device | Class II | 1 |
| 7 Aug 2014 | Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 2.5% Dextrose, 5000 mL Ambu-Flex II container bags, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015; Product Code L5B5202, NDC 0941-0457-05. | Baxter Healthcare Corp. | Drug | Class I | 1 |
| 7 Aug 2014 | alcosulph Moisturizing Cream, Net Contents: 60g. Product packaged within a plastic container individually placed in small carton. Country of Origin Guyana. | New Gpc Inc. | Drug | Class II | 7 |
| 6 Aug 2014 | Arrow Select Kits (ASK) and Maximal Barrier Precautions Kits (CDC) with BD Medical Posiflush 10mL Saline Flush Syringe. | Arrow International Inc | Device | Class II | 1 |
| 6 Aug 2014 | VITROS Immunodiagnostic Products Anti-HCV Reagent Pack for in vitro qualitative detection of immunoglobulin G antibody to hepatitis C virus (anti-HCV) in human serum and plasma. REF 680 2454, IVD -- Ortho-Clinical Diagnostics High Wycombe UK. Note that one sales unit has 5 Reagent Packs contained within it. Each… | ORTHO-CLINICAL DIAGNOSTICS | Device | Class II | 1 |
| 6 Aug 2014 | CHILDREN'S Q-PAP, Acetaminophen, ORAL SUSPENSION, BUBBLE GUM FLAVOR, Active ingredient (in each 5 mL = 1 tsp) Acetaminophen USP 160 mg, 4 FL OZ (118 mL), Made in the USA for Qualitest Pharmaceuticals, Huntsville, AL 35811, NDC 0603-0841-54, OTC | Qualitest Pharmaceuticals | Drug | Class II | 3 |
| 5 Aug 2014 | Rifampin for Injection USP, 600 mg*/vial (Sterile), supplied in sterile glass vials, Rx only For IV Infusion only, individually boxed, Mfd. for: Akorn, Inc., Lake Forest, IL --- NDC 17478-151-42 | Akorn, Inc. | Drug | Class III | 1 |
| 5 Aug 2014 | ZyGenerics ATENOLOL Tablets, USP 25 mg 1000 count bottle, Rx Only Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08634 USA NDC 68382-022-01 | Zydus Pharmaceuticals USA Inc | Drug | Class II | 1 |
| 5 Aug 2014 | Wheat Cake (Maruto "C" Cake), 6.3 ounces (180g), individually packaged in gold foil pouches and sold under the Maruto Brand. Sold at retail locations in display cases containing 8 bars per display case. (69199) | Ikko International Trading LLC | Food | Class II | 1 |
| 1 Aug 2014 | CUBICIN (daptomycin for injection), 500 mg single-use vial, Rx only, Manufactured for: Cubist Pharmaceuticals, Inc., Lexington, MA 02421, NDC 67919-011-01, UPC 3 67919-011-01 6. | Cubist Pharmaceuticals, Inc. | Drug | Class I | 1 |
| 31 Jul 2014 | CareFusion AirLife Heated Infant Breathing Circuit Product Usage: Respiratory breathing circuits are used with a ventilator when mechanical ventilation is administered to a patient. | Carefusion 2200 Inc | Device | Class II | 1 |
| 31 Jul 2014 | Mindray V21, Size: 515 mm X 335 mm X 685 mm, N.W.: 8 kg, G.W.: 11 kg, Qty:1 The V-Series Monitor is intended for intra hospital use under the direct supervision of a licensed healthcare practitioner. The indications for use include the monitoring of ECG waveform derived from 3,5,6 and 12-lead measurements, Heart… | Mindray DS USA, Inc. dba Mindray North America | Device | Class II | 1 |
| 30 Jul 2014 | Goya Black Beans Frijoles Negros 15.5 oz (439g) | Tradewind Foods de Puerto Rico Inc. | Food | Class II | 10 |
| 30 Jul 2014 | Boku Super Protein 3.0, Product Sizes: 21.2 oz, 1 oz., bulk. | BoKU International | Food | Class I | 3 |
| 29 Jul 2014 | Percutaneous Trial Lead Kit Model 3046 (4 ch percutaneous lead). Used as part of the St. Jude Medical Neurostimulation system indicated for Spinal Chord Stimulation. | St. Jude Medical, Inc. | Device | Class II | 2 |
