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SpeedControl Dials used with SmartDrive MX2+ Power Assist Devices may be unresponsive to users and fail to stop or start unexpectedly, causing injury
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FDA Approves Gene Therapy for Treatment of Spinal Muscular Atrophy
FDA Approves Gene Therapy for Treatment of Spinal Muscular Atrophy
http://www.fda.gov/news-events/press-announcements/fda-approves-gene-therapy-treatment-spinal-muscular-atrophy
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Early Alert: Large Volume Pump Primary Administration Set Reverse Flow Issue from Fresenius Kabi
Some Ivenix LVP Primary Administration Sets were assembled with the drip chamber and Luer Lock components in reversed positions, potentially leading to clinical complications
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Recall Alert: Intersurgical Inc Removes i-View Video Laryngoscope
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