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Tag Archives: Risk Manager
Medtronic DBS NDE Kits Class 1 Recall
Translation 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 … 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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Cardinal Health Various Presource Kits Class 1 Recall
TranslationCardinal 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
TranslationKadcyla (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
TranslationNewport 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
TranslationAnticoagulant 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
TranslationPiperacillin 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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GE Healthcare Giraffe OmniBed Giraffe Incubator Class I Recall
TranslationGE 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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CareFusion Alaris PC Unit Class 1 Recall
TranslationCareFusion 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
TranslationMedical 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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Stryker Orthopaedics ShapeMatch Cutting Guide Class 1 Recall
TranslationStryker Orthopaedics – ShapeMatch Cutting Guide: Class 1 Recall AUDIENCE: Surgery, Risk Manager ISSUE: FDA notified healthcare professionals of a Class 1 recall for this product due to a software defect that results in wider cutting ranges. The parameters of … Continue reading
Posted in FDA 2013, FDA Recall, Risk Manager, Surgery
Tagged Class 1 Recall, Class I Recall, FDA recall, Recall, Risk Manager, Risk Managers, ShapeMatch Cutting Guide, Stryker Orthopaedics, Stryker Orthopaedics ShapeMatch Cutting Guide Class 1 Recall, Surgery
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