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FDA: Medical Device Information For Consumers
Items added to the Center for Devices and Radiological Health's Consumer website within the last month.
Updated: 5 min 10 sec ago
Class I Medical Device Recall: Multi-Med, Inc., 22 Gauge x 1 inch Straight and Right Angle Huber Needles and Navilyst Medical Inc., Vaxcel Implantable Vascular Access Systems Containing Huber Needles (Two Class I Recalls)
Huber needles are safety needles used on vascular access ports implanted in patients in need of repeated intravenous therapy. A "coring" Huber needle could damage the implanted port by removing silicone slivers from the access membrane...
Categories: NEWS: U.S. Food and Drug Administration (FDA)
Class I Medical Device Recall: Ikaria Holdings, INOMAX DS Drug Delivery System
Reason for Recall: A component within the pressure switch, which monitors when the drug supply should be replaced, may tear. Risks to the patient may include interruption of drug flow due to an empty cylinder, and/or the time taken to switch to a...
Categories: NEWS: U.S. Food and Drug Administration (FDA)
Class I Medical Device Recall: St. Jude Medical 6 French Engage? Introducer Devices
The Company identified that some devices in the affected batches have the potential for separation of the shaft (sheath) from the hub or for a break in the hub assembly. If either of these were to occur during use, a potentially life threatening...
Categories: NEWS: U.S. Food and Drug Administration (FDA)
Class I Medical Device Recall: Cook Medical - Ciaglia Blue Rhino and Ciaglia Blue Dolphin Percutaneous Tracheostomy Introducer Sets and Trays that Contain a Covidien 6PERC or 8PERC Shiley Tracheostomy Tube
A tracheostomy is a surgical procedure to create an opening through the neck into the windpipe (trachea). A tracheostomy tube is usually placed through the windpipe to provide an airway and to provide a pathway to remove fluid from the trachea and lungs.
Categories: NEWS: U.S. Food and Drug Administration (FDA)
Consumer Information on: OraQuick HCV Rapid Antibody Test - P080027
The OraQuick HCV Rapid Antibody Test is used to detect a patient?s exposure to the hepatitis C virus (HCV). Antibodies are proteins produced by the body to fight against foreign substances, such as viruses and bacteria. The presence of the antibodies...
Categories: NEWS: U.S. Food and Drug Administration (FDA)
Class I Medical Device Recall: Alcon Research LTD doing business as Alcon Laboratories, Inc. - CONSTELLATION Vision System
Alcon initiated the recall after it identified both software and hardware problems which have been associated with unexpected system loss of power (shutdowns), unintended system error messages, unresponsive touchscreens, and system setting and infusion pe
Categories: NEWS: U.S. Food and Drug Administration (FDA)
Consumer Information on: Implantable Miniature Telescope - P050034
The VisionCare Ophthalmic Technologies Implantable Miniature Telescope TM (IMT) is a system to magnify objects to improve vision in patients with end-stage, age-related macular degeneration (AMD). The IMT is surgically implanted in one eye only and is...
Categories: NEWS: U.S. Food and Drug Administration (FDA)
Class I Medical Device Recall: Symbiq One-Channel Infuser and Symbiq Two-Channel Infuser
There is potential for the device to fail to detect air in line at the end of an infusion.
Categories: NEWS: U.S. Food and Drug Administration (FDA)
Class I Medical Device Recall: Cepheid Xpert MRSA/SA Blood Culture Assay for Use with the GeneXpert Dx System
Reason for Recall: The firm received increasing numbers of complaints for false negative MRSA results when compared to MRSA positive results received from culture methods. All Cepheid MRSA/SA Blood Culture Assay products have a potential of generating...
Categories: NEWS: U.S. Food and Drug Administration (FDA)
Class I Medical Device Recall: Physio-Control Inc., LIFEPAK 20 and LIFEPAK 20e External Defibrillator/Monitors
A failure on the power supply assembly can result in either "No DC power" or "No DC or AC power". A failure of DC (battery) power can result in the inability to deliver defibrillation therapy if the device will not turn on using DC (battery) power and...
