| Berries and Burgundy- possible pints/possible half gallon. Flavor of frozen dessert on the immediate package. No ingredients listed. |
Jenis Splendid Ice Creams LLC |
Event 69131 |
July 07, 2008 |
| Saigon Cinnamon- possible pints/possible half gallon. Flavor of frozen dessert on the immediate package. No ingredients listed. |
Jenis Splendid Ice Creams LLC |
Event 69131 |
July 07, 2008 |
| Bourbon Egg Nog- possible pints/possible half gallon. Flavor of frozen dessert on the immediate package. No ingredients listed. |
Jenis Splendid Ice Creams LLC |
Event 69131 |
July 07, 2008 |
| Sweet Basil with Honey- possible pints/possible half gallon. Flavor of frozen dessert on the immediate package. No ingredients listed. |
Jenis Splendid Ice Creams LLC |
Event 69131 |
July 07, 2008 |
| Torrone- possible pints/possible half gallon. Flavor of frozen dessert on the immediate package. No ingredients listed. |
Jenis Splendid Ice Creams LLC |
Event 69131 |
July 07, 2008 |
| Winter Squash- possible pints/possible half gallon. Flavor of frozen dessert on the immediate package. No ingredients listed. |
Jenis Splendid Ice Creams LLC |
Event 69131 |
July 07, 2008 |
| Cassis Sorbet- possible pints/possible half gallon. Flavor of frozen dessert on the immediate package. No ingredients listed. |
Jenis Splendid Ice Creams LLC |
Event 69131 |
July 07, 2008 |
| Strawberry Sorbet- possible pints/possible half gallon. Flavor of frozen dessert on the immediate package. No ingredients listed. |
Jenis Splendid Ice Creams LLC |
Event 69131 |
July 07, 2008 |
| Goat cheese with Fig Cognac- possible pints/possible half gallon. Flavor of frozen dessert on the immediate package. No ingredients listed. |
Jenis Splendid Ice Creams LLC |
Event 69131 |
July 07, 2008 |
| Cocoa Zin- possible pints/possible half gallon. Flavor of frozen dessert on the immediate package. No ingredients listed. |
Jenis Splendid Ice Creams LLC |
Event 69131 |
July 07, 2008 |
| Lime Cardamom with Lingonberries- possible pints/possible half gallon. Flavor of frozen dessert on the immediate package. No ingredients listed. |
Jenis Splendid Ice Creams LLC |
Event 69131 |
July 07, 2008 |
| GE Precision MPi is an all-digital multipurpose tilt-C x-ray system, intended for a multitude of diagnostic procedures, including radiology, fluoroscopy, interventional procedures, vascular and non-vascular procedures, and specialized applications including angiographic studies. |
Regulatory Insight, Inc |
Event 72515 |
July 01, 2008 |
| Navitrack¿ System - OS Knee Universal, Orthopedic Stereotaxic Instrument |
Orthosoft, Inc. dba Zimmer CAS |
Event 75612 |
June 20, 2008 |
| Benchmark XT/LT and Discovery XT Model Numbers: N750-BMK-FS, N750-BMKXT-FS, N750-BMKLT-FS, N750-DIS-FS, N750-DISXT-FS. Product Usage: Usage: The Benchmark product lines are intended to automatically stain histological or cytological specimens on microscope slides with specific immunohistochemistry or in situ hybridization reagents for in vitro diagnostic use. The Discovery Systems are research use only instruments with similar functionality. |
Ventana Medical Systems Inc |
Event 49516 |
June 12, 2008 |
| Banana Nut Bread packed in carton, placed in polypropelin Bag 1 lb each |
Servatii Inc |
Event 49017 |
June 09, 2008 |
| popchips¿ Sea Salt & Vinegar, Potato Popped Chip Snack, 0.4 oz (UPC 0 82666 76550 9), 0.8 oz (UPC 0 82666 75500 5), 3 oz (UPC 0 82666 70050 0), 85 g (UPC 0 82666 71240 4 and 0 82666 71240 4) |
Sonora Mills Foods |
Event 62275 |
June 07, 2008 |
| Cheddar Mini Rice Snacks under the following brand names: Fred Meyer, 3 oz, UPC 0 11110 90004 3; Kroger, 3 oz, UPC 0 11110 35789 2; Ralphs, 3 oz, UPC 0 11110 91220 9; Safeway, 3 oz. UPC 0 21130 29808 2; |
Sonora Mills Foods |
Event 62275 |
June 07, 2008 |
| popchips¿ Cheddar Potato, Popped Chip Snack, 0.8 oz, UPC 0 82666 78800 3 |
Sonora Mills Foods |
Event 62275 |
June 07, 2008 |
| Sesamoid Plasty, Stereotaxic Instrument The Sesamoid Plasty workstation is used to run the tracking software as part of the software based navigation systems. The affected Sesamoid Plasty components are the central structural column and its base that hold up the computer and the tracking camera on the Sesamoid Plasty workstation. They are also designed to be disassembled such that the column can be folded onto itself for ease of transport after use. This is a retrospective recall report for a removal initiated on 17 June 2008 |
Orthosoft, Inc. dba Zimmer CAS |
Event 75609 |
June 04, 2008 |
| Cannulaide, Model 101, 102, 103. Respirator. The Cannulaide product is composed of die-cut hydrocolloid-coated polyurethane film with an integral hook strip (i.e., Velcro) to allow for the use of a loop material to help secure a nasal interface. The Cannulaide is applied under and over the nose of infants to provide a protective barrier to the philtrum, columella, septum, nares, and tip of nose. It is available in multiple sizes that vary the external geometry and nare hole size and spacing to allow for use on infants ranging from less than 700 grams to greater than 3000 grams. It is a non-sterile, single patient use, disposable device. |
Beevers Manufacturing & Supply, Inc. |
Event 69627 |
May 13, 2008 |
| TSX-301A/2 Aquilion One CT System. The TSX-30IAl2 is a whole body CT scanner. This device captures cross sectional volume data sets. The device consists of a gantry, patient couch (table) and peripheral cabinets used for data processing and display. This device is intended to produce cross sectional volume sets of the anatomy. Additionally the system, when used by a trained professional, is capable of proving data for dynamic and perfusion studies of organs and extremities. |
Toshiba American Medical Systems Inc |
Event 63166 |
May 13, 2008 |
| EXCELART Vantage, Atlas, and Titan MRI Systems, MRT-1503 and MRT-1504. Imaging of the Whole Body, Fluid Visualization, 2D/3D Imaging, MR Angiography/MR Vascular Imaging, Blood Oxygenation Level Dependent Imaging, Perfusion I Diffusion Imaging, and Proton Spectroscopy. |
Toshiba American Medical Systems Inc |
Event 62853 |
May 13, 2008 |
| Straight Impactor - Dorado IBC, Part Number: SI02140. The device is used to position implants after they have been inserted into the disc space during implantation of intervertebral body fusion devices. |
SpineFrontier, Inc. |
Event 64991 |
May 10, 2008 |
| Finger Sensor for Remmers Recorder (Formerly SnoreSat Sleep recorder) To be used to gather heart rate and blood oxygen data during a sleep study. |
SagaTech Electronics, Inc. |
Event 65148 |
May 08, 2008 |
| GEMINI PET/CT System, a diagnostic imaging system for fixed or mobile installations that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. |
Philips Medical Systems (Cleveland) Inc |
Event 69082 |
May 01, 2008 |
