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Intersurgical is recalling the i-View Video Laryngoscope due to the device not turning on, battery liquid leakage and screen going blank.
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Correction Alert: Medline Industries, LP Updates Use Instructions for Medline Kits Containing Flexicare BritePro Solo Fiber Optic Laryngoscope Handles
Medline is updating labels for their medical kits containing the Flexicare BritePro Solo due to the light not illuminating as intended.
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Alert: NOxBOX Ltd. Issues Correction for NOxBOXi Nitric Oxide Delivery System Due to Risk for Nitric Oxide Dosing Fluctuations
There may be nitric oxide dosing fluctuations and therapy interruption when NOxBOXi Nitric Oxide Delivery System is used with certain ventilators.
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Alert: Medline Industries, LP Removes Certain Sterile Medline Convenience Kits
Medline is recalling certain Convenience Kits due to being labeled as sterile but not having gone through the sterilization process
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Alert: NOxBOX Ltd. Issues Correction for NOxBOXi Nitric Oxide Delivery System Due to Rapid Command Input Issue
If a user rapidly presses two or more on-screen buttons, the NOxBOXi Nitric Oxide Delivery System may experience sudden software interruption or restart.
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FDA Pilots Faster Clarifications to Meeting Minutes
FDA Pilots Faster Clarifications to Meeting Minutes
http://www.fda.gov/news-events/press-announcements/fda-pilots-faster-clarifications-meeting-minutes
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Alert: Update to Use Instructions for B Braun Hemodialysis Blood Tubing Set
B Braun Medical Inc. updates use instructions for the Streamline Bloodline Set for the Dialog+ Hemodialysis System
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Alert: Siemens Healthineers Issues Correction for 3 Tesla MRI Systems
Siemens Healthineers is correcting 3 Tesla MRI systems including MAGNETOM and BioGraph mMR due to the potential for ice blockage in the magnet venting system
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FDA Approves New Safety Warning and Revised Indication that Limits Use for Elevidys Following Reports of Fatal Liver Injury
FDA Approves New Safety Warning and Revised Indication that Limits Use for Elevidys Following Reports of Fatal Liver Injury
http://www.fda.gov/news-events/press-announcements/fda-approves-new-safety-warning-and-revised-indication-limits-use-elevidys-following-reports-fatal
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Update: FDA Encourages the Public to Follow Established Choking Rescue Protocols – FDA Safety Communication
These choking rescue protocols include abdominal thrusts (also called the “Heimlich” maneuver) for children and adults but not anti-choking devices.