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Recall Observatory FDA recall evidence

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Recalled products

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Indexed record set

86,536 products

Page 3400 of 3462

Product Firm Event Initiated
Hydrocodone Bitartrate & Acetaminophen Oral Solution 7.5 mg/325 mg per 15 mL, a) 15 mL Unit Dose Cups (50 unit dose cups per case), b) 473 mL Bottles, C III, Rx Only, Warning May be habit forming, Manufactured by VistaPharm, Largo, FL 33771, NDC a) 66689-023-50, b) NDC 66689-023-16. VistaPharm, Inc. Event 62405 May 30, 2012
Oskri, Peach Granola, Gluten Free, Nut Free, Dairy Free, Vegan, Halal, Kosher, Ingredients: Buck Wheat , Peaches 20% Sunflower Seeds , Apricots, Date Syrup, Chicory Root extract, Rice protein., NET WT 3.5oz (100) G., UPC 66616111743, Oskri, Lake Mills, Wisconsin 53551. Oskri Organics Corp. Event 61970 May 30, 2012
Mrs.Friday's Chef Dusted Pacific Oysters, 6/1 lb, Net Wt 6 lb (2.72 kg), Distributed By: King & Prince Seafood Corp., Brunswick, GA 31521. Product is packed in clear plastic bags with no individual labeling. King & Prince Seafood Event 62014 May 30, 2012
1) Mrs.Friday's brand, Gourmet Breaded Oysters, Medium 18-25 CT, Ready to Fry, Net Wt 2.5 lbs (1.13 kg). 2) Mrs.Friday's brand, (Canada) Gourmet Breaded Oysters, Medium, Ready to Fry, Net Wt 2.5 lbs (1.13 kg), Distributed by King & Prince Corp., Brunswick, GA 31521. Product is packed in unlabeled, clear plastic bags. King & Prince Seafood Event 62014 May 30, 2012
Mrs.Friday's brand, Gourmet Breaded Oysters, Small 26-34 CT, Ready to Fry, Net Wt 2.5 lbs (1.13 kg). King & Prince Seafood Event 62014 May 30, 2012
Napoleon canned, Smoked Oysters, Medium. Item no. 48-312. Net WT. per can is 3.66 oz (106 g). The UPC is 0 41253 00312 7. The product is labeled in parts: "***NAPOLEON***Medium***SMOKED OYSTERS***NET WT. 3.66 OZ (106 g)***INGREDIENTS: SMOKED OYSTERS, SOYA OIL, SALT***PRODUCT OF KOREA***FARM RAISED***". Napoleon Company, The Event 61983 May 30, 2012
Polar Whole Boiled Oysters, 8 oz. net weight, 12 cans/carton. Milky Way Intl Trading Corp Event 61981 May 30, 2012
Napoleon canned, Smoked Oysters, Large. Item no. 48-313. Net WT. per can is 3.66 oz (106 g). The UPC is 0 41253 00313 4. The product is labeled in parts: "***NAPOLEON***Large***SMOKED OYSTERS***NET WT. 3.66 OZ (106 g)***INGREDIENTS: SMOKED OYSTERS, SOYA OIL, SALT***PRODUCT OF KOREA***FARM RAISED***". Napoleon Company, The Event 61983 May 30, 2012
Canned oysters. Crown Prince Natural Smoked Oysters in Olive Oil, 3 oz. Each case is 3oz/18. Crown Prince Inc Event 62001 May 30, 2012
Canned oysters. Crown Prince Whole Boiled Oysters, 8 oz. Each case is 8oz/12. Crown Prince Inc Event 62001 May 30, 2012
Canned oysters. Crown Prince Whole Boiled Oysters, 8 oz. Each case is 8oz/12. Crown Prince Inc Event 62001 May 30, 2012
Canned oysters. Crown Prince Natural Smoked Oysters with Chili Pepper, 3 oz. Each case is 3oz/18. Crown Prince Inc Event 62001 May 30, 2012
Advantage Workstation Volume Share 2 (versionAW4.4_04) with Volume Viewer 3 and 3.1 (version7.0 to version7.5 and version 8.1) and only when or more of these applications is installed: " VesselIQ Xpress or AVA Xpress " CardIQ Xpress Pro or Plus " CardEP " CardIQ Fusion PET or SPECT Advantage Workstations Volume Share (v.AW4.3) and AW4.2 (version4.2-05 and above) provided with Volume Viewer 2(version6.0 to version6.11) and only when one or both of these applications is installed: " CardIQ Xpress Pro or Plus " CardEP Advantage Workstations AW Volume Share 2 (AW version 4.4). ONLY IF ONE OF FOLLOWING APPLICATIONS IS INSTALLED: ¿ VesselIQ Xpress or AVA Xpress ¿ CardIQ Xpress Pro or Plus ¿ CardEP ¿ CardIQ Fusion PET or SPECT provided with Volume Viewer 3 and 3.1 from versions 7.0 to 7.5 and 8.1. To verify the version installed on your system: Select the Admin menu from the Patient list page. Then select Display Configuration. You will find the version of your system in Installed Application(s). This version will appear as vxtl_7.x or vxtl_8.x. Intended use: K993792: Smart Vessel Analysis (Smart VA) is a software post-processing option for the Advantage Workstation (AW) platform, which can be used in the analysis of 3D angiography data. It provides a number of display, measurement