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Category Archives: Risk Manager
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:Â 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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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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Kadcyla ado-trastuzumab emtansine Drug Safety Communication
Kadcyla (ado-trastuzumab emtansine): Drug Safety Communication – Potential Medication Errors Resulting from Name Confusion AUDIENCE: Risk Manager, Pharmacy, Oncology ISSUE: The FDA notified health care professionals that the use of the incorrect nonproprietary name for the breast cancer drug Kadcyla … Continue reading
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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Anticoagulant Citrate Phosphate Dextrose Solution USP (CPD) BLOOD-PACK Unit Fenwal Recall
Anticoagulant Citrate Phosphate Dextrose Solution, USP (CPD) BLOOD-PACK Unit By Fenwal: Recall – Labeling Issue Identified Read the MedWatch Safety Alert, including links to the Recall at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm350275.htm AUDIENCE: Risk Manager, Health Professional, Pharmacy ISSUE: Fenwal has initiated a … Continue reading
Posted in FDA 2013, FDA Recall, Healthcare Professionals, Pharmacy, Risk Manager
Tagged (CPD), Anticoagulant Citrate Phosphate Dextrose Solution, Anticoagulant Citrate Phosphate Dextrose Solution USP (CPD) BLOOD-PACK Unit Fenwal Recall, BLOOD-PACK Unit, Dietary Supplements, drug risks, FDA recall, Fenwal, Health Professional, Pharmacy, Recall, Risk Manager, Risk Managers, USP)
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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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GE Healthcare Giraffe OmniBed Giraffe Incubator Class I Recall
GE Healthcare, Giraffe OmniBed and Giraffe Incubator: Class I Recall – Device May Randomly Delete Stored Information When Powered On AUDIENCE: Risk Manager, Biomedical Engineer ISSUE: The Giraffe Incubator and Giraffe OmniBed may randomly delete stored information and enter new … Continue reading
Posted in Biomedical Engineering, FDA 2013, FDA Recall, Risk Manager
Tagged Biomedical Engineering, Class 1 Recall, Class I Recall, drug risks, FDA recall, GE Healthcare, GE Healthcare Giraffe OmniBed Giraffe Incubator Class I Recall, Giraffe Incubator, Giraffe OmniBed, Recall, Risk Manager, Risk Managers
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