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Federal Court Enters Consent Decree Against Rizo Lopez Foods Inc. Following Multistate Outbreak of Listeriosis Linked to Queso Fresco and Cotija Cheese Products

Murilo Freitas - 20:40, 7 de October de 2024271

Federal Court Enters Consent Decree Against Rizo Lopez Foods Inc. Following Multistate Outbreak of Listeriosis Linked to Queso Fresco and Cotija Cheese Products
http://www.fda.gov/news-events/press-announcements/federal-court-enters-consent-decree-against-rizo-lopez-foods-inc-following-multistate-outbreak

 
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Resuscitator Recall: Mercury Medical Removes Neo-Tee T-Piece Resuscitators due to Risk of Inline Controller Detachment that May Impact Ventilation

Murilo Freitas - 04:00, 6 de October de 2024287
Neo-Tee Resuscitators are used for emergency breathing support for neonates and infants. The inline controller may come apart and impact ventilation.

http://www.fda.gov/medical-devices/medical-device-recalls/resuscitator-recall-mercury-medical-removes-neo-tee-t-piece-resuscitators-due-risk-inline-controller

 
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Philips Respironics Issues Additional Usage Instructions for Trilogy Evo Ventilators Related to Use of In-Line Nebulizers

Murilo Freitas - 04:00, 6 de October de 2024221
The use of in-line nebulizers placed in certain locations may lead to aerosol deposits forming over time on the ventilator flow sensor. Should this occur, there is a possibility of inaccurate flow measurements affecting therapy.

http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/philips-respironics-issues-additional-usage-instructions-trilogy-evo-ventilators-related-use-line

 
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IPV Therapy Device Correction: Sentec/Percussionaire Updates Use Instructions for Phasitron 5 In-Line Valve to Prevent Accidental Misuse of Expiratory Port Plug

Murilo Freitas - 04:00, 1 de October de 2024224
IPV Phasitron 5 In-Line Valve helps provide therapy to promote ventilation. Users need to remove the expiratory port plug before direct ventilation.

http://www.fda.gov/medical-devices/medical-device-recalls/ipv-therapy-device-correction-sentecpercussionaire-updates-use-instructions-phasitron-5-line-valve

 
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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 2024238
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 2024169
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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