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Coronavirus (COVID-19) Update: FDA Authorizes Moderna, Pfizer-BioNTech Bivalent COVID-19 Vaccines for Use as a Booster Dose

Murilo Freitas - 13:42, 30 de agosto de 2022285

Coronavirus (COVID-19) Update: FDA Authorizes Moderna, Pfizer-BioNTech Bivalent COVID-19 Vaccines for Use as a Booster Dose
http://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-moderna-pfizer-biontech-bivalent-covid-19-vaccines-use

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FDA Roundup: August 30, 2022

Murilo Freitas - 19:08, 29 de agosto de 2022244

FDA Roundup: August 30, 2022
http://www.fda.gov/news-events/press-announcements/fda-roundup-august-30-2022

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Hamilton Medical AG Recalls Hamilton-C6 Intensive Care Ventilator Due to Potential Water Ingress that May Cause Breathing Support to Stop

Murilo Freitas - 04:00, 28 de agosto de 2022289

If water enters the Hamilton-C6 Intensive Care Ventilator due to a loose status indicator board, it may cause the ventilator to stop providing breathing support.

http://www.fda.gov/medical-devices/medical-device-recalls/hamilton-medical-ag-recalls-hamilton-c6-intensive-care-ventilator-due-potential-water-ingress-may

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FDA Roundup: August 26, 2022

Murilo Freitas - 19:37, 25 de agosto de 2022241

FDA Roundup: August 26, 2022
http://www.fda.gov/news-events/press-announcements/fda-roundup-august-26-2022

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FDA Removes N95 Respirators from Medical Device Shortage List, Signaling Sufficient Supply

Murilo Freitas - 15:28, 25 de agosto de 2022242

FDA Removes N95 Respirators from Medical Device Shortage List, Signaling Sufficient Supply
http://www.fda.gov/news-events/press-announcements/fda-removes-n95-respirators-medical-device-shortage-list-signaling-sufficient-supply

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Update: FDA No Longer Authorizes Use of Non-NIOSH-Approved or Decontaminated Disposable Respirators – Letter to Health Care Personnel and Facilities

Murilo Freitas - 04:00, 25 de agosto de 2022335

The FDA revoked the emergency use authorizations for non-NIOSH-approved disposable respirators and the EUAs for decontamination and bioburden reduction systems.

http://www.fda.gov/medical-devices/letters-health-care-providers/update-fda-no-longer-authorizes-use-non-niosh-approved-or-decontaminated-disposable-respirators

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FDA and Mexican Counterparts Report Progress in Food Safety at Second Annual Partnership Meeting

Murilo Freitas - 20:42, 24 de agosto de 2022253

FDA and Mexican Counterparts Report Progress in Food Safety at Second Annual Partnership Meeting
http://www.fda.gov/news-events/press-announcements/fda-and-mexican-counterparts-report-progress-food-safety-second-annual-partnership-meeting

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Medtronic Recalls HeartWare HVAD System Batteries for Electrical Faults That Cause Battery Failure

Murilo Freitas - 04:00, 24 de agosto de 2022358

An electrical fault may cause the batteries of the HeartWare HVAD System to fail, leading to severe injury or death.

http://www.fda.gov/medical-devices/medical-device-recalls/medtronic-recalls-heartware-hvad-system-batteries-electrical-faults-cause-battery-failure

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FDA Roundup: August 23, 2022

Murilo Freitas - 20:22, 22 de agosto de 2022320

FDA Roundup: August 23, 2022
http://www.fda.gov/news-events/press-announcements/fda-roundup-august-23-2022

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Hospira Issues A Voluntary Nationwide Recall For One Lot of Propofol Injectable Emulsion (Containing Benzyl Alcohol), Due To The Potential Presence of Visible Particulates

Murilo Freitas - 04:00, 21 de agosto de 2022279

Hospira, Inc., a Pfizer company, is voluntarily recalling one lot of Propofol Injectable Emulsion (containing benzyl alcohol), 100mL Single Patient Use Glass Fliptop Vial; lot EA7470, to the user level due to visible particulates observed in two vials during annual examination of retention samples.

http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/hospira-issues-voluntary-nationwide-recall-one-lot-propofol-injectable-emulsion-containing-benzyl