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Latest Medical Device News

• 6 French Engage Introducer Devices by St. Jude Medical: Recall - Potential for Separation of Shaft From Hub - Potentially life threatening episode of bleeding could occur during surgical procedures.
• AngioSculpt "EX" PTCA Scoring Balloon Catheter by AngioScore, Inc.: Recall - Risk of Catheter Separation - Fragments of the catheter may become lodged in coronary arteries, resulting in serious injury or death.
• Combat Application Tourniquets (C-A-T): Suspected Counterfeit Product - Suspected counterfeit product is weaker, and breaks or bends before necessary force can be applied to stop blood flow. Excessive blood loss can endanger the victim’s life and ultimately lead to death.
• Fingerstick Devices to Obtain Blood Specimens: Initial Communication - Risk of Transmitting Bloodborne Pathogens - Increase in reports of bloodborne infection transmission resulting from the shared use of fingerstick and point-of-care blood testing devices.
• Huber Needles: Recall - Risk of Coring - Risk of infection, damage or death of tissue, swelling, or other serious adverse health consequences occurring as a result of the core travelling through blood vessels into the patient’s lungs.
• INOMAX DS Drug-Delivery System: Class I Recall - Risk of Interruption of Drug Flow - Potential for failure of a pressure switch, which may have an impact on the administration of INOMAX for inhalation to patients.
• Inferior Vena Cava (IVC) Filters: Initial Communication: Risk of Adverse Events with Long Term Use - Known long term risks associated with IVC filters include lower limb deep vein thrombosis, filter fracture, filter migration, filter embolization and IVC perforation.
• Lamictal (lamotrigine): Label Change - Risk of Aseptic Meningitis - Warnings and Precautions section of Prescribing Information and patient Medication Guide revised to include information about the risk of aseptic meningitis.
• MasXtreme Capsules (Natural Wellness) - product contains undeclared drug ingredient - UPDATED 08/25/2010. Product marketed as dietary supplement contains undeclared Aminotadalafil, which may interact with nitrates found in some prescription drugs and lower blood pressure to dangerous levels.
• Midodrine hydrochloride: FDA Proposes Withdrawal of Low Blood Pressure Drug - Companies failed to provide evidence of clinical benefit of midodrine hydrochloride because required post-approval studies that verify the clinical benefit of the drug have not been done.
• Mr. Magic Male Enhancer: Undeclared Drug Ingredient - Product marketed as dietary supplement contains undeclared hydroxythiohomosildenafil and sulfoaildenafil, which may interact with nitrates found in some prescription drugs and lower blood pressure to dangerous levels.
• Novacare LLC Products: Recall - Undeclared Drug Ingredient - Products marketed as dietary supplement sexual enhancers for men contain undeclared sulfoaildenafil, which may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels.
• Octagam (Immune Globulin Intravenous (human)) 5% Liquid Preparation: Market Withdrawal - Risk of Thromboembolic Events - Customers asked to immediately quarantine the use of affected lots due to the potential for serious thromboembolic events.
• Prolatis’: Undeclared Drug Ingredient - Product marketed as dietary supplement contains undeclared sulfoaildenafil, which may interact with nitrates found in some prescription drugs and lower blood pressure to dangerous levels.
• Qualaquin (quinine sulfate): New Risk Evaluation and Mitigation Strategy - Risk of serious hematological reactions - UPDATE 08/04/2010. Dear Healthcare Professional Letter issued. New Risk Management Plan. Reports of serious side effects in patients using Qualaquin "off-label" for night time leg cramps. Originally posted 07/08/2010
• Revivexxx Extra Strength: Recall - Undeclared Drug Ingredient - Product marketed as a dietary supplement sexual enhancer for men contains undeclared tadalafil, which may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels.
• Solo Slim, Solo Slim Extra Strength: Recall - Undeclared Drug Ingredient - Product contains undeclared didesmethyl sibutramine, which may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke.
• Stalevo(carbidopa/levodopa and entacapone): Ongoing Safety Review: Possible increased cardiovascular risk - FDA evaluating clinical trial data that suggest patients taking drug may be at an increased risk for cardiovascular events compared to those taking carbidopa/levodopa
• TimeOut Capsules: Undeclared Drug Ingredient - Product marketed as dietary supplement contains undeclared hydroxythiohomosildenafil, a chemical similar to sildenafil, which may interact with nitrates found in some prescription drugs and lower blood pressure to dangerous levels.
• Tygacil (tigecycline): Label Change - Increased Mortality Risk - Healthcare professionals should consider alternatives to Tygacil in patients with severe infections.

Archive for March, 2010

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