and batch filming/archive features and will aid physicians in studying user-selected vessels for stenosis analysis, pre/post stent planning and directional vessel tortuosity visualization. K031261: Card EP is a post processing software option for the Advantage Workstation (AW) Platform. This product can be used for the analysis of CT angiographic images for the assessment of the heart to include the atria, pulmonary veins, and coronary sinus. It provides quantitative analysis tools which include a number of display, measurement and model export capabilities. This product can be used to aid trained physicians in the visualization and assessment of cardiac anatomy. K041267: CardIQ Analysis III is a CT image analysis software package, which allows the visualization of 2D and 3D medical image data of the heart derived from DICOM 3.0 compliant CT scans for the purpose of cardiovascular disease assessment. It provides functionally for 2D/3D rendering, assessment of calcified and non-calcified plaque to determine the densities of the plaque within a coronary artery, ventricular function of the heart, and measurement tools to detect coronary artery stenosis. This product can be used to aid a trained physician to process, render, review, archive, print and visualizing cardiac anatomy and coronary vessels. CardIQ Analysis II will run on the AW workstation, scanner operator console and PACS system. K061370: CardIQ Fusion is intended to provide an optimized non-invasive application to analyze vascular anatomy and pathology, aid in the assessment of functional data e.g. PET perfusion, and aid in tailoring treatment plans based on the fused anatomical and functional information. Anatomical data could be from a set of Computed Tomography (CT) Angiographic images while functional data could be from PET, SPECT, or processed CT data. CardIQ Fusion is a software post-processing package for the Advantage Workstation (AW) platform, PET/CT and CT scanners and PACS reading stations. It is an additional tool for the analysis of 3D CT angiographic cardiac images/data providing a number of display, measurements and batch filming/archive features to study user-selected vessels. Also included is the capability to visualize reformatted CT/PET/SPECT perfusion and viability data. Finally, it provides different ways of visualizing CT anatomy fused with PET/SPECT functional information. With CardIQ Fusion, clinicians have the opportunity to overlay functional information over the (CT) anatomy of a patient's heart, and thus, they can potentially tailor their decision for that particular patient. CardIQ Fusion provides the visualization of the vessels in severa GE Healthcare, LLC Event 61593 May 29, 2012
This voluntary medical device correction is related to Alcon products that present a 23G nonvalved trocar cannula and infusion cannula together. These items are available as components within Accurus 23G TotalPLUS Pak, Accurus 23G Combined Procedure Packs (0.9mm and 1.1mm), Constellation 23G Total PLUS Pak, Constellation 23G Combined Pack (0.9 mm and 1.1 mm) and 23G Small Parts Kit. Single use 23G non-valved trocar cannulas are used to provide internal access to the ocular cavity during ophthalmic surgery. Single use infusion cannulas are used for the infusion of fluid or air during ophthalmic surgery to maintain intraocular pressure during posterior segment surgeries. Alcon Research, LTD. Event 62419 May 29, 2012
Trinity Biotech, Captia VZV IgG. Product code 2325600: 96 Tests; product code: 2325601: 480 tests. For in vitro diagnostic use. Intended for the detection and quantitative determination of IgG antibody to VZV in human sera. Clark Laboratories, Inc. (dba,Trinity Biotech USA) Event 62440 May 29, 2012
Microbiologics 217 Osseo Avenue North, St. Cloud, MN 56303, Gram Stain Control Slides, SLO3-10, ATCC Licensed Derivative, MediMart Europe, 11 rue Emile, Zola B.P. 2332, 38933 Grenoble Cedex 2 France. They are microscope slide preparations contains specific organisms populations of known and predictable characteristics. These slide support formal quality assurance programs by serving as quality control challenges to demonstrate and document satisfactory performance of staining regents and methods used in staining procedures and to document personnel's ability to perform the procedure and to properly interpret the microscopic test results. Microbiologics Inc Event 61998 May 29, 2012