| 29 Jul 2014 | Lidocaine HCl Injection, USP, 2%, 20 mg per mL, Preservative-Free, 5 mL Single-Dose Vial, Rx only, For Infiltration and Nerve Block including Epidural and Caudal, Manufactured by: Hospira, Inc., Lake Forest, IL, 60045, NDC 0409-2066-05 | Hospira Inc. | Drug | Class I | 1 |
| 29 Jul 2014 | Product is packaged in a cardboard box and labeled in part, "SOUTHERN HOME Mozzarella Sticks***CONTAINS: WHEY, MILK, EGG, SOY***DISTRIBUTED BY SOUTHERN HOME P.O.BOX 99 MAULDIN, SC 29662***" 6/case 30oz UPC 607880027150 | Great American Appetizers, Inc. | Food | Class II | 1 |
| 28 Jul 2014 | Minstrel (with scale) Product Usage: is a mobile passive hoist. It is intended for lifting and transporting adult residents on horizontal floors in hospitals, nursing homes or other health care facilitates. The Minstrel device aids in the lifting, transfer and lowering to safe position, of a patient. This is… | ARJOHUNTLEIGH POLSKA Sp. z.o.o. | Device | Class II | 1 |
| 28 Jul 2014 | The Symbia T Series consists of the T16, T6, T2, and T. The Symbia T integrates state-of-the-art SPECT and high quality spiral CT to provide precise attenuation correction and anatomical mapping. The system can also be used as a complete clinical SPECT system for general purpose, WB and SPECT applications. The Symbia… | Siemens Medical Solutions USA, Inc. | Device | Class II | 2 |
| 25 Jul 2014 | 0.9% Sodium Chloride Injection, USP BD PosiFlush(TM) SF Saline Flush Syringe 10 mL REF#306553 used in Centurion Convenience Kits. Recalled product is attached to the outside of the Convenience Kits. | Centurion Medical Products Corporation | Device | Class II | 1 |
| 25 Jul 2014 | Ultra Battery 1 Model: TA-UB1 NSN: 6515-01-592-5803 The Ultra Battery 1 (TA-UB1) is a rechargeable power source for the Thermal Angel Blood and IV Fluid Infusion Warmer. The TA-UB1 battery was designed to provide sufficient power for the Thermal Angel to warm and deliver one liter of blood or IV fluid infusion to a… (69242) | Estill Medical Technologies, Inc | Device | Class II | 1 |
| 24 Jul 2014 | Stryker T2 Tibia System Nail Insertion Sleeve, Elastic, Sterile, a) REF 1806-1406S, SPI 08-11 and b) REF 1806-1407S, SPI 08-13. Product Usage: The T2 Tibial Nailing system is intended to provide temporary stabilization of various types of fractures, malunion and nonunion of the tibia. The nails are inserted using an… | Stryker Howmedica Osteonics Corp. | Device | Class II | 1 |
| 24 Jul 2014 | Ham & Cheddar Sandwiches, 10.5 oz . The sandwiches are wrapped in plastic and then placed in a clear plastic clamshell. | Great American Marketing Company | Food | Class I | 2 |
| 24 Jul 2014 | All Raw Vegan, Raw Carob Powder, Net Wt. 8 oz. and 5 lb bag, - Keep Cool & Dry. Glaser Organic Farms, Miami, FL. (305) 238-7747. UPC Code: 83291005567 | Glaser Organic Farms | Food | Class I | 4 |
| 23 Jul 2014 | The product is labeled in part "***Arise & Shine Hydrated Bentonite Dietary Supplement Extra Thick Formula 32 FL OZ ***% Daily Value Iron 0***Distributed by: Arise & Shine Herbal Products 562 Parsons Drive Medford, Oregon 97501***" Product is packaged in a foil pouch with a plastic screw-on lid. UPC 701088032067 (68903) | Arise & Shine Herbal Products, Inc. | Food | Class II | 1 |