Categories: NEWS: U.S. Food and Drug Administration (FDA)
Consumer Information on: Photodynamic Diagnostic D-Light C (PDD) System - P050027
The Karl Storz Photodynamic Diagnostic D-Light C (PDD) System is used as an optional accessory to white light cystoscopy when used in combination with the diagnostic imaging drug Cysview® (Photocure ASA, a Norwegian pharmaceutical company).
Categories: NEWS: U.S. Food and Drug Administration (FDA)
Class I Medical Device Recall: Defibtech LLC, DBP-2800 Battery Pack for ReviveR AED? and Lifeline AED® Semi-automatic External Defibrillators
Reason for Recall: If the AED is used with an affected battery pack, the AED may falsely detect an error condition, cancel charge and not provide therapy.
Categories: NEWS: U.S. Food and Drug Administration (FDA)
Consumer Information on: Elecsys® Anti-HCV Immunoassay and Elecsys® PreciControl Anti-HCV on the cobas e 411 Immunoassay Analyzer - P090007
The Elecsys® Anti-HCV Immunoassay is a laboratory test used to detect antibodies associated with the hepatitis C virus (HCV) infection. Antibodies are proteins produced by the body to fight against foreign substances, such as viruses and bacteria.
Categories: NEWS: U.S. Food and Drug Administration (FDA)
Consumer Information on: Elecsys® Anti-HCV Immunoassay and Elecsys® PreciControl Anti-HCV on the cobas e 601 Immunoassay Analyzer - P090008
The Elecsys® Anti-HCV Immunoassay is a laboratory test used to detect antibodies associated with the hepatitis C virus (HCV) infection. Antibodies are proteins produced by the body to fight against foreign substances, such as viruses and bacteria.
Categories: NEWS: U.S. Food and Drug Administration (FDA)
Consumer Information on: Elecsys® Anti-HCV Immunoassay and Elecsys® PreciControl Anti-HCV on the MODULAR ANALYTICS E170 Immunoassay Analyzer - P090009
The Elecsys® Anti-HCV Immunoassay is a laboratory test used to detect antibodies associated with the hepatitis C virus (HCV) infection. Antibodies are proteins produced by the body to fight against foreign substances, such as viruses and bacteria.
Categories: NEWS: U.S. Food and Drug Administration (FDA)
Consumer Information on: Ethicon? OMNEX? Surgical Sealant - P060029
Ethicon? OMNEX? is a medical sealant that is used to help stop leaks in blood vessels. It is made of two synthetic components called cyanoacrylate monomers, and does not include any human or animal materials.
Categories: NEWS: U.S. Food and Drug Administration (FDA)
Class I Medical Device Recall: Counterfeit Polypropylene Surgical Mesh Products Marketed as C. R. Bard/Davol
Various sizes of counterfeit flat sheets of polypropylene surgical mesh have been marketed in the United States labeled with the C. R. Bard/Davol brand name. These meshes, specifically identified below, are NOT Bard-manufactured products.
Categories: NEWS: U.S. Food and Drug Administration (FDA)
Consumer Information on: Esteem® Implantable Hearing System - P090018
The Esteem® is the first totally implantable hearing system used to treat moderate to severe hearing loss caused by a defective inner ear function. The Esteem® system includes three implantable components (Sound Processor, Sensor, and Driver), and externa
Categories: NEWS: U.S. Food and Drug Administration (FDA)
Consumer Information on: Asthmatx, Inc. Alair Bronchial Thermoplasty System - P080032
The Alair Bronchial Thermoplasty System is composed of a catheter with an electrode that delivers radiofrequency energy2 (a form of electromagnetic energy) directly to the airways of the lungs. A controller unit generates and controls the energy.
Categories: NEWS: U.S. Food and Drug Administration (FDA)