Categories

FDA Proposes Significant Step Toward Reducing Nicotine to Minimally or Nonaddictive Level in Cigarettes and Certain Other Combusted Tobacco Products

FDA Proposes Significant Step Toward Reducing Nicotine to Minimally or Nonaddictive Level in Cigarettes and Certain Other Combusted Tobacco Products
http://www.fda.gov/news-events/press-announcements/fda-proposes-significant-step-toward-reducing-nicotine-minimally-or-nonaddictive-level-cigarettes

 
Categories

Endoscopic Vessel Harvesting (EVH) System Correction: Getinge and Maquet Cardiovascular Update Use Instructions for VasoView HemoPro 2 (VH-4000 and VH-4001) EVH Systems due to Risk for Bent or Detached Heater Wires and Silicone Peeling or Detaching During Use

HemoPro EVH Systems have updated instructions related to bent/detached heater wires and peeling/detaching silicone during minimally invasive surgery.

http://www.fda.gov/medical-devices/medical-device-recalls/endoscopic-vessel-harvesting-evh-system-correction-getinge-and-maquet-cardiovascular-update-use

 
Categories

Outpatient Telemetry Correction: Philips Issues Correction for Monitoring Service Application used with Mobile Cardiac Outpatient Telemetry Due to Potential for Missed Information or Notifications That May Impact Patient Care

Philips Monitoring Service Application processes mobile cardiac telemetry data but failed to send critical data for review by healthcare professionals.

http://www.fda.gov/medical-devices/medical-device-recalls/outpatient-telemetry-correction-philips-issues-correction-monitoring-service-application-used-mobile

 
Categories

FDA Requires Guillain-Barré Syndrome (GBS) Warning in the Prescribing Information for RSV Vaccines Abrysvo and Arexvy: FDA Safety Communication

FDA Requires Guillain-Barré Syndrome (GBS) Warning in the Prescribing Information for RSV Vaccines Abrysvo and Arexvy: FDA Safety Communication

http://www.fda.gov/safety/medical-product-safety-information/fda-requires-guillain-barre-syndrome-gbs-warning-prescribing-information-rsv-vaccines-abrysvo-and