Category Archives: Risk Manager

Maquet SERVO-i Ventilator Battery Module Class 1 Recall

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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

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Medtronic DBS NDE Kits Class 1 Recall

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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

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Covidien Surgical Stapler Reloads FDA Safety Communication

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Posted in Biomedical Engineering, FDA 2013, FDA Safety Communication, Nursing, Risk Manager, Surgery | Tagged , , , , , , , , , | Comments Off

Cardinal Health Various Presource Kits Class 1 Recall

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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

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Kadcyla ado-trastuzumab emtansine Drug Safety Communication

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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

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Newport Medical Instruments Inc HT70 HT70 Plus Ventilators Class I Recall

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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

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Anticoagulant Citrate Phosphate Dextrose Solution USP (CPD) BLOOD-PACK Unit Fenwal Recall

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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

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Piperacillin Tazobactam Injection USP 40.5 grams Recall

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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

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Hospira Inc GemStar Infusion System Recall

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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

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GE Healthcare Giraffe OmniBed Giraffe Incubator Class I Recall

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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

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