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Category Archives: Anesthesiology
Maquet SERVO-i Ventilator Battery Module Class 1 Recall
Maquet SERVO-i Ventilator Battery Module: Class 1 Recall – Battery Run Time Shorter Than Expected AUDIENCE: Anesthesiology, Biomedical Engineering, Nursing, Risk Managers ISSUE: Some battery modules distributed after Jan. 31, 2010 have a shorter battery run time than expected. This … Continue reading
Posted in Anesthesiology, Biomedical Engineering, FDA 2013, FDA Recall, Nursing, Risk Manager
Tagged Anesthesiology, Battery Module, Biomedical Engineering, Class 1 Recall, Class I Recall, FDA recall, Maquet, Maquet SERVO-i Ventilator Battery Module Class 1 Recall, Nursing, Recall, Risk Managers, SERVO-i Ventilator
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Cardinal Health Various Presource Kits Class 1 Recall
Cardinal Health: Class 1 Recall – Various Presource Kits Containing a Pre-Assembled Anesthesia Circuit AUDIENCE: Anesthesiology, Biomedical Engineering, Risk Manager, Surgery ISSUE: Cardinal Health discovered that various Presource Kits containing a pre-assembled anesthesia circuit and filter may contain outer plastic … Continue reading
Posted in Anesthesiology, Biomedical Engineering, FDA 2013, FDA Recall, Risk Manager, Surgery
Tagged Anesthesiology, Biomedical Engineering, Cardinal Health, Cardinal Health Various Presource Kits Class 1 Recall, Class 1 Recall, Class I Recall, FDA recall, Recall, Risk Manager, Surgery, Various Presource Kits
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Spacelabs Anesthesia Workstations Service Kits Class 1 Recall
Spacelabs Anesthesia Workstations and Service Kits: Class 1 Recall – Defect in CAS I/II Absorbers AUDIENCE: Anesthesiology, Biomedical Engineering, Risk Managers ISSUE: There is a defect in CAS I/II Absorbers in the Spacelabs Anesthesia Workstations and Service Kits that may … Continue reading
Posted in Anesthesiology, Biomedical Engineering, FDA 2013, FDA Recall, Risk Manager
Tagged Anesthesia, Anesthesiology, Biomedical Engineering, Class 1 Recall, Class I Recall, drug risks, FDA recall, Recall, Risk Managers, Service Kits, Spacelabs, Spacelabs Anesthesia Workstations Service Kits Class 1 Recall, Workstations
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Hamilton Medical Inc HAMILTON T1 Ventilators
Hamilton Medical, Inc., HAMILTON-T1 Ventilators with Software Versions 1.1.2 and Lower AUDIENCE: Anesthesiology, Risk Managers ISSUE: During ventilation of small pediatric patients with high airway resistance and low lung function, there may be unexpected high internal oxygen consumption by HAMILTON-T1 … Continue reading
Posted in Anesthesiology, FDA 2013, FDA Safety Communication, FDA Warning, Risk Manager
Tagged Anesthesiology, Drug Safety Communication, FDA notice, FDA warning, Hamilton Medical Inc, Hamilton Medical Inc HAMILTON T1 Ventilators, HAMILTON T1, Risk Managers, Safety Communication, Ventilators
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Fisher and Paykel Healthcare Reusable Breathing Circuit Class I Recall
Fisher and Paykel Healthcare Reusable Breathing Circuit: Class I Recall – Pinholes in Tubes AUDIENCE: Risk Manager, Anesthesiology ISSUE: FDA notified healthcare professionals that the Fisher & Paykel Healthcare Reusable Breathing Circuit, Model 900MR068, was recalled due to pinholes in the … Continue reading
Ventlab Adult and Pediatric Manual Resuscitators Recall
Ventlab Adult and Pediatric Manual Resuscitators: Recall-Valve Leak Prevents Flow of Air/Oxygen to Patient Audience: Risk Manager, Anesthesiology ISSUE: The affected manual resuscitators may have a valve leak which prevents the flow of air/oxygen to the patient. This lack of … Continue reading
Posted in Anesthesiology, FDA 2012, FDA Recall, Risk Manager
Tagged Anesthesiology, Pediatric Manual Resuscitators, Recall, Risk Manager, Ventlab Adult, Ventlab Adult and Pediatric Manual Resuscitators Recall
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Bunnell Life Pulse High-Frequency Ventilator Patient Circuits Recall
Bunnell Life Pulse High-Frequency Ventilator Patient Circuits: Recall- Melted Insulation Can Cause Sparking and Smoke Audience: Risk Manager, Anesthesiology ISSUE: FDA notified healthcare professionals and their provider organizations that this product has been found to have heater wire insulation … Continue reading
GlideScope GVL Video Laryngoscope Resuable Blades Recall
Verathon GlideScope Video Laryngoscope Reusable Blades: Class 1 Recall - Breaking Across the Tip of the Blade AUDIENCE: Anesthesiologists, Risk Managers ISSUE: The GlideScope GVL Video Laryngoscope Resuable Blades are being recalled due to potential cracking and/or breaking across the tip of the blade, … Continue reading
Posted in Anesthesiology, FDA 2012, FDA Recall, Risk Manager
Tagged Anesthesiologists, GlideScope GVL, GlideScope GVL Video Laryngoscope Resuable Blades Recall, Recall, Resuable Blades, Risk Managers, Video Laryngoscope
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Mindray A3 and A5 Anesthesia Delivery System Class I Recall
Mindray A3 and A5 Anesthesia Delivery System: Class I Recall – Gasket Leak AUDIENCE: Risk Manager, Anesthesiology ISSUE: FDA notified health professionals of a Class I Recall of the Mindray A3 and A5 Anesthesia Delivery System. The affected devices may … Continue reading
Posted in Anesthesiology, FDA 2012, FDA Recall, Risk Manager
Tagged A3 and A5, Anesthesia Delivery System, Class 1 Recall, Class I Recall, FDA recall, Mindray, Mindray A3 and A5 Anesthesia Delivery System Class I Recall, Recall, Risk Manager
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New England Compounding Center Fungal Meningitis Outbreak
New England Compounding Center (NECC) Potentially Contaminated Medication: Fungal Meningitis Outbreak Latest Update from The FDA AUDIENCE: Surgery, Anesthesia, Neurology, Healthcare Professionals ISSUE: FDA has observed fungal contamination by direct microscopic examination of foreign matter taken from a sealed vial … Continue reading
Posted in Anesthesiology, FDA 2012, FDA Warning, Healthcare Professionals, Neurology, Surgery
Tagged Anesthesia, CDC, drug risks, FDA news, FDA warning, Fungal Meningitis Outbreak, Healthcare Professionals, injectable steroid, methylprednisolone acetate, Neurology, New England Compounding Center, New England Compounding Center Fungal Meningitis Outbreak, Surgery
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