Murilo Freitas – Page 41 – PRAIS 2.0

FDA Roundup: October 29, 2024

Murilo Freitas - 19:29, 28 de October de 2024338

FDA Roundup: October 29, 2024
http://www.fda.gov/news-events/press-announcements/fda-roundup-october-29-2024

Air Compressor Device Correction: GE HealthCare Provides Updates to EVair Compressors Due to Final Formaldehyde Testing Results

Murilo Freitas - 04:00, 28 de October de 2024364

These air compressor devices’ instructions for use have been updated by GE HealthCare.

http://www.fda.gov/medical-devices/medical-device-recalls/air-compressor-device-correction-ge-healthcare-provides-updates-evair-compressors-due-final

Update: Use of GE HealthCare EVair and EVair 03 Compressors – Letter to Health Care Providers

Murilo Freitas - 04:00, 28 de October de 2024271

The recommendations for EVair Compressor use have been updated by GE HealthCare.

http://www.fda.gov/medical-devices/letters-health-care-providers/update-use-ge-healthcare-evair-and-evair-03-compressors-letter-health-care-providers

FDA Roundup: October 25, 2024

Murilo Freitas - 18:46, 24 de October de 2024344

FDA Roundup: October 25, 2024
http://www.fda.gov/news-events/press-announcements/fda-roundup-october-25-2024

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Tracheostomy Tube Recall: Smiths Medical Removes BLUselect, BLUgriggs, and BLUperc Tracheostomy Tube Kits due to Potential Disconnection of Pilot Balloon

Murilo Freitas - 04:00, 24 de October de 2024451

BLUselect tracheostomy tubes are used for artificial airways. Some lots may have an issue where the pilot balloon disconnects.

http://www.fda.gov/medical-devices/medical-device-recalls/tracheostomy-tube-recall-smiths-medical-removes-bluselect-blugriggs-and-bluperc-tracheostomy-tube

Assistive Arm Correction: Kinova Issues Correction for Jaco Assistive Robotic Arm due to Fire Hazard and Burn Risk

Murilo Freitas - 04:00, 24 de October de 2024343

Jaco assistive robotic arms are used when people have little or no arm mobility but a damaged arm contacting part of the wheelchair is a fire hazard.

http://www.fda.gov/medical-devices/medical-device-recalls/assistive-arm-correction-kinova-issues-correction-jaco-assistive-robotic-arm-due-fire-hazard-and

$76 Million in Illegal E-Cigarettes Seized in Joint Federal Operation

Murilo Freitas - 14:31, 21 de October de 2024311

$76 Million in Illegal E-Cigarettes Seized in Joint Federal Operation
http://www.fda.gov/news-events/press-announcements/76-million-illegal-e-cigarettes-seized-joint-federal-operation

FDA Roundup: October 18, 2024

Murilo Freitas - 20:15, 17 de October de 2024288

FDA Roundup: October 18, 2024
http://www.fda.gov/news-events/press-announcements/fda-roundup-october-18-2024

Vascular Embolization Device Correction: Boston Scientific Updates Use Instructions for Obsidio Conformable Embolic for Increased Ischemia Risk When Used for GI Bleeding

Murilo Freitas - 04:00, 17 de October de 2024472

These vascular embolization devices’ instructions for use have been updated by Boston Scientific.

http://www.fda.gov/medical-devices/medical-device-recalls/vascular-embolization-device-correction-boston-scientific-updates-use-instructions-obsidio

Voluntary Recall Notifying Medtronic Insulin Pump Users of Potential Risks of Shortened Pump Battery Life

Murilo Freitas - 04:00, 17 de October de 2024361

Medtronic plc (NYSE: MDT), a global leader in healthcare technology, voluntarily issued a field action starting on July 31, 2024, notifying global customers of its MiniMed™ 600 series or 700 series insulin pumps to follow their pump’s built-in alerts and alarms for battery status and to contact Medt

http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/voluntary-recall-notifying-medtronic-insulin-pump-users-potential-risks-shortened-pump-battery-life

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