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Monthly Archives: May 2011
Beckman Coulter, Inc., Synchron LX Clinical Systems Ion Selective Electrolyte (ISE) Flow Cell: Class I Recall – Incorrect Electrolyte Results
Translation Beckman Coulter, Inc., Synchron LX Clinical Systems Ion Selective Electrolyte (ISE) Flow Cell: Class I Recall – Incorrect Electrolyte Results AUDIENCE: Laboratory, Risk Manager ISSUE: Healthcare professionals were notified that there may be ratio pump wear, silver iodide build-up … Continue reading
Posted in FDA 2011, FDA Notice, FDA Recall, FDA Warning
Tagged Beckman Coulter Inc, Class 1 Recall, Class I Recall, FDA notice, FDA recall, FDA warning, Ion Selective Electrolyte (ISE) Flow Cell, Synchron LX Clinical Systems
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Pentrexyl Forte Natural: Recall – Misleading Packaging
TranslationPentrexyl Forte Natural: Recall – Misleading Packaging AUDIENCE: Consumer, Pharmacy ISSUE: Phoenix Import & Distribution LLC and FDA notified the public of a recall for Pentrexyl Forte Natural because the packaging is believed to be misleading, causing it to be … Continue reading
Posted in FDA 2011, FDA Notice, FDA Recall, FDA Warning
Tagged Dietary Supplements, FDA notice, FDA recall, FDA warning, Pentrexyl Forte Natural
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SimplyThick: Public Health Notification
TranslationSimplyThick: Public Health Notification – Risk of Life-Threatening Bowel Condition AUDIENCE: Consumers, Pediatrics, Emergency medicine ISSUE: FDA notified parents, caregivers and health care providers not to feed SimplyThick, a thickening agent for management of swallowing disorders, to infants born before … Continue reading
Posted in FDA 2011, FDA Notice, FDA Warning
Tagged drug risks, FDA notice, FDA warning, newborn risk, SimplyTick, thickening agent
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April 2011 Safety Labeling Changes FDA Drugs
Translation The MedWatch April 2011 Safety Labeling Changes posting includes 43 products with safety labeling changes to the following sections: BOXED WARNINGS, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, PATIENT PACKAGE INSERT, and MEDICATION GUIDE. The “Summary Page” provides a listing … Continue reading
Posted in FDA 2011, FDA Notice
Tagged April 2011, FDA Drugs, FDA notice, safety label changes
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Defibtech Lifeline and ReviveR Automated External Defibrillators (AEDs): Recall – Software Defect May Cancel Shock
TranslationDefibtech Lifeline and ReviveR Automated External Defibrillators (AEDs): Recall – Software Defect May Cancel Shock AUDIENCE: Emergency Medicine, Risk Manager ISSUE: Devices subject to this recall include Model DDU-100 series with software version 2.004 or earlier, sold under the brand … Continue reading
Posted in FDA 2011, FDA Recall
Tagged AEDs, Defibtech Lifeline, FDA recall, ReviveR Automated External Defibrillators
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Multi-Mex Distributor Inc. Dietary Supplements: Recall – Product Packaging Mimics OTC Antibiotics
TranslationMulti-Mex Distributor Inc. Dietary Supplements: Recall – Product Packaging Mimics OTC Antibiotics AUDIENCE: Consumer, Pediatrics ISSUE: Multi-Mex Distributor, Inc., recalled dietary supplements that may be labeled as antibiotic drugs. The recall was initiated after an FDA inspection revealed the product … Continue reading
Posted in Consumer Products, FDA 2011, FDA Recall
Tagged Dietary Supplements, FDA notice, FDA recall, MultiMex
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Coumadin (warfarin sodium) Crystalline 5 mg Tablets: Recall – Tablets May Have Higher than Expected Potency
TranslationCoumadin (warfarin sodium) Crystalline 5 mg Tablets: Recall – Tablets May Have Higher than Expected Potency AUDIENCE: Cardiology, Pharmacy, Patients ISSUE: Bristol-Myers Squibb initiated a voluntary recall of one lot of 1,000-count bottles of Coumadin (warfarin sodium) Crystalline 5 mg … Continue reading
Posted in Consumer Products, FDA 2011, FDA Recall, FDA Warning
Tagged 5 mg Tablets, Coumadin (warfarin sodium) Crystalline, FDA recall, FDA warning, Warfarin, warfarin sodium tablets
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Needleless Pre-filled Glass Syringes: Drug Safety Communication – Compatibility Problems with Needleless Intravenous Access Systems
TranslationNeedleless Pre-filled Glass Syringes: Drug Safety Communication – Compatibility Problems with Needleless Intravenous Access Systems Reports Received on Adenosine and Amiodarone Products [UPDATED 05/06/2011] FDA recommends that, to reduce the potential risks to patients, healthcare professionals and risk managers stock … Continue reading
Posted in FDA 2011, FDA Notice
Tagged Adenosine, Amiodarone, FDA notice, FDA warning, Needleless Pre-filled Glass Syringes
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Weck Hem-o-Lok Ligating Clips: Contraindicated for Ligation of Renal Artery During Laparoscopic Living-Donor Nephrectomy
TranslationWeck Hem-o-Lok Ligating Clips: Contraindicated for Ligation of Renal Artery During Laparoscopic Living-Donor Nephrectomy AUDIENCE: Urology, Transplant Surgery, Risk Manager ISSUE: FDA notified health care providers that Weck Hem-o-Lok Ligating Clips should not be used for the ligation of the … Continue reading
Posted in FDA 2011, FDA Warning
Tagged FDA notice, FDA warning, Weck Hem-o-Lok Ligating Clips
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Boston Scientific Devices Stolen – Risk of Infection
TranslationBoston Scientific Devices Stolen – Risk of Infection AUDIENCE: Risk Manager, Gastroenterology, Urology ISSUE: Boston Scientific Corporation is alerting the public about a stolen shipment of Endoscopy and Urology/Women’s Health medical devices. These devices were stolen while en route to … Continue reading
Posted in FDA 2011, FDA Notice
Tagged Boston Scientific, Endoscopy, FDA notice, Urology Device
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