Murilo Freitas – Page 2

FDA Roundup: September 24, 2024

Murilo Freitas - 20:07, 23 de September de 202444

FDA Roundup: September 24, 2024
http://www.fda.gov/news-events/press-announcements/fda-roundup-september-24-2024

Compounding Device Inlet Correction: Baxter Healthcare Corporation Updates Use Instructions for Exactamix Automated Compounding Device Inlets due to Risk for Particulate Matter in Device Components

Murilo Freitas - 04:00, 23 de September de 202431

Automated Compounding Device Inlets used with Exactamix Compounding Devices may contain particulate matter that poses a risk to patients.

http://www.fda.gov/medical-devices/medical-device-recalls/compounding-device-inlet-correction-baxter-healthcare-corporation-updates-use-instructions-exactamix

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Gilead Issues Voluntary Nationwide Recall of One Lot of Veklury (Remdesivir) for Injection 100 mg/vial Due to the Presence of a Glass Particle

Murilo Freitas - 04:00, 22 de September de 202443

Foster City, Calif., September 20, 2024 – Gilead Sciences, Inc. (Nasdaq: GILD) today announced it is issuing a voluntary recall of one lot of Veklury® (remdesivir) for Injection 100 mg/vial, to the consumer level. Gilead received a customer complaint and confirmed the presence of a glass particle in

http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/gilead-issues-voluntary-nationwide-recall-one-lot-veklury-remdesivir-injection-100-mgvial-due

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Electrode Pad Correction: Megadyne Issues Correction for MEGA SOFT, MEGA SOFT DUAL and MEGA 2000 Patient Return Electrodes to Limit Risk of Pediatric Burns

Murilo Freitas - 04:00, 22 de September de 202420

MEGA SOFT and MEGA 2000 Patient Return Electrodes used during monopolar electrosurgery may cause serious patient burn injuries.

http://www.fda.gov/medical-devices/medical-device-recalls/electrode-pad-correction-megadyne-issues-correction-mega-soft-mega-soft-dual-and-mega-2000-patient

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FDA Roundup: September 20, 2024

Murilo Freitas - 19:10, 19 de September de 202466

FDA Roundup: September 20, 2024
http://www.fda.gov/news-events/press-announcements/fda-roundup-september-20-2024

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FDA Approves Nasal Spray Influenza Vaccine for Self- or Caregiver-Administration

Murilo Freitas - 15:47, 19 de September de 202454

FDA Approves Nasal Spray Influenza Vaccine for Self- or Caregiver-Administration
http://www.fda.gov/news-events/press-announcements/fda-approves-nasal-spray-influenza-vaccine-self-or-caregiver-administration

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FDA Approves First Treatment for Niemann-Pick Disease, Type C

Murilo Freitas - 14:05, 19 de September de 202476

FDA Approves First Treatment for Niemann-Pick Disease, Type C
http://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-niemann-pick-disease-type-c

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Ventilator Recall: Smiths Medical Removes ParaPAC Plus Ventilators due to Loosened or Detached Patient Outlet Connector

Murilo Freitas - 04:00, 19 de September de 202421

paraPAC Plus P300 and P310 are emergency and transport portable ventilators. The patient outlet connector may be loose or detached, impacting ventilation.

http://www.fda.gov/medical-devices/medical-device-recalls/ventilator-recall-smiths-medical-removes-parapac-plus-ventilators-due-loosened-or-detached-patient

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FDA Roundup: September 17, 2024

Murilo Freitas - 18:33, 16 de September de 202465

FDA Roundup: September 17, 2024
http://www.fda.gov/news-events/press-announcements/fda-roundup-september-17-2024

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FDA Issues Draft Guidance on Conducting Multiregional Clinical Trials in Oncology

Murilo Freitas - 13:13, 15 de September de 202458

FDA Issues Draft Guidance on Conducting Multiregional Clinical Trials in Oncology
http://www.fda.gov/news-events/press-announcements/fda-issues-draft-guidance-conducting-multiregional-clinical-trials-oncology