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Category Archives: Cardiology
Vascular Solutions Inc Guardian II NC Hemostasis Valves Class I Recall
Vascular Solutions Inc., Guardian II and Guardian II NC Hemostasis Valves: Class I Recall – Risk of Air Being Introduced Into Device Model Numbers 8210, 8211, 8215, and 8216 AUDIENCE: Risk Manager, Cardiology ISSUE: FDA notified healthcare professionals of a … Continue reading
Posted in Cardiology, FDA 2013, FDA Recall, Risk Manager
Tagged 8210, 8211, 8215, 8216, Cardiology, Class 1 Recall, Class I Recall, drug risks, FDA recall, Guardian II, Hemostasis Valves, Model Numbers, NC, Recall, Risk Manager, Vascular Solutions Inc, Vascular Solutions Inc Guardian II NC Hemostasis Valves Class I Recall
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AMPLATZER TorqVue FX Delivery System Class I Recall
St. Jude Medical, AMPLATZER TorqVue FX Delivery System: Class I Recall – Core Wire May Fracture AUDIENCE: Risk Manager, Surgery, Cardiology ISSUE: FDA notified healthcare professionals of a Class I recall of the St. Jude Medical, AMPLATZER TorqVue FX Delivery … Continue reading
Posted in Cardiology, FDA 2013, FDA Recall, Risk Manager, Surgery
Tagged AMPLATZER TorqVue FX Delivery System, AMPLATZER TorqVue FX Delivery System Class I Recall, Cardiology, Class 1 Recall, Class I Recall, FDA recall, Recall, Risk Manager, Surgery
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Pradaxa dabigatran etexilate mesylate Drug Safety Communication
Pradaxa (dabigatran etexilate mesylate): Drug Safety Communication – Should Not Be Used in Patients with Mechanical Prosthetic Heart Valves AUDIENCE: Cardiology, Patient ISSUE: The U.S. Food and Drug Administration (FDA) is informing health care professionals and the public that the … Continue reading
Posted in Cardiology, FDA 2012, FDA Notice, FDA Warning, Patients
Tagged dabigatran etexilate mesylate, Drug Safety Communication, Pradaxa, Pradaxa (dabigatran etexilate mesylate) Drug Safety Communication
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Chantix Varenicline Safety Communication
Chantix (Varenicline): Safety Communication – Updated Safety Review On The Risk of Cardiovascular Adverse Events AUDIENCE: Family Practice, Cardiology, Patient ISSUE: FDA is informing the public about the results of a large, combined analysis (called a meta-analysis) of clinical trials … Continue reading
Posted in Cardiology, Family Practice, FDA Safety Communication, Patients
Tagged Cardiology, Chantix, Chantix Varenicline Safety Communication, drug risks, Drug Safety Communication, Family Practice, FDA notice, Patient, Safety Communication, Varenicline
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Isovue iopamidol injection Pre-Filled Power Injector Syringes Recall
Isovue (iopamidol injection) Pre-Filled Power Injector Syringes by Bracco Diagnostics Inc.: Recall – Presence of Particulates AUDIENCE: Risk Manager, Cardiology ISSUE: Bracco Diagnostics Inc. (BDI) is voluntarily initiating a Class I recall of nine (9) lots of Isovue (iopamidol injection) … Continue reading
Revatio sildenafil Drug Safety Communication
Revatio (sildenafil): Drug Safety Communication – Recommendation Against Use in Children AUDIENCE: Pediatrics, Cardiology, Pulmonology ISSUE: FDA notified healthcare professionals and their medical care organizations that Revatio (sildenafil) should not be prescribed to children (ages 1 through 17) for pulmonary … Continue reading
Posted in Cardiology, FDA 2012, FDA Safety Communication, FDA Warning, Pediatrics, Pulmonology
Tagged Cardiology, drug risks, Drug Safety Communication, FDA warning, PAH, Pediatrics, pulmonary arterial hypertension, Pulmonology, Revatio, Revatio sildenafil Drug Safety Communication, safety label changes, Safety Labeling Changes, sildenafil
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St Jude Medical Riata Implantable Cardioverter Defibrillator ICD Leads
St. Jude Medical Riata Implantable Cardioverter Defibrillator (ICD) Leads: Safety Communication – Premature Insulation Failure [Posted 08/16/2012] AUDIENCE: Cardiology, Radiology, Surgery, Family Practice ISSUE: The Food and Drug Administration (FDA) is providing information and recommendations regarding safety concerns with the … Continue reading
Posted in Cardiology, Family Practice, FDA 2012, FDA Notice, Radiology, Surgery
Tagged Cardiology, Cardioverter Defibrillator, drug risks, Family Practice, FDA notice, ICD Leads, Implantable, Radiology, St Jude Medical Riata, St Jude Medical Riata Implantable Cardioverter Defibrillator ICD Leads, Surgery
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Alere Triage Diagnostic Tests Class I Recall
Alere Triage Diagnostic Tests (Multiple Tests): Class I Recall – Potential for Significantly Decreased Precision Including Triage CardioProfiler Panel, Triage Cardiac Panel, Triage Profiler SOB Panel, Triage BNP, and Triage D-dimer AUDIENCE: Laboratory, Cardiology, Pulmonology, Risk Manager ISSUE: FDA notified … Continue reading
Posted in Cardiology, FDA 2012, FDA Recall, Laboratory, Pulmonology, Risk Manager
Tagged Alere Triage Diagnostic Tests, Alere Triage Diagnostic Tests Class I Recall, Cardiology, Class 1 Recall, Class I Recall, FDA recall, Laboratory, Pulmonology, Recall, Risk Manager
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Zithromax azithromycin FDA Drug Risks
Zithromax (azithromycin): FDA Statement on risk of cardiovascular death Read the MedWatch safety alert, including a link to the Drug Safety Communication at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm304503.htm Audience: Primary Care, Pharmacy ISSUE: FDA notified healthcare professionals that it is aware of the study … Continue reading
Posted in Cardiology, FDA 2012, FDA Notice, Pharmacy
Tagged azithromycin, FDA Drug Risks, Zithromax, Zithromax azithromycin FDA Drug Risks
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Elecsys Troponin I and STAT Immunoassays Recall
Roche Diagnostics Operations Elecsys Troponin I and Elecsys Troponin I STAT Immunoassays: Recall – Doctors may receive a falsely low result AUDIENCE: Cardiology, Laboratory ISSUE: With certain types of plasma samples, doctors may receive a falsely low result (up to … Continue reading
Posted in Cardiology, FDA 2012, FDA Recall, Laboratory
Tagged Cardiology, drug risks, Elecsys Troponin I, Elecsys Troponin I and STAT Immunoassays Recall, Laboratory, Recall, Roche Diagnostics Operations, STAT Immunoassays
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