Blog – Page 2 – PRAIS 2.0

Insulin Pump Correction: Tandem Diabetes Care Issues Correction for Tandem Mobi Insulin Pumps

Murilo Freitas - 04:00, 21 de April de 202693

Tandem is correcting Mobi insulin pumps operating on affected software versions (7.6.0.1, 7.6.0.3, and 7.7.0.1) which may incorrectly detect a motor issue.

http://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/insulin-pump-correction-tandem-diabetes-care-issues-correction-tandem-mobi-insulin-pumps

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FDA Achieves Year 1 Goals in Reducing Animal Testing in Drug Development

Murilo Freitas - 15:12, 19 de April de 202695

FDA Achieves Year 1 Goals in Reducing Animal Testing in Drug Development
http://www.fda.gov/news-events/press-announcements/fda-achieves-year-1-goals-reducing-animal-testing-drug-development

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Windstone Medical Packaging dba Aligned Medical Solutions Issues Nationwide Recall of Namic Angiographic Rotating Adapter 10CC Control Syringe Placed into the Following Kits; AMS6908E Angio Pack, and AMS6908F Angio Pack

Murilo Freitas - 04:00, 19 de April de 202676

On April 02, 2026, Aligned Medical Solutions, Billings, MT, initiated a nationwide recall of two convenience kits that contain the Medline Namic Angiographic Rotating Adapter(RA) 10CC Syringe. Associated kits are AMS6908E Angio Pack and AMS6908F Angio Pack.

http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/windstone-medical-packaging-dba-aligned-medical-solutions-issues-nationwide-recall-namic

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FDA Takes Step Forward on Testosterone Therapy for Men

Murilo Freitas - 15:24, 15 de April de 2026112

FDA Takes Step Forward on Testosterone Therapy for Men
http://www.fda.gov/news-events/press-announcements/fda-takes-step-forward-testosterone-therapy-men

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Early Alert: Convenience Kit Issue from Medical Action Industries

Murilo Freitas - 04:00, 15 de April de 2026121

The adaptor on Namic RA syringes may unwind during use. The resulting loose connection or disconnection may lead to infection, blood loss, or air embolism.

http://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/early-alert-convenience-kit-issue-medical-action-industries

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Early Alert: Convenience Kit Issue from American Contract Systems

Murilo Freitas - 04:00, 15 de April de 202687

The adaptor on Namic RA syringes may unwind during use. The resulting loose connection or disconnection may lead to infection, blood loss, or air embolism.

http://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/early-alert-convenience-kit-issue-american-contract-systems

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PAHO launches new policy guidance to strengthen long-term care in Latin America and the Caribbean

admin - 17:48, 14 de April de 2026112

PAHO launches new policy guidance to strengthen long-term care in Latin America and the Caribbean

Oscar Reyes

15 Apr 2026

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Ventilator Correction: Philips Issues Correction for Trilogy Evo Platform Ventilators

Murilo Freitas - 04:00, 14 de April de 2026123

Philips Trilogy Evo Ventilators may not function as intended if used with certain nebulizers.

http://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/ventilator-correction-philips-issues-correction-trilogy-evo-platform-ventilators

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Reconstruction Prosthesis Correction: Stryker Updates Use Instructions for Patient-Fitted TMJ Implants

Murilo Freitas - 04:00, 14 de April de 2026129

Stryker is updating use instructions for TMJ Unilateral and Bilateral Implants due to a discrepancy in the positioning of the screw hole.

http://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/reconstruction-prosthesis-correction-stryker-updates-use-instructions-patient-fitted-tmj-implants

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Ventilator Tubing Correction: Percussionaire Corporation Updates Use Instructions for Phasitron In-Line Valve

Murilo Freitas - 04:00, 14 de April de 202697

Percussionaire Corporation issues updated instructions for ventilator tubes due to design defect that could cause hypoventilation, respiratory failure

http://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/ventilator-tubing-correction-percussionaire-corporation-updates-use-instructions-phasitron-line