Murilo Freitas – Page 21 – PRAIS 2.0

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 2025302

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 2025339

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 2025237

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 2025195

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 2025206

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 2025199

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 2025203

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

FDA Roundup: March 21, 2025

Murilo Freitas - 19:44, 20 de March de 2025301

FDA Roundup: March 21, 2025
http://www.fda.gov/news-events/press-announcements/fda-roundup-march-21-2025

HHS, FDA Announce Chemical Contaminants Transparency Tool for Foods

Murilo Freitas - 18:06, 19 de March de 2025254

HHS, FDA Announce Chemical Contaminants Transparency Tool for Foods
http://www.fda.gov/news-events/press-announcements/hhs-fda-announce-chemical-contaminants-transparency-tool-foods

Early Alert: Aspiration System Issue from Calyxo

Murilo Freitas - 04:00, 19 de March de 2025167

This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program

http://www.fda.gov/medical-devices/medical-device-recalls/early-alert-aspiration-system-issue-calyxo

PRAIS 2.0