| 22 Jul 2014 | BD PosiFlush SF Saline Flush Syringe 0.9 Sodium Chloride Injection, USP 10 mL REF 306553. Intended to be used only for the flushing of indwelling vascular access devices.10 mL BD PosiFlush Normal Saline Flush Syringes are generally compatible for use with syringe pumps. | Becton Dickinson & Company | Device | Class II | 1 |
| 21 Jul 2014 | PEONY MARK brand ROASTED AND SALTED PUMPKIN SEED, NET WT. 12 oz. (340 gm), Barcode 6 932692 225765, PRODUCT OF CHINA --- PACKED FOR: STARWAY INC 137 GRATTAN STREET, BROOKLYN, NEW YORK 11237 --- NUTRITION FACTS: Serving Size 1 oz., Servings per container 12 (68911) | Starway Inc. | Food | Class I | 1 |
| 18 Jul 2014 | RENASYS EZ/ RENASYS EZ Plus 250 mL canister with Solidifier Product Usage: RENASYS EZ and RENASYS EZ Plus Canisters are used for the collection of exudate removed from wounds being treated by negative pressure wound therapy (NPWT). | Smith & Nephew, Inc. | Device | Class II | 3 |
| 18 Jul 2014 | N-Acetyl Cysteine 20% 4 mL Vial Stock Code: 4133 | Unique Pharmaceutical, Ltd | Drug | Class I | 2 |
| 16 Jul 2014 | Rugby Children's Pain and Fever Acetaminophen Oral Suspension 160 mg/5 mL, Cherry Flavor, 2 FL. oz bottle, OTC, Distributed by: Rugby Laboratories Livonia, MI 48150, NDC 0536-3606-96 Major Children's Mapap Suspension Liquid, Cherry Flavor, 4 FL OZ bottle, OTC, Distributed by: Major Pharmaceuticals Livonia, MI 48150 ,… (68847) | Bio-pharm, Inc. | Drug | Class II | 1 |
| 15 Jul 2014 | Daytrana (methylphenidate transdermal system) patch, Delivers 20 mg over 9 hours (2.2mg/hr), 1 patch per pouch , packaged in 30-count patches per box, Rx Only. Manufactured for Noven Therapeutics, LLC, Miami, FL 33186, By Noven Pharmaceuticals, Inc., Miami, FL 33186. NDC 68968-5554-3. | Noven Pharmaceuticals, Inc. | Drug | Class II | 1 |
| 15 Jul 2014 | Tunas Turkish Delight Rose Flavored, Net Wt. 14.11 oz., US Importer and Distributor: Turkana Food, Inc., Exporter: Tunas Food Industry, UPC 86925940080 | Turkana Food Inc. | Food | Class III | 1 |
| 14 Jul 2014 | Lakewood Organic Fresh Pressed GMO Free Pure Apple Cold Pressed Not from Concentrate Juice Fruit 32 FL OZ (1 QT) 946 mL Lakewood Miami, FL 33127 (68809) | Florida Bottling, Inc. | Food | Class II | 1 |
| 9 Jul 2014 | The Hulka Clip is a sterile packaged medical device that carries a two year expiration date. It is packaged two clips per procedural tray. Theses procedural trays are then sealed in a Tyvek/Mylar pouch and packaged in a cardboard shipping carton with ten pouches in each shipping carton. | Richard Wolf Medical Instruments Corp. | Device | Class II | 1 |
| 9 Jul 2014 | Dipyridamole API, NET WT 10 Kg, Rx Only, S.I.M.S. , Chemical Product for Medicines Preparation, Made in Italy, NDC 012660-0084 | Gyma Laboratories Of Amer,Inc | Drug | Class II | 4 |
| 8 Jul 2014 | Shell Eggs packaged under the following labels: (1) Abbotsford Farms Cage Free Pasteurized Shell Eggs, Grade A Large Brown Eggs, packaged as 15 dozen per 1 case. Distributed by Abbotsford Farms, Gaylord, MN 55334. UPC Code 1 00 14616 64010 7. (2) AbbotsFord Farms Cage Free 1 Dozen Large Eggs Pasteurized for Safety.… | Michael Foods, Inc. | Food | Class III | 1 |
| 3 Jul 2014 | Metoprolol Succinate Extended-release Tablets, USP 50mg, 90-count Bottles, Rx only, Mfg by Mylan Pharmaceuticals, Inc. Morgantown, WV 26505. NDC 0378-4596-77. | Mylan Pharmaceuticals Inc. | Drug | Class II | 1 |
| 1 Jul 2014 | Oriya organics Superfood Protein Medley Sprouted Chia Seeds Spirulina Sprouted Brown Rice Protein Hemp Protein Chlorella in NET WT. 21.2 OZ. (600 g) white poly bottles USDA ORGANIC (68702) | Oriya Organics | Food | Class I | 1 |