AirLife Isothermal Breathing Circuit Accessory - Infant Patient Y Connector; an Rx device for single patient use; 30 connectors per box; CareFusion, 22745 Savi Ranch Parkway, Yorba Linda, CA 92887 USA, Made in Mexico Respiratory breathing circuits are used with a ventilator when mechanical ventilation is administered to a patient. Carefusion 2200 Inc Event 61943 May 29, 2012
AirLife Isothermal Breathing Circuit, Infant Respiratory Circuit, Non-Heated; an Rx device for single patient use; CareFusion, 22745 Savi Ranch Parkway, Yorba Linda, CA 92887 USA, Made in Mexico Respiratory breathing circuits are used with a ventilator when mechanical ventilation is administered to a patient. Carefusion 2200 Inc Event 61943 May 29, 2012
Acrobat 3000 (AC3000) Spring Arm as support arm for iLED operating lights, TRUMPF Medizinsysteme GmbH + Co KG 82178 Puchheim. The TRUMPF surgical lights are intended to locally illuminate an operating or examination area of the patients body with a high intensity light. Trumpf Medical Systems, Inc. Event 62593 May 29, 2012
Horizon Medical Imaging system. Product Usage: Horizon Medical Imaging is a medical image and information management application that is intended to receive, transmit store, retrieve, display, print and process digital medical images, digital medical video, and associated medical information from various medical image systems. The medical modalities of these medical imaging systems include, but are not limited to, all modalities supported by ACR/NEMA DICOM 3.0 (specifically including mammographic images). Horizon Medical Imaging is intended to function with a variety of storage systems and printers via DICOM and other computer industry standard interfaces and protocols. Horizon Medical Imaging is indicated for use by trained medical professionals including, but not limited to, radiologist, physicians, and medical technologists. Horizon Medical Imaging is also indicated for use in soft copy diagnostic interpretation of medical images and video by physicians trained in such practice (specifically including soft copy diagnostic interpretation of mammographic images). Mckesson Medical Imaging Group Event 62567 May 29, 2012
TRESTLE LUXE¿ Anterior Cervical Plating System, Product code KWQ. 510(k) K102820. The TRESTLE LUXE Anterior Cervical Plating System is a temporary device used to stabilize the cervical spine during bone fusion development. Device implants include a range of plate sizes and bone screws to provide the versatility required for the specific indications noted. Fixation is achieved by means of a rigid plate that is surgically attached to the spine with bone screws. The TRESTLE LUXE Anterior Cervical Plating System is intended for use in the anterior cervical spine (C2-C7). Patients with trauma (including fractures), spondylolisthesis, and pseudoarthrosis, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spinal stenosis, tumors, and failed previous fusion. Alphatec Spine, Inc. Event 51437 May 29, 2012
AirLife Isothermal Breathing Circuit, Infant Respiratory Circuit, Heated; an Rx device for single patient use; CareFusion, 22745 Savi Ranch Parkway, Yorba Linda, CA 92887 USA, Made in Mexico Respiratory breathing circuits are used with a ventilator when mechanical ventilation is administered to a patient. Carefusion 2200 Inc Event 61943 May 29, 2012
syngo(R) Lab Data Manager and syngo(R) Lab Process Manager, all versions. This device is classified as a data calculator and processing module for use with In-vitro diagnostic devices. It also provides work flow management as well as remote instrument control to multiple interfaced instruments. Siemens Healthcare Diagnostics, Inc. Event 62709 May 29, 2012
IDEV Technologies SUPERA VERITAS Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System. Indicated for palliative treatment of biliary strictures produced by malignant neoplasms IDEV Technologies, Inc. Event 65245 May 29, 2012
MULTIGENT Acetaminophen for use with Architect/Aeroset Cat. No. 2K99-20. Assay is intended for the quantitative determination of acetaminophen in human serum or plasma. Sekisui Diagnostics Llc Event 62017 May 29, 2012

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