Category Archives: Critical Care Medicine

Nitroglycerin in 5% Dextrose Injection by Baxter Recall

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Nitroglycerin in 5% Dextrose Injection by Baxter: Recall – Particulate Matter AUDIENCE: Risk Managers, Critical Care Medicine, Cardiology ISSUE: Baxter International Inc has initiated a voluntary recall of one lot of Nitroglycerin in 5% Dextrose Injection due to particulate matter … Continue reading

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Hospira GemStar Infusion System Class I Recall

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Hospira GemStar Infusion System: Class I Recall – Pressure Sensor Calibration Drift AUDIENCE:  Biomedical Engineering, Nursing, Critical Care Medicine, Home Care, Risk Manager ISSUE: The proximal and distal pressure sensor calibration can drift resulting in the pump failing the Proximal … Continue reading

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Fabius Anesthesia Machines Recall

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Fabius Anesthesia Machines: Recall – Did Not Pass High Voltage Test Portion Of Final Production Test AUDIENCE: Risk Manager, Anesthesiology, Critical Care Medicine ISSUE: Dräger issued a statement regarding its voluntary recall on specific Fabius anesthesia machines. Investigations determined that on … Continue reading

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Emergency Cricothyrotomy Kit By H H Medical Corporation Recall

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Emergency Cricothyrotomy Kit By H&H Medical Corporation: Recall – Defective Cuff Balloon On Endotracheal Airway AUDIENCE: Health Professional, Risk Manager, Critical Care ISSUE: On August 27, 2013, H&H Medical Corporation initiated a nationwide recall of 6,619 units of the H&H … Continue reading

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Carefusion Avea Ventilator Recall

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Carefusion Avea Ventilator: Recall – Underreporting Of Tidal Volume If used In Conjunction With Neonatal Hotwire Flow Sensor AUDIENCE: Risk Manager, Anesthesiology, Critical Care Medicine ISSUE: CareFusion announced a voluntary recall of AVEA ventilators regarding barometric pressure sensor compensation when … Continue reading

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Tygacil tigecycline Drug Safety Communication

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Tygacil (tigecycline): Drug Safety Communication – Increased Risk of Death AUDIENCE: Infectious Disease, Critical Care, Pharmacy ISSUE: FDA notified health professionals and their medical care organizations of a new Boxed Warning describing an increased risk  of death when intravenous Tygacil … Continue reading

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Hydroxyethyl Starch Solutions FDA Safety Communication

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Hydroxyethyl Starch Solutions: FDA Safety Communication – Boxed Warning on Increased Mortality and Severe Renal Injury and Risk of Bleeding   AUDIENCE: Critical Care Medicine, Nephrology, Patient, Pharmacy, Health Professional ISSUE: FDA has analyzed recent data that indicate an increased … Continue reading

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Multi Lumen Venous Catheterization Set Recall

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Arrow International, Inc. Multi-Lumen Venous Catheterization Set with Blue FlexTip ARROWg+ard Catheter: Class I Recall – Contains Unlabeled Drug Ingredient AUDIENCE: Nursing, Critical Care Medicine ISSUE: The device’s labeling erroneously states that the product “contains no medication,” however, the device … Continue reading

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CareFusion Alaris PC Unit Model 8015 Class I Recall

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CareFusion Alaris PC Unit, Model 8015: Class I Recall – Error Code AUDIENCE: Risk Manager, Critical Care Medicine ISSUE: FDA notified healthcare professionals of a Class I Recall of the Alaris PC unit, model 8015. A component on the PC … Continue reading

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CareFusion EnVe Ventilators Class I Recall

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CareFusion EnVe Ventilators: Class I Recall – Leak In Patient Breathing Circuit or System   AUDIENCE: Critical Care Medicine, Risk Manager ISSUE: FDA notified healthcare professionals of a Class I Recall of CareFusion EnVe Ventilators manufactured from December, 2010 through … Continue reading

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