Murilo Freitas – Page 8

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 2025100

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 2025268

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 202598

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 2025102

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 2025153

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

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FDA Eliminates Risk Evaluation and Mitigation Strategies (REMS) for Autologous Chimeric Antigen Receptor CAR T cell Immunotherapies

Murilo Freitas - 20:16, 26 de June de 2025118

FDA Eliminates Risk Evaluation and Mitigation Strategies (REMS) for Autologous Chimeric Antigen Receptor CAR T cell Immunotherapies
http://www.fda.gov/news-events/press-announcements/fda-eliminates-risk-evaluation-and-mitigation-strategies-rems-autologous-chimeric-antigen-receptor

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Sandoz Inc. Issues Voluntary Nationwide Recall of One Lot of Cefazolin for Injection Due to Product Mispackaging

Murilo Freitas - 20:00, 26 de June de 2025135

Sandoz, Inc. (“Sandoz”) is initiating a voluntary recall of one (1) lot of Cefazolin for Injection, USP, 1 gram per vial.

http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/sandoz-inc-issues-voluntary-nationwide-recall-one-lot-cefazolin-injection-due-product-mispackaging

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mRNA COVID-19 Vaccines: FDA Safety Communication – FDA Approves Required Updated Warning in Labeling Regarding Myocarditis and Pericarditis Following Vaccination

Murilo Freitas - 04:00, 24 de June de 2025253

mRNA COVID-19 Vaccines: FDA Safety Communication – FDA Approves Required Updated Warning in Labeling Regarding Myocarditis and Pericarditis Following Vaccination

http://www.fda.gov/safety/medical-product-safety-information/mrna-covid-19-vaccines-fda-safety-communication-fda-approves-required-updated-warning-labeling

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Angiographic Catheter Recall: Cook Removes Beacon Tip Angiographic Catheters due to Tip Separation

Murilo Freitas - 04:00, 24 de June de 2025114

Affected device lots may experience tip separation; field complaints reported that the tip separation can occur both prior to and during patient contact.

http://www.fda.gov/medical-devices/medical-device-recalls/angiographic-catheter-recall-cook-removes-beacon-tip-angiographic-catheters-due-tip-separation

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Flexible Tracheostomy Tube Recall: Medtronic Removes Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff Reusable Inner Cannula Due to Risk for Disconnection of the Flange from the Device Cannula

Murilo Freitas - 04:00, 23 de June de 2025227

The Shiley Adult Flexible Tracheostomy Tube is being recalled as it may come loose if the flange disconnects, potentially leading to a blocked airway.

http://www.fda.gov/medical-devices/medical-device-recalls/flexible-tracheostomy-tube-recall-medtronic-removes-shiley-adult-flexible-tracheostomy-tube