| 25 Jun 2014 | The synthetic non-absorbable surgical sutures CARDIOXYL are composed of a polyester [poly(ethylene terephtalate)] braids, with or without PLEDGET of different sizes. CARDIOXYL braids are coated with polysiloxane. CARDIOXYL sutures are green dyed (D&C green # 6, CI 61565) and white (undyed). Some packs are composed of… | Peters Surgical | Device | Class II | 2 |
| 25 Jun 2014 | McKesson Cardiology Hemo. McKesson Cardiology" Hemo is intended for complete physiological/hemodynamic monitoring, clinical data acquisition, medical image and data processing, and analytical assessment. | Mckesson Information Solutions LLC | Device | Class II | 1 |
| 23 Jun 2014 | Fresenius Naturalyte Liquid Bicarbonate Concentrate Product Number: 08-4000-LB The concentrate is formulated to be used with a three steam hemodialysis machine which is calibrated for acid and bicarbonate concentrates. | Fresenius Medical Care Holdings, Inc. | Device | Class II | 1 |
| 17 Jun 2014 | Marcaine (bupivacaine HCl) injection, USP, 0.5%, Preservative-Free, 30 mL (150 mg) Single-dose Vial, Rx only, Hospira, Inc., Lake Forest, IL 60045 NDC 0409-1560-29 | Hospira Inc. | Drug | Class I | 1 |
| 5 Jun 2014 | AXIOM Artis or Artis zee system Product Usage: Axiom Artis and Artis zee / zeego are dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed include cardiac… | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 5 Jun 2014 | Artis zee and Artis zeego systems. x-ray, angiographic system | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 5 Jun 2014 | UltraStream Chronic Hemodialysis Catheter Standard Kit; Model Number 32101524 (24 cm), 32101528 (28cm), 32101532 (32 cm), and 32101536 (36 cm) and 32102540 (40 cm). The Rex Medical UltraStream Chronic Hemodialysis Catheter is a chronic hemodialysis catheter that can achieve high flow rates at low arterial pressure. | Argon Medical Devices, Inc | Device | Class II | 3 |
| 3 Jun 2014 | eye-pak 7407 Tray Support Cover REF 8065740745 | Alcon Research, Ltd. | Device | Class II | 1 |
| 2 Jun 2014 | Atorvastatin Calcium 40 MG Tablet, MFG: Apotex NDC# 6050525808 (68917) | Unit Dose Solutions Inc | Drug | Class II | 1 |
| 2 Jun 2014 | Oven Baked Lay's BBQ flavor crisps in 1 1/8 oz package, UPC 2840007189 | Frito-Lay, Inc | Food | Class II | 1 |
| 30 May 2014 | Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to use. The instruments are intended to be used by qualified physicians to provide access, illumination and visualization of internal structures and for manipulating soft tissue (grasping, cutting,… | Instrumed International, Inc. | Device | Class II | 10 |
| 30 May 2014 | Dehydrated minced green onion sold under the Silva brand and packaged in 28 lb. box. (68641) | Silva International, Inc. | Food | Class I | 1 |
| 22 May 2014 | Ciprofloxacin 500 mg tablets, 20 count bottle, Rx only, Packaged by Aidarex Pharmacecuticals LLC, MFG: Unique Pharmaceutical Laboratories, Mumbai, India | Aidarex Pharmaceuticals LLC | Drug | Class II | 1 |
| 21 May 2014 | Vaseretic (enalapril maleate/hydrochlorothiazide) 10/25 mg Tablets, NDC 0187-0146-01, 100 ct. bottles manufactured at Valeant Pharmaceuticals International, Inc., Steinbach, MD R5G 1Z7 Canada | Valeant Pharmaceuticals North America LLC | Drug | Class III | 2 |
