Category Archives: Nursing

Hospira GemStar Infusion System Class I Recall

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Hospira GemStar Infusion System: Class I Recall – Pressure Sensor Calibration Drift AUDIENCE:  Biomedical Engineering, Nursing, Critical Care Medicine, Home Care, Risk Manager ISSUE: The proximal and distal pressure sensor calibration can drift resulting in the pump failing the Proximal … Continue reading

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Iradimed Corporation MRidium 3860 Infusion Systems Class 1 Recall

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Iradimed Corporation, MRidium 3860+ Infusion Systems equipped with MRidium 1145 Dose Error Reduction System (DERS) Drug Library Kit: Class I Recall – Potential for Incorrect Recommended Infusion Rate AUDIENCE: Biomedical Engineering, Nursing, Radiology, Risk Manager ISSUE: FDA notified healthcare professionals … Continue reading

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Bryan Medical Tracoe Mini 3.0mm Tracheostomy Tube Class 1 Recall

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Bryan Medical Tracoe Mini 3.0mm Tracheostomy Tube: Class 1 Recall – Mislabeled Packaging AUDIENCE: Anesthesiology, Emergency Medicine, Nursing, Pediatrics, Risk Manager ISSUE: The outside of the device packaging stated a 3.0mm neonatal tube. The product inside the box was actually … Continue reading

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Nephron Pharmaceuticals EZ Breathe Atomizer Class 1 Recall

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Nephron Pharmaceuticals Corp. EZ Breathe Atomizer: Class 1 Recall – Washer Could Become Dislodged AUDIENCE: Consumer, Patient, Nursing, Pharmacy, Risk Managers ISSUE: A Medical Device Recall was issued due to a manufacturing defect which could result in the washer (“Plate … Continue reading

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Magnesium Sulfate Recommendation Drug Safety Communication

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Magnesium Sulfate: Drug Safety Communication – Recommendation Against Prolonged Use in Pre-term Labor AUDIENCE: OB/GYN, Nursing, Risk Manager ISSUE: FDA is advising health care professionals against using magnesium sulfate injection for more than 5-7 days to stop pre-term labor in … Continue reading

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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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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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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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