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Infusion Pump Software Correction: Fresenius Kabi USA, LLC, Issues Correction for Ivenix Infusion System Large Volume Pump (LVP) Software due to Multiple Anomalies that May Cause Delay or Underdosage of Therapy

Murilo Freitas - 04:00, 30 de September de 2024292
Ivenix LVP allows for controlled administration of large volumes of fluids but software anomalies may lead to delay or underdosing of therapy.

http://www.fda.gov/medical-devices/medical-device-recalls/infusion-pump-software-correction-fresenius-kabi-usa-llc-issues-correction-ivenix-infusion-system

 
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Ventilator Software Correction: Philips Respironics Issues Mandatory Software Correction and Updates Use Instructions for Trilogy Evo, EV300, EvoO2, and Evo Universal to Address Multiple Issues that May Impact Ventilation

Murilo Freitas - 04:00, 30 de September de 2024231
Trilogy Evo, EV300, EvoO2 and Evo Universal ventilators support patient breathing. A mandatory software correction was issued to address previously reported issues.

http://www.fda.gov/medical-devices/medical-device-recalls/ventilator-software-correction-philips-respironics-issues-mandatory-software-correction-and-updates

 
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Ventilator Correction: Smiths Medical Issues Correction for paraPAC Plus P300 and P310 Ventilators due to Inadvertent Tidal Volume Knob Movement

Murilo Freitas - 04:00, 29 de September de 2024284
paraPAC Plus P300 and P310 Ventilators are gas-powered emergency and transport portable ventilators. The tidal volume knob may move out of the set position.

http://www.fda.gov/medical-devices/medical-device-recalls/ventilator-correction-smiths-medical-issues-correction-parapac-plus-p300-and-p310-ventilators-due

 
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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 2024386
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 20243,589
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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