Blog – Page 33 – PRAIS 2.0

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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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 2025432

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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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 2025450

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

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Import Alerts for Certain Olympus Medical Devices Manufactured in Japan – Letter to Health Care Providers

Murilo Freitas - 04:00, 23 de June de 2025435

The U.S. Food and Drug Administration (FDA) is alerting health care providers about import alerts for certain medical devices manufactured in Japan by Olympus Medical Systems Corporation (Olympus) and its subsidiaries.

http://www.fda.gov/medical-devices/letters-health-care-providers/import-alerts-certain-olympus-medical-devices-manufactured-japan-letter-health-care-providers

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