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Category Archives: Nursing
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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Medtronic DBS NDE Kits Class 1 Recall
Medtronic: Class 1 Recall – Medtronic Deep Brain Stimulation Lead Kit and Activa Dystonia HDE Kit AUDIENCE: Neurology, Nursing, Risk Manager, Surgery ISSUE: Medtronic sent an Urgent Medical Device Correction letter to all affected customers notifying them of the potential … Continue reading
Posted in FDA 2013, FDA Recall, Neurology, Nursing, Risk Manager, Surgery
Tagged Activa Dystonia HDE, Class 1 Recall, Class I Recall, DBS, Deep Brain Stimulation Lead Kit, FDA recall, Kits, Medtronic, Medtronic DBS NDE Kits Class 1 Recall, NDE, Neurology, Nursing, Recall, Risk Manager, Surgery
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Covidien Surgical Stapler Reloads FDA Safety Communication
Posted in Biomedical Engineering, FDA 2013, FDA Safety Communication, Nursing, Risk Manager, Surgery
Tagged Biomedical Engineering, Covidien, Covidien Surgical Stapler Reloads FDA Safety Communication, FDA Safety Communication, FDA warning, Nursing, Risk Managers, Safety Communication, Surgery, Surgical Stapler Reloads
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Newport Medical Instruments Inc HT70 HT70 Plus Ventilators Class I Recall
Newport Medical Instruments, Inc., HT70 and HT70 Plus Ventilators: Class I Recall – Unit Goes Into Internal Backup Battery Sooner Than Expected AUDIENCE: Risk Manager, Nursing ISSUE: The recall is in response to customer reports of Newport Medical Instrument’s HT70 … Continue reading
Posted in FDA 2013, FDA Recall, Nursing, Risk Manager
Tagged Class 1 Recall, Class I Recall, FDA recall, HT70, Newport Medical Instruments Inc, Newport Medical Instruments Inc HT70 HT70 Plus Ventilators Class I Recall, Nursing, Pharmacy, Plus Ventilators, Recall, Risk Manager, Risk Managers
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Piperacillin Tazobactam Injection USP 40.5 grams Recall
Piperacillin and Tazobactam for Injection, USP 40.5 grams: Recall – Precipitation or Crystallization in IV Bag or IV Line Upon Reconstitution AUDIENCE: Risk Manager, Nursing, Health Professional ISSUE: Apotex Corp. notified healthcare professionals it is conducting, on behalf of the … Continue reading
Posted in FDA 2013, FDA Recall, Healthcare Professionals, Nursing, Risk Manager
Tagged drug risks, FDA recall, Health Professional, Injection, Nursing, Piperacillin, Piperacillin Tazobactam Injection USP 40.5 grams Recall, Recall, Risk Manager, Tazobactam, USP 40.5 grams
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Hospira Inc GemStar Infusion System Recall
Hospira Inc., GemStar Infusion System: Recall – Lithium Battery Low Voltage Models 13000, 13100, 13150, 13086, 13087, 13088 AUDIENCE: Risk Manager, Biomedical Engineering, Nursing ISSUE: Hospira notified healthcare professionals of a Class I recall of the GemStar Infusion System, Models … Continue reading
Posted in Biomedical Engineering, FDA 2013, FDA Recall, Nursing, Risk Manager
Tagged 13086, 13087, 13088, 13100, 13150, Biomedical Engineering, Class 1 Recall, Class I Recall, FDA notice, FDA recall, GemStar Infusion System, Hospira Inc, Hospira Inc GemStar Infusion System Recall, Models 13000, Nursing, Recall
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CareFusion Alaris PC Unit Class 1 Recall
CareFusion Alaris PC Unit with Software V9.12: Class 1 Recall – Communication Error When Attached to EtCO2 or SpO2 Modules AUDIENCE: Biomedical Engineering, Nursing, Risk Managers ISSUE: CareFusion Corporation has received reports of customers experiencing a communication error on the … Continue reading
Posted in Biomedical Engineering, FDA 2013, FDA Recall, Nursing, Risk Manager
Tagged Alaris PC Unit, Biomedical Engineering, CareFusion, CareFusion Alaris PC Unit Class 1 Recall, Class 1 Recall, Class I Recall, FDA recall, Nursing, Recall, Risk Manager, Risk Managers
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Medical Bed Mattresses FDA Safety Communication
Medical Bed Mattresses: FDA Safety Communication – Damaged or Worn Covers Pose Risk of Contamination and Infection AUDIENCE: Biomedical Engineering, Infectious Disease, Nursing, Risk Managers ISSUE: From January 2011 to January 2013, the FDA received 458 reports associated with medical … Continue reading
Posted in Biomedical Engineering, FDA 2013, FDA Label Change, FDA Safety Communication, Infectious Disease, Nursing, Risk Manager
Tagged Biomedical Engineering, Drug Safety Communication, FDA notice, FDA Safety Communication, Infectious Disease, Medical Bed Mattresses, Medical Bed Mattresses FDA Safety Communication, Nursing, Risk Manager, Risk Managers, Safety Communication
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Hospira Symbiq Infusion System Touchscreen Class 1 Recall
Hospira Symbiq Infusion System Touchscreen: Class 1 Recall – May Not Respond to Selection 16026 Symbiq One Channel Infuser16027 Symbiq Two Channel Infuser AUDIENCE: Risk Manager, Nursing, Biomedical Engineering ISSUE: FDA notified healthcare professionals and provider organizations of the Class … Continue reading
Posted in Biomedical Engineering, FDA 2012, FDA Recall, Nursing, Risk Manager
Tagged 16026 Symbiq One Channel Infuser, 16027 Symbiq Two Channel Infuser, Biomedical Engineering, Class 1 Recall, Class I Recall, FDA recall, Hospira, Hospira Symbiq Infusion System Touchscreen Class 1 Recall, Nursing, Recall, Risk Manager, Symbiq Infusion System Touchscreen
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I-Flow ON-Q Pump with ONDEMAND Bolus Button Class I Recall
I-Flow ON-Q Pump with ONDEMAND Bolus Button: Class I Recall – Risk of Continuous Infusion at a Rate Greater Than Expected AUDIENCE: Risk Manager, Nursing ISSUE: FDA notified healthcare professionals that the I-Flow ON-Q Pump with ONDEMAND Bolus Button may … Continue reading
Posted in FDA 2012, FDA Recall, Nursing, Risk Manager
Tagged Class 1 Recall, Class I Recall, drug risks, FDA recall, I-Flow ON-Q Pump, I-Flow ON-Q Pump with ONDEMAND Bolus Button Class I Recall, Nursing, ONDEMAND Bolus Button, Recall, Risk Manager
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