| 19 May 2014 | CelluTome Epidermal Harvesting System Part number CT-H25 or Part Number CT-H50 | KCI USA, Inc. | Device | Class II | 1 |
| 19 May 2014 | BAR HARBOR JAM COMPANY Maine Wild Blueberry Pancake Mix; Net Wt. 1 lb 6 oz (624 g) | Bar Harbor Jam Company | Food | Class II | 3 |
| 13 May 2014 | Frozen Pasteurized Human Milk in glass bottles. Label contains lot code followed by expiration date (month day year) and the description of the product which states Mature Milk. There is a Mothers' Milk Bank logo | Mothers' Milk Bank of Montana | Food | Class III | 2 |
| 5 May 2014 | Black Ant, 2800 mg, four capsules per box, Manufacturer Qinghai Baojiantang Pharmaceutical Co., Ltd. | Eugene Oregon, Inc. | Drug | Class I | 3 |
| 24 Apr 2014 | Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 75 mg/0.2 mg, 60-count bottle, Rx only, Manufactured by: Watson Laboratories, Inc., Corona, CA 92880, NDC 0591-0398-60, UPC 3 05910 39860 6. | Actavis Laboratories, FL, Inc. | Drug | Class II | 2 |
| 24 Apr 2014 | Brilliant Cake with Filling Milk (Biscuits), NET WT 13.9 oz (396 g), UPC 6 908166 500140, Product of China --- The product is packed in a plastic wrapped package. | Domega NY International Co Ltd | Food | Class I | 1 |
| 18 Apr 2014 | Olanzapine Orally Disintegrating Tablets 5 mg, 30-count Bottle, Rx only, Manufactured by Apotex Inc. Toronto, Ontario Canada M9L1T9, Manufactured for Apotex Corp., Weston, Florida 33326, NDC # 60505-3275-03 | Apotex Corp. | Drug | Class III | 1 |
| 18 Apr 2014 | Mini Butter Croissant 6 Pack Ingredients: Wheat Flour (unbleached enriched wheat flour, malted barley flour, niacin, Iron, thiamin mononitrate, riboflavin, ascorbic acid, folic acid), Butter, Water, Sugar, Non Fat Dry Milk, Yeast, Salt, Dough Conditioner (dextrose, wheat flour, soybean oil, ascorbic acid, natural… | Whole Foods Market Brand 365, Llc | Food | Class I | 1 |
| 2 Apr 2014 | Circular Lock Screws, part # G826, lot # 11406. The Lock Screws are part of the Genesys Spine TiLock Pedicle Screw System. The TiLock Pedicle Screw System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following… (67900) | Genesys Orthopedics Systems, LLC | Device | Class II | 1 |
| 31 Mar 2014 | EZ-IO 45mm (40kg & up) Needle Set, part number 9079-VC-005; lot code 3606455 (67912) | Vidacare Corporation | Device | Class II | 1 |
| 27 Mar 2014 | SWISS CHOCOLATE CHOCOLAT ALPROSE 52% CACAO PREMIUM DARK CHOCOLATE, within stand-up maroon colored gift box. NET WT 3.5 oz (100g). Packed as a carton containing 6 boxes x 20 units. UPC 689423025038. Product of Swtizerland. Distributed By: BBM CHOCOLATE DISTRIBUTORS, LTD. Brooklyn, NY 11205. | BBM Chocolate Distributors, Ltd. | Food | Class I | 3 |
| 26 Mar 2014 | OSCAR'S SMOKE HOUSE JALAPENO PEPPER CHEDDAR SPREAD, NET WT 7 OZS, keep refrigerated. Distributed by: Oscar's Smoke House Warrensburg, NY 12885. | Oscar's Hickory House, Inc. | Food | Class I | 11 |
| 17 Mar 2014 | ArjoHuntleigh Contoura C1000 series beds are designed to accommodate patients weighing up to 990 lbs. (450 kg). Model C1000 is the basic bed. Model C1080 includes a weighing system and a power outlet for an ArjoHuntleigh approved mattress pump. Product Usage: The Contoura series bariatric beds are electrically… | Arjo Hospital Equipment AB | Device | Class II | 1 |
| 4 Mar 2014 | Zoledronic Acid Injection 5 mg per 100 mL (0.05 mg/mL), 100 mL single-use bag packaged in a foil overwrap, Rx only, Sterile, For Intravenous Infusion, Mfd. for Sagent Pharmaceuticals Schaumburg, IL ---- NDC 25021-830-82 | Sagent Pharmaceuticals Inc | Drug | Class II | 1 |
