Murilo Freitas – Page 28 – PRAIS 2.0

Max Mobility / Permobil Expands Nationwide Recall of SmartDrive Speed Control Dial Due to the Motor Being Unresponsive to the User

Murilo Freitas - 04:00, 6 de April de 2025285

Max Mobility/Permobil has expanded the recall of the Speed Control Dial, a wired control option for the SmartDrive MX2+ Power Assist Device due to safety and performance concerns. The recall was originally initiated on December 20, 2024, and has been expanded to address recalled product that may hav

http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/max-mobility-permobil-expands-nationwide-recall-smartdrive-speed-control-dial-due-motor-being

Bausch + Lomb Announces Voluntary Recall of enVista Aspire™, enVista Envy™ and Certain enVista® Monofocal Intraocular Lenses in the U.S.

Murilo Freitas - 04:00, 6 de April de 2025299

Bausch + Lomb Corporation (NYSE/TSX: BLCO), a leading global eye health company dedicated to helping people see better to live better, today announced a voluntary recall of intraocular lenses (IOLs) on its enVista platform.

http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/bausch-lomb-announces-voluntary-recall-envista-aspiretm-envista-envytm-and-certain-envistar

Martin A. Makary, M.D., M.P.H., Sworn in as FDA Commissioner

Murilo Freitas - 16:45, 31 de March de 2025325

Martin A. Makary, M.D., M.P.H., Sworn in as FDA Commissioner
http://www.fda.gov/news-events/press-announcements/martin-makary-md-mph-sworn-fda-commissioner

Vascular Cannula Recall: Medtronic Removes Aortic Root Cannula Due to Unexpected Loose Material in the Male Luer

Murilo Freitas - 04:00, 30 de March de 2025358

Aortic Root Cannulas are used during heart surgery. There is a risk of extra material in the device due to a manufacturing error.

http://www.fda.gov/medical-devices/medical-device-recalls/vascular-cannula-recall-medtronic-removes-aortic-root-cannula-due-unexpected-loose-material-male

Peritoneal Dialysis Set Correction: Baxter Issues Correction for MiniCap Extended Life Peritoneal Dialysis Transfer Sets Due to Risk of Patient Exposure to Higher Than Allowable Levels of Toxic Compound NDL-PCBA and/or NDL-PCBs

Murilo Freitas - 04:00, 30 de March de 2025405

Use of Baxter MiniCap Extended Life PD Transfer Sets during peritoneal dialysis may expose patients to higher than allowable NDL-PCBAs.

http://www.fda.gov/medical-devices/medical-device-recalls/peritoneal-dialysis-set-correction-baxter-issues-correction-minicap-extended-life-peritoneal

FDA Approves Novel Treatment for Hemophilia A or B, with or without Factor Inhibitors

Murilo Freitas - 18:17, 27 de March de 2025286

FDA Approves Novel Treatment for Hemophilia A or B, with or without Factor Inhibitors
http://www.fda.gov/news-events/press-announcements/fda-approves-novel-treatment-hemophilia-or-b-or-without-factor-inhibitors

FDA Roundup: March 28, 2025

Murilo Freitas - 17:48, 27 de March de 2025246

FDA Roundup: March 28, 2025
http://www.fda.gov/news-events/press-announcements/fda-roundup-march-28-2025

FDA Grants Marketing Authorization of First Home Test for Chlamydia, Gonorrhea and Trichomoniasis

Murilo Freitas - 13:30, 27 de March de 2025240

FDA Grants Marketing Authorization of First Home Test for Chlamydia, Gonorrhea and Trichomoniasis
http://www.fda.gov/news-events/press-announcements/fda-grants-marketing-authorization-first-home-test-chlamydia-gonorrhea-and-trichomoniasis

Safe Use of Megadyne Mega 2000 and Mega Soft Patient Return Electrodes – Letter to Health Care Providers

Murilo Freitas - 04:00, 25 de March de 2025245

Read the FDA’s recommendations related to four recalls of Megadyne Mega 2000 and Mega Soft patient return electrodes for patient burn injuries.

http://www.fda.gov/medical-devices/letters-health-care-providers/safe-use-megadyne-mega-2000-and-mega-soft-patient-return-electrodes-letter-health-care-providers

Endotracheal Tube Recall: Smiths Medical Removes Intubation ORAL/NASAL Endotracheal Tubes Due to Smaller Than Expected Tube Diameter That May Cause Underventilation

Murilo Freitas - 04:00, 24 de March de 2025251

ORAL/NASAL Endotracheal Tubes keep air flowing through a patient’s airway, but some tubes may be smaller in diameter than expected.

http://www.fda.gov/medical-devices/medical-device-recalls/endotracheal-tube-recall-smiths-medical-removes-intubation-oralnasal-endotracheal-tubes-due-smaller

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