rss – PRAIS 2.0

A Statement from FDA Commissioner Marty Makary, M.D., M.P.H: 100 Days of Embracing Gold-Standard Science, Transparency and Common Sense

Murilo Freitas - 15:03, 9 de July de 202538

A Statement from FDA Commissioner Marty Makary, M.D., M.P.H: 100 Days of Embracing Gold-Standard Science, Transparency and Common Sense
http://www.fda.gov/news-events/press-announcements/statement-fda-commissioner-marty-makary-md-mph-100-days-embracing-gold-standard-science-transparency

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FDA Embraces Radical Transparency by Publishing Complete Response Letters

Murilo Freitas - 12:17, 9 de July de 202554

FDA Embraces Radical Transparency by Publishing Complete Response Letters
http://www.fda.gov/news-events/press-announcements/fda-embraces-radical-transparency-publishing-complete-response-letters

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Closed Suction Catheter Recall: Avanos Medical, Inc. Removes Ballard Closed Suction Systems Due to Risk of Non-Sterility

Murilo Freitas - 04:00, 9 de July de 202532

Select Ballard Closed Suction Systems lots may not be sterilized, increasing risk of infection, airway injury, prolonged inflammation, sepsis, or death if used.

http://www.fda.gov/medical-devices/medical-device-recalls/closed-suction-catheter-recall-avanos-medical-inc-removes-ballard-closed-suction-systems-due-risk

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FDA Encourages Industry Leaders to Streamline, Enhance Product Recall Communications to Safeguard Foods for Infants and Children

Murilo Freitas - 19:45, 8 de July de 202535

FDA Encourages Industry Leaders to Streamline, Enhance Product Recall Communications to Safeguard Foods for Infants and Children
http://www.fda.gov/news-events/press-announcements/fda-encourages-industry-leaders-streamline-enhance-product-recall-communications-safeguard-foods

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Infant Breathing System Recall: AirLife/Vyaire Removes Infant Heated Wire Circuits Due to Risk for Inadvertent Adapter Disconnection During Ventilation

Murilo Freitas - 04:00, 8 de July de 202533

AirLife Infant Heated Wire Circuits heat up gas during ventilation. An included adapter may disconnect when the device reaches operating temperature.

http://www.fda.gov/medical-devices/medical-device-recalls/infant-breathing-system-recall-airlifevyaire-removes-infant-heated-wire-circuits-due-risk

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Broselow Pediatric Emergency Rainbow Tape Recall: AirLife Removes Certain Broselow Pediatric Emergency Rainbow Tapes due to Misprinted Information

Murilo Freitas - 04:00, 8 de July de 202533

Certain Broselow Pediatric Emergency Rainbow Tapes were manufactured with incorrect information on the tape.

http://www.fda.gov/medical-devices/medical-device-recalls/broselow-pediatric-emergency-rainbow-tape-recall-airlife-removes-certain-broselow-pediatric

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Cybersecurity Vulnerabilities with Certain Patient Monitors from Contec and Epsimed: FDA Safety Communication

Murilo Freitas - 04:00, 1 de July de 2025231

The FDA is raising awareness about cybersecurity vulnerabilities with Contec CMS8000 and Epsimed MN-120 patient monitors.

http://www.fda.gov/medical-devices/safety-communications/cybersecurity-vulnerabilities-certain-patient-monitors-contec-and-epsimed-fda-safety-communication

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Early Alert: Infusion Pump Software Issue from Baxter

Murilo Freitas - 16:00, 30 de June de 202544

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-infusion-pump-software-issue-baxter

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Early Alert: Blood Pump Controller Issue from Abiomed

Murilo Freitas - 04:00, 30 de June de 202555

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-blood-pump-controller-issue-abiomed

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Extended-Release Stimulants for ADHD: FDA Drug Safety Communication – FDA Requires Expanded Labeling about Weight Loss Risk in Patients Younger than 6 Years

Murilo Freitas - 04:00, 30 de June de 202541

The FDA is revising the labeling of all extended-release stimulants indicated to treat attention-deficit/hyperactivity disorder (ADHD) – including certain formulations of amphetamine and methylphenidate – to warn about the risk of weight loss and other adverse reactions (side effects) in patients yo

http://www.fda.gov/safety/medical-product-safety-information/extended-release-stimulants-adhd-fda-drug-safety-communication-fda-requires-expanded-labeling-about