| 26 Feb 2014 | All sterile drugs compounded between 2/21/14 and 2/24/14. (67687) | New England Home Therapies, Inc | Drug | Class II | 1 |
| 26 Feb 2014 | saba; ACE; Appetite Control Energy; 052234; 07/2015; Distributed by Saba; 711 NE 39th Street, Oklahoma City, OK 73105 (67701) | AMS Health Sciences | Food | Class II | 1 |
| 20 Nov 2013 | Wild'erb Seasoning 2 oz and 4 oz plastic jars; seasoning contained less than 1% sassafras leaves. | Ohio Valley Herbal Products, Inc. | Food | Class III | 2 |
| 28 Oct 2013 | Symbia E is a multi-purpose SPECT system ideal for hospitals and outpatient centers. It is used to detect or image the distribution of radionuclides in the body or organ. | Siemens Medical Solutions USA, Inc. | Device | Class II | 2 |
| 18 Oct 2013 | CRN Crono Syringe CRN20 with 19G x 1 "Steel Needle" (66541) | Intra Pump Infusion Systems | Device | Class II | 1 |
| 17 Oct 2013 | 15 L Cycler Drainage Bag Product Usage: For use with Baxter Cycler Tubing sets as a peritoneal dialysis accessory. | Baxter Healthcare Corp | Device | Class II | 1 |
| 10 Oct 2013 | The Verigene Gram Negative Blood Culture Nucleic Acid Test (BC-GN), performed using the sample-to-result Verigene System, is a qualitative multiplexed in vitro diagnostic test for the simultaneous detection and identification of selected gram-negative bacteria and resistance markers. BC-GN is performed directly on… | Nanosphere, Inc. | Device | Class II | 5 |
| 17 Jun 2013 | Verigene BC-GP Kit (Catalog number 20-005-018); 1) 20 Verigene BC-GP Test Cartridges; are qualitative multiplexed in vitro diagnostic tests for simultaneous detection and identification of selected gram-positive (BC-GP) and gram-negative (BC-GN) bacteria and resistance markers. | Nanosphere, Inc. | Device | Class II | 2 |
| 25 Apr 2013 | Mini Cannulated Titanium Headed and Headless Screw Set and 2.5, 3.0, and 4.0 mm countersink/depth gauges in the Mini Screw Set/System | Instratek, Incorporated | Device | Class II | 1 |
| 21 Jan 2013 | Medium 2-Hooks Spreader Bar for use with Loop Slings, sizes small, medium and large on the Maxi Sky 2 Ceiling Lift; Model 700-19425. Intended to be used for general transfers in hospitals. | Arjo, Inc. dba ArjoHuntleigh | Device | Class II | 1 |
| 12 Jun 2012 | Fuze Manual Tilt Wheelchair. Fuze T50, Fuze T20 and Fuze T50 Jr (69035) | Pdg Product Design Group Inc | Device | Class II | 1 |
| 18 Jan 2011 | Nemschooff, Model Numbers - Serenity II:790-12, Serenity III: 791-12, Serenity III Exam: 791-12E, and Serenity IIS: 792-12. Designed to provide patient comfort during patient treatment sessions. The chair may include a manual control reclining mechanism. Customer configurable models are also available. The Serenity… (69092) | Nemschoff Chairs, Inc. | Device | Class II | 1 |
| 9 Jan 2007 | No packaging. The device is a computed tomography scanner. Intended to provide corss sectional images of the human body and visualization of the internal organs of the body. | Philips Medical Systems (Cleveland) Inc | Device | Class II | 1 |
| 27 Dec 2005 | Brilliance CT System 6/10/16/16P/40 configuration. No packaging, sold as single unit. Computed tomography scanner intended to provide cross sectional images of the human body and visualization of the internal organs. | Philips Medical Systems (Cleveland) Inc | Device | Class II | 1 |